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�й�ҩѧ��־ 2015, Vol. 50 Issue (4) :284-286    DOI: 10.11669/cpj.2015.04.003
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1.�й�ʳƷҩƷ�춨�о�Ժ,����100050;
2. �㽭��ѧ,���� 310015;
3.����ҩ��ίԱ��,����100061
SUN Lei1,JIN Hong-yu1,MA Shuang-cheng1*,DAI Zhong1,CHENG Yi-yu2,QIAN Zhong-zhi3
1.National Institutes for Food and Drug Control, Beijing 100050, China;
2. Zhejiang University, Hangzhou 310015, China;
3. Chinese Pharmacopoeia Commission, Beijing 100061, China

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�ؼ����� �������Ʒ��   һ�������   ˫���ⷨ   ˫������У����   ������ȡ��   ��׼����(����Ʒ)     
Abstract�� Substitute reference substance method is an effective approach for quality control of multiple components in accordance with the characteristics of traditional Chinese medicines. The purpose of the guideline is to guide the establishment of substitute reference substance method, prove the conformance of the method to the requirements for testing, and standardize the study method and its application in national drug standards. The topics of the guideline include the definition and classification of substitute reference substance method, the principles and approaches of quantitative analysis, the identification and confirmation of chromatographic peaks, and technical requirements. When substitute reference substance method is used for fingerprint identification or multiple components assay in traditional Chinese medicines, the analytical method can be validated following the guideline.
Keywords�� substitute reference substance method (SRS),   quantitative analysis of multi-components by single marker (QAMS),   two reference substances for determination of multiple components (TRSDMC),   linear calibration using two reference substances (LCTRS),   extract reference substance,   reference substance     
�ո�����: 2015-03-09;
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����ʮ����“�ش���ҩ����”ר��(2014ZX09304307-002);������Ȼ��ѧ����������Ŀ(81303214,81173506); �й�ʳƷҩƷ�춨�о�Ժ�����귢չ�о�����(2011A1)

ͨѶ���� ��˫��,��,��ʿ,�о�Ա,��ʿ����ʦ �о�����:ҩ���������ҩѧ Tel:(010)67095272 E-mail:masc@nicfdc.org.cn     Email: masc@nicfdc.org.cn
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����, �����, ��˫��*�� .��ҩ��׼��������ⶨ������ָ��ԭ��[J]  �й�ҩѧ��־, 2015,V50(4): 284-286
SUN Lei-, JIN Hong-Yu-, MA Shuang-Cheng-* etc .Guideline of Substitute Reference Substance Method for Evaluation of Traditional Chinese Medicines[J]  Chinese Pharmaceutical Journal, 2015,V50(4): 284-286
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