心可宁胶囊质量评价分析  

Quality Evaluation and Analysis of Xin Kening Capsules

作　　者：梁秀坤 贾善学 李漫漫 

机构地区：[1]滨州市食品药品检验检测中心,滨州256600

出　　处：《中国药事》2015年第8期850-853,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:通过对心可宁胶囊抽样检验及探索性研究,对其质量及质量标准状况进行评价和分析,为心可宁胶囊质量监管和质量标准提高提供参考。方法:按法定标准对样品进行检验;并进行如下探索性研究:采用薄层色谱法对心可宁胶囊中红花、人参须进行鉴别;采用高效液相色谱法对蟾酥中的华蟾酥毒基和脂蟾毒配基、丹参中丹酚酸B进行含量测定;采用原子吸收分光光度法对胶囊壳中的铬进行含量测定。结果:按照法定的质量标准检验,结果全部符合规定。探索性研究结果表明:胶囊壳中铬含量均在限度范围内;但有14批样品的红花和16批的人参须投料量或质量存在问题;27批样品丹酚酸B含量不足4.4 mg·粒-1;46批样品华蟾酥毒基和脂蟾毒配基含量存在问题。结论:虽然按照法定标准检验,结果全部符合规定,但探索性研究结果表明:产品质量还存在一定的问题,有必要进一步提升;质量标准尚存在不足,有必要进一步提高;产品生产过程中日常监管还有待进一步加强。Objective： To evaluate the quality and the quality standard of Xin Kening capsules by sample testing and exploratory research, so as to provide references for quality supervision and improvement of quality standards. Methods： Samples were tested according to the legal drug specifications and the exploratory research was conducted as follows： to identify safflower and ginseng fibrous root by TLC; to determine contents of cinobufagin and bufogenin in venenum bufonis as well as salvianolic acid B in salvia miltiorrhiza by HPLC; to determine content of chromium in the capsule shell by atomic absorption spectrophotometer. Results： The results of samples all conformed to the legal drug specifications. The exploratory research showed that the content of chromium was in the limit range, However, there were inventory or quality problems in 14 batches of test samples of safflower and 16 batches of ginseng fibrous root; the salvianolic acid B content in 27 batches of test samples was less than 4.4 mg/per particle; problems also existed in the contents of cinobufagin and bufogenin in 46 batches of venenum bufonis. Conclusion： Although the results of samples all conformed to the legal drug specifications, the results of the exploratory research showed that there were some problems in the quality of the products which needed further improvement. The quality standard was not desirable enough, and it is necessary to be further improved. Daily supervision in the process of production also needs to be further strengthened.

关 键 词：药品安全监测 药品监管 心可宁胶囊 药品质量评价 药品质量标准 薄层色谱鉴别 显微鉴别 含量测定 蟾酥 丹参 人参须 铬检测 

分 类 号：R917[医药卫生—药物分析学]