[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
基金Supported by Traditional Chinese Medicine and Ethnic Minority Medicine Technique Research Subject of Guizhou Administrative Bureau of TCM(QZYY2011-40)
文摘[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.
