Nghiên cứu chiết tách, tinh chế một số hợp chất tự nhiên đặc trưng từ dược liệu để làm chất chuẩn phục vụ kiểm nghiệm dược liệu

Tom tat cac ngi dung, cong viec chii yeu: Neu tgi miic 15 cua thuyet minh, khong bao gom: Hgi thao klioa ligc, dieu tra kitdo sdt trong nu&c vd nuoc ngodi Cdc moc ddnh gid ciiu yeu Qu

BO Y Tt

iN'H KU&CN •('RONG BifeM CAP N H A ^nj•(k:

! i fffig tl^og cSug ngih? pb'je *tj bao vf,

u- »• '.a isimg eao sii^ kiiAe «:diig <^^ag

CHirONG T R I N H KH&CN TRQNG B I £ M CAP N H A NlTdC

KC.10/06-10

NghiSn cfSru vk (mg dyng cdng nghf phyc vy bio vf,

chftm 96c vi nfing cao sdx kbde c$ng d6ng

BAO CAO TONG HOP

KtT QUA KHOA HQC C 6 N G N G H $ Ot XAl/DV" A N

D^TAI

NGHIEN CtJtJ CHrtX TACH, TINH CHE M Q T S 6

H Q P CHAT TV NHlfeN D^C TRlTNG TlT DlTQC LI?U Bt LAM

CHAT CHUAN PHyC Vy KIEM NGHI$M DlTQC U$V

(MA S 6 Bt TAI: KC.10.16/06-10)

Cor quan chu tri (ti tii: Vi$n Kiim nglii|m tliu6c Trung inmg

Chii Dbifm de tii: PGS.TS Trjuh Yin l i u

w =1

CHl/ONG TRINH KH&CN TRQNG DifeM CAP NHA NlTCJC

KC.10/06-10 Nghien ciru vi irng dgng cong nghf phyc vu bao vf,

chSm sic vi nang cao sire khde cpng ddng

BAO CAO TONG HQfP KET QUA KHOA HQC CONG NGH|; DE TALTDy AN

DETAI

NGHIEN c i r u CHIET TACH, TINH CHE M Q T S 6

HQP C H A T TV NHIEN DAC TRlTNG TlT DUQC LIEU DE LAM CHAT CHU A N P H V C v y K I E M N G H I E M D U Q C LIEU

( M A S 6 D E TAI: KC.10.16/06-10)

Chu nhiem de tai

(ky ten)

PGS.TS Trjnh Van Lau

Ccr quan chii tri de tai/du an:

^-{Ir^iiya dong dau)

lUcLO udn

Ban chu nhi?m chucmg trinh BQ Khoa hpc va Cong ngh?

(ky ten) (ky ten vd dortg dau khi girl liru trie)

l i

Ha Ngi-2010

•m

PHAN A

BAG CAO T H 6 N G KE KET QUA THIJC HI$N DE TAI

PHANB

BAO C A O T 6 N G THUAT

PHAN A

BAG CAO THONG KE KET QUA

THlTC HIEN DE TAI

TRUNG UONG f)§c lap - Tir do - Hanh phuc

HaNqi, ngay 30 thiing 6 nam 2010

BAO CAO TH6NG KE

KET QUA T H V C HItN DE T A I / D I / A N SXTN

1 THONG TIN CHUNG

l T e n de t i i / d i r i n :

NGHIEN CtlU C H l t T TACH, TINH CHfe M Q T S 6 HQP CHAT

T V NHIEN DAC TRUNG TU DUQC LIEU DE LAM CHAT CHUAN

PHVC v y KIEM NGHI$M DlTQC LI$U

Ma so de tai, d\i an: KC.10.16/06-10

Thupc:

- Chuong trinh.' Khoa hpc v i cong nghe phuc vu cham soc v i

bao ve sire khoe cpng dong KC.10/06-10

2 Chii nhiem de tii/dir an:

Hp va ten: Trjnh Van Liu

Ngay, thang, nSm sinh: 4/3/1951 Nam/ NO; Nam

Hpc ham, hpc vi: Pho giao su-, Tien si

Chirc danh khoa hpc: Nghien cij'u vien cao cap, Chii tjch HDKH Vien

'~' lie vu: Vifn truong Vien Kiem nghiem thuoc Trung irong

.ithoai: To'cAirc; 043.8255742 /V/mne«g.-043.8341830

Mobile: 0913235398

Fax: 043.8256911 E-mail: tvIauvkn@hotniail.com

Ten 16 chijc dang cong lac: Vifn Kiem nghiem thuoc Trung uong

Dia chi td chijc: 48 Hai Bi Trung, Qujln Hoan Kiem, Hi Noi

Bja chi nha rieng: So 2, Ngo 149, Phd Dircmg Quang Ham, Q u ^ Ciu Giiy, Ha Npi

Ten to chirc chu Iri de lai: Vien Kiem nghiem thuoc Trung uong

(ViSt lat V.KNT T.U) Bien thoai: 043.8252791 Fax: 043.8256911

E-mail: vndQC(5)vnn.vn/khlhvkn(5)hn.vnn.vn

Website:

Dja chi: 48 Hai Bi Trung, Quan Hoin Kiem, Hi Npi

Hp va Ien thii trudng lo chuc; PGS.TS Trjnh Van L I U

S6 tai khoan: 301.01.162.1

Ngan hang: Kho B$c nhi nafrc Qu$n Hoan Kiem, Ha Npi

TSn CO quan chu quin de lai: Bp V te

II TINH HINH THVC H l f N

1 Thoi gian thyc hi|n de taildtf i n :

- Theo Hpp dong da ky ket: tit ihang 1/nam 2008 dSnhJt thang 6/nam 2010

- Thuc tS thuc hien: lir thanglir thang 1/nam 2008 dSnhdllhing 6/nam 2010

- Dupe gia han (neu co):

-Lan 1 lir thang nam den thang nam

- L a n 2

2 Kinh phi v i sir dung kinh phi:

a) Tong so kinh phi th\ic hipn: 3905,9 tr.d, Irong do:

+ Kinh phi h6 trp lir SNKH: 2.835,5 tr.d

+ Kinh phi tir cac nguon khac: 1.070,4 tr.d

+ Ty le va kinh phi thu hoi doi voi du an (neu co):

b) Tinh hinh c5p va su dung kinh phi tir nguon SNKH

970

Tlitfc te a

Thoi gian (Thdng, nim)

2008

2009

It duffc

Kinh phi (Tr.d) 1.190 1.480

Glii chu (So de nghi quyet todn)

1.720,5

Bdi v&i de lai:

ctic khoan chi

Tra cong Jao dpng

(khoa hpc, pho

thong)

Nguyen, v^t lieu,

n5n^ lupng

Thiet bj, mdy moc

Xay d\mg, sira ch&a

SNKH

1.485

1.100

265 2.8S0

Nguon khdc

Nguon khdc

879,0

191,4 1070,4

- Ly do thay doi (neu co): Do mua sSm qua dau thau, kinh phi nguyen vat lieu thap hon so voi ke hoach

3 Cac van ban hanh chinh trong qua trinh thuc hien de tai/dyan:

(Liet ke cdc quyet dinh, van bdn cua co quan quan ly tic cong doan xdc dinh nhiem vu, xet chQn, phe diQ'et kinh phi h^ dong, dieuchinh (th&igian, npidw^g kinh phi thuc hien neu co); van bdn cua to chuc chii tri de tai, du dn (don, kien nghi dieu chinh neu co)

Hum 2007 ciia Bo tmong Bp KH&CN ve viec phe

duyet cac to chirc, ca nhan trung luyen chu Iri thuc hien cac de lai nam 2007 (dpt II) Ihupc Chuong trinh

"Nghien ciru, img dyng va phat trien cong nghe phuc

vu bao ve, cham soc va nang cao sire khoe cpng

d6ng", ma s6 KC.10/06-10

Cong van so 198/VPCT-TCKT ngay 30 thdng 10

nijm 2007 cua Van phong Cac chuong trinh ve viec

lap d\r loan ngan sach nam 2007

Cong van so 589/KHBT-VKNTTW ngdy 2

thdngl 1 ndm 2007 ciia Vien Kiem nghiem thudc

T.U" ve viec dieu chinh kinh phi

Cong van so 590/ KHDT-VKNTTW ngdy 2

thdngl 1 ndm 2007 ciia Vien Kiem nghiem thu6c

Ghi chii

ndm 2007 ciia Bp truong Bp KH&CN ve viec phe

duyet kinh phi 04 dd tai, 02 du an san xuat thu nghiem bat dau lh\rc hipn nam 2007 Ihupc Chuong trinh "Nghien ciru, img dung vd phat Irien cong ngh? phuc vp bao v?, cham soc va nang cao sire khoe cpng ddng", ma so KC.10/06-10

Quyet djnh so 3I2/QD-VKNTTW-KHBT ngdy 01

thdng 04 ndm 2008 ciia Vi?n truong Vien Kiem

nghiem thuoc Trung ucmg ve viec phe duyet c^c ca nhan chii tri de tai nhanh thupc De tai KHCN cap

nha nuoc m5 so KC.10.16/06-10 "^ghiin cii-u chiet

tich, tinh cite mgt sS hgp chat tu- nhien dgc trung tit dugc li^u de lam chal chuan phuc vu kiem nghiem dugc lieu"

Cong van so 38/VPCT-HCTH ngay 21 thdng 3 ndm

2008 ciia Gidm doc Van phong Cac chuong trinh trpng diem cap nha nuoc giri cac Ban chu nhiem Chucmg trinh va cdc Chu nhiem de tdi du an ve viec

Ke hoach di cong tdc nu6c ngoai ngan han cua cdc

de tai du dn thupc cdc chuong trinh KH&CN trpng diem cap nhd nuoc

Ke hoach di hpp tac quoc te nam 2008 cua Vien Kiem nghiem thuoc Trung uong giri Ban Chu nhiem Chuong trinh KC.10/06-10 va Van phong cac Chuong trinh KH&CN trpng diem cap nha nuoc

Quyet djnh s6 877/QD-BKHCN ngay 20 thdng 5

ndm 2008 cua Bp truong Bp KH&CN ve viec cir cdc

doan di cong tdc nude ngoai

To trinh s6 517/VKNTTW-TTr ngay 7 thdng 8 ndm

2008 cua Vipn trucmg Vien Kiem nghiem thuoc Trung uong giri Van phong Cdc chuong trinh trpng diem cap nhd nuoc va Ban chu nhiem chuong trinh KC.10/06-10 vj viec Phe duyet KS hoach ddu thiu mua sdm tai san nam 2008

QuySt djnh so 1894/QD-BKHCN ngdy 29 thdng S

nam 2008 ciia Bp truong Bp KH&CN ve viec pile

duyet ke hoach dau thau mua sam tdi sdn cho cdc de tai thupc Chuong trinh "Nghien cuu, img dung vd phat Iriln cong nghe phuc vu bdo ve, cham soc vd nang cao siic khoe cpng dong", md so KC.10/06-10

Cong van s6 668/KC.I0.16/06-10-Cy ngdy 23

thdng 10 ndm 2008 cua Chu nhiem de tdi

KC.10.16/06-10 giri Ban Chii nhiem Chuong trinli

KC 10/06-10, van phong Cdc chuong trinh trpng diim cip nhd nude ve viec mua sam bo sung hoa

ndm 2008 ciia Giam doc VSn phong Cdc chuong

trinh trpng diem cap nhd nuoc giri Vien Kiem nghiem thuoc Trung uong va Chii nhipm de tdi

KC.IO.16/06-10 ve vipc dieu chinh npi dung va kinh

phi cua dj tdi KC.10.16/06-10

Cong vdn so 231/VKNTTW-KC.10.16/06-10 ngay

10 thdng 4 nSm 2009 ve ke hoach mua sim nguyen lieu, h6a chit phpc vu nghien ciru nam 2009 ciia ih

tdi KC.10.16/06-10

Cong van so 130/VPCT-CTKClO ngdy 14 thdng 4

ndm 2009 cua Van ph6ng cdc chuong trinh trpng

diim cap nhd nu6c ve vice cung cip thong tin xay

difng bdo cdo giifa ky Chucmg trinh KC.10/06-10

Quyat djnh so 711/QB-BKHCN ngdy 29 thdng 4

ndm 2009 ve vipc phe duypt phe duyet ke hoach ddu

Ihdu mua h6a chit, vdt tu cho ii tai KC.10.16/06-10

thupc Chuong trinh "Nghien ciru, img dung vd phdt trien cong nghe phuc vy bao ve, cham soc vd nang

cao sire khoe cpng dong", ma so KC.10/06-10

Thong bdo xet duyet quyet todn ngdn sdch nam

2009, de tdi "nghien cim chiet tach, tinh chS mpt s6 hpp chdt tu nhien ddc tnmg tir dupe lieu de ldm chdt chudn phuc vu kiem nghiem dupe lieu"

Bdo cdo djnh ky, Ky 1 ngdy 14 thdng 9 nam 2008 kem Bien bdn kiem tra djnh ky vd vdn bdn xdc nhan cdc npi dung d§ hodn thdnh cua Bp KH&CN Bdo cao djnh ky, Ky 2 ngay 15 thdng 3 nam 2009 Bdo cao djnh ky, Ky 3 ngay 15 thang 9 nam 2009 kem Bien bdn kiem tra djnh ky vd van ban xdc nhdn cac npi dung da hoan thanh cua Bp KH&CN Bdo cdo djnh ky, Ky 4 ngay 14 thdng 4 nam 2010 kem Bien bdn kiem tra djnh ky vd van bdn xac nhan cdc npi dung da hoan thdnh cua Bo KH&CN

ndm 2008 ciia Giam doc Van phong Cdc chuong

trinh trpng diem cap nhd nuoc gui Vien Kiem nghiem thuoc Trung ucmg va Chii nhipm de lai

KC.10.16/06-10 ve viec dieu chinh npi dung va kinh

phi cua de tdi KC.10.16/06-10

Cong van so 231/VKNTTW-KC.10.I6/06-10 ngdy

10 tlidng 4 ndm 2009 vj kS hoach mua sim nguyen

lipu, h6a chat phye vy nghien ciru ndm 2009 ciia dl

lai KC.10.16/06-10

Cong van so 130/VPCT-CTKCIO ngdy ] A thdng 4

ndm 2009 ciia Van ph6ng cdc chuong trinh trpng

diem cap nhd nu6c ve vi^c cung cdp thong tin xay dyng bdo cdo giCta ky Chucmg trinh KC.10/06-10

Quyjt djnh so 711/QD-BKHCN ngdy 29 thdng 4

ndm 2009 \e vipc phe duy?t phe duyet kl hoach diu

thiu mua h6a chit, vdt tu cho dl tdi KC 10.16/06-10 thupc Chucmg trinh "Nghien cim, img dung vd phdt men cong nghe phyc vy bdo ve, cham soc vd nang cao sire Idioe cpng dong", ma so KC.10/06-10 Thong bdo xet duyet quyet todn ngdn sdch nam

2009, de tai "nghien cuu chiet tach, tinh chi mpt s6 hpp chdt tu nhien dac tnmg tir dupe lieu de lam chit chudn phyc vu kiem nghiem duoc lieu"

Bdo cdo djnh ky, Ky 1 ngdy 14 thdng 9 nam 2008 kem Bien bdn kiem tra djnh ky vd van bdn xdc nhdn cdc npi dung da hoan thdnh ciia Bp KH&CN Bdo cdo djnh ky, Ky 2 ngay 15 thdng 3 nam 2009 Bdo cdo djnh ky, Ky 3 ngdy 15 thang 9 ndm 2009 kem Bien bdn kiem tra djnh ky vd van ban xdc nhdn cdc npi dung d§ hodn thanh ciia Bp KH&CN Bdo cao djnh ky, Ky 4 ngdy 14 thdng 4 nam 2010 kem Bien bdn kiem tra djnh ky vd van bdn xdc nhdn cdc npi dung da hodn thdnh ciia Bo KH&CN

nghigm thu cap co' sff

So, thoi gian ban

hanh van ban

Ten van ban

Quyel djnli so 787/QB-VKNTTW-KHDT ciia Vien trucmg Vien KN thuoc TW ve viec thanh lap Hpi dong danh gid nghiem thu cdc dl tdi nhdnh ciia De lai cip Nhd nuoc, ma so KC 10.16/06-10 kem Iheo Bien ban ciia Hpi dong ddnh gid nghiem thu cdc de tdi nhdnh

Quyet djnh s6 268/QB-VKNTTW-KHBT ciia Vien truong Vien KN thuoc TW ve viec thdnh lap Hpi dong ddnh gid nghiem Ihu de tdi nhdnh ciia De tdi cdp Nhd nuoc, ma s6 KC.10.16/06-10 kem theo Bien bdn cua Hpi dong ddnh gid nghiem thu de tai nhdnh Nhdn xet ciia to chirc thuc hipn de tdi du dn

Quyet djnh so 353/QB-VKNTTW-KHBT ciia Vien

Inrong Vien ICN thuoc TW ve viec thanh lap Hpi dong KHCN cdp co so ddnh gid nghiem thu De tdi cdp Nhd nuoc, ma so KC.10.16/06-10 kem theo Bien bdn ddnh gia cap co so ket qua de tdi KHCN cap nha nuoc

Bdo cao ve viec hoan thien ho so ddnh gid cap co sir Danh sdch tdc gid thuc hien de tdi KHCN/Du dn SXTN cip nhd nude

Ddnh gid ciia to chue thuc hien de tdi du dn

Quyet djnh so 1231/QB-BKHCN ngay 16 thdng 7

nam 2010 ciia Bp trudng Bd KHCN ve viec thdnh lap HD KH&CN cap nhd nude vd Id chuyen gia ddnh gid nghiem thu de tdi cap nha nude ma sd

KC.10.I6/06 - 1 0 , thudc Chuong trinh

KC.10/06-10

Ghi chu

Nghi?m thu

08 nhdnh: 1,2,3,5,7,8,9

Nghiem thu nhdnh 4

Nghiem thu ngay 10/6/2010

Truong DH Dugc

HN

Vien Hoa hpc cac hgp chat thien nhien, Vien KH&CN Viet Nam

Vien Dugc lieu

Chiet xuat, phan lap, tinh che, xay dung

bo du lieu chuan va dieu

cU 2,0 g

Holothurin B

va 2,0 g Malloapelta B

Chiet xuat, phan lap, tinh che, xay dung bpdulieu chuan va dieu chi 2,0 g Silybin va 2,0

g Phyllanthin

Sdn phdm chu yeu dat duQ'C

- Quy trinh

chiet xuat

- Quy trinh phan lap

- Quy trinh tinh che

- Bg do-lieu chuan -2,0g Connessin va 2,0 g Kaempferol

CO dg tinh khilt > 95%

- Quy trinh chiet xuat

- Quy trinh phan lap

- Quy trinh tinh che

- Bg du lieu chuan -2,0g Holothurin B

va 2,0 g Malloapelta

B CO do tinh khilt > 95%

- Quy trinh chiet xuat

- Quy trinh phan lap

- Quy trinh tinh che

- Bgdulieu chuan -2,0g Silybin va 2,0 g Phyllanthin

CO dg linh khilt > 95%

Ghi chu*

(NgifOi tJiam gia thirc hien de tdi thugc to ch'tc dm tri va ca quan phoi hop, iiliong qud

10 ngudi lie ca elm nhi^m)

PGS.TS Trjnh Van L3u

TS Nguyen Van Tuu

TS.TrJnVift Hiing

- Chu nhiem de tai

- Chii nhipm de tai nhdnh 1

- Thu ky de tai, Chu nhiem de tdi nhanh 2

TS Doan Cao So'n - Chii nhipm de tai nhdnh 3

ThS Nguyen Thj Kim Thanh - Chu nhiem dl lai nhanh 4

GS.TS Pham Thanh Ky - ChO nhiem dl lai nhanh 5

PGS.TS Thai Nguyen Hung Thu - Chu nhiem dl tai nhdnh 6

PGS.TS Phan Van Kiim

TS Trjnh Thj Diep

TS Le Viet Diing

Chii nhieni cac nhanh de t^i

Nhanh 1 Chii nhifm

- Chu nhiem de lai nhanh 7

- Chii nhiem de tai nhanh 8

- Chu nhiem de tai nhdnh 9

TS Nguyen Van Tuu

"NGHIEN CUU CHIET TACH, TINH C H 6 NUCIFERIN TU' LA SEN OS T H I 6 T LAP CHAT CHUAN PHUC VU KIEM NOHljM DU'OC LI$U"

Nhanh 2 Chii nhiem TS Tran Viet Hiing

"NGHIEN OJ'U CHlfeT TACH, TINH CHfe LINARIN TU' COc HOA DE T H I 6 T LAP CHAT CHUAN

"NGHIEN CU'U CHIET TACH, TINH CHE ACID CHLOROGENIC TU'KIM NGAN HOA HOA DE THI6T LAP CHAT CHUAN PHUC VU KlfeM NGHIfM DUOC LI$U"

Nhanh 4 Chu nhi?m ThS Nguyen Thj Kim Thanh

"NGHIEN CUU THI6T LAP 10 CHAT CHUAN CHltTTU'DU'OC LI$U (ACID CHLOROGENIC, CONESSIN HOLOTHIRIN B, KAEMPFEROL, LINARIN, MALOAPELTA B, MYRICETIN, NUCIFERIN, PHYLANTHIN, SILYBIN"

Nhanh 5 Chu nhifm GS.TS Pham Thanh Ky

"NGHIEN CU'U CHlfiT TACH, TINH CHfi MYRICETIN TU'CHt DAY Dt THifeT LAP CHAT CHUAN

PHUC VU K I £ M N G H I $ M DUOC L I $ U "

Nhdnh 6 Chii nhi|m PGS.TS Thai Nguyin Hiing Thu

"NGHIEN CUU CHI6T TACH, TINH CH£ KAEMPFEROL TU'DON LA 00 VA CONESSIN TU'MU'C HOA TRANG D6 T H | £ T LAP CHAT CHUAN PHUC v u KIEM NGHIEM DU'OC LI$U"

Nhanh 7 Chii nhiem PGS.TS Phan Van Kiem

"NGHIEN CUU CHlfiT TACH, TINH CHfi HOLOTHURIN B TU' HAI SAM VA MALLOAPELTA B Til BUM BUP Bt THI6T LAP CHAT CHUAN PHUC VU K | 6 M NGHIEM DUOC LIEU"

Nhanh 8 ChO nhipm TS Trjnh Thj Di?p

"NGHIEN c i m CHlfeT TACH, TINH CHt SILYBIN TU'CtJC GAI DE THIET LAP CHAT CHUAN PHUC VU KlfiM N 0 H I $ M DU'OC LI$U"

Nhanh 9 Chii nhiem TS Le Viet Dung

"NGHIEN CUU CHlfiT TACH, TINH CHfe PHYLLANTHIN TU'DON DI$P HA CHAU OANO OE THIET LAP CHAT CHUAN PHUC VU KIEM NGHIEM DUQC LlfU"

Tran Viet Hung

Doan Cao Son

Pham Thanh Ky

Thai Ng.H Thu

Phan Van Kiem

tham gia thuc hien

Doan Cao Scm Tran Th.H.Anh

Le Thi Thu Hien

Pham Thanh Ky Tran Viet Hung

Vu Hucmg Thuy

Thai Ng.H Thu Nguyen Thai An Hoang Tuyet Nhung

Ng Viet Than Hoang Lan Nhung Ng.T.Thu Hucmg Phan Van Kiem

Nguyen Hoai Nam

Ngi dung tham gia chinh

Chu nhiem DT CNDT nhdnh 1

Thuc hien de tai nhanh 1

T h u k y de tai, CNDT nhanh 2

Thuc hien de tai nhanh 2

nuciferin ham

lucmg > 95%

QT chiet, phan lap, tinh che, bg du lieu va 2,0 g

linarin ham

lugng > 95%

QT chiet, phan lap, tinh che, bp du lieu va 2,0 g

a chlorogenic

ham lugng > 95%

QT chiet, phan lap, tinh che, bg du lieu va 2,0 g

myricetin ham

lugng > 95%

QT chiit, phan lap, tinh che, bg du lieu va 2,0 g

conessine, 2,0

g kaempferol

hamlugng > 95%

QT chiet, phan lap, tinh che, bg dii lieu va 2,0 g

- Ly do thay doi ( neu c6):

6 Tinh hinh hgp tac quoc te:

So

TT

1

Tlieo ke hogch

(Ngi dung, th&igian, kinh phi, dia

diem, ten td cliuc hgp tdc, sd

dodn, so lugng ngudi tham gia )

Ngi dung: Hijc l?p va trao doi

kinh nghiem ve phuang phdp

chiet tach, linh che hop chat tu

nhien tir duac lieu

Ngi dung: Hoc lap va trao doi

kinh nghiem ve phuong phap chiet tach, linh che hop chat lu nhien tir duoc lieu

Th&ieian: 16/10 - 8/11/2008 Kinh Dili: 75.093.800 VND Bja diim: Bac Kinh, Trung

Quoc

Ten To chuc: Vien KN thuoc

va sinh pham y te CHND Trung Hoa

So dodn: 01

SS ngu&i: 02

Ghi chu*

- Ly do thay doi (neu cd):

- Thay doi ve thcri gian do phia Trung Quoc khong tiep nhan doan vao trong thcri

gian diin ra ThS van hpi Bdc Kinh 2008

- Thay doi ve kinh phi do su chenh lech sau;

Ti^n ve may bay: 1.030 USD

Ti^n taxi III san bay v^

0

Thuc chi

19.588.800 2.696.000 25.949.000 26.286.000 574.000

Chenh lech

-3.998.200

0

0 -521.600 -574.000

Do khi xdy d\mg de cuong vd l§p dif todn chua luong tru6c bien dpng ty gid ngoai te nen

ty gid o thoi diem lap d\l todn Id: 1 USD = 16.092 ddng, thuc te 6 thcri diim di nuoc ngodi

ty gid Id: 1 USI3 = 16.850 dong vi vdy kinh phi dodn ra hien tai dang con 5.093.800 dSng chua dugc quyet toan

7 Tinh hinh to chirc hoi thao, hgi nghj;

Npi dung: Chiet xuat, phan lap va

tinh che cac hpp chat tu nhien dac

trung tir dupe lieu

Th&igian dtrkien: 01/2009

Kinh phi: 15.000.000 VND

Bia diim: VKNT.TLT

Noi dung: Phan tich du lieu

chuan lien quan den cau true va

dinh danh hgp chat tu nhien dac

trung tir dupe lieu

Th&igian dukien: 06/2009

Kinh phi: 15.000.000 VND

Dia diem: VKNT.TU'

Npi dung:

Thiet lap chat chuan doi chieu

hoa hgc tir hgp chat tu nhien dac

trung tir dupe lieu

Th&igian dukien: 06/2009

Kinh phi: 22.500.000 VND

Dia diem: VKNT.TU'

Thuc te dat dirprc (Noi dung, thoi gian, kinh pJii, dia diem ) Npi dung: Chiet xuat, phan

lap va tinh che cac hpp chat

tu nhien dac trung tir dupe lieu

77(07 g/a/i: 03/2010

Kinh phi: 15.000.000 VND Dia diem: VKNT.TU"

A'^j dung: Phan tich du lieu

chuan lien quan den cau true

va dinh danh hgp chat lu nhien dac trung tir dupe lieu

Tii&igian: OVIOIO Kinh phi: 15.000.000 VND

Ghichu*

Ly do thay doi (neu co); Thay doi ve thcri gian 16 chirc (mupn hon so voi du kien) vi cac ly do;

+ Ngoai ra cac ly do khac lien quan din ti6n dp cdp kinh phi, Ihanh phdn tham gia bdo cao,.,vv

8 Tom tat cac ngi dung, cong viec chii yeu:

(Neu tgi miic 15 cua thuyet minh, khong bao gom: Hgi thao klioa ligc, dieu tra kitdo sdt trong nu&c vd nuoc ngodi)

(Cdc moc ddnh gid ciiu yeu)

Quy trinh chiet xuat 10 hgp chat

Quy trinh phan lap 10 hgp chat

Quy trinh tinh che 10 hgp chat

Bg dir lieu chuan ciia 10 hgp chat

Tieu chuan chat lugtig (10

Protocol ddnh gid 10 chat chuan)

Ket qua kiem nghiem va phieu KN

10 chat chuin DCHHQG

Bao cao ket qua danh gia lien

phong TN chat chuin DCHHQG

Tai lieu chuyen khao

Van bdng sof hiin tri tue 10 san

pham chat chuan DCHH Quoc gia

San pham ong chuan DCHHQG

Th&i gian

(Bat ddu, ket thuc

- tildng nam)

Theo ke hoach 05/2008 07/2008 09/2008 04/2009 11/2009 11/2009 11/2009 01/2010 01/2010 04/2010

Thuc te dat dugc 05/2008 09/2008 11/2009 04/2009 12/2009 12/2009 12/2009 06/2010 04/2010 03/2010

Ngudi,

CO quan thtfc hifn

VKNTTW VDL VHHHCTN TBHDHN VKNTTW VKNTTW VKNTTW VKNTPHCM VKNTTW TDHDHN VKNTTW VKNTTW

• Ly do thay doi (neu co):

1 San phSm KH&CN da tao ra;

a) San pham Dang I;

Muoi chat chuan doi

chieu h6a hgc quoc

10 chat X 1.000 mg = 10.000 mg (500 lg,

20 mg/lg)

nhu k.hoach

-nt nt nt nt nt nt nt-Tinh khiet >

10 chat X 1.000 mg = 10.000 mg (500 lg,

20 mg/lg) dat yeu cau

50 lg

50 lg SOIg dat yeu cau

99,97 % 97,80 % 96,17 %

95,21 %

9 5 , 1 0 %

99,93 % 99,69 %

1 0 0 , 1 1 % 99,97 % 100,15%

- Ly do thay doi (neu co);

rang \k khoa hpc phii hgp vai dieu

kien \'cri trang thiel hi cua co so va tinh tien lien Iren the gioi Su dyng dung moi it dgc hai Cho san pham

on djnh ve so lugng (hieu suai) va chSt lupng (d^t dugc dg tinh khiet t6i thieu 95%)

Su dung dung moi it dgc hai Quy trinh on dinh ve hieu suat chiel va cho san pham it lap chat

Sii dung dung moi it dgc hai Phan lap dugc hpp chat co dp tinh khiet

80 % tro Ien

Quy trinh su dung cac ky thuat tinh che tien tien, tao ra san pham on dinh ve chat lupng va dat dupe dp

tinh khilt l6i thi^u 95 %

Thyc te dat dygrc

Da tham djnh, dat yeu cau

Dat yeu cau

Dat yeu cau

Dat yeu cau

Ghi chu

- Ly do thay doi (neu co);

c) San pham Dang 111;

Bai bao khoa hgc

Nghien cim chiet xu

nuciferin tu la sen (F

vu kiem nghiem dug

Yeu cau khoa hgc

18 bai

il, phan lap, tinh che va nhan dang olium nelumbilis) lam chit chuin phuc

c lieu (D3 dang) Nghien cii-u chiSl tach silybin til qua ciic gai silybum

marianum (L) Gaertn lam chit chuan (Da dSng)

Nghien cOru chiSl tach va linh che phyllanthin lir cay digp Ha

Chau Ding Phyllathus amarus Schum et Thonn

(Da dang)

Nghien cuu chi6t xu^l, phan lap, linh che va nhan dang

Myricetin lir 14 Che Day lam chat chuan phuc vu kijm

Sd luang, nai

cong bo (Tgp chi, nhd xudt bdn)

Tgp chi Kiem nghiem thudc, w 3A-2008 Tgp chi Kiem nghiem Ihudc, so 3A-2008 Tgp chi Kiem nghiem thudc, so 3A-2008 Tgp chi Kiem nghiem thudc, sd 1-

nuciferin trong nguyen lieu (da dang)

Nghien cuu dinh lupng Nuciferin trong la sen va mgt so che

ph^m tiJr la sen bang HPLC (da giri)

Nghien cuu chiet xuat, phan lap va linh ch§ acid chlorogenic

lir cay K.im Ngan Hoa (da dang)

Djnh lupng kaempferol chiet xuat tir don la do bing phucmg

phap sac ky long hieu nSng cao (d3 dSng)

Development of a chromatographic fingerprint for the

quality control of Mallolus apella by using LC-DAD-ION

trap MS with malloapelta B as marker compound (da dSng)

Development of a chromatographic fingerprint for the

quality control of Mallolus apelia by using LC-DAD-ION

trap MS with malloapelta B as marker compound (submit

and revised)

Xac djnh holothurin B trong dich chiet loai Holothuria

scabra bing s4c ky long cao ap ket n6i voi khoi pho (da

dang)

Study of isolation and purification often chemical standards

for herbal product quality control (da dang)

Nghien cuu chiet xuit, phan lap, tinh che va nhan dang

nuciferin tir la sen {Folium nelumhinis) lam chat chuan phuc

vu kiem nghiem dugc lieu (da dang)

Research on extraction and isolation and purification of

nuciferine, linarine, chlorogenic acid and myricetine from

medicinal plantes to establish the reference standards (da

dana)

Study on extraction and isolation of kaempferol from leaves

of Excoecaria cochinchinensis lour, Euphobiaceae and

Conessin from stem bark of Hollarrena antidysenterica (L.)

wall to be used as reference standard for quality control of

some medicinal herbs and herbal products (da dang)

Nghien cuu chiSt xuSt tinh che kaempferol tir cay dan la do

nghiem thuoc .so

l-2010 Tgp chi Kiem nghiem thuoc, 2010 Tgp chi Kiem nghiem thuoc, sC) 2 -2010

Tgp chi Kiem nghiem thuoc so 2 -2010

Tgp chi hoa hoc

Journal of Organic Chemistry Insight

Hoi nghi KH Nghien cuu KH phuc vu dao tgo va phdi trien kinh te - van hoa - xa hpi giai doan hien nay, Dgi hpc suphgm 11,

-Ha Npi (2009) Hpi nghi HOPE Meetings 2009" do Japan Society for the Promotion of Science (JSPS), Hakone, Japan Hpi nghi khoa hpc cdn bp tre nganh Iwa hpc; Tgp chi H()a hpc, so dgc bi$t2A'2009, T.47 Pharma indochina

VJ (2009)

Pharma indochina

Vi (2009)

Tgp chi dmrc Iwc

) Thong ke danh muc san pham KHCN da dugc irng dung vao ihuc IS

Sd

TT

1

2

Ten ket qud

Bja diem

(Ghi ro ten, dia chi noi ung dung)

Kit qua

sabg

! D4nh gia ve hi|u qua do de t&i, dy in mang lai:

i) Hieu qu^ \i khoa hgc va cong nghe;

(Neu ro danh muc cong nglie vd muc dg ndm vihig, ldm chu, so sanh vdi trinh do cdng nghe so voi khu vuc vd the giai )

Lan dau lien 10 chat chuan DDVN co nguon goc tir dugc lieu dugc thiel lap

6 Vigl Nam mgt cich bai ban va khoa hgc vcri so lugng dij 1cm, 16 2,0 g tuong ung vdi 100 lg 20,0 mg, dap ung nhu cau kiem tra chat lugng dugc li$u lai Vi6n Kiem nghiem thuoc Trung uong va co th^ cung cap cho cac don

vi nghien cuu va kiem nghiem khac

Da nam dugc co ban ky thuat chiet chat, phan lap, linh che va thiel lap bg du lieu nhan dang chal dac trung lit dugc lieu, thu dugc chat doi chieu co dg tinh khiet tuong duong voi chat chuan quoc gia Trung Quoc, noi co trinh dp thiit lap chuin lien li Jn nhit trong khu vuc va tuong duong voi cac chat chuan tren the gioi (do tinh khiet > 95,0 %

b) Hieu qua ve kinh te xa hpi;

(Neu ro hieu qud ldm Igi tinh bdng lien du kien do de tdi, du dn tgo ra so vol cdc sdn phdm ciing logi tren thi tru&ng )

San xu§l dugc va chii dgng ve chat chuan, gop phan vao cong lac tieu chuan hoa va kiim nghipm chat lugng dugc lieu va thuoc lir dugc lieu

Tilt kiem dugc khoan ngan sach mua chat chuan Vol gia mua chat chuan tinh trung binh 200 USD/lg, vay se tao ra dugc;

10 chit X 50 lg X 200 USD = 100.000 USD tugng duong

1.900.000.000 VND (Mgl ty chin tram trifu dSng Viet Nam)

18

19

2

long hieu nang cao (da dang)

Nghien cuu chiet xuat linh che conessin lir mirc hoa lr3ng de

lam chat doi chieu trong kiem nghiem (da d3ng)

Xay dyng va tham dinh phucmg phip dinh lupng linarin

bang HPLC

Tai lifu chuyen

Hoan thanh 01 TLCK,

Phuong phdp chiet, phan lap, tinh cbi, nhgn dgng vd thiet lap chat chudn la chat dgc trung tie dupe li^u

.s6 06/2010 Tap chi duvc h()c .sd 03/2010 Hpi nghj phdn tich loan qu()c ldn thu 3

Nghiem Ihu tgi DH Dmrc HN

d) Ket quS dao tao;

s6

TT

1

2

Cap ddo tgo, Chuyen

nganh dao tgo

03

01

Thuc te dat 6ugc

06 (I) Vu Huong Thuy (2) Hoang Lan Nhung (3) Ng T Thu Huong (4) Le Thi Thu Hiin (5) 06 Thi Nggc Lan (6) Vu T Nguyet Minh

01 Hoang Tuyet Nhung

Ghi chii

(Thdi gian ket

thuc)

Bao v? thanh cong 12/2008 Bao ve thanh cong 08/2009 Bao ve thanh cong 09/2009 Bao ve thanh cong 12/2009 Bao ve thanh cong 12/2009

Du kien bao ve 10/2010

Du kien bao ve 12/2010

- L^ do thay doi (neu co);

d) Tinh hinh dang ky bao hg quyen so hUu cong nghiep, quyen doi voi giong cay trong;

GIA CO NGUON OOC I'D'DUyC

I.II-U VA CAC CI lAT CI IDAN 11 IU

Thuc te dat duac

2010

Ba ngp, CN don 4/2010;

cong bo don

Ghi chd (Th&i gian kit thuc)

2010

Thong ke danh muc san pham KHCN da dugc irng dung vao thuc le

0

T

1

>

Ten ket qud

Dja diem

(Ghi ro ten, dja chi noi ung dung)

Ket qud

50 bp

Danh gia ve hif u qua do de t^i, du an mang lai:

Hieu qua \ e khoa hgc va cong nghe;

leu ro danh muc cong nghg vd muc dg ndm virng, ldm chit, so sank v&i trinh do

mg nghe so v&i kJiu virc vd the gioi )

Lan dau lien 10 chat chuan DDVN co nguon goc lir dugc lieu dugc thiel lap

6 Vigl Nam mgt each bai ban va khoa hgc vdi so lupng du Ion, 16 2,0 g luong img vdi 100 lg 20,0 mg, dap ung nhu cau kiem tra chat lugng dugc ligu lai Vien Kiem nghiem thuoc Trung ucmg va co the cung cap cho cac don

vi nghien cuu va kiem nghiem khac

Da nam dugc co ban ky thuat chiel chal, phan lap, linh che va thiet lap bg dij lieu nhan dang chat dSc trung lir dugc lieu, thu dugc chat doi chieu cd dg linh khiet luong duong vdi chat chuan quoc gia Trung Quoc, noi co trinh do thiet lap chuan lien tien nhat trong khu vuc va tuong duong vdi cac chat chuan tren the gidi (dg tinh khiet > 95,0 %

)) Hieu qua ve kinh le xa hpi;

"Neu ro hiiu qud ldm Igi tinh bdng tiin du kiin do di tdi, du dn tgo ra so v&i cdc ldn phdm ciing logi trin tbi truong )

San xuat dugc va chu dgng ve chal chuan, gdp phan vao cong lac tieu chuan hoa va kiim nghiem ch4l lugng dugc lieu va thudc lir dugc lieu

Tiet kiem dugc khoan ngan sach mua chat chuan Vdi gia mua chat chuan tinh trung binh 200 USD/lp, vay se tao ra dupe:

10 chit X 50 lp X 200 USD = 100.000 USD luong duong

1.900.000.000 VND (Mgl ly chin Iram Irlgu ddng Viel Nam)

Hoan thanh va to chirc thjmdinh 10 QT chill xuat, 10 QTphan lap Hoan thanh cac ngi dung theo diing lien do Hoan thanh 10 QT linh che Hoan thanh cac npi dung nghien ciru va dat dugc cac ket qua theo dung lien dg

va muc chat lugng da dang

ky Xay dyng 10 bg dir lieu chuin nhan dang chat Dieu che du lugng chat (1,0 g mdi chat, SP dang 1)

de thiel lap chat chuan Hoan thanh npi dung theo dung lien dp va dat ket qua nhu dang ky

Ddng dng chuan Xay dyng 10 TCCL (protocol danh gia chat chuan)

Danh gia lien phdng Hoan thanh eg ban cac ngi dung va san pham KH&CN

da dang ky theo Ihuyel minh va hgp ddng

so vdi hgp dong do kinh phi cap cham v^ do ke hoach mua nguyen vat li?u phS duyft cham CSc ngi dung dS thyc hi?n dam bio theo hpp ddng, cdc chuyen de dS dugc thim djnh bdi l6 chuyen gia

Ve CO ban hoan thanh theo lien dp nhu dSng ky trong thuyet minh va hgp ddng

07/07 thanh vien bd phieu

danh ^ia dgi yiu ciu;

Hgi ddng danh gia de lai

da diiu ki^n ddnh gid de lii & cip nha nir&c

Chii nhifm dl tii

(Hg tin, chO ky)

Thii trirong to chirc chii tri

(HQjen^^a ky vd dong ddu)

^^ HP Vltri! 1SU01I3

PGS.TS Trinh VSn Liu

PHAN B

MUCLUC

Ten Muc

DANH UVC CAC CHir VIET TAT

DANH MUC CAC BANG VA HINH

Trang M6DAU I CHl/ONG M O T T O N G QUAN 3

1.1 XU T H 6 P H A T TRlfeN THU6C CO NGUON G 6 C THIEN NHIEN 3

1.2 T 6 N G QUAN V6 D 6 1 TUONG NGHIEN CU'U CUA Dfi TAI 5

1.2.1 Acid chlorogenic til' Kim Ngdn Hoa 5

1.2.2 Conessin tit Muc Hoa Trdng 6

1.2.3 Holothurin B til Hdi SSm 7

1.2.4 Kaempferol tis Bern Ld Dd 10

1.2.5 Linarin tir Cue Hoa 11

1.2.6 Malloapelta B tir Biim Bup 12

1.2.7 Myricetin tir Chi DSy 14

1.2.8 Nuciferin tir Ld Sen 15

1.2.9 Phyllanthin tir Diep Hg Chdu 16

1.2.10 Silybin tir Cric Gai 22

1.3 THIET LAP CHAT CHUAN Tlj' DUQC Ll£U 23

1.4 PHU'ONG PHAP CHIET, PHAN LAP VA TINH CHE CAC CHAT

DAC TRUNG TU'DUOC LIEU 26

1.4.1 Chi^txuat 26

1.4.2 PhSn lap va tinh che 29

1.5 PHUONG PHAP BJNH TINH, BINH LU'ONG,

NHAN DANG VA XAC BINH BO TINH KHIET 36

1.5.1 Dinh tinh, dinh luong hyp chat dac tnmg trong dirpc lieu,

cac san ph3m chiit xuat, phan lap va tinh che tir duoc lieu

bling sac k^ long hieu nang cao (HPLC) 36

1.5.2 Phuong phap nhan dang 36

1.5.2.1 Diem chdy, MP , 37

1.5.2.2 Phd ta ngogi kha kiin, UV- VIS 37

1.5.2.3 PhS hong ngogi, IK 37

1.5.2.4 Pho cgng hudng tic hgt nhan, NMR 38

IJ.2.5 Phi kiwi tugng, MS 39

1.5.3 Xac djnh dp tinh khiet ciia chat bSng phuong phap quct

nhiet vi sai - differential scanning calorimctry (DSC) 41

1.6 PHU'ONG PHAP THIET LAP CHAT CHUAN 42

1.6.1 Thijt lap, bao quan va phSn phoi chat doi chieu

Theo hu-ong din ciia WHO 42

1.6.1.1 Ltfa chgn nguyen lieu 43

1.6.1.2 Xay dgng quy trinh phan lich 43

PHUONG PHAP NGHIEN CUU 2.1 DOI TU'ONG NGHIEN CUU

2.2 NGUYEN VAT LIEU

2.2.1 Duyc lieu nghien cuu

2.2.2 H6a chat, thuoc thir

2.2.3 Thiet hi, dung cu

2.3 PHUONG PHAP NGHIEN CLTU

2.3.1 Thiet ke thi nghiem

2.3.2 Dinh tinh nhom chat va doi tu'9'ng nghien cuu trong diroc lieu, san pham chiet, phan lap va tinh che

2.3.3 Djnh lypng nh6m chat va doi tugng nghien cuoi trong dirge lieu, san pham chiet, phan lap va tinh che

2.3.3.1 Djnh lupng cdc hpp chat dgc trung trong

duvc li^u vd cdc sdn phdm chief, phdn lap

vd tinh che bang HPLC 2.3.3.2 Dinh lupng nhom chat vd doi tupng nghien cuu trong dupe li^u, sdn pham chiet, phdn Idp vd tinh che bdng phuong phdp khdc

2.3.4 Chiet, phSn lap va tinh che

2.3.5 Xay dung bp dfr lieu nhan dang chat

2.3.6 Danh gia dg tinh khiet va phan tich tap chat

2.3.7 Thiet lap chat chuan va xay dung tieu chuan danh gia chat chuan

2.3.7.1 Xdy dung tieu chuan chat luong vd cdc chi tieu chdt lupng

2.3.7.2 Quy trinh thiet lap vaphdn tich ddnh gid chat chudn 2.3.7.3 Ddnh gid chat lupng chudn thdng qua lien phong thi nghiem

2.3.7.4 Phuong phdp xu- ly so lieu

CHU'O'NG BA KET QUA NGHIEN ClTU

3.1 DINH TINH NHOM CHAT VA DOI TU'ONG NGHIEN CUU 3.1.1 Djnh tinh doi tuong nghien ciru trong duoc lieu

3.1 J.I Binh tinh bdng cdc phdn ung hoa hpc

3.1.1.2 Dinh tinh bdng SKLM * 3.1.1.3 Dinh tinh bdng HPLC-PDA vd bdng vd IC-MS

3.1.2 Dinh luong doi tugng nghien ciiu trong dugc lieu 3.2 XAY DUNG QUY TRINH CHIET XUAT,

PHAN LAP VA TINH CHE

3.2.1 Quy trinh chiet xuat

3.2.2 Quy trinh phan lap

3.2.3 Quy trinh tinh che

3.3 B O DO' LIEU N H A N DANG CHAT

3.3.1 Dac diem hinh th^i

3.3.2 Dii' lieu pho va mgt so hang so vat ly

3.5.1 Xay du-ngva tham dinh phuong phap phan tich 127

3.5.1.1 Xdy dung phuong phdp djnh tinh, dinh lugng

vet xdc dinh tgp chat bdng HPLC 127 3.5.1.2 Tham dinh phuong phdp phan tich 136

3.5.2 Tieu chuan chat lugng danh gi^ chat chat chuan 144

3.5.3 Ap dung tieu chuan chat lupng va phuong ph^p phan tich

da du'p'c tham dinh de x^c dinh chat lu'png nguyen lieu 144

3.5.3.1 Djnh tinh ' ' 145

3.5.3.2 Diem chdy 145

3.5.3.3 Xdc dinh do tinh khiit 145

3.5.3.4 Xdc dinh Igp chal lien quan 146

3.5.3.5 Binh'lugng 152

3.5.4 Dong g6i vii danh gia dong nhat 16 156

3.5.5 Ddnh gid chat lu-png chuan thong qua lien phdng

thir nghiem (PTN) va xac dinh gid tri an dinh 157

CHl/OT<G B 6 N BAN L O A N 161

4.1 VE PHU'ONG THU'C TRIEN KHAI, PHUONG PHAP

VA NOI DUNG NGHIEN CUU CUA BE TAI 161

4.1.1 Phuong thirc triin khai, tinh moi va hifu qua kinh te 161

4.1.2 Phuong phap va noi dung nghien cihi 163

4.1.2.1 Ve dugc lieu vd chat lugng dugc lifu su: dung

cho chiet xuat, phdn lap vd tinh che 163 4.1.2.2 Chiit hgp chit todn phin (HCTP) tic dugc lifu 163

4.1.2.3 Phdn lap hgp chit dgc trung tir HCTP 164

4.1.2.4 Tinh chi chit tu: sdn phim phan lap 165

4.1.2.5 Xdy dung bg du lieu nhgn dgng chit 165

4.1.2.6 Thiit lap chat chuin, xdy dgiig TCCL

(Protocol ddnh gid chuan) 165

4.2 VE MOT SO KET QUA DAT B U Q C 166

4.2.1 Giai doan chiit xuat, phan lap, tinh chi

va xay dung bo dulicu nhan dang 166

4.2.2 Giai doan thiit lap chat chuan 167

KET LUAN VA D t XUAT 171

KET LUAN 171

BE XUAT 174 TAI LIEU THAM KHAO 175

Phan tich phirong sai

Bao cao tongtiiuat

British Pharmacopoeia

Dirpc dien Anh

Chat doi chieu (DC: doi chieu)

Chemical Shift Correlation spectrometry

Lien h? djch chuyen hoa hpc

Chinese Pharmacopoeia

Dug'c dien Trung Quoc

Chemical referrence standard

Chat chuan doi chieu hda hpc

Chiet xu^t

Dung djch

Dung moi

Dupe dien Vi?t Nam

Distortionless Enhancement by Polarization Transfer

Chuyen doi phan eye bien d^ng (pho)

Differentia! Scanning Calorimetry

Quet nhi?t vi sai

Electron Impact

Va cham dien tii

Du'pc dien Chau Au

Electro Spray lonisation

Ion hoa bang phun di?n tit

Fast atom bombardment

Bin pha nguyen thtr nhanh

Fourier Transform Infrared Spectrophotometry

Hong ngo^i bi6n doi Fourier

Gel Permeation Chromatography

SSc ky tham qua gel (dong nghia vcri SEC)

Hpp chat toan phan

Hoa hgc

Heteronuclear MuUiple Bond Coherence

Lien h? da lien ket dj nhan

High Performance Liquid Chromatogarphy,

s i c ky long hieu nang cao (Sir dyng tir viet lit ciia thuat nghu Anh vi da trd Ien thong dyng)

Hi?u suat

Hi^u suat phan lap

Heteronuclear Singular Quantum Coherence

Lien he dan iu-png tir dj nhan

Infra-red

• l i e n g

Pho khoi Iu-png gpi tit la pho khoi

: Nghien ciru sinh

National Institute for Control of Pharmaceuticals and Biological Products

Vi?n Kiem nglii?m thuoc va sinh pham Trung Quoc Nuclear Magnetic Resonance

COng huong tu hat nhan

Pha dpng

Phan l^p

Phong thi nghiem

Quy trinh

Size eclusion chromatography

s i c ky ray (sang lpc) phan tu (d6ng nghTa vai GPC)

sic ky

s i c ky cpt

s i c ky do

s i c ky Icrp mong

Signal to noise ration

Ty s6 dap ung (tin hieu) chia cho nhieu

Vi?n Dupe li?u

Vien Kiim nghiem thudc trung uong

World Health Organization

Nhi?t dp nong chay

Thoi gian luu

MQT S 6 QUY UQC

Ten dupe Ii?u:

Theo DDVN ten dupe li?u dupe \iet hoa chii' cai dau tien, vi dy Che day Cue hoa, Kim ngan hoa, Biim byp \v Tuy nhien, day la d6i tupng nghien cuu cua de tai, la ten rieng eung e6 the viet la Che Day, Cue Hoa, Kim Ngan Hoa vv Trong pham vi

tai li?u nay, viet Hoa va viet nghieng nhu sau: Che Ddy, Cue Hoa, Kim Ngan

Hoa vv

Mpt so dupe li?u c6 trong dupe dien dupe djnh nghia ca bp phan dung nhu Cue Hoa

la hoa cua cay Ciic Hoa, Kim Ngdn Hoa la hoa cua cay Kim Ngdn vv Tuy nhien mpt so dupe lieu chua eo trong duoc dien, vi dy Che Ddy, bp phan dung la la cay Che

Ddy, Biim Bup bp ph^n dung la la 5u»i Bup, Muc (Mpc) Hoa Trdng, bp phan dimg la

vo than cay

MifC Hoa Trdng, dupe dien ghi la Mpc Hoa Trdng, do do trong bao cao tong hpp

dupe ghi la Mpc Hoa Trdng, con trong mpt so phan khac nhu phu lye, eac bai bao va tai lieu tham khao van ghi la Mii-c Hoa Trang hay Mifc Hoa Trdng

Ten thyc v^t, ten chi va ten loai viet nghieng, rieng ten tac gia va ten hp khong viet nghieng

Ten hoa chat thuoc thir, theo Dupe dien Viet Nam, dupe viet nghieng Pic sac ky eothe viet la pic, pie hoac peak sic ky, trong bao cao tong hpp quy uac la peak sac ky Toe dp dong la mililil/phut, theo quy uac eiia Tong eye TCDL viet tat la ml/min., trong tai li?u nay van quy uoc ghi ml/ph

DANH MUC CAC BANG VA CAC HINH

BANH MUC CAC BANG

Bang 2.1 Bieu kiln sjc ky (HPLC) phan ticli djnh tinh va dinh lugng cac cliSt trong dugc

lieu va trong san pham chiit, phan lap va tinh chi

Bang 2.2 Tom tat xit ly mau thir va ndng dp phan tich

Bang 2.3 Tom tat cac chi tieu va phugiig phap thir cua cac chit CBC

Bang 2.4 Quy tac lam tron so

Bang 2.5 Hucing dan loai bo gia trj tho

Bang 2.6 Mo hinh phong thir nghi?m

Bang 2.7 Bang ANOVA

Bang 2.8 Bang torn tat cdch tinh gia tri an dinh

Bang 3.1 Cac phep thii djnh tinh sir dung trong kiem tra sir c6 mSt cua d6i tugng phan tich

trong dugc li?u

Bang 3.2 Kit qua djnh lugng hgp chat dSc tnmg trong dugc lieu

Bang 3.3 Tom tat cdc phucmg phap chiit

Bang 3.4 Hieu suit va lugng hgp chit toan phin thu dugc giai doan chiit xuit Bang 3.5 Tom tit phuang phap va diiu kien phan lap (PL)

Bang 3.6 Hieu suat, lugng chat PL dugc va ham lugng hgp chit thu dugc

Bang 3.7 Tom tat phuang phap va dieu kien tinh che (TC)

Bang 3.8 Hieu suat, lugng chat ket tinh dugc va ham lugng hgp chit thu dugc

Bang 3.9 Dac diem hinh thai cac chat thu dugc

Bang 3.10 Ket qua do diem chay

Bang 3.11 Ket qua do ph6 tir ngoai kha kiin (UV - VIS)

Bang 3.12 Ket qua do pho hong ngoai (IR)

Bang 3.13 Kit qua do phd khii lugng (ESI MS)

Bang 3.14 Ket qua do pho cpng hucmg tir hat nhan (NMR)

Bang 3.15 Ket qua do DSC cua mpt so chat

Bang 3.16 Cgt phan tich HPLC da khao sat xay dyng phuang phap phan tich

Bang 3.17 Khao sat pha dgng va thanh phan pha dpng

Bang 3.18 Mgt s6 thong so the hien sy phii hgp ciia he HPLC da lya chgn

Bang 3.19 Khao sat buoc song phat hien

Bang 3.20 Kit qua khao sat dp luyen tinh

Bang 3.21 Kit qua khao sat dp chum

Bang 3.22 Kit qua khao sdt do dung

DANH MUC CAC BANG VA CAC HINH

DANH MUC CAC BANG

Bang 2.1 Bieu kien sic ky (HPLC) phan lich djnh tinh va djnh lugng cac chit trong dugc lieu va trong san pham chiit, phan lap va tinh chi

Bang 2.2 Tom tit xir ly mau thir va ndng dp phan tich

Bang 2.3 Tom tat cac chi tieu va phuong phdp thir cua cac chat CDC

Bang 2.4 Quy tic lam trim s6

Bang 2.5 Hudng dan loai bd gia trj thd

Bang 2.6 Md hinh phdng thir nghiem

Bang 2.7 Bang ANOVA

Bang 2.8 Bang tdm tit cdch tinh gia trj in djnh

Bang 3.1 Cac phep thir djnh linh su dung trong kiim tra sy c6 mat ciia ddi tugng phan tich trong dugc lieu

Bang 3.2 Kit qua djnh lugng hgp chit dac trung trong dugc lieu

Bang 3.3 Tdm tat cdc phuang phap chiit

Biing 3.4 Hieu suat va lugng hgp chit toan phan thu dugc giai doan chiit xuit Bang 3.5 Tdm tit phucmg phap va diiu kijn phan lap (PL)

Bang 3.6 Hieu suat, lugng chit PL dugc va ham lugng hgp chit thu dugc

Bang 3.7 Tdm tit phucmg phap va diiu kien tinh chi (TC)

Bang 3.8 Hieu suat, lugng chit kit tinh dugc va ham lugng hgp chit thu dugc

Bang 3.9 Bac diem hinh thai cac chit thu dugc

Bang 3.10 Ket qua do diem chay

Bang 3.11 Kit qua do phd tir ngoai kha kiin (UV - VIS)

Bang 3.12 Ket qua do phd hdng ngoai (IR)

Bang 3.13 Ket qua do phd khdi lugng (ESI MS)

Bang 3.14 Ket qua do pho cdng hudng tir hat nhan (NMR)

Bang 3.15 Ket qua do DSC cua mgt sd chat

Bang 3.16 Cpt phan tich HPLC da khdo sdt xdy dyng phucmg phap phan tich

Bang 3.17 Khdp sdt pha d$ng vd thanh phan pha dpng

Bang 3.18 Mdt sd thdng sd thi hien sy phii hgp ciia he HPLC da lya chpn

Bang 3,19 Khdo sdt budc sdng phat hien

Bang 3.20 Ket qud khao sat dp tuyen tinh

Bang 3.21 Ket qua khdo sdt do chum

Bang 3.22 Kit qua khao sdt dp dung

Bang 3.25 Diem chay cua 10 hgp chit d5c trung, nguyen lieu thiet lap chat chuan

Bang 3.26 Ket qua phan tich tap trong mau thir acid chlorogenic

Bang 3.27 Ket qua phan tich tap trong mau thir conessin

Bang 3.28 Kit qua phan tich tap trong mau thir holotliwin B

Bang 3.29 Ket qua phan tich tap trong mau thir kaempferol

Bang 3.30 Ket qua phan ti'ch tap trong mau thir linarin

Bang 3.31 Ket qua phan tich tap trong mau thOr malloapelta B

Bang 3.32 Ket qua phan ti'ch t^p trong mau thir myricetin

Bang 3.33 Ket qua phan tich tap trong mau thii nuciferin

Bang 3.34 Ket qua phan tich tap trong mau thii phyllanthin

Bang 3.35 Ket qua phan tich tap trong mau thir silybin

Bang 3.36 Ket qua dinh lucmg mau thir acid chlorogenic

Bang 3.37 K^t qua djnh \uqng mau thu conessin

Bang 3.38 Ket qua dinh lucmg mau thir holothurin B

Bang 3.39 KM qua dinh lu(?ng mau thir kaempferol

Bang 3.40 Ket qua dinh lucmg mau thir linarin

Bang 3.41 K^t qua dinh luong mau thir malloapelta B

Bang 3.42 Ket qua dinh lugng mau thu myricetin

Bang 3.43 K^t qua dinh lu-gng mlu thir nuciferin

Bang 3.44 K£t qua dinh lugng mau thitphyllanthin

Bang 3.45 Kit qua dinh lugng mlu thur silybin

Bang 3.46 Ket qua danh gia dg ddng nhit 16

Bang 3.47 Kh qua ham lugng chinh thuc cua cac chat chuan ghi tren nhan

Bang 4.1 KSt qua dat dugc ciia nghien cu-u chiet, phan lap va tinh che chat Bang 4.2 S6 lieu thdm dinh phuong phap HPLC

Bang 4.3 Cac chi tieu da danh gia

Bang 4.4 KSt qua chit lugng hgp chAt dSc trung truoc khi thiit lap chit chuan Bang 4.5 Kit qua kiim tra d6ng nhit 16

Bang 4.6, S6 lugng chat chuin da san xuat

Hinh 1.1 Mpt sd hpp chat phan lap dugc tir loai Hdi Sdm

Hinh 1.2 Ciu true cua holothurin B va holothurin A

Hinh \.i Acid Chlorogenic tis Kim Ngdn Hoa, Flos Lonicerae japonicae

Hinh 1.4 Conessin tit Mgc Hoa Tring, Cortex Hollarenae antidysentericae

Hinh 1.5 Holothurin B Ms Hai Sdm, Holothuria scabra

Hinh 1.6 Kaempferol tu Don Ld Bo, Folium Excoecariae cochinchinesis

Hinh 1.7 Linarin tir Ciic Hoa, Flos Chrysanthemi indici

Hinh 1.8 Malloapelta B tir Bum Bup, Folium Mallotus apeltae

Hinh 1.9 Myricetin tir Che Day, Folium Ampelopsis cantoniensis

Hinh 1.10 Nuciferin tCr Ld Sen, Folium Nelumbinis niciferae

Hinh 1.11 Phyllanthin tis Digp Hg Chdu, Herba Phyllanthi amari

Hinh 1.12 Silybin tir Ciic Gai, Fructus Silybi mariani

Hinh 1.13 Thiit bj sic ky tham qua ge/: (A, B) mpt sd bp phan eg ban cua cpt, (C) mpt he

thdng sic ky tham qua gel ty dpng

Hinh 1.14 SKD md ta the tich phan tach ciia qud trinh lpc gel va mpt phin ciu true cua pha tinh Sephadex LH20

Hinh 1.15 Mgt so hinh dnh md ta viec sir dung cdt sac ky trong phan lap

Hinh 1.16 He thdng sic ky Idng bdn dieu che Shimadzu LC 8A t^i Vien Dugc lieu Hinh 1.17.Mpt sd hinh anh ve cgt sac k^ ban dieu che/dieu che: (A) sa dd cau tag cdt; (B) cdt sac ky dieu che nhdi sin ((p 50 mm, L 500 mm); (D): phan biet sic ky phan tich, sic ky bdn dieu che va dieu che

Hinh 1.18 Thiit bi LC-MS va nguyen ly cua kj thuat phan tich ESI MS

Hinh 1.19 Bao quan chat chuan tai Vien Kiem nghiem Indonesia

Hinh 1.20 Hinh anh mpt sd chit chuan doi chiiu hda hpc: (A) chuin dugc diin My USPCRS, (B) chuin Qudc ti va (C) chuan khu vyc Asean

Hinh 2.1 Mpt sd thiit bj sir dung trong nghien ciru

Hinh 3.1 SKB cda dung djch ddi chiiu acid chlorogenic vd dich chiit dugc lieu Kim Ngdn

Hoa dual anh sang thuang vd duoi den tu ngoai 366 nm

Hinh 3.2 SKD cua dung dich ddi chiiu conessin va djch chiit dugc lieu Mirc Hoa Trdng

phun thudc thiir hi$n mdu Dragendoff, quan sat dual anh sang thuong

Hinh 3.3 SKD ciia dung dich ddi chieu holothurin B va djch chiit Hdi Sdm sau khi hien

mau quan sdt dudi dnh sdng thuong

Hinh 3.5 SKD ciia dung dich ddi chiiu linarin va djch chiit Ciic Hoa, sau khi hien mdu

quan sdt dudi dnh sdng thuong va dudi den UV 254 nm

Hinh 3.6 SKD cua dung dich doi chiiu malloapelta B va djch chiit Bum Bup, sau khi hien

mdu va quan sdt dudi anh sdng thugng

Hinh 3.7 SKD ciia dung djch doi chiiu myricetin (M), dihydro myricetin va djch chiit

dugc lieu Che Ddy dudi dnh sdng diudng vd dudi den tir ngoai 254 nm

Hinh 3.8 SKD cua dung djch doi chiiu nuciferin va djch chiit Ld Sen quan sat dudi anh

sdng thuong

Hinh 3.9 SKD ciia dung dich ddi chiiu phyllantin va djch chiit Diep Hg Chdu quan sdt

dudi dnh sang thuong

Hinh 3.10 SKD cua dung dich ddi chiiu silybin vd djch chiit Ciic Cai quan sdt dudi dnh

sdng thudng

Hinh 3.11 SKB dung djch thir Kim Ngan Hoa (A) va acid chlorogenic doi chiiu (B) phdn

tich bing HPLC - PDA

Hinh 3.12 SKB ciia phan doan cloroform cua dich chiet Hdi Sdm phan tich bing HPLC

-PDA (hinh A) va tiem tryc tiep vao detector MS cua LC MS (hinh B)

Hinh 3.13 SKD dung djch thir mau Dem Ld Dd phan tich bdng HPLC - PDA (A) va dung

dich ddi chieu kaempferol (B)

Hinh 3.14 SKB dung dich thir mdu Cue Hoa Ngi Mdng phdn tich bSng HPLC - PDA (A)

va dung dich ddi chieu linarin (B)

Hinh 3.15 SKD ciia phan doan cloroform ciia djch chiet Biim Bup phan tich bing HPLC

-PDA (hinh A) vd tiem tryc tiep vdo detector MS cua LC MS (hinh B)

Hinh 3.16 SKD dung djch thir mau djch chiit Ld Sen va dung dich ddi chiiu nuciferin

phan tich bing HPLC - PDA (A, B, C) va phan tich bing MS (D)

Hinh 3.17 Kiim tra phdn tir lugng ciia cdc hgp chat PL dugc bing phd khdi (ESI MS)

Hinh 3.18 Phd tir ngoai kha kiin (UV - ViS), ghi tir 200 - 900 nm cua mdu thit acid

Hinh 3 JO Phd hdng ngoai (IR) ciia mdu thir holothurin B, 2.000 - 400 cm"

Hinh 3 J 1 Phd hdng ngoai (IR) ciia mau thir kaempferol, 2.000 - 400 cm"

Hinh 332 Phd hdng ngoai (IR) ciia mdu thu linarin, 2.000 - 400 cm"

Hinh 333 Phd hdng ngoai (IR) ciia mau thu malloapelta B, 2.000 - 400 cm"

Hinh 3.34 Phd hdng ngoai (IR) ciia mlu thii myricetin, 2.000 ~ 400 cm"

Hinh 335 Phd hdng ngoai (IR) ciia mau thir nuciferin, 2.000 - 400 cm"

Hinh 336 Phd hdng ngoai (IR) ciia mdu this phyllanthin, 2.000 - 400 cm"'

Hinh 3.37 Phd hdng ngoai (IR) ciia mau thir silybin, 2.000 - 400 cm"'

Hinh 3.38 Phd khdi (ESI MS) ciia mau thii acid chlorogenic

Hinh 339 Phd khdi (ESI MS) ciia mau thir conessin

Hinh 3.40 Phd khdi (ESI MS) ciia mau thir holothurin B

Hinh 3.41 Phd khdi (ESI MS) ciia mlu thir kaempfiirol

Hinh 3.42 Phd khdi (ESI MS) ciia mlu thu linarin

Hinh 3.43 Phd khdi (ESI MS) ciia mau thu malloapeha B

Hinh 3.44 Phd khdi (ESI MS) ciia mau thir myricetin

Hinh 3.45 Phd khdi (ESI MS) cua mdu thir nuciferin

Hinh 3.46 Phd khdi (ESI MS) cua mau this phyllanthin

Hinh 3.47 Pho khii (ESI MS) cua mau thir lilyhin

Hinh 3.48 Phd cdng hudng tir hat nhan ( ' H - N M R , " C - N M R ) ciia mlu thir acid

chlorogenic