| 引用本文: | 程继业,陈礼峰,许奇,周悦鹏,邢以文,陈蓉.基于国家药品抽检的小儿氨酚那敏片质量评价[J].中国现代应用药学,2024,41(13):36-42. |
| chengjiye,chenlifeng,xuqi,zhouyuepeng,xingyiwen,chenrong.Quality Evaluation of Compound Paracetamol and Chlorphenamine Tablets for Infant Based on National Drug Sampling Inspection[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(13):36-42. |
|
| 摘要: |
| 目的 评价小儿氨酚那敏片的质量现状和存在的问题。方法 采用法定标准对抽检样品进行检验，并建立或完善多个分析方法用于有关物质、含量测定、溶出度、刻痕功能性、基因毒性杂质等探索性研究。结果 按法定标准检验合格率100.0%，但法定标准缺乏对有关物质的控制，且含量及含量均匀度测定方法存在明显问题。探索性研究结果表明含量和含量均匀度符合要求；有关物质和基因毒性杂质风险可控；但作为可分割片剂，其分割性能不能满足要求；部分企业产品溶出性能不能达到国外药典同类产品的要求。结论 本品总体质量良好，但由于上市时间较早，部分质量属性已不能满足现行法规或相关指南的要求，企业应参照国外同类制剂，优化处方和生产工艺；法定质量标准有待修订完善。 |
| 关键词: 小儿氨酚那敏片 国家药品抽检 质量评价 刻痕片功能性 |
| DOI：10.13748/j.cnki.issn1007-7693.20232214 |
| 分类号: |
| 基金项目:国家药品抽检计划项目(国药监药管[2022]1号) |
|
| Quality Evaluation of Compound Paracetamol and Chlorphenamine Tablets for Infant Based on National Drug Sampling Inspection |
|
chengjiye, chenlifeng, xuqi, zhouyuepeng, xingyiwen, chenrong
|
|
Suzhou Institute for Drug Control
|
| Abstract: |
| OBJECTIVE To evaluate the quality and existing problems of Compound Paracetamol and Chlorphenamine Tablets for Infant. METHODS The samples were tested by the regulatory specification, and several analytical methods were subsequently established or improved for the exploratory research on related substances, assay, dissolution, subdivision characteristics of scored tablets, and genotoxic impurities. RESULTS All samples met the regulatory specification, and the pass rate was 100%. However, the control for related substances is lacking, and the method for assay and content uniformity is defective. The exploratory studies showed that the assay and content uniformity of the two components met the requirements, and the risk of related substances and genotoxic impurities was acceptable. As a divisible tablet, the subdivision characteristics could not meet the requirements of the scored tablet, and the dissolution performance of some samples could not meet the requirements of similar products in foreign pharmacopoeias. CONCLUSION The overall quality of this product is adequate. However, due to the early time on the market, some quality attributes no longer meet the requirements of current regulations or relevant guidelines. The manufacturers should further optimize the prescription and production process, referring to foreign similar products. The current specification needs to be revised and improved. |
| Key words: compound paracetamol and chlorphenamine tablets for infant national drug sampling inspection quality evaluation subdivision characteristics of scored tablets |
