盐酸维拉帕米缓释片微生物限度检查方法学的建立

Establishment of methodology for microbial limit test of Verapamil Hydrochloride Sustained-release Tablets

目的建立盐酸维拉帕米缓释片微生物限度检查方法。方法按《中国药典》2015年版四部通则,采用中和剂硫氰酸铵(1g/100m L)+稀释法(1∶50)进行微生物计数法和控制菌检查法的方法学验证。结果对盐酸维拉帕米缓释片进行了3次验证,每次的菌种回收率在50%~200%范围内,控制菌的检查都符合2015版《中国药典》规定。结论中和法能有效去除盐酸维拉帕米缓释片的抑菌成分,不影响污染微生物的生长,适用于检查该制剂微生物限度和控制菌检查。

Objective To Establish a microbial limit test for Verapamil Hydrochloride Sustained-release Tablets. Methods According to the four general rules of the 2015 edition of China Pharmacopoeia, the methods of microbial count and control bacteria examination were carried out by the neutralizer ammonium thiocyanate（1 g/100 m L） ＋ dilution method（1：50）. Results 3 tests were carried out on Verapamil Hydrochloride Sustained-release Tablets. The recovery rate of bacteria was within the range of 50% to 200%. The control bacteria were checked in accordance with the 2015 edition of China Pharmacopoeia.Conclusion The neutralization method can effectively remove the bacteriostasis components of Verapamil Hydrochloride Sustained-release Tablets, and does not affect the growth of contaminated microorganisms. It is suitable for checking the microbial limit of the preparation and controlling the bacteria check.