1、BS ISO 18668-4:2017Traditional Chinese medicine Coding system for ChinesemedicinesPart 4: Codes for granule forms ofindividual medicinals for prescriptionsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 18668-4:2017 BRITISH STANDARDNational forewordThis Britis
2、h Standard is the UK implementation of ISO 18668-4:2017.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 purp
3、ort to include all the necessary 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 90984 9 ICS 11.120.10 Compliance with a British Standard cannot confer immunity from legal obliga
4、tions.This British Standard was 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 18668-4:2017 ISO 2017Traditional Chinese medicine Coding system for Chinese medicines Part 4:
5、 Codes for granule forms of individual medicinals for prescriptionsMdecine traditionnelle chinoise Systme de codage des mdecines chinoises Partie 4: Codes pour les granuls de mdicaments individuels pour les prescriptionsINTERNATIONAL STANDARDISO18668-4First edition2017-03Reference numberISO 18668-4:
6、2017(E)BS ISO 18668-4:2017ISO 18668-4:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED 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 m
7、echanical, 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 ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva,
8、SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 18668-4:2017ISO 18668-4:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Coding principles . 14.1 Uniqueness . 14.2 Scientificity . 14.3 Scalability 24.4 Compatibility
9、 24.5 Stability 25 Coding structure . 26 Codes for granule forms of individual medicinals for prescriptions . 2Bibliography .80 ISO 2017 All rights reserved iiiContents PageBS ISO 18668-4:2017ISO 18668-4:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federatio
10、n 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.
11、 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 tho
12、se 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 documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (
13、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 identified during the development of the
14、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 voluntary nature of standa
15、rds, 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) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was p
16、repared 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 reservedBS ISO 18668-4:2017ISO 18668-4:2017(E)IntroductionAs the pharmaceutical materials extracted from natural and botanical pr
17、oducts have become increasingly attractive, significant progress has been achieved in identifying new sources of natural products for traditional and alternative medicine. In particular, Chinese traditional medicine has been the focus of tremendous research, development and applications worldwide. A
18、ccordingly, 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 present, the annual sale of Chinese medicines has reached more than USD 16 bill
19、ion 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 synthetic drugs have been recognized. Therefore, many countries are developing vigorous controls and regulations on using antibiot
20、ics and other synthetic drugs, while recognizing the importance of traditional and alternative medicines. Thus, this brings more opportunities 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. F
21、or 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 sufficient attention, making it difficult to categorize individual items for international trade and research development. This brin
22、gs 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 into the current bar code system that is used for other commercial products. In this way, bar codes can be used to track sourc
23、es 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 specific Chinese medicine product.The coding system for Chinese medicines is developed based on science and research rooted in p
24、lant taxonomy, Chinese medicine, Chinese medicinal processing, and other established regulatory handbooks and guidelines of GS1 General standard, central product classification (CPC), and ISO/IEC 15420, etc. The codes help translate complicated names of a wide variety of decoction pieces, Chinese Ma
25、teria 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 identification.The coding system for Chinese medicines aims to promote standardization and digitalization for Chi
26、nese medicine, to ensure authenticity, equality, fairness, and transparency in international markets and trade and to facilitate government supervision and regulation of Chinese medicine. It is hoped that it will help pharmaceutical enterprises to manage workflow and increase economic returns. It wi
27、ll help healthcare delivery organizations, such as hospitals and dispensaries, improve information management systems that can ensure the accuracy of dispensing, ensuring the safe and effective use of prescribed medicine.Chinese medicines are substances or combinations of substances used under the g
28、uidance of traditional Chinese medicine (TCM) theory for medical care and the prevention and treatment of disease, including Chinese Materia Medica, decoction pieces, granule forms of individual medicinals for prescriptions (GFIMP), and Chinese patent medicines (CPM). As it has been previously ackno
29、wledged, 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 t
30、hey 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 this set of coding rules. Granule forms of individual medicinals for prescriptions are innovative products made from decoction pi
31、eces. 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, although Chinese patent medicines (CPM) are made from decoction pieces, their coding rules are more complicated and differ from decoct
32、ion 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 18668-4:2017BS ISO 18668-4:2017Traditional Chinese medicine Coding system for Chinese medicines Part 4: Codes for granule forms of individual
33、medicinals for prescriptions1 ScopeThis document encodes 777 kinds of granule forms of individual medicinals for prescriptions, according to the rules in ISO 18668-1.This document is suitable for coding of granule forms of individual medicinals for prescriptions, as well as granule forms of individu
34、al medicinals for prescriptions 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 requirements of this document. For date
35、d 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 medicines3 Terms and definitionsFor th
36、e purposes of this document, the terms and definitions 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
37、 .iso .org/ obp4 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 medicine are
38、used as basis for classification and coding. Thus, the structure of 17 digits with 10 layers as coding rules for Chinese medicines covers the information on medicinal source, medicinal part, specification, and processing method, which respectively represent the basic characteristics, commercial attr
39、ibutes, and professional attributes of Chinese medicines.INTERNATIONAL STANDARD ISO 18668-4:2017(E) ISO 2017 All rights reserved 1BS ISO 18668-4:2017ISO 18668-4:2017(E)4.3 ScalabilityThe coding rules allow sufficient space for expansion.4.4 CompatibilityThe coding rules are consistent with relevant
40、existing International 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 pr
41、oduction 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 technical requirements.Figure 1 Coding struc
42、ture of Chinese medicines6 Codes for granule forms of individual medicinals for prescriptionsCodes for granule forms of individual medicinals for prescriptions are given in Table 1.2 ISO 2017 All rights reservedBS ISO 18668-4:2017ISO 18668-4:2017(E)Table1 Codes for granule forms of individual medici
43、nals for prescriptions (777 kinds)No.Latin nameEnglishnameChinesenameChinesephoneticalphabet(PinYin)MedicinalsourceMedicinalpartsCodes30001Lycopodii Herba GranulaCommonClubmossHerb Granules伸筋草配方颗粒Shenjincao Pei fang ke liLycopodiumjaponicumThunb.Whole plant/ herb0613025010010900030002Selaginellae He
44、rba GranulaSpikemossGran-ules卷柏配方颗粒Juan bai Pei fang ke li(1)Selaginellatamariscina(Beauv.)Spring;(2)Selaginel-lapulvinata(Hook. et Grev.)Maxim.Whole plant/ herb0613035010010900730003Selaginellae Tamariscinae GranulaCarbonizedSpikemossGran-ules卷柏炭配方颗粒Juan bai tan Pei fang ke li(1)Selaginellatamarisc
45、ina(Beauv.)Spring;(2)Selaginel-lapulvinata(Hook. et Grev.)Maxim.Whole plant/ herb0613035010010941030004Equiseti Hiema-lis HerbaGranulaCommonScouringRush Herb Gran-ules木贼(賊)配方颗粒Mu zei Pei fang ke liEquisetumhyemaleL.Aerialpart0613055050010900730005Osmundae Rhi-zoma GranulaJapaneseOsmundaRhizomeGranul
46、es紫萁贯(貫)众(眾)配方颗粒Zi qi guan zhong Pei fang ke liOsmundajaponicaThunb.Rhizomeandfrondbases0613131050010900630006Lygodii Spora GranulaJapaneseClimbingFernSporeGranules海金沙配方颗粒Haijin sha Peifang keliLygodiumjaponicum(Thunb.) Sw.Ripespores0613179010010900030007Cibotii Rhizoma GranulaCibotRhizomeGranules狗脊
47、配方颗粒Gou ji Pei fang ke liCibotiumbarometz(L.) J. Sm.Rhizome0613191050010900830008Cibotii Rhizoma Aquosus GranulaScaldedCibotRhizomeGranules烫(燙)狗脊配方颗粒Tang gou ji Pei fang ke liCibotiumbarometz(L.) J. Sm.Rhizome0613191050010922030009DryopteridisCrassirhizomatisRhizomaGranulaMale Fern RhizomeGranules绵马
48、(馬)贯(貫)众(眾)配方颗粒Mian ma guan zhong Pei fang ke liDryopteriscrassirhizomaNakaiRhizomeandfrondbases0613451050010900730010DryopteridisCrassirhizom-atis Rhizoma CarbonisatumGranulaCarbonized Male FernRhizomeGranules绵马(馬)贯(貫)众(眾)炭配方颗粒Mian ma guan zhong tan Pei fang ke liDryopteriscrassirhizomaNakaiRhizome
49、andfrondbases06134510500109410NOTE1“No.”issortedasfollows:10001to19999indicateChineseMateriaMedica,20001to29999indicatedecoctionpieces,and30001to39999indicategranuleformsofindividualmedicalsforprescriptions.NOTE2TheEnglishnamesforthegranuleformofindividualmedicinalsforprescriptionsarewrittenasmedicinalforshortinthistableregardingthelengthofthenames. For example, the granule form of individual Common Clubmoss Herb for prescriptions is written as Common Clubmoss Herb to save the space in the table. ISO 2017 All rights reserved 3BS ISO
