盐酸左西替利嗪口服溶液抑菌体系的评价研究

Evaluation of the antimicrobial system of Levocetirizine dihydrochloride oral solution

关键词:  盐酸左西替利嗪口服溶液  尼泊金酯类抑菌剂  抑菌体系  抑菌效力  种类筛查和含量测定

Key words:  Levocetirizine dihydrochloride oral solution  paraben antimicrobial agent  antimicrobial system  antimicrobial effectiveness  screening types and content determination

摘要:

目的 对2021年国家药品评价性抽验品种盐酸左西替利嗪口服溶液的抑菌效力及其抑菌剂使用情况进行评价研究,分析其抑菌体系对微生物污染的控制能力。方法? 参照《中国药典》二部阿昔洛韦滴眼液的方法对8家企业的样品开展抑菌剂种类筛查；根据企业提供的方法对添加抑菌剂的6家企业的样品进行抑菌剂含量测定；根据《中国药典》2020年版四部通则1121抑菌效力检查,评判样品的抑菌性是否满足药典要求。结果? 8家企业所有样品抑菌剂的种类、添加量均与处方一致；抑菌效力检查结果为添加抑菌剂的6家企业的样品均满足药典规定,未添加抑菌剂的2家企业的样品,1家满足规定、1家不满足规定。结论 70批次盐酸左西替利嗪口服溶液均未发现违规添加或滥用抑菌剂的情况,但抑菌体系是否为最优处方存疑,建议生产企业结合辅料特性、水分活度等,基于风险评估的理念开展评价,优化处方设计,建立更合理的抑菌体系。

Abstract:

OBJECTIVE To evaluate and study the antimicrobial effectiveness and use of antimicrobial agent of Levocetirizine oral solution, a national drug evaluation sample in 2021, and analyze the control level of its antimicrobial system to microbial contamination. METHODS According to the method of Aciclovir eye drops in Part II of the Chinese Pharmacopoeia, the samples produced by 8 manufacturers were screened for the types of antimicrobial agent; Determine the content of samples produced by 6 manufacturers added with antimicrobial agent according to the method provided by the manufacturers; According to General Rule 1121 of the 2020 edition of the Chinese Pharmacopoeia, evaluate whether the antimicrobial effectiveness of the sample meets the requirements of the pharmacopoeia. RESULTS The types and dosage of antimicrobial agent in all samples produced by 8 manufacturers are consistent with the prescription. The results of the antimicrobial effectiveness test showed that the samples produced prescription. The results of the antimicrobial effectiveness test showed that the samples produced by the 6 manufacturers that added antimicrobial agent all met the requirements of the pharmacopoeia. Among the samples produced by the 2 manufacturers that did not add antimicrobial agent, one met the requirements and one did not. CONCLUSION 70 batches of Levocetirizine oral solution did not add or abuse antimicrobial agent in violation of regulations, but there is doubt whether the antimicrobial system is the best prescription. It is suggested that the manufacturer should carry out evaluation based on the concept of risk assessment in combination with the characteristics of excipients, water activity, etc., optimize the prescription design, and establish a more reasonable antimicrobial system.