复方银翘氨敏胶囊质量分析报告

Quality Analysis of Compound Yinqiao and Paracetamol and Chlorphenamine Maleate Capsules

目的:国家药品计划抽验是对国内上市药品质量进行评价的一项研究工作,本文对2015年全国药品生产及流通领域的78批次复方银翘氨敏胶囊的质量进行考察分析,评价本品的质量现状及分析存在问题。方法:将法定检验与探索性研究相结合,针对现行标准对产品质量的不可控等问题,采用HPLC法进行含量测定;采用GC法鉴别薄荷油等;采用TLC法考察连翘苷等;采用近红外光谱扫描法建立近红外光谱库,为快速检验提供依据;对法定检验及探索性研究的结果进行统计分析。结果:法定检验与探索性研究结果之间存在显著差异。结论:探索性研究结果表明法定标准存在较多缺陷,且各厂家产品质量参差不齐,应引导企业进行制剂工艺改进,提高质量,采用更专属、准确、灵敏的方法全面控制产品质量。

Objective： Combining with national drug sampling program, to evaluate the current quality situation and problems of compound Yinqiao and paracetamol and chlorphenamine maleate capsules by testing and analyzing 78 batches of samples collected from the realm of drug production and circulation all over the country in 2015. Methods： As the current standard could not control the prod- uct quality, and combined the prescribed examination with exploratory research, the method of HPLC was used to determine the con- tents. GC and TLC was respectively used to identify peppermint oil and study on forsythin. Near infrared spectrum database was estab- lished by near-infrared spectroscopy （NIRS）, which provided the basis for rapid testing. The results of the prescribed examination and exploratory research were statistically analyzed. Results ： There were significant differences in the results of the prescribed examination and exploratory research. Conclusion： The results of exploratory research show that there are many defects in the statutory standards. The product quality of different manufactures was divers, and it is necessary to guide them to improve the preparation process and the quality. More exclusive, accurate and sensitive methods should be used to comprehensively control the quality.