具抗菌活性胶囊剂的微生物限度检查方法及验证

Method and validation of the microbial limit tests on capsules of antibacterial activity

目的:建立抗菌活性类胶囊剂的微生物限度检查方法并对其进行验证。方法:抗生素胶囊,剪破胶囊壳,加冷的pH 7.0氯化钠蛋白胨缓冲液稀释,取不含胶囊壳的混悬液500r·min^(-1)离心5min,离心后的上清液用膜过滤器进行薄膜过滤并用0.1%蛋白胨水溶液冲洗,薄膜置营养琼脂培养平板上培养。被稀释液浸润的胶囊壳用0.1%蛋白胨水溶液冲洗充分洗涤后,采用常规法测定其菌落数。结果:此方法有效地解决了这类胶囊剂的胶囊壳、辅料、水中未溶部分药物的前处理问题,并较为完全地消除了具有抗菌活性类胶囊剂对微生物限度检查的内在干扰。

Objective： To provide a method of the microbial limit test on antibiotic capsule and to test the validation of the method. Methods： Take antibiotic capsules, break the capsule, add the cold pH 7. 0 sodium chloride peptone solution, put the solution of shell - less capsule into centrifugal tube （500 r·min^- 1 ）. Extract the upper solution, Filter with the membrane filter and wash the filter with 0. 1% peptone solution washing liquid, Raise the thin - layer using nutrition agar slab. The capsules soaked in the cold pH 7.0 sodium chloride peptone solution, and wash it compeletly with 0. 1% peptone solution washing liquid, determine the bacteria with dilute methods. Results： This method effectively solve the problem of the front - dealing of capsule shell, supplementary material and the dissolved material in water , and completely eliminated the disturbance in microbial limit test of it. Conclusion：This method is suitable for the microbial limit test on the cupsules of antibacterial active.