黄云通便胶囊和喘咳安丸的微生物限度检查方法的适用性试验研究

Experimental Study on Applicability of Microbial Limit Test Method for Huangyun Tongbei Capsule and Chuankean Pill

目的 按照医院质量控制需求建立两种医院制剂的微生物限度检查方法。方法 根据《中华人民共和国药典》2020年版四部对黄云通便胶囊和喘咳安丸两种中药制剂的需氧菌、霉菌和酵母菌计数分别采用常规法、增加稀释剂体积法进行适用性试验,通过计算回收率比值确定合适的检查方法;控制菌采用常规法和增加稀释液体积法,根据阳性对照结果,确定合适的检查方法。结果 黄云通便胶囊和喘咳安丸的需氧菌检查可采用增加稀释液体积法,将供试液稀释至50倍,霉菌和酵母菌采用常规法时,各菌株的回收比值均在0.5~2.0,可按照此法进行微生物计数检查;在控制菌适用性试验中,耐胆盐革兰阴性菌和大肠埃希菌均采用常规法进行检查,沙门菌检查时,黄云通便胶囊与喘咳安丸则需要将胰酪大豆胨液体培养基(TSB)增加至200ml。结论 黄云通便胶囊和喘咳安丸的需氧菌总数检查采用增加稀释液体积法,霉菌和酵母菌总数检查采用常规法;耐胆盐革兰阴性菌和大肠埃希菌采用常规法进行检查,沙门菌采用增加稀释液体积法进行检查。

Objective To establish microbial limit test methods for two kinds of hospital preparations according to the requirements of hospital quality control.Methods According to the China Pharmacopoeia 2020 edition,the applicability of the methods of routine count of aerobic bacteria,mould count and yeast count of Huangyun Tongbian capsule and chuankean pill was tested by increasing the volume of diluent,the suitable test method was determined by calculating the recovery ratio,and the control bacteria were determined by routine method and adding dilution volume method.Results The aerobic bacteria of Huangyun Tongbian capsule and Xuankeca An pill can be tested by increasing the volume of the dilution liquid to 50 times.For the fungi and yeasts,the conventional method can be used,with the recovery ratios of all strains ranging from 0.5 to 2.0.This method can be used for microbial enumeration tests.In the test for the suitability of the control bacteria,the enteric bacteria and Escherichia coli were tested using the conventional method,while the Salmonella test required increasing the TSB liquid culture medium to 200 ml for Huangyun Tongbian capsule and Xuankeca An pilll.Conclusion The total number of aerobic bacteria in Huangyun Tongbian capsule and chuankean pill was detected by increasing dilution volume method,the total number of mold and yeast was detected by routine method,and the bile-resistant gram-negative bacteria and Escherichia coli were detected by routine method,salmonella was examined by increasing the dilution volume.