青霉素V钾片微生物限度检查方法适用性研究

Validation Study on Microbial Limit Test of Phenoxymethylpenicillin Potassium Tablets

目的:建立青霉素V钾片的微生物限度检查方法。方法:按《中国药典》2020年版(四部)非无菌产品微生物限度检查:微生物计数法、控制菌检查法进行适用性试验。结果:本品需氧菌总数计数可采用薄膜过滤法冲洗800 mL,将膜贴于胰酪大豆胨琼脂平板(每200 mL含1 000万单位青霉素酶)依法检查;霉菌和酵母菌总数计数可采用常规法依法检查;质控菌大肠埃希菌可采用薄膜过滤法冲洗500 mL依法检查。结论:青霉素V钾片对试验菌均有不同程度的抑菌作用,采用薄膜过滤法、中和法联用可消除其抑菌作用,客观地反映药物中微生物的污染状况,以达到检测目的。

Objective: To establish the method of microbial limit test for phenoxymethylpenicillin potassium tablets. Methods: Microbial counting method and specified microorganisms test were adopted for validation evaluation based on non-sterile product microbial limit test cited in the Chinese Pharmacopoeia(2020 edition). Results: The aerobic bacteria could be quantified by 800 mL solution(200 mL solution with 10 million units of penicillinase) rinsing the membrane that attached on the tryptic soy peptone agar plate according to membrane filtration method. Molds and yeasts could be quantified by conventional method, specified microorganisms of Escherichia coli could be measured by 500 mL solution rinsing according to membrane filtration method. Conclusion: Phenoxymethylpenicillin potassium tablets have different degrees of antibacterial effects on the tested bacteria. The combination of membrane filtration and neutralization can eliminate the antibacterial effects, and objectively reflect the contamination status of microorganisms in the drug to achieve the purpose of detection.