青霉素V钾片微生物限度检查方法适用性研究

目的：探讨西安市儿童医院特殊使用级抗菌药物应用情况，评估特殊使用级抗菌药物应用合理性，以加强抗菌药物临床应用管理。方法：利用医院信息系统（HIS）抽取2018年7月至12月所有使用特殊级抗菌药物的出院病历共1 044份，对患儿特殊使用级抗菌药物应用情况进行点评分析。结果：1 044份病历中特殊级抗菌药物使用不合理医嘱共146条，占特殊使用级抗菌药物医嘱总数的7.8%。不合理医嘱主要包括给药剂量或频次不适宜、遴选药物不适宜，分别占23.97%、13.01%。结论：我院特殊使用级抗菌药物的应用仍存在不合理现象，应加强对临床医师、药师的专业培训，以确保抗菌药物应用的安全性。

Validation Study on Microbial Limit Test of Phenoxymethylpenicillin Potassium Tablets

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.