中国药师
中國藥師
중국약사
China Pharmacist
2015年
10期
1813-1817
,共5页
盐酸特拉唑嗪%片剂%胶囊剂%溶出度%相似因子
鹽痠特拉唑嗪%片劑%膠囊劑%溶齣度%相似因子
염산특랍서진%편제%효낭제%용출도%상사인자
Terazosin hydrochloride%Tablets%Capsules%Dissolution%Similar factor
目的:比较国内盐酸特拉唑嗪片及胶囊的溶出情况,为临床用药提供参考. 方法:分别考察各企业产品在pH 1. 0盐酸溶液、pH4. 5磷酸盐缓冲液、pH 6. 8磷酸盐缓冲液及水4种溶出介质中的体外溶出行为;溶出方法采用桨法,转速为50 r· min-1 ,溶出度测定方法为高效液相色谱法;采用相似因子法进行各企业产品间溶出行为的比较. 结果:国内片剂生产企业的产品与参比制剂的相似较高,胶囊剂产品溶出行为差异较大. 结论:部分企业的规格计算方式与参比制剂不一致是造成受试制剂与参比制剂不相似的重要原因,临床用药时应加以注意.
目的:比較國內鹽痠特拉唑嗪片及膠囊的溶齣情況,為臨床用藥提供參攷. 方法:分彆攷察各企業產品在pH 1. 0鹽痠溶液、pH4. 5燐痠鹽緩遲液、pH 6. 8燐痠鹽緩遲液及水4種溶齣介質中的體外溶齣行為;溶齣方法採用槳法,轉速為50 r· min-1 ,溶齣度測定方法為高效液相色譜法;採用相似因子法進行各企業產品間溶齣行為的比較. 結果:國內片劑生產企業的產品與參比製劑的相似較高,膠囊劑產品溶齣行為差異較大. 結論:部分企業的規格計算方式與參比製劑不一緻是造成受試製劑與參比製劑不相似的重要原因,臨床用藥時應加以註意.
목적:비교국내염산특랍서진편급효낭적용출정황,위림상용약제공삼고. 방법:분별고찰각기업산품재pH 1. 0염산용액、pH4. 5린산염완충액、pH 6. 8린산염완충액급수4충용출개질중적체외용출행위;용출방법채용장법,전속위50 r· min-1 ,용출도측정방법위고효액상색보법;채용상사인자법진행각기업산품간용출행위적비교. 결과:국내편제생산기업적산품여삼비제제적상사교고,효낭제산품용출행위차이교대. 결론:부분기업적규격계산방식여삼비제제불일치시조성수시제제여삼비제제불상사적중요원인,림상용약시응가이주의.
Objective:To compare the dissolution of domestic terazosin hydrochloride tablets and capsules to provide reference for clinical use. Methods:The dissolution of the products from different manufacturers was investigated respectively in 4 kinds of media:pH 1. 0 hydrochloric acid solution,pH 4. 5 phosphate buffer solution,pH 6. 8 phosphate buffer solution and water. The dissolution tests were carried out by a paddle method at the stirring speed of 50 r·min-1 and an HPLC method was used to determine the dissolution rate. The dissolution behavior of the samples from different manufacturers was compared by a similar factor method. Results:The do-mestic tablets showed higher similarity with the reference formula, and the dissolution behavior of the capsules had significant differ-ence. Conclusion:The calculation method for the specification in some manufacturers is different from that of the reference prepara-tion, which leads to the difference between the testing preparation and the reference preparation, and should be paid attention in clini-cal use.
