地拉罗司分散片微生物限度检查方法研究

Microbial Limit Test Method of Deferasirox Dispersible Tablets

关键词:  地拉罗司分散片  微生物限度检查  方法验证

Key words:  Deferasirox Dispersible tablets  microbial limit  verification and evaluation of methodology

摘要:

目的 建立地拉罗司分散片的微生物限度检查方法。方法 根据中国药典2015年版四部通则1105非无菌产品微生物限度检查中的微生物计数法，通则1106非无菌产品微生物限度检查中的控制菌检查法和通则1107非无菌药品微生物限度标准进行方法适用性试验。微生物限度检查方法学适用性试验采用常规法筛查了抑菌性，然后利用稀释和中和原理改进供试液的制备，即将中和剂3%聚山梨酯-80、0.3%卵磷脂添加至pH 7.0氯化钠-蛋白胨缓冲液作为稀释液，需氧菌总数计数（稀释成1：500）及霉菌和酵母菌总数计数（稀释成1：50）均采用平皿法，控制菌检查法采用培养基稀释法（500 mLTSB）。结果 5种试验菌的回收试验结果均在0.5~2.0之间。结论 该方法适用于地拉罗司分散片微生物限度的检查。

Abstract:

OBJECTIVE To establish a microbial limit test method of Deferasirox Dispersible tablets. METHODS According to the fourth volume of Chinese Pharmacopoeia(the 2015 Edition), general rule 1105:microbial counting method for microbial limit test of non-sterile products, general rule 1106:the control bacteria examination method for microbial limit test of non-sterile products, general rule 1107:the test method for suitability of microbiological limits for non sterile drugs. Several methods were tried in the suitability of microbial limit test. When the samples were diluted in pH 7.0 sodium chloride buffer-peptone solution (containing 3% Tween-80, 0.3% lecithin) and were made a 1 in 500 dilution (the total aerobic microbial count), 1 in 50(the total yeast and mold count). A plate method was used in the total aerobic microbial count and the total yeast and mold count. The direct inoculation method was used for the detection of Escherichia coli(500 mL TSB). RESULTS The recoveries of the five strains were from 0.5 to 2.0. CONCLUSION The method is suitable for the microbial limit examination of Deferasirox Dispersible tablets.