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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: National drug program sampling is a research work to evaluate the quality of listed pharmaceuticals in China. In this paper, the quality of 78 batches of AstraZeneca capsules in the field of pharmaceutical production and distribution in 2015 was investigated and analyzed. Quality status and analysis of existing problems. Methods: The statutory test and exploratory research were combined to solve the problem of uncontrollable quality of products such as the current standards. HPLC method was used to determine the content of peppermint oil. The TLC method was used for the determination of forsythin and so on. The establishment of near infrared spectroscopy library by infrared spectrum scanning provides a basis for rapid test; the statistic test and exploratory research results are statistically analyzed. Results: There was a significant difference between statutory and exploratory findings. Conclusion: The exploratory research results show that there are many defects in the statutory standards and the product quality varies from manufacturer to producer. Therefore, enterprises should be guided to improve the formulation process and improve the quality. The product quality should be controlled more completely, accurately and sensitively.