醒脑聪胶囊微生物限度检验方法的建立

Establishment of Microbial Limit Test for Xingnaocong Capsules

目的依据《中国药典》2015年版建立医院制剂醒脑聪胶囊的微生物限度检验方法。方法按照《中国药典》2015年版(四部)通则微生物限度检查法的规定,采用平皿法对醒脑聪胶囊的微生物限度检验方法进行适用性试验。结果所建立的检查方法对金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌、黑曲霉五种验证菌株的回收比值均在0.5～1.5之间,控制菌(大肠埃希菌、沙门菌、耐胆盐革兰阴性菌)可检出,阴性对照组没有检出控制菌。结论采用常规法对醒脑聪胶囊进行微生物限度检查,操作简单快速、结果准确可靠,可以客观地反映药物中微生物的污染状况,能较好的控制醒脑聪胶囊的质量。

Objective To establish the method of microbial limit test for Xingnaocong capsules according to ‘Chinese pharmacopoeia＇ 2015 edition. Methods Routine pour-plate method are used in the suitability test refer to the microbial limit test method in ‘Chinese Pharmacopoeia＇ 2015 edition Part IV. Results The recoveries of all kinds of strains in the tests of total aerobic microbial count, total yeast and mold count are 0.5 ～ 2.0. In the method validations, Escherichia coli, bile-tolerant gram-negative bacteria and Salmonella enterica subsp are detected, while the negative control is no growth detected. Conclusion The microbial limit test for Xingnaocong capsules is validated in this study. The method is quick, accurate and suitable for quality control for Xingnaocong capsules to reflect medicine microbial contamination.