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Validation of Microbial Limit Test Methods of Tongmai Tangyanming Capsule
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作者 Renhui YANG Yali YAO Xunrong ZHOU 《Agricultural Biotechnology》 CAS 2018年第1期104-108,共5页
[ Objectives] This study was conducted to establish a method for microbial limit test of Tongmai Tangyanming Capsule. [ Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules, the microb... [ Objectives] This study was conducted to establish a method for microbial limit test of Tongmai Tangyanming Capsule. [ Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules, the microbiological limits of non-sterile products were verified. [ Results] Tongmai Tangyanming Capsule has a strong inhibitory effect on Bacillus subtilis and Candida albicans. The antimicrobial activity was significantly eliminated after increasing the diluent ( 1 : 20) ; and the recoveries were in the range of 0.5 -2 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 dilution method (1:20), the recoveries were from 0.5 to 2, and Escherichia coli, cholate-tolerant Gram-negative bacteria and Salmonella can be detected by the test solution dilution method. [ Condusions] 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 was used for examination of control bacteria including E. coli, cholatetolerant Gram-negative bacteria and Salmonella. This method has been proved effective for microbial limit test of Tongmai Tangyanming Capsule, and can effectively control the quality of the preparation. The method is accurate and reliable. 展开更多
关键词 Tongmai Tangyanming Capsule microbial limit test method Dilution method
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Validation of Microbial Limit Test Methods of Compound Gangbangui Capsule
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作者 Xiangling QU Xianmei XU +1 位作者 Sibu MA Renhui YANG 《Agricultural Biotechnology》 CAS 2018年第2期105-108,共4页
[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 microbiol... [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. 展开更多
关键词 Compound Gangbangui Capsule microbial limit test method Dilution methodHome
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