Validation of Microbial Limit Test Methods of Compound Gangbangui Capsule

作     者：Xiangling QU Xianmei XU Sibu MA Renhui YANG Xiangling QU;Xianmei XU;Sibu MA;Renhui YANG

作者机构：The Second Affiliated Hospital of Guiyang College of Traditional Chinese MedicineGuiyang 550003China Guiyang College of Traditional Chinese MedicineGuiyang 550001China 

出 版 物：《Agricultural Biotechnology》 (农业生物技术（英文版）)

年 卷 期：2018年第7卷第2期

页      面：105-108页

学科分类：1008[医学-中药学(可授医学、理学学位)] 1006[医学-中西医结合] 100602[医学-中西医结合临床] 10[医学] 

基　　金：Supported by Traditional Chinese Medicine and Ethnic Minority Medicine Technique Research Subject of Guizhou Administrative Bureau of TCM(QZYY2011-40) 

主　　题：Compound Gangbangui Capsule Microbial limit test method Dilution methodHome 

摘      要：[Objectives] This study was conducted to establish a method for microbial limit test of Compound Gangbangui Capsule. [Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules,the microbiological limits of non-sterile products were verified. [Results]Compound Gangbangui Capsule has a strong inhibitory effect on S. aureus,and the antimicrobial activity was significantly eliminated after increasing the diluent（ 1∶ 20）; and the recoveries were in the range of 0. 5-2. 0 when the total quantities of aerobic microbes were determined by dilution method（ 1∶ 20）. When the total quantities of mould and yeast were determined by conventional method（ 1∶ 20）,the recoveries were from 0. 5 to 2. 0,and Escherichia coli can be detected in experimental groups by the test solution dilution method. [Conclusions]With the plate method,the total quantities of aerobic bacteria and the quantities of mould and yeast were examined by increasing diluent and conventional method,respectively,and control bacteria,E. coli was examined by conventional method. This method has been proved effective for microbial limit test of Compound Gangbangui Capsule,and can effectively control the quality of the preparation. The method is accurate and reliable.