BS ISO 20409-2017 Traditional Chinese medicine -- Panax notoginseng root and rhizome《中医 人参根和根茎》.pdf

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1、Traditional Chinese medicine Panax notoginseng root and rhizomeBS ISO 20409:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06 ISO 2017Traditional Chinese medicine Panax notoginseng root and rhizomeMdecine traditionnelle chinoise Rhizome et racine de Panax notogins

2、engINTERNATIONAL STANDARDISO20409First edition2017-06Reference numberISO 20409:2017(E)National forewordThis British Standard is the UK implementation of ISO 20409:2017.The UK participation in its preparation was entrusted to Technical Committee CH/100/1, Traditional Chinese Medicine.A list of organi

3、zations represented on this committee can be obtained on request to its secretary.This publication does not purport 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 2017

4、ISBN 978 0 580 93045 4ICS 11.120.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2017.Amendments/corrigenda issued since publicationDate Text affectedB

5、RITISH STANDARDBS ISO 20409:2017 ISO 2017Traditional Chinese medicine Panax notoginseng root and rhizomeMdecine traditionnelle chinoise Rhizome et racine de Panax notoginsengINTERNATIONAL STANDARDISO20409First edition2017-06Reference numberISO 20409:2017(E)BS ISO 20409:2017ISO 20409:2017(E)ii ISO 20

6、17 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 mechanical, including photocopying, or posting on the i

7、nternet 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, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47co

8、pyrightiso.orgwww.iso.orgBS ISO 20409:2017ISO 20409:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Descriptions 25 Requirements 45.1 General characteristics . 45.2 Notoginseng root . 45.2.1 Morphological features of root 45.2.2 Moisture 45.2.3 Total a

9、sh 45.2.4 Acid-insoluble ash 45.2.5 Ethanol-soluble extractives 45.2.6 Identification of notoginsenoside R1and ginsenosides Rg1, Re, and Rb1.45.2.7 Content of notoginsenoside R1and ginsenosides Rg1and Rb145.2.8 Heavy metals . 55.2.9 Pesticide residues . 55.2.10 Root weight, root length and root numb

10、er per 500 g 55.3 Notoginseng rhizome 55.3.1 Morphological features of rhizome 55.3.2 Moisture 55.3.3 Total ash 55.3.4 Acid-insoluble ash 55.3.5 Ethanol-soluble extractives 55.3.6 Identification of notoginsenoside R1and ginsenosides Rg1, Re, and Rb1.65.3.7 Content of notoginsenoside R1and ginsenosid

11、es Rg1and Rb165.3.8 Heavy metals . 65.3.9 Pesticide residues . 66 Sampling 67 Test methods . 77.1 Macroscopic identification . 77.2 Determination of moisture content 77.3 Determination of total ash content 77.4 Determination of acid-insoluble ash content . 77.5 Determination of ethanol-soluble extra

12、ctives content . 77.6 Identification of notoginsenoside R1and ginsenosides Rg1, Re, and Rb1.77.7 Determination of notoginsenoside and ginsenosides content 77.8 Determination of heavy metals . 77.9 Determination of pesticide residues 77.10 Root weight 77.11 Root length . 87.12 Root number per 500 g 8

13、8 Test report . 89 Packaging, storage and transportation . 810 Marking and labelling . 8Annex A (normative) Determination of moisture content 9Annex B (normative) Determination of ethanol-soluble extractives content 10Annex C (normative) Identification of ginsenosides Rb1, Re, Rg1and notoginsenoside

14、 R111 ISO 2017 All rights reserved iiiContents PageBS ISO 20409:2017ISO 20409:2017(E)Annex D (normative) Determination of notoginsenoside R1and ginsenosides Rg1and Rb113Annex E (informative) Reference values of national and regional limits of notoginsenoside R1,ginsenosides Rg1, Re, Rb1and Rd in not

15、oginseng16Bibliography .17iv ISO 2017 All rights reservedBS ISO 20409:2017ISO 20409:2017(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 ou

16、t 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 co

17、llaborates 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 appr

18、oval 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 (see www .iso .org/ directives).Attention is drawn to the possibility that some of the elements of this document may be th

19、e 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 document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents).

20、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 standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs

21、 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 prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine. ISO 2017 All rights reserved vBS ISO 20409:2017IS

22、O 20409:2017(E)IntroductionPanax notoginseng root and rhizome are medicinal parts of Panax notoginseng (Burk.) F.H. Chen named Sanqi, which is a well-known traditional Chinese medicine. Due to its ability to treat bleeding, blood stasis and some other blood disorders, Panax notoginseng root and rhiz

23、ome soared to great importance during Qing dynasty times after being praised by the master herbalist Li Shizhen in the 16thcentury. Panax notoginseng root and rhizome are native to the southern Chinese provinces of Yunnan and Guangxi, as well as Vietnam. The root and rhizome exhibit a variety of bot

24、anical and biochemical similarities to ginseng, and are frequently consumed as soup. Despite this high rate of consumption, there are relatively few reported side effects, making Panax notoginseng root and rhizome two of the safest substances in traditional Chinese medicine. While most often consume

25、d as a popular food tonic, practitioners of Oriental medicine know Panax notoginseng root and rhizome best for the medicinal qualities: moving stagnant blood, stopping bleeding and resolving swelling. Due to the high price and demand in the global market, trade in Panax notoginseng root and rhizome

26、has been complicated by substitution, adulteration and species identification issues. The genuine material is often replaced by less valuable material(s), some of which exhibit potentially toxic properties. Therefore, the establishment of an international standard for Panax notoginseng root and rhiz

27、ome is necessary to support the clinical effectiveness, safety and consistency of this valuable medicine in international trade.vi ISO 2017 All rights reservedBS ISO 20409:2017Traditional Chinese medicine Panax notoginseng root and rhizome1 ScopeThis document specifies minimum requirements and test

28、methods for notoginseng root and rhizome which are derived from the plant Panax notoginseng (Burk.) F.H. Chen.It is applicable to notoginseng root and rhizome that are sold and used as food supplements, functional food or natural medicines in international trade, including Chinese materia medica (wh

29、ole medicinal materials) and decoction pieces derived from this plant.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 cited applies. For undated

30、 references, the latest edition of the referenced document (including any amendments) applies.ISO 1575, Tea Determination of total ashISO 1577, Tea Determination of acid-insoluble ashISO 18664, Traditional Chinese Medicine Determination of heavy metals in herbal medicines used in Traditional Chinese

31、 MedicineCODEX STAN 229-1993, REV.1-2003: Analysis of pesticide residues: Recommended methodsCODEX STAN 1-1985: Codex general standard for the labelling of prepackaged foodsCAC/MRL01-2009: Maximum Residue Limits for Pesticides in FoodsWorld Health Organization 2011: Quality control methods for herba

32、l materials, General advice on sampling3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/ www .electropedia. org

33、/ ISO Online browsing platform: available at http:/ www. iso. org/ obp3.1notoginsengplant of Panax notoginseng (Burk.) F. H. Chen that has been cultivated for at least three years3.2root weightaverage weight of final samples of root3.3root lengthlargest distance from the bottom to the stem scar of t

34、he tap rootNote 1 to entry: See Figure 1.INTERNATIONAL STANDARD ISO 20409:2017(E) ISO 2017 All rights reserved 1BS ISO 20409:2017ISO 20409:2017(E)3.4root diameterdiameter of the tap root3.5root number per 500 gnumber of tap roots per 500 g3.6batchsamples collected from the same particular place at t

35、he same timeNote 1 to entry: This is not more than 5 000 kg.3.7final samplesamples after the final sampling4 DescriptionsIn this document, dried notoginseng root and rhizome consist of tap root, lateral root and rhizome, as shown in Figure 1.2 ISO 2017 All rights reservedBS ISO 20409:2017ISO 20409:2

36、017(E)a) Plant of Panax notoginseng b) Dried tap rootc) Transverse section of the tap root d) Dried rhizomeKey1 fruit 8 rootlets 15 ray2 flower 9 tap root length 16 xylem3 leaf 10 stem scar 17 central cylinder4 stem 11 warty protrusion 18 stem scar5 rhizome 12 lateral root scar 19 strip-shaped protr

37、uding6 tap root 13 epidermis 20 root scar7 lateral root 14 phloemFigure 1 Structure of notoginseng ISO 2017 All rights reserved 3BS ISO 20409:2017ISO 20409:2017(E)5 Requirements5.1 General characteristicsThe following requirements shall be met before sampling.a) Notoginseng root and rhizome shall be

38、 clean and free from rootlets and foreign matter.b) The presence of living insects, mouldy root and rhizome and external contaminants which are visible to the naked eye shall not be permitted.5.2 Notoginseng root5.2.1 Morphological features of roota) The shape of the tap root is subconical or cylind

39、rical as shown in Figure 1 b).b) The root length is 1 cm to 6 cm long, and the root diameter is 1 cm to 4 cm.c) The outer surface is greyish-yellow or greyish-brown with intermittent longitudinal wrinkles and branch root scar.d) Stem scars at the apex are surrounded by warty protrusions.e) The textu

40、re is heavy and compact.f) The fracture is greyish-green, yellowish-green or greyish-white with xylem rays distributed radially.5.2.2 MoistureThe mass fraction of moisture shall not be more than 12,0 % (w/w).5.2.3 Total ashThe mass fraction of total ash shall not be more than 6,0 % (w/w).5.2.4 Acid-

41、insoluble ashThe mass fraction of acid-insoluble ash shall not be more than 1,0 % (w/w).5.2.5 Ethanol-soluble extractivesThe mass fraction of ethanol-soluble extractives shall be more than 16,0 % (w/w).5.2.6 Identification of notoginsenoside R1and ginsenosides Rg1, Re, and Rb1The identification of n

42、otoginsenoside R1and ginsenosides Rg1, Re, and Rb1with thin-layer chromatogram (TLC) or high-performance liquid chromatogram (HPLC) shall present spots or peaks obtained from the test and reference solutions in the same position with the same colour (TLC) or same absorbance curve (HPLC).5.2.7 Conten

43、t of notoginsenoside R1and ginsenosides Rg1and Rb1The sum of the mass fraction of notoginsenoside R1and ginsenosides Rg1and Rb1shall be not less than 5,0 %. The content determination is carried out according to the method described in Annex B.4 ISO 2017 All rights reservedBS ISO 20409:2017ISO 20409:

44、2017(E)5.2.8 Heavy metalsThe contents of heavy metals including arsenic, mercury, lead and cadmium shall be determined.5.2.9 Pesticide residuesThe contents of pesticide residues including Benzex, DDT and quintozene shall be determined.5.2.10 Root weight, root length and root number per 500 gThe root

45、 weight, root length and root number per 500 g of each batch of notoginseng root shall comply with the requirements in Table 1. The quantity of roots that fail to meet the minimum weight requirement of the grade shall not be more than 5 %. Otherwise, it shall be considered to be of inferior grade.Ta

46、ble 1 Grading requirements of notoginseng rootGradeRoot weight gRoot length cmRoot number per 500 gFirst 25,0 6,5 20Second 17,0 6,0 30Third 12,5 5,5 40Fourth 8,5 4,5 60Fifth 6,5 3,5 80Sixth 4,5 3,0 120Seventh 2,5 2,5 200Unqualified 2,5 200NOTE 1 The root weight is determined when the moisture conten

47、t of the tap root is approximately 12 %.NOTE 2 The grading requirements are established according to the traditional grading system of notoginseng root and rhizome that has long been extensively used in the market and trading.The grade shall be established only when all three requirements, i.e. root

48、 weight, root length, and root number per 500 g, are met.5.3 Notoginseng rhizome5.3.1 Morphological features of rhizomeThe appearance of rhizome is irregularly shrunken, lump-shaped or slat-shaped, and there are several conspicuous stem scars and annulations on the surface of rhizome as shown in Fig

49、ure 1 d). The fracture is greyish-green, or greyish-white in the centre and deep green or grey at margin.5.3.2 MoistureThe mass fraction of moisture shall not be more than 14,0 % (w/w).5.3.3 Total ashThe mass fraction of total ash shall not be more than 6,0 % (w/w).5.3.4 Acid-insoluble ashThe mass fraction of acid-insoluble ash shall not be more than 3,0 % (w/w).5.3.5 Ethanol-soluble extractivesThe mass fraction of ethanol-soluble extractives shall be more than 20,0 % (w/w). ISO 2017 All rights re