摘要
目的:建立双氢青蒿素哌喹片中双氢青蒿素(DHA)的溶出度测定方法,为其质量控制和溶出度评价提供依据。方法:参照中国药典2015年版四部通则溶出测定项下第二法装置,分别采用4种溶出介质进行溶出试验,用配蒸发光检测器的高效液相色谱(HPLC-ELSD)进行检测,对同一厂家双氢青蒿素哌喹片在不同溶出介质中的溶出曲线进行研究。结果:同一厂家同一批次样品在不同溶出介质中的溶出度存在明显差异,溶出效果为:pH 1.2盐酸溶液> pH 4.0醋酸盐缓冲溶液> pH6.8磷酸盐缓冲溶液>水。同一厂家不同批次样品在同一溶出介质中的溶出度也存在较大差异,溶出效果为:pH 1.2盐酸溶液> pH 4.0醋酸盐缓冲溶液> pH 6.8磷酸盐缓冲溶液>水;在120 min范围内,不同批次样品在pH 1.2盐酸溶液和pH 4.0醋酸盐缓冲溶液中溶出效果差异较少,而在pH 6.8磷酸盐缓冲溶液和水中的溶出效果差异明显。结论:该溶出度测定方法简便、灵敏,结果准确、实时,为在线监测药物溶出的全过程以及全面评价药品内在质量提供了参考依据。
Objective： To establish an HPLC-ELSD method to determine the dissolution of dihydroartemisinin （DHA） in dihydro- artemisinin and piperaquine phosphate tablets in different media in order to provide basis for its quality control and dissolution evaluation. Methods： According to the second method described in Chinese Pharmacopeia （2015 edition, the fourth part）, an HPLC-ELSD method with a RCZo8M dissolution tester was used to determine DHA in piperaquine phosphate tablets in four kinds of media. The dissolution curves of dihydroartemisinin and piperaquine phosphate tablets from the same manufacturer in the different dissolution media were studied. Results： The dissolution of the same batch of samples from the same manufacturer in different media was obviously different with the following order： pH 1.2 hydrochloric acid solution 〉 pH 4.0 acetate buffer solution 〉 pH 6.8 phosphate buffer solution 〉 water. The dissolution of different batches of samples from the same manufacturer in the same dissolution medium was also quite dif- ferent with the following order： pH 1.2 hydrochloric acid solution 〉 pH 4.0 acetate buffer solution 〉 pH 6.8 phosphate buffer solution 〉 water. Within 120 min, the dissolution of different batches of samples in pH 1.2 HC1 solution and pH 4.0 acetate buffer solution was less different, while that in pH 6.8 phosphate buffer solution and water was significantly different. Conclusion ： The method is simple, sensitive, accurate and real-time. It provides reference for on-line monitoring of drug dissolution process and comprehensive evaluation of drug quality.
作者
吴旭
来国防
Wu Xu;Lai Guofang(Yunnan Institute for Drug Control,Kunming 650031,China)
出处
《中国药师》
CAS
2018年第11期2062-2065,共4页
China Pharmacist
