新型复方氢氯噻嗪片研制

Preliminary Studies on the New -Type Compound Hydrochlorothiazide Tablets

采用分别制粒混合压片技术制备新型复方氢氯噻嗪片,以双波长紫外分光光度法测定制剂中氢氯噻嗪与氨苯蝶啶的含量及其均匀度。结果表明两者浓度分别在0.8～8μg/ml及1.2～12μg/ml范围内具有良好的线性关系,制剂辅料对测定无干扰,平均回收率分别为100.2%±0.7%、100.2%±1.5%。与国外Maxzide片对比性溶出度试验结果表明,自制片达到了Maxzide类似的溶出水平。

A parallel granulating technique has been used to prepare compound hydrochlorothiazide tablets. A dual-wavelength spectrophotometric method for content and uniformity determination of the tablets has been developed. The method is free of interference from tablet vehicles. The average recoveries of hydroehlorothiazide and triamtrene are 100.2%±0.7%, 100.2%±1.5% respectively, Hydroehlorothiazide can be quantitated from 0.8 to 8.0μg/ml, and triamtrene from 1.2 to 12μg/ml, Compound hydrochlorothiazide tablets have the similar dissolution behavior to Maxzide tablets.