复方缬沙坦片的制备及体外溶出度测定

Preparation and dissolution determination of compound valsartan and hydrochlorothiazide tablets

目的:研制缬沙坦和氢氯噻嗪的复方片。方法:选用交联聚维酮(PVPP)、微晶纤维素(MCC)、α-乳糖、硬脂酸镁为辅料与缬沙坦和氢氯噻嗪混匀后制片,采用正交法设计实验,考察不同处方制备的复方缬沙坦片在0.05 M pH6.8磷酸盐缓冲液中的溶出度,通过溶出度(主)、物料流动性(次)等指标对处方进行优化,确定最佳处方。结果:优化处方每片含缬沙坦80 mg、氢氯噻嗪12.5 mg、PVPP 6 mg、MCC 37.5 mg、硬脂酸镁4.5 mg、α-乳糖9.5 mg,其溶出度为88.74%。结论:自制片外表光洁美观,溶出度符合中国药典要求。

Objective:To prepare the compound valsartan and hydrochlorothiazide tablets and investigate the dissolution of valsartan in vitro.Methods:The formulation of compound tablets was optimized by an orthogonal design test in terms of valsartan dissolution and material fluidity with polyvinylpolypyrrolidone(PVPP)as the disintegrating agent,MCC as the adhesive,α-galactose as the filler,and magnesium stearate as the lubricant.Results:Each of the optimized tablets was composed of valsartan 80 mg,hydrochlorothiazide ...