盐酸阿洛司琼片剂的研制

Preparation and study of Alosetron hydrochloride tablets

研制盐酸阿洛司琼片剂,建立了紫外分光光度法测定片剂的含量。在0.1 mol/L盐酸溶液中测定波长为295 nm,标准曲线A=0.0279C-0.0012,相关系数r=0.9999。加样回收率分别为99.01％、99.48％、100.63％,RSD均小于1％。三批片剂的含量分别为99.32％、100.04％、99.70％,含量均匀度分别为6.61、6.97、5.05,日间和日内误差分别为0.88％、0.63％。三批片剂30min的溶出度高于90％。

Alosetron hydrochloride tablets were prepared and studied. The content of tablets was determined by method of UV spectrum. The wavelength was defined at 295 nm in 0. 1 mol/L hydrochloride solution. The equation of standard curve was expressed as A = 0. 0279C-0. 0012, r = 0. 9999. The contents of three batches were 99. 32%, 100. 04%,99. 70%, respectively. The evenness was 6. 61, 6. 97, 5. 05. Recovery was 99. 01 % . 99. 48% , 100. 63% . respectively. RSD was less than 1 %. The SD for within-day and between-days is 0. 88% , 0. 63%. Average dissolution rates of three batches were greater than 90% at 30 minutes.