摘要
目的建立芪连降糖片的微生物限度检查方法。方法分别采用稀释法、平皿法、薄膜过滤法,加入金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌、黑曲霉进行计数法适用性试验;将10 mL 1∶10和1∶50(m/V)供试液分别接种至胰酪大豆胨琼脂培养基、胰酪大豆胨液体培养基中,接种大肠埃希菌进行控制菌检查适用性试验。结果需氧菌总数的计数采用薄膜过滤法(1∶10供试液,m/V),霉菌和酵母菌总数的计数采用平皿法(1∶10供试液,m/V),控制菌检查采用培养基用量100 m L的平皿法符合要求。结论联用平皿法和薄膜过滤法的微生物计数法可有效去除芪连降糖片中微生物的抑菌作用,有利于检出潜在污染微生物。
Objective To establish a microbial limit test method for Qilian Jiangtang Tablets.Methods Dilution method,plate method and membrane filtration method were adopted for the suitability test of counting method of Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger.Precisely 10 mL of 1∶10 and 1∶50(m/V)test solution was inoculated into agar medium and liquid medium of casein soybean peptone respectively,and Escherichia coli was inoculated for the suitability test of control bacteria.Results The membrane filtration method was used for the determination of the total number of aerobic bacteria(1∶10 of test solution,m/V),the plate method was used for the determination of the total number of mould and yeast(1∶10 of test solution,m/V),the plate method with the amount of culture medium of 100 m L was used for the control bacteria test,which met the require ments.Conclusion The microbial count method combined with the plate method and membrane filtration method can effectively remove the antibacterial effect of microorganisms in Qilian Jiangtang Tablets,which is conducive to the detection of potentially contaminated microorganisms.
作者
沈锐
周剑
严海元
沈伟
赵壮志
SHEN Rui;ZHOU Jian;YAN Haiyuan;SHEN Wei;ZHAO Zhuangzhi(Chongqing Yongchuan Institute for Food and Drug Control,Chongqing,China402160;Chongqing Institute for Food and Drug Control,Chongqing,China 401121;Chongqing Engineering Research Center for Pharmaceutical Process and Quality Control,Chongqing,China 401121)
出处
《中国药业》
CAS
2021年第8期52-54,共3页
China Pharmaceuticals
关键词
芪连降糖片
微生物限度
抑菌
计数方法
质量控制
Qilian Jiangtang Tablets
microbial limit
bacteriostasis
counting method
quality control
