参橘止咳滴丸微生物限度检查法的建立和最大耐受量实验

摘要

目的：建立参橘止咳滴丸微生物限度检查方法，并测定其最大耐受量。方法：测定参橘止咳滴丸对5种验证菌株的回收率，并对控制菌的检查法进行验证；同时，小鼠灌胃给予参橘止咳滴丸120 g/（kg·d）(相当于人临床用量的2290.08倍)，观察14天，记录有无死亡发生，确定小鼠对参橘止咳滴丸的最大耐受量。结果：回收率试验结果表明，参橘止咳滴丸供试品试验菌的回收率试验均高于70%，证明无抑菌现象；一次性给予高剂量参橘止咳滴丸，经过14天的连续观察，小鼠无死亡且一般状态良好。结论：参橘止咳滴丸可按常规方法进行微生物限度检查，且具有较高的安全性。%Objective:To establish microbial limit test and measure the maximum-tolerated dose (MTD) of ShenJu ZhiKe dripping pills. Methods:The recovery rates of 5 verified strains treated by ShenJu ZhiKe dripping pills were detected by routine method, and the microbial limit test method for the control bacteria was validated;Mean-while, rats were observed continuously for 14 days after being given ShenJu ZhiKe dripping pills 120 g/(kg·d) by in-tragastric administration ( equivalent to 2290.08 times of the clinical dosage), then the dead rats were recorded and their MTD could be obtained. Results: The recovery rates of ShenJu ZheKe dripping pills for the verified strains were higher than 70%, which indicated no antimicrobial effect of the pills;in the experiment of MTD, after rats be-ing given ShenJu ZhiKe dripping pills of high dose one time, no rats died for 14-day observation and they were in perfectly good condition. Conclusion:Microbial limit tests for ShenJu ZheKe dripping pills can be conducted with conventional method and the higher safety can be ensured.