头孢妥仑匹酯片微生物限度检查方法的研究

目的:建立头孢妥仑匹酯片的微生物限度检查方法。方法:按《中国药典》2015版四部通则1105和1106,对头孢妥仑匹酯片进行微生物限度方法学适用性试验。结果:头孢妥仑匹酯片具有较强的抗菌活性,以pH 7.0无菌氯化钠-蛋白胨缓冲液(含0.1%卵磷脂以及0.7%聚山梨酯80)为稀释液,将供试品稀释成1∶20的供试液,静置沉淀,并采用薄膜过滤法和中和法结合(200 mL稀释,冲洗量每膜800 mL),加入头孢菌素酶,可消除其抑菌活性。结论:采用薄膜过滤法和中和法相结合,并在培养基中加入中和剂的方法可用于头孢妥仑匹酯片的微生物限度检查。

Study on microbial limit test of Cefditoren Pivoxil Tablets

Objective: To establish a method for microbial limit test of Cefditoren Pivoxil Tablets. Methods: The suitability of microbial limit test of Cefditoren Pivoxil Tablets was verified according to general chapters 1105 and 1106 of ChP 2015 Vol Ⅳ. Results: Cefditoren Pivoxil Tablets had the strong antibacterial activity. pH 7.0 sterile sodium chloride peptone buffer(containing 0.1% lecithin and 0.7% polysorbate 80) was used as the diluent. The test solution was prepared by diluting the test sample with the ratio of 1∶20, then it was placed for static precipitation. The membrane filtration and neutralization methods were used together(diluted with 200 mL solution, flushing volume 800 mL per membrane), cephalosporinase was added to eliminate the antibacterial activity. Conclusion: The established method of combining the membrane filtration and neutralization methods and adding neutralization agent in culture medium is applicable to microbial limit test for Cefditoren Pivoxil Tablets.