BS ISO 18668-3-2017 Traditional Chinese medicine Coding system for Chinese medicines Codes for Chinese Materia Medica《中医 中药编码系统 中药药物编码》.pdf

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1、BS ISO 18668-3:2017Traditional Chinese medicine Coding system for ChinesemedicinesPart 3: Codes for Chinese Materia MedicaBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 18668-3:2017 BRITISH STANDARDNational forewordThis British Standard is the UK implementati

2、on of ISO 18668-3:2017. The UK participation in its preparation was entrusted to Technical Committee CH/100/1, Traditional Chinese Medicine.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary

3、 provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 90983 2 ICS 11.120.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was

4、published under the authority of the Standards Policy and Strategy Committee on 31 March 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 18668-3:2017 ISO 2017Traditional Chinese medicine Coding system for Chinese medicines Part 3: Codes for Chinese Materia Medic

5、aMdecine traditionnelle chinoise Systme de codage des mdecines chinoises Partie 3: Codes pour les matires mdicales chinoisesINTERNATIONAL STANDARDISO18668-3First edition2017-03Reference numberISO 18668-3:2017(E)BS ISO 18668-3:2017ISO 18668-3:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED

6、DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, 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 writ

7、ten permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 18668-3:20

8、17ISO 18668-3:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Coding principles . 14.1 Uniqueness . 14.2 Scientificity . 14.3 Scalability 14.4 Compatibility 24.5 Stability 25 Coding structure . 26 Codes for Chinese Materia Medica . 2Bibliography .54 IS

9、O 2017 All rights reserved iiiContents PageBS ISO 18668-3:2017ISO 18668-3:2017(E)ForewordISO (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

10、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

11、 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 1. In particular the different approval crit

12、eria 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 2 (see www .iso .org/ directives).Attention is drawn to the possibility that some of the elements of this document may be the subject

13、 of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified 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

14、 name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adheren

15、ce to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.A list of all parts in the ISO 18668 series can be found o

16、n the ISO website.iv ISO 2017 All rights reservedBS ISO 18668-3:2017ISO 18668-3:2017(E)IntroductionAs the pharmaceutical materials extracted from natural and botanical products have become increasingly attractive, significant progress has been achieved in identifying new sources of natural products

17、for traditional and alternative medicine. In particular, Chinese traditional medicine has been 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

18、70 countries that have established administrative systems to regulate Chinese medicine. At present, the annual sale of Chinese medicines has reached more than USD 16 billion and is increasing at a rate of 10 % to 20 % per year with great future potential. At the same time, concerns of harm to the bo

19、dy 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 drugs, while recognizing the importance of traditional and alternative medicines. Thus, this brings more o

20、pportunities for the development of the market of Chinese medicines.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 identifiable bar code. Yet, so far, a bar coding system for products used i

21、n Chinese medicine has not been given sufficient attention, making it difficult to categorize individual items for international trade and research development. This brings challenges and concerns in government supervision and proper use by patients. As products for medicinal use, Chinese medicines

22、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 p

23、roducts that will enable to identify each specific Chinese medicine product.The coding system for 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 Ge

24、neral standard, central product classification (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,

25、 each Chinese medicine corresponds to a unique code as its identification.The coding system for Chinese medicines aims to promote standardization and digitalization for Chinese medicine, to ensure authenticity, equality, fairness and transparency in international markets and trade and to facilitate

26、government supervision and regulation of Chinese medicine. It is hoped that it will help pharmaceutical enterprises to manage workflow and increase economic returns. It will help healthcare delivery organizations, such as hospitals and dispensaries, improve information management systems that can en

27、sure the accuracy of dispensing, ensuring the safe and effective use of prescribed medicine.Chinese medicines are substances or combinations of substances used under the guidance of traditional Chinese medicine (TCM) theory for medical care and the prevention and treatment of disease, including Chin

28、ese Materia Medica, decoction pieces, granule forms of individual medicinals for prescriptions (GFIMP), and Chinese patent medicines (CPM). As it has been previously acknowledged, Chinese decoction pieces are processed products of Chinese Materia Medica, which are also known as raw materials. Thus,

29、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 specific, their divergence and commodity attributes can be clearly de

30、scribed in one of the layers (layer 8) in this set of coding rules. Granule forms of individual medicinals for prescriptions are innovative products made from decoction pieces. Based on the same considerations of feasibility and cost-control, the granular forms can be included within the same set of

31、 rules for decoction pieces.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. ISO 2017

32、 All rights reserved vBS ISO 18668-3:2017BS ISO 18668-3:2017Traditional Chinese medicine Coding system for Chinese medicines Part 3: Codes for Chinese Materia Medica1 ScopeThis document encodes 592 kinds of Chinese Materia Medica, according to the rules in ISO 18668-1.This document is suitable for c

33、oding of Chinese Materia Medica, as well as Chinese Materia Medica in the fields of clinical medication, scientific research, teaching, statistics and management.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requ

34、irements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 18668-1, Traditional Chinese medicine Coding system for Chinese medicines Part 1: Coding rules for Chinese med

35、icines3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 18668-1 apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online brows

36、ing platform: available at h t t p :/ www .iso .org/ obp/ 4 Coding principles4.1 UniquenessEach variety and processed form corresponds to a unique code.4.2 ScientificityBy applying scientific research to decide the classification methods and principles, the most stable properties, attributes, and ch

37、aracteristics of each Chinese medicines are used as basis for classification and coding. Thus, the structure of 17 digits with 10 layers as coding rules for Chinese medicines covers information of medicinal source, medicinal part, specification, and processing method, which respectively represent th

38、e basic characteristics, commercial attributes and professional attributes of Chinese medicines.4.3 ScalabilityThe coding rules allow sufficient space for expansion.INTERNATIONAL STANDARD ISO 18668-3:2017(E) ISO 2017 All rights reserved 1BS ISO 18668-3:2017ISO 18668-3:2017(E)4.4 CompatibilityThe cod

39、ing rules are consistent with relevant existing International Standards.4.5 StabilityThe code for each Chinese medicine remains unchanged once assigned.The code for each Chinese medicine remains unchanged once assigned, as long as the basic characteristic of the medicinal does not change. Even if so

40、me Chinese medicines are discontinued for production and use, their codes should still be kept.5 Coding structureCoding rules are represented by 10 layers with 17 digit Arabic numerals in order. The structure is encoded according to the rules in ISO 18668-1 as shown in Figure 1. See ISO 18668-1 for

41、technical requirements.Figure 1 Coding structure of Chinese medicines6 Codes for Chinese Materia MedicaCodes for Chinese Materia Medica are given in Table 1.2 ISO 2017 All rights reservedBS ISO 18668-3:2017ISO 18668-3:2017(E)Table1 Codes for Chinese Materia Medica (592 kinds)No.Latin nameEnglishname

42、ChinesenameChinesephoneticalphabet(PinYin)MedicinalsourceMedicinalpartsCodes10001LycopodiiHerbaCommonClubmossHerb伸筋草Shen jin caoLycopodiumjaponicumThunb.Wholeplant/herb0613025010019900110002SelaginellaeHerbaSpikemoss卷柏Juanbai(1)Selaginellatamariscina(Beauv.)Spring;(2)Selaginellapulvinata(Hook. et Gr

43、ev.) Maxim.Wholeplant/herb0613035010019900810003Equiseti Hiemalis HerbaCommonScouringRush Herb木贼(賊)Mu zeiEquisetumhyemaleL. Aerialpart0613055050019900810004Osmundae RhizomaJapaneseOsmundaRhizome紫萁贯(貫)众(眾)Zi qi guan zhongOsmunda japonica Thunb.Rhizomeandfrondbases0613131050019900710005LygodiiSporaJap

44、aneseClimbingFernSpore海金沙Hai jin shaLygodiumjaponicum(Thunb.) Sw.Ripespores0613179010019900110006CibotiiRhizomaCibotRhizome狗脊Gou jiCibotium barometz (L.) J. Sm.Rhizome0613191050019900910007DryopteridisCrassirhizomatisRhizomaMale Fern Rhizome绵马(馬)贯(貫)众(眾)Mian ma guan zhongDryopteriscrassirhizomaNakai

45、Rhizomeandfrondbases0613451050019900810008Drynariae RhizomaFortunes Drynaria Rhizome骨碎补(補)Gu sui buDrynariafortunei(Kunze)J.Sm.Rhizome0613561050019900410009Pyrrosiae FoliumShearers Pyrrosia Leaf石韦(韋)Shiwei(1)Pyrrosiasheareri(Bak.) Ching; (2)Pyrrosialingua(Thunb.)Farwell;(3)Pyrrosiapetiolosa(Christ)C

46、hingLeaf0613562070019900110010GinkgoFoliumGinkgo Leaf银(銀)杏叶(葉)Yin xing yeGinkgobilobaL.Leaf0614022070019900510011GinkgoSemenGinkgo Seed白果BaiguoGinkgobilobaL.Ripekernel0614024050019900510012Pini Lignum NodiTabularformedPineNode油松节(節)You song jie(1)PinustabulieformisCarr.;(2)PinusmassonianaLamb.Tuberc

47、ulate or branchednodes06140420400199002NOTE“No.” is sorted as follows: 10001 to 19999 indicate Chinese Materia Medica, 20001 to 29999 indicate decoction pieces and 30001 to 39999 indicate granule forms of individualmedicalsforprescriptions. ISO 2017 All rights reserved 3BS ISO 18668-3:2017ISO 18668-

48、3:2017(E)No.Latin nameEnglishnameChinesenameChinesephoneticalphabet(PinYin)MedicinalsourceMedicinalpartsCodes10013PseudolaricisCortexGoldenLarchBark土荆皮Tu jing piPseudolarixamabilvs(Nelson)Rehd.Root bark orstem bark0614042060019900010014PiniPollenPinePollen松花粉Song hua fen(1)PinusmassonianaLamb.;(2)Pi

49、nustabulaeformisCarr.Pollen0614043050019900010015PlatycladiCacumenChineseArborvitae Twig andLeaf侧柏叶(葉)Ce bai yePlatycladusorientalis(L.)FrancoTwig and leaf0614062120019900510016PlatycladiSemenChinese Arborvitae kernel柏子仁Bai zi renPlatycladusorientalis(L.)FrancoRipekernel0614064050019900310017Torreyae SemenGrand Torreya Seed榧子FeiziTorreyagrandisFort.Ripeseed0614094060019900310018Ephedrae Radix et RhizomaEphedraRoot麻黄根Ma huang gen(1)EphedrasinicaStapf; (2)EphedraintermediaSchrenk et C. A. Mey.Rootandrhizome0614101030019900510019Ephed

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