ISO INTERNATIONAL STANDARD 21314 First edition 2019-02 Traditional Chinese medicine Salvia miltiorrhiza root and rhizome Médecine traditionnelle chinoise - Racine et rhizome de Salvia miltiorrhiza Reference number IS0 21314:2019(E) osi @IS02019 IS0 21314:2019(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2019 All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2019 - All rights reserved IS0 21314:2019(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions 4 Descriptions ..2 5 Requirements .2 5.1 General characteristics .2 5.2 Salvia miltiorrhiza root and rhizome 3 5.2.1 Morphological features of root and rhizome 3 5.2.2 Thin-layer chromatogram (TLC) identification .3 5.2.3 Moisture 3 5.2.4 Total ash .3 5.2.5 Acid insoluble ash limit 3 5.2.6 Extractives .3 5.2.7 Content of tanshinones 3 5.2.8 Content of salvianolic acid B .3 5.2.9 Heavymetals 4 5.2.10 Pesticide residues .4 6 Sampling. .4 7 Test methods. ..4 7.1 Macroscopic identification .4 7.2 TLC identification 4 7.3 Determination of moisture content .4 7.4 Determination of total ash. ..4 7.5 Determination of acid-insoluble ash 7.6 Determination of extractives .4 7.7 Determinationoftanshinones .4 7.8 Determination of salvianolic acid B 4 7.9 Determination of heavy metals ..4 7.10 Determination of pesticide residues .4 8 Test report .5 9 Packaging, storage and transportation ..5 10 Marking and labelling ..5 Annex A (informative) TLC identification. ..6 Annex B (informative) Determination of extractives ..8 AnnexC(informative)Determinationoftanshinones .9 Annex D (informative) Determination of salvianolic acid B ..12 Annex E (informative) Information on requirements of Salvia miltiorrhiza root and rhizome in different countries and regions ..14 Bibliography ..16 @ IS0 2019 - All rights reserved ii
ISO 21314 2019 Traditional Chinese medicine — Salvia miltiorrhiza root and rhizome