缬沙坦氨氯地平片处方工艺筛选及溶出度评价  

Prescription selection and dissolubility evaluation of valsarian and amlodipine tablets

作　　者：董萱[1] 陆步实[1] 周立新[1] 孙磊[2] 卢定强[1] 

机构地区：[1]南京工业大学江苏省药物研究所,江苏南京210009 [2]南京工业大学生物与制药工程学院,江苏南京210009

出　　处：《南京工业大学学报（自然科学版）》2012年第4期128-132,共5页Journal of Nanjing Tech University(Natural Science Edition)

摘　　要：以制剂的溶出度为指标,筛选片剂处方和制备工艺以国外原制刺为参比制剂,采用∫_2相似因子法进行氨氯地平和缬沙坦溶出曲线的相似度评价。确定的处方工艺为缬沙坦80.0 g,笨磺酸氨氯地平6.9 g,微粉硅胶1.5g,微晶纤维素54.4 g,交联聚维酮25.5 g,硬脂酸镁1.7 g,共制1000片。在不同pH的溶出介质中,自研制剂中氨氯地平和缬沙坦的溶出曲线与参比制剂比较,∫_2相似因子均大于50。自研制剂和参比制剂在不同pH的溶出介质中体外溶出行为相似。Based on the dissolubility of the product, valsartan and amlodipine tablets were prepared for the establishment of the in-vitro dissolution. The presciption and preparation crafts were selected with overseas valsartan and amlodipine tablets as reference. The similarity of dissolubility curves was evaluated by the similarity factor （f2） method. The optimized prescription for 1 000 tablets was composed of valsatan 80. 0 g, amlodipine 6.9 g, tiny pouder silica gel 1.5 g, microcrystalline cellulose 54.4 g, polyvinylpolypyrroli- done 25.5 g, and stearic acid magnesium 1.7 g. In dissolution media with different pH, the comparison of the dissolubility curves of valsartan and amlodipine between self-prepared preparations and reference ones indicated that similar factors f2 were both more than 50, and the in vitro dissolution behavior of self- prepared preparation and of reference one was similar.

关 键 词：缬沙坦氨氯地平片 处方工艺 溶出曲线 f2相似因子 

分 类 号：R94[医药卫生—药剂学]