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3种中药制剂微生物限度检查法的验证 被引量:3

Validation of Microbial Limit Test for 3 Chinese Herba Preparations
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摘要 目的建立肾康丸、抗类风湿丸和骨伤酒3种中药制剂的微生物限度检查法。方法测定3种制剂对5个规定试验菌株的回收率,对控制菌的检查法进行验证。结果肾康丸、抗类风湿丸对金葡菌、大肠埃希菌、枯草芽孢杆菌有抑制作用,对白色念珠菌和黑曲霉无抑制作用;骨伤酒对全部试验菌无抑制作用。结论肾康丸、抗类风湿丸可采用培养基稀释法检测细菌总数,微生物限度其他项目及骨伤酒全部项目均可按常规法检查。 Objective To establish the microbial limit test(MLT) method for Shenkang pills,Kang Leifengshi pills,and Gushang vine. Methods The recoveries of 5 tested bacterial strains were detected to validate the accuracy and feasibility of MLT of the 3 preparations.Results All of the 3 preparations had no inhibitory effect on Blastomyces albicans and Black mold.Shenkang pills and Kang Leifengshi pills showed antibacterial activity to Escherichia coli,Staphylococcus aureus,and Bacillus subtilis.Conclusion The total bacterial count of Shenkang pills and Kang Leifengshi pills can be detected by culture media dilution method,while other subjects of those 2 preparations and all subjects of Gushang vine can be detected by MLT.
出处 《今日药学》 CAS 2010年第5期32-34,共3页 Pharmacy Today
关键词 方法验证 微生物限度检查 培养基稀释法 method validation microbial limit test culture medium diluted method
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