复方克林霉素溶液微生物限度检查方法的建立

目的 建立复方克林霉素溶液微生物限度检查方法.方法 依据＆lt;中国药典＆gt;2010年版二部附录微生物限度检查方法验证试验的要求.结果 细菌、霉菌和酵母菌检查法的验证试验中,采用稀释法与薄膜过滤法（0.5mL/膜）联用的方法,去除复方克林霉素溶液的抗菌活性.试验组及稀释剂对照组的五种阳性试验菌株的回收率均大于70%.控制菌检查法的验证试验中,金黄色葡萄球菌采用薄膜过滤法、铜绿假单胞菌采用常规法;本方法依据＆lt;中国药典＆gt;2010年版验证试验的要求,方法可靠、准确.结论 该方法可作为复方克林霉素溶液微生物限度检查方法.

Establishment of microbial limit test methodology of compound clindamycin solution

OBJECTIVE To establish compound clindamycin solution of microbial limit inspection. METHODS Chinese pharmacopoeia 2010 edition department under appendix microbial limit test method for method validation was referenced. RESULTS In the test of compound clindamycin solution bacteria, yeast, mold, combine dilution method with menbrane filtration method to remove the antibacterial activity of compound clindamycin solu- tion. Recovery of five positive strains tested in experimental group and diluent control group were greater than 70% Control staphylococcus aureus membrane filter method was used to check staphylococcus aureus, the pseudomonas aeruginosa was checked by the conventional method. CONCLUSION It can be use for compound clindamycin solution of microbial limit test methodology.