喘舒片微生物限度检查方法的建立

Establishment of Microbial Limit Test Method for Chuanshu Tablets

目的建立喘舒片微生物限度检查方法。方法按照《中华人民共和国药典》2020年版四部通则1105、1106,分别采用常规法、增加稀释液法及增加培养基体积法进行方法适用性试验,通过计算回收比及阳性对照结果,确定合适的检查方法。结果增加稀释液法(需氧菌总数、霉菌和酵母菌总数检查分别须稀释至500倍、50倍)、增加培养基体积法(0.2 ml/皿)均可消除药物抑菌性,回收比在0.5~2.0。常规法检查耐胆盐革兰阴性菌和大肠埃希菌,阳性对照组均为阳性,阴性对照组均为阴性。沙门菌检查须采用增加培养基体积法(胰酪大豆胨液体培养基体积增加到200 ml)才可消除药物抑菌性。结论喘舒片需氧菌总数检查、霉菌和酵母菌总数检查用增加稀释液法,耐胆盐革兰阴性菌、大肠埃希菌检查用常规法,沙门菌检查须用增加培养基体积法。

Objective To establish a microbial limit test method for Chuanshu Tablets.Methods According to the four general rules 1105 and 1106 of Chinese Pharmacopoeia 2020 edition,the applicability of the method was tested by conventional method,diluent-increasing method and medium volume increasing method,and the appropriate test method was determined by calculating recovery ratio and positive control.Results Increasing the dilution method(the total number of aerobic bacteria should be diluted to 500 times,the total number of mold and yeast should be diluted to 50 times)and increasing the volume of culture medium(0.2 ml/dish)could eliminate the antibacterial activity of drugs,and the recovery ratio was between 0.5~2.0.Bile-Tolerant Gram-Negative Bacteria and Escherichia coli were detected by conventional method,positive control group were positive,negative control group were negative.The bacteriostasis of the drug can be eliminated by increasing the volume of medium(the volume of tryptone liquid medium of soybean was increased to 200 ml)for salmonella detection.Conclusion The total number of aerobic bacteria,mold and yeast in Chuanshu Tablet can be detected by adding diluent method,Bile-Tolerant Gram-Negative Bacteria and Escherichia coli can be detected by conventional method,salmonella can be detected by adding medium volume method.