| 王立云,陈正伟,牛萌萌,姬俊.养阴清肺口服液抑菌效力研究及其抑菌剂使用情况分析[J].中国药事,2022,36(11):1253-1259 |
| 养阴清肺口服液抑菌效力研究及其抑菌剂使用情况分析 |
| Study on the Antimicrobial Effectiveness of Yangyin Qingfei Oral Liquid and the Analysis of the Use of Preservatives |
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| DOI：10.16153/j.1002-7777.2022.11.007 |
| 中文关键词: 养阴清肺 抑菌剂 抑菌效力 含量检测 情况分析 |
| 英文关键词: Yangyin Qingfei Oral Liquid antimicrobial preservatives antimicrobial effectiveness content determination analysis |
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| 摘要点击次数: 775 |
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| 中文摘要: |
| 目的：对2020年国家药品抽检品种养阴清肺口服液的抑菌效力及其抑菌剂使用情况进行分析， 评价其抑菌体系对微生物污染的控制能力。方法：依据《中华人民共和国药典》(简称《中国药典》) 2020年版四部通则1121抑菌效力检查法，对抽样自16个省、市、自治区的31批次养阴清肺口服液的抑菌效果进行考察，评价产品抑菌体系是否满足要求；并构建方法对样品中添加的抑菌剂含量进行检测， 分析添加的抑菌剂种类和用量情况是否合理。结果：抽样自16个省、市、自治区的31批次养阴清肺口服液均达到《中国药典》中口服制剂的抑菌效力判断标准；抑菌剂种类及浓度均在《中国药典》要求范围内，31批次均使用山梨酸，浓度在0.061%~0.069%之间。结论：国家药品抽检品种养阴清肺口服液是按法定处方工艺进行生产的，未存在违规添加抑菌剂的情况，添加的抑菌剂种类和用量合理，在保质期内的防腐体系是有效的。 |
| 英文摘要: |
| Objective: To analyze the antimicrobial effectiveness of Yangyin Qingfei Oral Liquid and the use of preservatives, and evaluate the control ability of the preservative system to microbial contamination. Methods: According to the general rule 1121 of the fourth part of the Chinese Pharmacopoeia (2020 edition), the antimicrobial effectiveness of 31 batches of Yangyin Qingfei Oral Liquid from 16 provinces, cities and autonomous regions was investigated by the antimicrobial effectiveness test to evaluate whether the antimicrobial system of the product met the requirements, and the content of the preservatives added in the sample was detected by the self-built method to analyze the rationality of the type and amount of the preservatives added. Results: 31 batches of Yangyin Qingfei Oral Liquid sampled from 16 provinces, cities and autonomous regions all met the criteria for determining the antimicrobial effectiveness of oral preparations in the Chinese Pharmacopoeia, the types and concentrations of preservatives were within the requirements of the Chinese Pharmacopoeia, and the concentration of sorbic acid was 0.061%-0.069% in 31 batches. Conclusion: Yangyin Qingfei Oral Liquid, the national drug sampling variety, was produced according to the legal prescription process, and there was no illegal addition of bacteriostatic agents. The type and dosage of bacteriostatic agents added were reasonable, and the antiseptic system was effective within the shelf life. |
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