紫苏方胶囊微生物限度检查方法的研究

Verification of microbial limit test method for Zisu Fang

目的:建立中药抗菌药物紫苏方胶囊微生物限度检查方法并对其进行验证。方法:参照2015年版《中国药典》四部通则,利用卵磷脂、L组氨酸、聚山梨酯80的中和作用,采用薄膜过滤法和平皿法测定紫苏方胶囊对金黄色葡萄球菌等5种试验菌种的回收率,并对其进行了控制菌适用性试验。结果:5种试验菌回收率均在0.5~2.0范围,控制菌可检出。结论:本试验所建立方法可用于紫苏方胶囊的微生物限度检查。

Objective： To establish and verify the microbial limit test method for the traditional Chinese medicine of Zisu Fang capsule. Methods： According to the fourth part of the 2015 edition of Chinese Pharmacopoeia principles, the recovery rates of Zisu Fang capsule against 5 kinds of test microorganisms including Staphylococcus aureus were measured by membrane filtration and Petri dish methods and using the neutralization of lecithin, L-histidine and polysorbate 80, and the applicability test of E.coli as the control bacterium was also performed. Results： The recovery rates of the 5 kinds of experimental microorganisms were in the range of 0.5-2, and the control bacterium could be detected. Conclusion： The methods established in this experiment can be used for the microbial limit test of Zisu Fang capsule.