新型药用辅料对复方丹参片药剂学性质及溶出性能的影响  

Influence of novel excipients on pharmaceutical qualities of compound Danshen tablets

作　　者：韩丽妹[1] 付艳[1] 张丽红[1] 黄大唯 张贤英 阮克萍 王建新[1] 

机构地区：[1]复旦大学药学院药剂教研室,上海201203 [2]国际特品医药技术服务中心(中国),上海200233

出　　处：《复旦学报（医学版）》2011年第3期233-236,共4页Fudan University Journal of Medical Sciences

基　　金：科技部重大新药创制科技重大专项(2009ZX09301-011)

摘　　要：目的考察微晶纤维素、交联聚维酮及微粉硅胶等新型辅料的应用对复方丹参片药剂学性质的影响。方法以片剂硬度、崩解时间和可压性为指标,比较不同的填充剂、崩解剂对复方丹参片药剂学性质的影响;并对采用新辅料制备的片剂与原薄膜衣片中丹参酮ⅡA的溶出度进行比较。结果应用新辅料可显著加速复方丹参片的崩解和丹参酮ⅡA的溶出速率。结论新辅料可以改善复方丹参片的崩解和丹参酮ⅡA的溶出,对加快中药制剂(traditional Chinese medicine,TCM)的起效时间可能起到一定的促进作用,但对其生物药剂学性质和疗效的影响仍待进一步研究。Objective To investigate the influence of novel excipients,such as microcrystalline cellulose,polyvinylpyrrolidone and aerosil,on the quality of compound Danshen tablets. Methods The effects of different excipients on the quality of compound Danshen tablets were compared for hardness,disintegration time and compressibility as evaluation indexes.The dissolution of tanshinone ⅡA from experimental formulation prepared with novel excipients or conventional formulation was determined. Results The disintegration and dissolution rate of compound Danshen tablets were significantly increased by novel excipients. Conclusions Novel excipients can accelerate the disintegration and dissolution rate of compound Danshen tablets.It may improve the onset time of traditional Chinese medicine（TCM） preparation,whereas its influence on bio-pharmaceutical properties and therapeutic efficiency needs to be further studied.

关 键 词：复方丹参片 新型辅料 溶出度 丹参酮ⅡA 

分 类 号：TQ460.4[化学工程—制药化工]