Tiêu chuẩn iso 18668 1 2016

INTERNATIONAL STANDARD ISO 8668-1 First edition 01 6-04-01 Traditional Chinese medicine — Coding system for Chinese medicines — Part : Coding rules for Chinese medicines Médecine traditionnelle chinoise — Système de codage des médecines chinoises — Partie : Règles de codage des médecines chinoises Reference number ISO 8668-1 : 01 6(E) © ISO 01 ISO 18668-1:2 016(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2016, Published in Switzerland All rights reserved Unless otherwise speci fied, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester ISO copyright office Ch de Blandonnet • CP 401 CH-1214 Vernier, Geneva, Switzerland Tel +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org ii © ISO 2016 – All rights reserved ISO 18668-1:2 016(E) Contents Page Foreword iv Introduction v Scope Normative references Terms and de initions f Coding principles 4.1 4.2 4.3 4.4 4.5 Uniqueness Scienti fic integrity Scalability Compatibility Stability Coding technology Technical basis Structure Detailed description 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6 5.1.7 5.1.8 5.1.9 5.1.10 Layer Layer Layer Layer Layer Layer Layer Layer Layer Layer 10 Annex A (normative) Code table of layer to layer Annex B (normative) Calculation of check digit 17 Annex C (informative) Examples 18 Bibliography 2 © ISO 01 – All rights reserved iii ISO 18668-1:2 016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies) The work of preparing International Standards is normally carried out through ISO technical committees Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part In particular the different approval criteria needed for the different types of ISO documents should be noted This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part (see www.iso.org/directives) Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights ISO shall not be held responsible for identifying any or all such patent rights Details of any patent rights identi fied during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents) Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement For an explanation on the meaning of ISO speci fic terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers to Trade (TB T) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 249, T ditio n a l Ch in e se ISO 18668 consists of the following parts, under the general title s ystem — — — — iv f o r Ch in e se m edicin e s m edicin e T ditio n a l Ch in e se m edicin e — Co din g : Pa rt : Co din g ru le s f o r Ch in e se m e dicin e s Pa rt 2: Co de s f o r deco ctio n Pa rt 3: Co de s f o r Ch in e se m a teria Pa rt 4: Co de s f o r g n u le f o rm s o f in dividu a l m edicin a ls f o r p re scrip tio n s p iece s m e dica © ISO 01 – All rights reserved ISO 18668-1:2 016(E) Introduction As the p h a r m ac e u tic a l m ate r i a l s e x trac te d fro m n atu r a l a nd b o ta n ic a l p ro duc t s h ave b e co me increasingly attractive, signi ficant progress has been achieved in identifying new sources of natural p ro duc ts fo r trad i ti o n a l a nd a l te r n ati ve me d ic i ne I n p a r ti c u l a r, C h i ne s e trad i tio n a l me d ic i ne h a s b e e n the focus of tremendous research, development and applications worldwide Accordingly, Chinese medicinal materials are increasingly being used in countries around the world Currently, there are more than 70 countries that have established administrative systems to regulate Chinese Medicine At p re s e n t, the a n nu a l s a le o f C h i ne s e me d ic i ne s has re ac he d mo re th a n U S D 16 b i l l i o n a nd is i nc re a s i n g at a rate of 10 % to 20 % per year with great future potential At the same time, concerns of harm to the body associated with the long-term use of synthetic drugs have been recognized Therefore, many countries are developing vigorous controls and regulations on using antibiotics and other synthetic d r u gs , wh i le re c o g n i z i n g the i mp o r t a nce o f trad i tio n a l a nd a l te r n ati ve me d ic i ne s T hu s , th i s b r i n gs mo re o p p o r tu n i tie s fo r the de ve lo p me n t o f the m a rke t o f C h i ne s e me d ic i ne s Today, bar codes are widely used for managing almost all ordinary products that are put up for sale, for example, an eraser or a pencil has its individually identi fiable bar code Yet so far, a bar coding system for products used in Chinese medicine has not been given sufficient attention, making it difficult to c ate go r i z e the i nd i vi du a l i te m s fo r i n te r n ati o n a l tr ade a n d re s e a rch de ve lo p me nt T h i s b r i n gs ch a l le n ge s and concerns in government supervision and proper use by patients As products for medicinal use, Chinese medicines could have bar codes that can be integrated into the current bar code system that is used for other commercial products In this way, bar codes can be used to track sources and monitor the quality of the products Therefore, there is an urgent need to develop a bar code system for Chinese medicine products that will enable to identify each speci fic Chinese medicine product The Coding System of Chinese Medicines is developed based on science and research rooted in plant taxonomy, Chinese medicine, Chinese medicinal processing, and other established regulatory handbooks and guidelines of GS1 General standard, central product classi fication (CPC) and ISO/IEC 15420, etc The codes help to translate complicated names of a wide variety of decoction pieces, Chinese Materia Medica (raw materials), and granule forms of individual medicinals for prescriptions into transparent digits In this way, each Chinese medicine corresponds to a unique code as its identi fication The Coding System of Chinese Medicines aims to promote standardization and digitalization for Chinese medicine, to ensure authenticity, equality, fairness and transparency in international markets a n d trade a n d to fac i l i tate go ve r n me n t s up e r vi s i o n a n d re g u l ati o n o f C h i ne s e me d i c i ne I t i s ho p e d th at it will help pharmaceutical enterprises to manage work flow and increase economic returns It will help healthcare delivery organizations, such as hospitals and dispensaries, to improve information management systems that can ensure the accuracy of dispensing, ensuring the safe and effective use of p re s c r ib e d me d ic i ne As it has been previously acknowledged, Chinese decoction pieces are processed products of Chinese Materia Medica, which are also known as raw materials Thus when designing the coding system for Chinese medicines, it is feasible that one set of rules could incorporate all the features of each category of Chinese medicines, as they share the same medicinal source and medical part To be speci fic, their divergence and commodity attributes can be clearly described in one of the layers (layer 8) in this set o f co d i n g r u le s Gr a nu le fo r m s o f i nd i v idu a l me d ic i n a l s fo r p re s c r i p ti o n s a re i n no vati ve p ro duc ts m ade from decoction pieces Based on the same considerations of feasibility and cost-control, the granular fo r m s c a n b e i nclude d w i th i n the s a me s e t o f r u le s fo r de co c ti o n p i e c e s However, although Chinese patent medicines (CPM) are made from decoction pieces, their coding rules are more complicated and differ from decoction pieces Therefore, this coding system is not fit for CPM, and coding rules for CPM need to be formulated separately © I S O – Al l ri gh ts re s e rve d v INTERNATIONAL STANDARD ISO 18668-1:2 016(E) Traditional Chinese medicine — Coding system for Chinese medicines — Part : Coding rules for Chinese medicines Scope This part of ISO 18668-1 speci fies rules to encode Chinese medicines, including decoction pieces, Chinese Materia Medica (raw materials) and granule forms of individual medicinals for prescriptions (GFIMP), but not Chinese patent medicines (CPM) Re le va n t c o d i n g s ta n d a rd s fo r Ka mp o me d i c i ne , Ko re a n me d i c i ne a n d o the r trad i tio n a l me d ic i ne s w i l l be separately formulated as needed by experts in these areas This part of ISO 18668-1 is suitable for decoction pieces, Chinese Materia Medica (raw materials), and granule forms of individual medicinals for prescriptions (GFIMP) in the fields of clinical medication, scienti fic research and teaching, and statistics and management Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application For dated references, only the edition cited applies For undated references, the latest edition of the referenced document (including any amendments) applies Information technology — Automatic identification and data capture techniques — EAN/UPC bar code symbology specification I S O/ I E C 42 , 3 Terms and de initions f For the purposes of this document, the following terms and de finitions apply Chinese medicine substance or combination of substances used under the guidance of traditional Chinese medicine (TCM) theory for medical care and the prevention and treatment of disease Note to entry: This includes Chinese Materia Medica, decoction pieces, granule forms of individual medicinals for prescriptions (GFIMP), and Chinese patent medicines (CPM) Chinese Materia Medica CMM medicinal parts of medicinal plants, animals, and minerals after preliminary processing, which are u s e d a s r aw m ate r i a l s i n C h i ne s e me d ic i ne s Note to entry: This refers to the raw materials used to make decoction pieces © I S O – Al l ri gh ts re s e rve d ISO 18668-1:2 016(E) 3.3 decoction piece prescription medicinal processed from Chinese Materia Medica under the guidance of TCM and p ro ce s s i n g me tho d s fo r C h i ne s e me d ic i ne s Note to entry: Decoction pieces are directly used in clinical practice or the production of prepared medicines granule form of individual medicinal for prescriptions GFIMP granular preparation processed from single decoction piece after extraction, concentration, and drying Note to entry: This refers to a preparation of decoction pieces that can be directly dispensed without decocting layer s e t o f the ch a rac te r s w i th i n the c o de EXAMPLE A sub- field within the code Coding principles 4.1 Uniqueness Each variety and processed form corresponds to a unique code 4.2 Scienti ic integrity f T he mo s t s t ab le p ro p e r ti e s , at tr i b u te s , o r ch a r ac te r i s tic s o f e ach C h i ne s e me d i c i ne a re s e le c te d a s b a s i s for classi fication and coding The basic attributes, the main applications, as well as its quality, of each Chinese medicine are re flected in the codes 4.3 Scalability The coding rules allow sufficient space for expansion 4.4 Compatibility T he c o d i n g r u l e s a re c o n s i s te n t w i th re le va n t e x i s ti n g I n te r n atio n a l S ta nd a rd s 4.5 Stability T he co de fo r e ac h C h i ne s e me d ic i ne re m a i n s u nc h a n ge d o nc e a s s i g ne d , a s lo n g a s the b a s ic c h a r ac te r i s tic o f the me d ic i n a l e s no t ch a n ge E ve n i f s o me C h i ne s e me d i c i ne s a re d i s c o n ti nue d fo r p ro duc tio n a nd u s e , the i r c o de s s ho u ld s ti l l b e ke p t Coding technology 5.1 5.1.1 Technical basis Layer Layer with digit, Chinese medicines, with the categories of agriculture, forestry, animal husbandry, and fishery are symbolized by 0, which is developed according to central product classi fication (CPC) developed by United Nations Statistical Commission © I S O – Al l ri gh ts re s e rve d ISO 18668-1:2 016(E) 5.1.2 Layer Layer with digit, the product code of Chinese medicines, symbolized by 6, is developed according to the request of CPC and GB/T 7635.1-2002 It is used to express the natural and commodity properties of Chinese medicines, which is important for identi fication and trade 5.1.3 Layer Layer with digit, the main code of medicinal source, is encoded according to classi fication and codes of plants, which is based on Linnaean taxonomy categories with the modern Five Kingdoms classi fication In layer 3, refers to plant, refers to animal, refers to mineral, refers to fungus, refers to lichen, refers to algae, and refers to mi xed kingdom 5.1.4 Layer Layer with digits (‘001’ to ‘999’), the subdivided code of medicinal source, indicates sources (family or group) and serial numbers of C hinese medicines 5.1.4.1 In the plant category, different families of plants are encoded according to a certain classi fication rule from lower plants to higher plants In layer 4, for the first digit, refers to liverwort, refers to moss, refers to pteridophytes, refers to gymnosperm, and refers to Archichlamydeae of dicotyledoneae, refers to Sympetalae of dicotyledoneae, and refers to monocotyledon and are designed for future extension as needed In the animal category, different families of animals are encoded according to a certain classi fication rule from lower animals to higher animals, followed by Porifera, Coelenterata, Annulata, Mollusca, Arthropoda, Ectoprocta and Phylum Chordata 5.1.4.2 5.1.4.3 In the mineral category, groups of minerals are encoded according to a certain classi fication rule from simple minerals to complex minerals, followed by Elemental mineral, Sul fides and Related Analogues, Oxides and hydroxides, Oxysalt, Halide,Magmatic rocks, Metamorphic rocks, and Fossils 5.1.5 Layer Layer with digit, the main code of medicinal part, ranged from to 9, in which different numbers s tand for different kinds of medicinal parts 5.1.5.1 In the plant category, medicinal parts are divided into roots and bulbs, stems, woods, cortex and leaves, flowers, fruits and seeds, whole plants, and other products, symbolized by 1, 2, 3, 4, 5, and respectively 5.1.5.2 In the animal category, medicinal parts are divided into subdivisions One indicates the whole animal and eviscerated animal, indicates animal skin, horn, scale, conch, indicates animal skeleton and visceral organ, indicates animal product and processed goods 5.1.5.3 In the fungus category, medicinal parts are divided into mycelium, sporocarp, and other products, which are symbolized by 1, 2, and respectively 5.1.6 Layer Layer with digits, the subdivided code of medicinal part, ranged from 01 to 99, is the second order division For instance, as a type of medicinal plant part, rhizomes and roots can be divided into subdivisions such as root, fibrous root, and so on; while flowers can be divided into subdivisions as in florescence, simple flower, flower bud, receptacle, stamen, and pistil © ISO – All rights reserved ISO 18668-1:2 016(E) 5.1.7 Layer Layer with digits, the varieties code of Chinese medicines ranged from 001 to 999 is the sequence number of the medicinal located in the code table for C hinese medicines from the same medicinal part of the same family EXAMPLE Both Decoction pieces of Arisaematis Rhizoma (code: 06191610600100005) and Pinellia Tuber (code: 06191610600200002) are derived from Tuber of Araceae Their codes are same from layer to 6, i.e 061916106, but codes of layer are different, i.e Arisaematis Rhizoma encoding as 001, referring as the No.001 decoction pieces derived from Tuber of Araceae, Pinellia Tuber encoding as 02 , referring as the No 02 decoction pieces derived from Tuber of Araceae 5.1.8 Layer Layer with digits, ranged from 00 to 99, is used to indicate speci fications of Chinese medicines 00 indicates purifying, 01 indicates extremely thin pieces (thinner than 0,5 mm), 02 indicates thin pieces (1 mm to mm) , 03 indicates thick pieces (2 mm to mm) or pieces, indicates segments, 05 indicates blocks, 06 indicates shreds, 07 indicates powder, 08 indicates fresh medicinal, 09 indicates granule forms of individual medicinals for prescriptions, 99 indicates Chinese Materia Medica If there are more than one kind of cutting speci fications of the same Chinese medicine, the commonly used one is selected in order to reach uni fication For example, Rhubarb can be speci fied both as piece and block, among which block is selected to stand for the speci fication code 5.1.9 Layer Layer with digits, ranged from 00 to 99, is used to indicate the processing methods of Chinese medicines The first and second digits indicate processing methods and requirements respectively For example, as the first digit indicates plain stir-frying, while 11 and 12 indicate stir-frying until yellowish and stir-frying until brown The number as the first digit indicates stir-frying with a solid adjuvant, while 21 indicates stir-frying with bran, 22 with sand, 23 with talcum powder, 24 with clamshell powder, 25 with rice, 26 with soil, 27 with cattail pollen The number as the first digit indicates stir-frying with a liquid adjuvant, while 31 indicates stir-frying with wine, 32 with vinegar The number as the first digit indicates processing to scorch, while 41 indicates stir-frying to scorch, 42 indicates calcining to scorch 9 indicates other processing methods 5.1.10 Layer 10 Layer 10, is the check digit with one number, which refers to the last number calculated by a certain kind of operation method to test the accuracy of the 16 numbers former Check digit is calculated by the method in ISO/IEC 15 420 5.2 Structure Coding rules are represented by 10 layers with 17 digit Arabic numerals in order, as shown in Figure © ISO 01 – All rights reserved ISO 18668-1:2 016(E) Table A.2 — Classi ication code of animal sources (family) f Phylum Class Porifera Demopongiae Coelenterata Actinozoa Annulata Oligochaeta Hirudinea Lamellibranchia Mollusca Gastropoda Spongillidae 001 Melitodidae Dendrophylliidae Megascolecidae 022 Lumbricidae 032 Hirudinidae 041 Ostreidae 051 Veneridae 052 Arcidae 053 Haliotidae 061 021 031 Cypraeidae 062 Sepiidae 071 Chilopoda Scolopendridae 081 Grapsidae 091 Calliphoridae 092 Palaemonidae 093 Pentatomidae 101 Corydiidae 102 Coccidae 103 Mantidae Meloidae 104 Vespidae 106 Apidae 107 Cicadidae 108 Bombycidae 109 Arthropoda Insecta 10 Code (Layer 4) Cephalopoda Crustacea Ectoprocta Scores 105 Lacciferidae 110 Gryllotalpidae Cynipidae 111 112 Tabanidae 113 Scarabaeidae 114 Gryllidae 115 Formicidae 116 Myrmeleontidae Staphylinidae 117 118 Calliphoridae 119 Blattellidae 120 Arachnoida Buthidae 151 Gymnolaemata Poricellariidae 181 Hominidae 201 Bovidae 202 Equidae 203 Manidae 204 Suidae 205 © ISO 2016 – All rights reserved ISO 18668-1:2 016(E) Table A.2 (continued) Phylum Class Mammalia Code (Layer 4) Scores C e r v i d ae 206 Ve s p e r ti l i o n i d ae 07 Mustelidae 208 C a n i d ae 209 P e t au r i s ti d ae 10 P h o c i d ae 211 E l e p h a n ti d ae 212 E r i n ac e i d ae 213 R a n i d ae 31 B u fo n i d ae 232 P h a s i a n i d ae 41 A n a ti d ae 42 C u c u l i d ae 43 A mp h i b i a Phylum Chordata Ave s C o l u b r i d ae 51 Emydidae Re p ti l i a 52 E l ap i d ae 253 G e k ko n i d ae 254 Vi p e r i d ae 255 Trionychidae 256 C he l o n i i d ae 257 Hydrophiidae 258 A ga m i d ae 259 Syngnathidae 71 S c i ae n i d ae 272 Cyprinidae P i s ce s 273 P e g a s i d ae 74 Tr i a k i d ae 75 Multi-sources Classi fication code of mineral sources are presented in 999 Tab l e A Table A.3 — Classi ication code of mineral sources (group) f Main category Subdivided category Metals E l e m e n ta l m i n e r a l N o n m e ta l s Mixture of metals and nonmetals Sul fides and Related Analogues Monosul fide D i s u lp h ide NOTE Classi fied according to the anion type of mineral sources © I S O – Al l ri gh ts re s e rve d Source I ro n Code (Layer 4) 01 N at u r a l s u l fu r 031 S te e l 81 G a l e n i te 101 C i n n ab a r 102 Re a l g a r 103 Pyrite 121 11 ISO 18668-1:2 016(E) Table A.3 (continued) Main category Subdivided category Oxides and hydroxides Code (Layer 4) Source C o r u n du m 141 S o ft m a n ga n e s e o r e 142 Qu a r tz 143 Magnetite O x i de s 14 A r s e n o l i te Hydroxides I n o s i l i c a te s 14 L i mo n i te 71 A mp h i b o l e 01 Ta l c u m 221 Muscovite Phyllosilicates B o r ate s Oxysalt 222 K ao l i n i te 223 Ve r m i c u l i te 224 B o x 41 Anhydrite Melanterite S u l fa te s 61 62 A l u n i te 63 G l au b e r ’s s a l t s 264 B l u e v i tr i o l 65 C a rb o n a te s C a l c i te 266 N i tr ate s S a l t p e te r 81 F luo r ide s F l uo r i te 01 H a l i te 321 H a l i de C h l o r i de s a n d b r o m i o d i de s Magmatic rocks Metamorphic rocks Magmatic rocks Metamorphic rocks Fo s s i l s Fo s s i l s NOTE 145 Mercuric oxide Mercurous chloride S a l a m mo n i ac 333 E r up ti ve r o c k 61 Metamorphic rocks Fo s s i l s Classi fied according to the anion type of mineral sources 322 81 Multi-sources Classi fication code of fungus, lichen, and algae sources are presented in 71 999 Tab l e A Table A.4 — Classi ication code of fungus, lichen, and algae sources (family) f Kingdom Source Lycoperdaceae Polyporaceae Fungus 01 02 C l av i c i p i t ac e ae 03 Tr i c ho l o m at ac e ae 004 Au r i c u l a r i ac e ae 005 A ga r i c ac e ae 006 Hydnaceae 12 Code (Layer 4) 07 © I S O – Al l ri gh ts re s e rve d ISO 18668-1:2 016(E) Table A.4 (continued) Kingdom Source Code (Layer 4) S a r ga s s ac e ae 01 O s c i l l a to r i ac e ae 02 D e l e s s e r i ac e ae 03 L a m i n a r i ac e ae 004 L ichen A l g ae U m b i l i c a r i ac e ae 01 U s n e ac e ae 02 Classi fication code of medicinal parts are presented in Tab l e A Table A.5 — Classi ication code of medicinal parts f Main code (Layer 5) category R h i z o me a nd ro o t S tem , wo o d , b a rk a nd le a f Subdivided code (Layer 6) code category code Tap r o o t 01 F ib ro u s ro o t 02 Ro o t a n d rh i z o me 03 Ro o t t u b e r 04 R h i z o me 05 Tu b e r 06 B u lb 07 C o r m , p s e u b u l b 08 Liana 01 R a mu l u s/ B r a n c h 02 S te m th o r n a n d p i th 03 Wo o d a n d h e a r t wo o d/ L i g nu m 04 S te m B a rk 05 Ro o t b a rk 06 L e a f b l ade 07 P e ti o l e 08 E r e c t s te m 09 H e rb ac e o u s s te m 10 S u c c u l e n t s te m 11 S te m , b r a nc h a n d l e a f 12 In florescence Simple f lower Pl a nts F l o we r 02 F l o we r b u d 03 Re c e p t ac l e 04 Stamen or anther, pollen, filament Pistil or stigma, style, ovary S pic a Persistent calyx © I S O – Al l ri gh ts re s e rve d 01 05 06 07 08 13 ISO 18668-1:2 016(E) Table A.5 (continued) Main code (Layer 5) category code F r u i t a nd s e e d T he Subdivided code (Layer 6) who l e plant category code Unripe or young fruit Ripe or nearly ripe fruit 01 02 — 03 Pe r ic a r p o r e xo c a r p , me s o c a r p , s a rc o c a r p , e n c a r p 04 Ke r n e l 05 Seed 06 S e e d co at 07 Ari l 08 O th e r 09 W ho l e p l a n t/ H e rb 01— 02 Ab o ve g r o u n d p a r t/ae r i a l p a r t 05 —06 Sp o re 01 Re s i n 02 Pl a nt o i l 03 P r o c e s s e d go o d s 08 O th e r p a r t 09 T he wh o l e a n i m a l 01 E v i s c e r ate d a n i m a l 02 S ki n 01 Horn 02 S c a le a nd co nch 03 S ke l e to n 01 Vi s c e r a l o r ga n 02 A n i m a l p r o d uc t 01 P r o c e s s e d go o d s 02 O th e r 09 and g ro u nd p l a nt O th e r p r o du c ts T he wh o l e animal and e v i s c e r ate d a n i m a l A n i m a l s ki n , ho r n , s c a l e , co nch An ima l s A n i m a l s ke l e to n a n d v i s cera l o rga n A n i m a l p ro du c t a nd p r o c e s s e d go o d s Mineral Mineral Mycelium 1 01 Fungus Sporocarp (fruiting body) 01 Fungus S p o ro c a r p O the r p r o du c ts O th e r 01 A l gae F ro nd Fro nd 01 L i c he n T h a l lu s T l lu s 01 M i x e d Mixed kingdom ki n gd o m Mineral Mixed kingdom Speci fication and processing codes are presented in 14 01 01 Tab le A © I S O – Al l ri gh ts re s e rve d ISO 18668-1:2 016(E) Table A.6 — Speci ication and processing code f Speci ication (Layer 8) Category and speci ication code of CMM, decoction pieces, and GFIMP Processing (Layer 9) f f Code Main processing Purifying (e.g eliminating impu- rities and removing non-medical Subdivided processing Code Purifying 00 Stir-frying until yellow 11 02 Stir-frying until brown 12 03 Stir-frying with bran 21 00 parts) Extremely thin pieces (thinner than 0, mm) Thin pieces (1 mm to mm) T h ick pie ce s (2 m m to m m) D e c o c t i o n or pieces pieces 01 Segments 04 Blocks 05 Shreds 06 Plain stir-frying Stir-frying with sand (scalding) Stir-frying with solid adjuvant Stir-frying with clamshell powder 22 23 Powder 07 Use fresh 08 Stir-frying with talc powder Stir-frying with rice Stir-frying with earth 09 Stir-frying with cattail pollen 27 99 Wine 31 Vinegar 32 Salt 33 Ginger 34 Stir-frying with Honey liquid adjuvant Soil 35 Granu le form s of i nd i vidua l me d ic i n a l s for prescriptions (GFIMP) Chinese Materia Medica (CMM) 25 26 36 P ro ce s s i ng to Gancaozhi (Liquorice juice) Wuzhuyuzhi (Evodia fruit juice) Other adjuvant Stir-frying to scorch scorch Calcining to scorch 42 Calcining openly 51 Calcining and quenching 52 Without adjuvant 60 Calcining Wine © ISO 01 – All rights reserved 24 37 38 39 41 61 S t e a m i n g o r Vinegar 62 s tewing Salt 63 Autoclaving 64 Other adjuvant 69 15 ISO 18668-1:2 016(E) Table A.6 (continued) Speci ication (Layer 8) Category and speci ication code of CMM, decoction pieces, and GFIMP Processing (Layer 9) f f Code Main processing Subdivided processing Without adjuvant Gancao (Liquorice) as main D e co c ti ng or rep eate d pro cessing adjuvant Shengjiang (Fresh Ginger) as main adjuvant B fan (Alu m) as mai n ad- 70 71 72 juvant Solid adjuvant as main ad juvant Other adjuvant 73 Roas ting 80 Simmering/braising 81 C han (one method of water O thers Code 74 79 82 and fire processing) Crystallizing or powdering Making herbs into wool 84 83 Grinding with water 85 Sprouting 86 Fermenting 87 Stirring and mixing with Zhusha (Cinnabar) Stirring and mixing with Qingdai (Natural Indigo) 88 89 Rinsing with rice water 90 Washing with wine 91 Xianzhi (processing with a decoction of the appropriate 92 prescription) Processing with Zhuli (Bam- 16 93 boo juice) More than methods 94 Processing into glue 96 O ther 99 © ISO 01 – All rights reserved ISO 18668-1:2 016(E) Annex B (normative) Calculation of check digit B.1 General Check digit is calculated by the method in ISO/IEC 15420:2009 B.2 Serial number of code location It indicates the serial number of the 17 digits from the right to the left, among which check digit is speci fied as B.3 Calculation steps Calculation steps are shown as follows: a) sum up the digits located below even serial numbers from serial number 2, to get result ①; b) multiply ① by to get result ②; c) sum up the digits located below odd serial numbers from serial number 3, to get result ③; d) sum up ② and ③ to get result ④; e) subtract ④ by a number which is larger or equal to ④, and also be the smallest multiple of 10, to get the digit of check digit For example: The calculation of code 06141021000199004 (the check digit is the last number ‘5’) for Mahuang (Herba Ephedrae, Ephedra) is demonstrated in Table B Table B.1 — Calculation of check digit Steps Demonstration Number from the right to the left Serial 17 16 15 14 13 12 11 10 number Digits 0 9 0 X Sum up the digits located below even serial numbers from serial number 2, to get result 0+9+1+0+1+0+4+6˙ 21   Multiply  by to get result  21×3˙ 63  Add the digits located below odd serial numbers from serial number 3, to get result 0+9+0+0+2+1+1+0˙ 13   Add  and  to get result  63+13 ˙ 76  Subtract  by a number which is a larger 80–76 = or equal to , and also be the smallest multiple of 10, to get the digit of check digit Check digit X=4 a) b) c) d) e) © ISO 01 – All rights reserved 17 ISO 18668-1:2 016(E) Annex C (informative) Examples An example is provided to explain the coding rules Codes of Ephedra (Chinese Materia Medica), Ephedra (decoction pieces), Ephedra Root, Honey-processed Ephedra, and Granular Ephedra are presented in Figure C Ephedra varieties Pictures Names Codes Ephedra 41 10 001 99 00 41 10 001 04 00 41 03 001 03 00 41 10 001 04 35 41 10 01 09 00 (Chinese Materia Medica) Ephedra (decoction pieces) Ephedra Root Honey- processed Ephedra Granular Ephedra (Granule form of individual medicinal for prescriptions) Figure C.1 — Code for Ephedra speci ications f 18 © ISO 01 – All rights reserved ISO 18668-1:2 016(E) NOTE These items share the same source, so their codes are same from layer to However, with different medicinal parts, layer and are different, 03 indicates rhizome and root, 10 indicates the herbaceous stem With different speci fications and processing methods, codes of layer and are different: In layer 8, 99 refers to Chinese Materia Medica; 04 refers to segments; 03 refers to pieces; 09 refers to granule forms of individual medicinals for prescriptions In layer 9, 00 stands for decoction pieces without special processing; 35 refers to honey-processing The 10th check digit is omitted E p he d a nd E p he d Ro o t a re d i ffe re n t i n cl i n ic a l ap p l ic atio n , wh ich s ho u ld b e d i s ti n g u i s he d i n c o de s E p he d is a p u n ge n t- wa r m e x te r io r- re le a s i n g me d ic i ne to p ro mo te s we ati n g , b u t E p he d Ro o t i s an astringent medicine used to stop sweating Layers and from Ephedra and Ephedra Root are different in coding, i.e 210 and 103 Since they all originate from the official speci fied ephedra plants, i.e Schrenk et C.A.Mey Ephedra equisetina same from layers to 4, i.e 410 X XX XXX XX XX X However, Ephedra and Ephedra Root are from Ep h edra sin ica S tap f, Ep h edra d i ffe re nt p a r ts in term edia o f the p l a n t, th at i s , , the fo r me r a nd o r i g i n ate s B ge , fro m the he rb ace o u s the i r s te m , c o de s wh i l e a re the the l at te r fro m the ro o t a nd rh i z o me Consider Pinellia Tuber as another example Since Pinellia Tuber is toxic, it is generally used after processing instead of being used raw Processing helps to: 1) reduce toxicity or side effects, ensuring safety in administration, 2) alter its efficacy to expand its application, 3) change its channel tropism Types of Pinellia Tuber can be classi fied into raw Pinellia Tuber, Alum-processed Pinellia Tuber, GingerA lu m- p ro ce s s e d P i ne l l i a Tub e r, l i me wate r- p ro ce s s e d P i ne l l i a L iquo r ic e - l i me wate r- p ro ce s s e d P i ne l l i a Tu b e r, Tub e r In the s ta nd a rd ap p l i c atio n o f C h i ne s e a nd g nu l a r L iquo r ic e - me d ic i ne , the p ro c e s s i n g of Pinellia Tuber is varied and complicated, which results in varied efficacy and applications But the forms are the same in origin and plant parts, so that their codes are the same from layers to 7, i.e shows how to distinguish them by codes 6 0 X X X X X F i g u re C © I S O – Al l ri gh ts re s e rve d 19 ISO 18668-1:2 016(E) Pinellia varieties Pictures Names Codes Pinellia Tuber (Chinese Materia Medica) 91 06 002 99 00 Pinellia Tuber(decoction pieces ) 91 06 002 00 00 Alum- processed Pinellia Tuber 91 06 002 00 73 00 72 Ginger-Alum- processed Pinellia Tuber Liquorice-limewater- processed Pinellia Tuber Granular Liquorice-limewater- processed Pinellia Tuber 91 06 002 91 06 002 00 71 91 06 002 09 71 Figure C.2 — Codes for Pinellia Tuber speci ications f NO TE P i ne l l i a Tu b e r i s to x i c , a nd th e p ro ce s s i ng i s c o mp l i c a te d T he e ffe c t s o f d i ffe r e n t p r o c e s s e d P i ne l l i a vary in clinical practice Since they share the same source and medical part, their codes are same from layers to But with different speci fications and processing methods, codes of layer are different: Chinese Materia Medica is encoded as 99; Pinellia Tuber, Alum-processed Pinellia Tuber, Ginger-Alum-processed Pinellia Tuber, Liquorice-limewater-processed Pinellia Tuber, all purifying processed, are encoded as 00; Granular Liquoricelimewater-processed Pinellia Tuber is encoded as 09 Codes of layer are different: 71 refers to processing mainly with Liquorice, 72 mainly with Fresh Ginger, 73 mainly with Alum The 10th check digit is omitted T he re is raw P i ne l l i a Tub e r, A lu m- p ro ce s s e d P i ne l l i a Tu b e r, G i n ge r- A lu m- p ro ce s s e d a nd p ro duce P i ne l l i a Tu b e r, mo u th , th ro at Liquorice-limewater-processed Pinellia Tuber in application of Chinese medicines They have similar efficacy including drying dampness, resolving phlegm, descending qi, relieving vomiting, dispersing abdominal masses and dissipating masses Additionally, they also have different efficacy: for example, raw P i ne l l i a Tu b e r i s to x ic w i tho u t p ro c e s s i n g , can s tro n g i r r i t atio n o f the and gastrointestinal mucosa, as well as symptoms including aphonia, salivation, breathing difficulties, a nd e ve n fu r u ncle s , c ho ki n g a nd to de ath fo r e x te r n a l P i ne l l i a Tu b e r ap p l ic atio n is used to A lu m- p ro ce s s e d d i s p el w i nd , P i ne l l i a d i s s i p ate Tub e r i s used s tatic to b lo o d , d i s p el w i nd d i s p ers e p h le g m , resolve fluid retention, dissipate chest stuffiness and descend counter flow qi Ginger-Alum-processed 20 © I S O – Al l ri gh ts re s e rve d ISO 18668-1:2 016(E) Pinellia Tuber is used to harmonize the stomach and relieve vomiting, dispel cold-phlegm, and relieve cough and fluid retention Liquorice-limewater-processed is used to dispel phlegm and relieve cough and remove turbid dampness In summary, raw Pinellia Tuber, Alum-processed Pinellia Tuber, GingerAlum-processed Pinellia Tuber, Liquorice-limewater-processed Pinellia Tuber are from the same origin, but the differences in their processing will result in different applications They cannot be mixed and interchanged Therefore, the different types of Pinellia Tuber have different codes Detailed description of coding structure of Pinellia Tuber (decoction pieces) are presented in Figure C Figure C.3 — Detailed description of coding structure of Pinellia Tuber (decoction pieces) © ISO 01 – All rights reserved 21 ISO 18668-1:2 016(E) Bibliography [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] GS1 General standard, General Specifications, Version 15 Central product classification (CPC), Part 1, Statistical Commission, 1998 GB 12904:2008, GB/T 7635.1:2002, National central product classification and codes GB/T 14467:1993, Classification and codes of Chinese plants GB/T 7027:2002, GB/T 31774:2015, GB/T 31773:2015, GB/T 31775:2015, Announcement No.128, The fourth Standing Committee of Shenzhen People’s Congress, published on 2010-4-23, and implemented from 2010-7-1 China Pharmacopoeia Commission Part [12] China Pharmacopoeia Commission [13] C hina P harmacopoeia C ommission Pharmacopoeia of the People’s Republic of China (the first [14] Korea food and drug administration English ed 2002 [15] Japanese pharmacopoeia committee The Japanese Pharmacopoeia Pharmacopoeia, Tokyo, Sixteenth Edition, 2011 [16] C hina P harmacopoeia C ommission Work Manual of National Drug Standard Medicines and Technology Press, Beijing, Fourth Edition, 2013 [17] B ureau of D rug P olicy & A dministration of M inistry of P ublic H ealth National processing standard of decoction pieces of Chinese medicines People’s Medical Publishing House, Beijing , 1988 Guangdong Food and Drug Administration The processing standard of decoction pieces of Chinese medicines of Guangdong Guangdong Scienti fic and Technical Publishers , Guangdong, 2011 Document (2007) No.11, State Administration of traditional Chinese medicines of People’s Republic of China, published on 2007-3-12, and implemented from 2007-3-12 G ao X Chinese medicines China Publishing House of Traditional Chinese Medicine , Beijing , 2007 K ang T Science of Chinese medicinal identi fication China Publishing House of Traditional [18] [19] [20] [21] [22] 22 Ba r co de Th e f o r co m m o dity — Reta il co m m o dity n u m b erin g b a sic p rin cip le s a n d m eth o ds f o r in f o rm a tio n a n d b a r co de m a rkin g cla ssifyin g a n d co din g Co din g Ru le s f o r Ch in e se Medicin e s a n d Th eir Co de s Co din g Ru le s f o r Ch in e se Medicin a l Fo rm u la e s a n d Th eir Co de s Co din g Ru le s f o r Ch in e se Me dicin e s in Ch in e se m e dicin e s o rdin a n ce o f Sh en zh en Su p p ly Ch a in Ma n a g em en t sp ecia l eco n o m ic zo n e Ph a rm a co p o eia of Chinese medicines and Technology Press, Beijing, 2015 Ph a rm a co p o eia of th e th e medicines and Technology Press, Beijing, English ed 2010 Pe o p le’s Peo p le’s Rep u b lic Rep u b lic of of Ch in a Ch in a Chinese supplement) Chinese Medicines and Technology Press, Beijing, 2012 Ho sp ita l de co ctio n p iece s o f Ch in e se Th e Ko rea n m edicin e s h erb a l p h a rm a co p o eia m a n a g em en t : Yakup Daily, Seoul, Society of Japanese Chinese sta n da rd Chinese Medicine, Beijing, 2007 Yao Z Medicinal botany China Publishing House of Traditional Chinese Medicine , Beijing , 2007 © ISO 2016 – All rights reserved ISO 18668-1:2 016(E) [23] G ong Q Chinese medicinal processing China Publishing House of Traditional Chinese Medicine, [24] Z heng H., & C S Pharmaceutical Botany and Pharmakognosie People’s Medical Publishing [25] Nanjing university of Traditional Chinese medicines Dictionary of Chinese medicine Vol and Vol Shanghai Science and Technology Press, Shanghai, 2006 [26] Chinese medicines Dictionary Committee Chinese medicines Dictionary China Press of Traditional Chinese Medicine, Beijing, 2006 [27] WFCMS International Standard Chinese-English Basic Nomenclature of Chinese Medicines People’s Publishing House, Beijing, 2008 [28] Beijing, 2007 House, Beijing, 2003 L iping Liao, & L iu Ronglu Prescriptions and pharmaceutical preparation standards of Chinese medicines Beijing: China press of Traditional Chinese Medicine, 2005 [29] K ang K Pharmacology of Kampo China Publishing House of Traditional Chinese Medicine, [30] L iping L Quality analysis of decoction pieces samples of Chinese medicines Chinese patent medicines(CPM) 1987, 11, pp 14 ISSN 1001-1528 L iping L A tentative study on writing of Chinese medicines tests and test reports Chinese Medicines Journal 1988, 4, pp 54 ISSN 1001-5302 L iping L My humble opinion on Chinese herbal medicine mixing and management Chinese Patent Medicines(CPM) 1989, 5, pp 43 ISSN 1001-1528 L iping L., L in X., Wu Z Study on coding system of decoction pieces of Chinese medicines Chinese Journal of TCM Information 2010, 17(12), pp 103-105 ISSN 1005-5304 L iping L., L in X., Wu Z Study on coding system of Chinese medical formulas Chinese Journal of TCM Information 2011, 18(1), pp 34-35 ISSN 1005-5304 L iping L., Ao Z., Weng S Coding of decoction pieces of Chinese medicines in supply chain management and its application research World Chinese Medicines 2012, 7(7) pp 80-83 ISSN 1673-7202 [31] [32] [33] [34] [35] Beijing, 2006 © ISO 2016 – All rights reserved 23 ISO 18668-1:2 016(E) ICS 11.120.10 Price based on 23 pages © ISO 2016 – All rights reserved