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

摘要

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 Ⅱ A 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.%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.