利福平胶囊的微生物限度检查方法的研究

目的建立利福平胶囊的微生物限度检查法,并对方法进行验证。方法取供试品10g,用100mL十四烷酸异丙酯分散制成油性供试品混悬液,取50mL油性供试品混悬液(相当于利福平胶囊5g),用pH7.0氯化钠-蛋白胨缓冲液100mL萃取,取水层作为1:20供试液,稀释至1:200供试液,需氧菌按薄膜过滤法,用44℃水浴保温的含0.1%吐温80的pH7.0氯化钠-蛋白胨缓冲液1000mL冲洗,霉菌和酵母菌按常规法计数,控制菌按薄膜过滤法,用pH7.0氯化钠-蛋白胨缓冲液500mL冲洗,可消除利福平胶囊的抑菌活性。结果采用上述方法进行验证,5种菌的回收比值均达到0.5～2,控制菌生长良好。结论本方法可用于利福平胶囊的微生物限度的检查。

Study on the microbial limit test method of rifampicin capsules

Objective To establish a microbial limit test method of rifampicin capsules, and carry on the verification of methodology. Methods The oil sample was dispersed with 10g of sample and 100mL of isopropyl myristate. 50mL of oil sample (equivalent to 5g of rifampicin capsules) was extracted with 100mL of pH 7.0 NaCl-peptone buffer. The water layer was used as 1:20 test solution, and diluted to 1:200 test solution. The aerobic bacteria were counted by the membrane filtration method. The filter was washed with 1000mL 0.1% polysorbate 80 NaCl-peptone buffer (at 44℃ and pH7.0). Mold and yeast were counted by a routine method. The controlled bacteria were tested with the membrane filtration method, which was washed with 500mL PH7.0 NaCl-peptone buffer. This method can eliminate the bacteriostasis of rifampicin capsules. Results Using the above method, the recovery of five kinds of bacteria was between 0.5 and 2, and the controlled bacteria grew well. Conclusion This method can be used as the microbial limit test of rifampicin