复方丹参片微生物限度检查方法的建立

Establishment of microbial limit test for Compound Danshen Tablets

目的:建立复方丹参片的微生物限度检查方法。方法:按照《中国药典》2015年版四部通则1105、1106,分别采用常规法、增加稀释液法、薄膜过滤法和中和法进行方法适用性试验,计算试验菌回收比。结果:中和法可去除或灭活药物抑菌作用,在微生物计数法中回收比均在0.5~2.0,符合《中国药典》的相关要求;在控制菌检查中,阳性试验组检出阳性菌,阴性试验组均无菌生长。结论:建立了适用于复方丹参片微生物限度检查的中和法(中和剂为聚山梨酯80-卵磷脂)。

Objective:To establish a method for microbial limit test of Compound Danshen Tablets.Method:The suitability test of conventional method,addition dilution method,membrane filtration method and neutralization method were performed as per general notice 1105,1106 in ChP 2015 VolⅣ,and the recoveries were calculated.Results:The bacteriostatic effect of drugs was eliminated or inactivated by neutralization method and the recoveries fell into 0.5-2.0 with microbial count method,which met the requirements of Chinese Pharmacopoeia.In the control bacteria test,positive bacteria were detected in the positive test group and sterile growth was observed in the negative test group.Conclusion:A neutralization method for microbial limit test of Compound Danshen Tablets is established with polysorbate 80-lecithinas the neutralizers.