羟基脲片与胶囊的质量评价分析  

Quality Evaluation and Analysis of Hydroxycarbamide Tablets and Capsules

作　　者：李立 朱韵洁 张媛媛 于玮洁 栾成章 Li Li Zhu Yunjie Zhang Yuanyuan Yu Weijie Luan Chengzhang(Qingdao Institute for Food and Drug Control, Qingdao 266071, China)

机构地区：[1]青岛市食品药品检验研究院,青岛266071

出　　处：《中国药事》2016年第11期1091-1095,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:对抽验结果进行统计分析,检测和评价羟基脲片及胶囊的质量现状,为提高临床用药安全提供参考依据。方法:采用法定检验方法并结合探索性研究对样品进行检测;开展如下探索性研究:有关物质测定、含量测定方法的改进,脲的薄层色谱研究,溶出曲线的考察,近红外快速检验模型的建立,主要杂质的研究。结果:按法定标准检验,样品合格率为100%。探索性研究表明,片剂现行标准项目设置较为全面,限度较为合理,对药品质量的控制具有一定的可行性,但在有关物质与含量测定、脲检查方法上存在一些问题。胶囊剂现行标准相对较为落后。按探索性研究方法进行检验,样品的合格率也为100%。结论:法定检验和探索性研究结果表明,羟基脲片及胶囊的质量均较好,但现行标准检验方法存在缺陷,质量标准需进一步提高。Objective： To investigate and evaluate the quality of hydroxycarbamide tablets and capsules through the statistical analysis of the sampling results in section data, so as to provide references for the improvement of clinical medication safety. Methods： Statutory testing methods combined with the exploratory study were adopted to the sample examination. The exploratory study was conducted, including the tests of related substances and content determination, the research of the thin layer chromatography of urea, the determination of dissolution curve, the establishment of near infrared spectroscopic model, and the study of main impurities. Results： The statutory test showed the pass rate was 100%. The exploratory study showed that the current standards of the tablet were comprehensive and reasonable, which was feasible to control the quality of drugs; however, there were problems in the related substances and content determination, and urea test method. The current standard of capsule was relatively backward. According to the exploratory research method, the qualified rate of the sample was also 100%. Conclusion： The results of statutory and exploratory tests showed that the quality of hydroxycarbamide tablets and capsules was satisfying, but the current standards were defective which need to be further improved.

关 键 词：药品安全监测 药品质量评价 药品评价性抽验 抗肿瘤药物质量分析 羟基脲片剂 羟基脲胶囊剂 

分 类 号：R917[医药卫生—药物分析学]