1、BS ISO 18668-2:2017Traditional Chinese medicine Coding system for ChinesemedicinesPart 2: Codes for decoction piecesBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 18668-2:2017 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of
2、ISO 18668-2:2017. The UK participation in its preparation was entrusted to TechnicalCommittee CH/100/1, Traditional Chinese Medicine.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisio
3、ns of a contract. Users are responsible for its correctapplication. The British Standards Institution 2017. Published by BSI Standards Limited 2017ISBN 978 0 580 86652 4ICS 11.120.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published un
4、der the authority of theStandards Policy and Strategy Committee on 31 March 2017.Amendments/corrigenda issued since publicationDate Text affectedBS ISO 18668-2:2017 ISO 2017Traditional Chinese medicine Coding system for Chinese medicines Part 2: Codes for decoction piecesMdecine traditionnelle chino
5、ise Systme de codage des mdecines chinoises Partie 2: Codes pour les pices de dcoctionINTERNATIONAL STANDARDISO18668-2First edition2017-03Reference numberISO 18668-2:2017(E)BS ISO 18668-2:2017ISO 18668-2:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in Switze
6、rlandAll 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 written permission. Permission can be requ
7、ested 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 18668-2:2017ISO 18668-2:2017(E)Foreword ivIntrod
8、uction 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 decoction pieces . 2Bibliography .75 ISO 2017 All rights reserved iiiContents PageB
9、S ISO 18668-2:2017ISO 18668-2:2017(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 ISO technical committees. Each member body i
10、nterested 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 Electrotechn
11、ical 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 criteria needed for the different types of ISO d
12、ocuments 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 of patent rights. ISO shall not be held res
13、ponsible 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 name used in this document is information g
14、iven 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 adherence to the World Trade Organization (WTO) pri
15、nciples 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 on the ISO website.iv ISO 2017 All rights res
16、ervedBS ISO 18668-2:2017ISO 18668-2:2017(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 for traditional and alternative medicine. In
17、 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 70 countries that have established administr
18、ative 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 body associated with the long-term use of synt
19、hetic 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 opportunities for the development of the mark
20、et 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 in Chinese medicine has not been given suffic
21、ient 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 could have bar codes that can be integrated
22、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 sp
23、ecific 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 General standard, central product classificati
24、on (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 uniq
25、ue 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 government supervision and regulation of Chi
26、nese 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 ensure the accuracy of dispensing, ensuring th
27、e 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 Chinese Materia Medica, decoction pieces, granul
28、e 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, when designing the coding system for Chinese
29、 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 described in one of the layers (layer 8) in th
30、is 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 rules for decoction pieces.However, althoug
31、h 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 All rights reserved vBS ISO 18668-2:2017BS
32、ISO 18668-2:2017Traditional Chinese medicine Coding system for Chinese medicines Part 2: Codes for decoction pieces1 ScopeThis document encodes 828 kinds of decoction pieces, according to the rules in ISO 18668-1.This document is suitable for coding of decoction pieces, as well as decoction pieces i
33、n 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 requirements of this document. For dated references, only the edition c
34、ited 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 medicines3 Terms and definitionsFor the purposes of this document, the
35、 following 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 browsing platform: available at h t t p :/ www .iso .org/ obp4
36、 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 characteristics of each Chinese medicines are used as basis f
37、or 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 the basic characteristics, commercial attributes, and profess
38、ional attributes of Chinese medicines.4.3 ScalabilityThe coding rules allow sufficient space for expansion.INTERNATIONAL STANDARD ISO 18668-2:2017(E) ISO 2017 All rights reserved 1BS ISO 18668-2:2017ISO 18668-2:2017(E)4.4 CompatibilityThe coding rules are consistent with relevant existing Internatio
39、nal Standards.4.5 StabilityThe code for decoction pieces 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 some Chinese medicines are discontinued for production and use, t
40、heir 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 technical requirements.Figure 1 Coding structure of Chinese med
41、icines6 Codes for decoction piecesCodes for decoction pieces are given in Table 1.2 ISO 2017 All rights reservedBS ISO 18668-2:2017ISO 18668-2:2017(E)Table1 Codes for decoction pieces (828 kinds)No.Latin nameEnglishnameChinesenameChinesephoneticalphabet(PinYin)MedicinalsourceMedicinalpartsCodes20001
42、LycopodiiHerbaCommonClubmossHerb伸筋草Shen jin caoLycopodiumjaponicumThunb.Wholeplant/herb0613025010010400520002Selaginellae HerbaSpikemoss卷柏Juanbai(1)Selaginellatamariscina(Beauv.)Spring;(2)Selaginellapulvinata(Hook. et Grev.) Maxim.Wholeplant/herb0613035010010400220003SelaginellaeTamariscinae Carboni
43、zedSpikemoss卷柏炭Juanbaitan(1)Selaginellatamariscina(Beauv.)Spring;(2)Selaginellapulvinata(Hook. et Grev.) Maxim.Wholeplant/herb0613035010010441520004EquisetiHiemalisHerbaCommonScouringRush Herb木贼(賊)Mu zeiEquisetumhyemaleL. Aerialpart0613055050010400220005OsmundaeRhizomaJapaneseOsmundaRhizome紫萁贯(貫)众(眾
44、)Zi qi guan zhongOsmunda japonica Thunb.Rhizomeandfrondbases0613131050010300420006LygodiiSporaJapaneseClimbingFernSpore海金沙Hai jin shaLygodiumjaponicum(Thunb.) Sw.Ripespores0613179010010000720007CibotiiRhizomaCibotRhizome狗脊Gou jiCibotium barometz (L.) J. Sm.Rhizome0613191050010300620008Cibotii Rhizom
45、aAquosusScaldedCibotRhizome烫(燙)狗脊Tang gou jiCibotium barometz (L.) J. Sm.Rhizome0613191050010322820009DryopteridisCrassirhizomatisRhizomaMale Fern Rhizome绵马(馬)贯(貫)众(眾)MianmaguanzhongDryopteriscrassirhizomaNakaiRhizomeandfrondbases0613451050010300520010DryopteridisCrassirhizomatisRhizomaCarbonisatumC
46、arbonizedMale FernRhizome绵马(馬)贯(貫)众(眾)炭Mian ma guan zhongtanDryopteriscrassirhizomaNakaiRhizomeandfrondbases0613451050010341820011DrynariaeRhizomaFortunes Drynaria Rhizome骨碎补(補)Gu sui buDrynariafortunei(Kunze)J.Sm.Rhizome0613561050010300120012DrynariaeRhizomaPraeparatumScalded Fortunes Drynaria Rhiz
47、ome 烫(燙)骨碎补(補)Tang gu sui buDrynariafortunei(Kunze)J.Sm.Rhizome06135610500103223NOTE“No.”issortedasfollows:10001to19999indicateChineseMateriaMedica,20001to29999indicatedecoctionpiecesand30001to39999indicategranuleformsofindividualmedicalsforprescriptions. ISO 2017 All rights reserved 3BS ISO 18668-2
48、:2017ISO 18668-2:2017(E)No.Latin nameEnglishnameChinesenameChinesephoneticalphabet(PinYin)MedicinalsourceMedicinalpartsCodes20013Pyrrosiae FoliumShearers Pyrrosia Leaf石韦(韋)Shiwei(1)Pyrrosiasheareri(Bak.)Ching;(2)Pyrrosialingua(Thunb.)Farwell;(3)Pyrrosiapetiolosa(Christ)ChingLeaf061356207001040052001
49、4GinkgoFoliumGinkgo Leaf银(銀)杏叶(葉)Yin xing yeGinkgobilobaL.Leaf0614022070010000120015GinkgoSemenGinkgo Seed白果仁Bai guo renGinkgobilobaL.Ripekernel0614024050010000120016Ginkgo Semen TostusStir-fried Ginkgo Seed炒白果仁Chao bai guo renGinkgobilobaL.Ripekernel0614024050010011720017Pini Lignum NodiTabularformedPineNode油松节(節)You song jie(1)PinustabulieformisCarr.;(2)PinusmassonianaLamb.Tuberculate orbranchednodes0614042040010500320018PseudolaricisCortexGoldenLarchBark土荆皮Tu jing piPseudolarixamabilvs(Nelson) Rehd.Root bark or stembark06140420