盐酸雷洛昔芬胶囊的制备及其质量标准研究
盐酸雷洛昔芬,,盐酸雷洛昔芬；胶囊；紫外分光光度法；溶出度,1试剂与仪器,2处方与制备,3质量控制,4讨论
摘 要 目的：建立盐酸雷洛昔芬胶囊的制备工艺及质量标准。方法：筛选辅料，确定处方的组成，制备盐酸雷洛昔芬胶囊，并建立紫外分光光度法测定盐酸雷洛昔芬的含量，制定其质量标准。结果：使用微晶纤维素及羧甲淀粉钠作为本胶囊的主要辅料，45 min溶出度为(94.60±3.14)%、(96.32±2.33)%、(96.75±2.14)%；雷洛昔芬的平均回收率为99.32%， RSD为089%。结论：该制剂制备工艺简单、稳定性好、质量控制方法简便、准确、精密度好，有较好的应用推广前景。关键词 盐酸雷洛昔芬；胶囊；紫外分光光度法；溶出度
Preparation of raloxifene hydrochloride capsules and establishment of its quality control standard
CHEN Yanzhong, LU Zhufeng, ZHANG Jixing
(Institute of Materia Medica, Guangdong College of Pharmacy, Guangzhou，Guangdong 510240)
Abstract Objective: study on the preparation of raloxifene hydrochloride capsules and establishment of its quality control standard. Methods: preparation of raloxifene hydrochloride capsules after screening of additives, and formulation, and establishment of its quality control standard with the assaying of raloxifene hydrochloride with uv spectrophotometry. Results: dissolution at 45 min is (94.60±3.14)%, (96.32±2.33)%, and (96.75±2.14)% with microcrystalline cellulose and carboxymethyl starch sodium (CMS) as the main additives of the capsules, with the average recovery of raloxifene of 99.32% and RSD% of 0.89%. Conclusions: the preparation method is simple with good stability, and the quality control method is simple, accurate with ideal precision, showing a good prosperity of application. ......
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