5种粉碎工艺对熊去氧胆酸胶囊体外溶出的影响  

Effects of Different Grinding Methods on in Vitro Dissolution of Ursodeoxycholic Acid Capsules

作　　者：丁倩 唐柳 

机构地区：[1]西安利君制药有限责任公司,西安710077

出　　处：《中国药学杂志》2016年第23期2037-2040,共4页Chinese Pharmaceutical Journal

摘　　要：目的对比不同粉碎工艺制得的熊去氧胆酸胶囊体外溶出度，筛选最佳粉碎方式。方法采用大杯法，以高效液相色谱法检测熊去氧胆酸胶囊中主药的溶出度。通过与原研药物优思弗@对比，在4种介质中溶出曲线相似性五因子均能合格则为最佳方法。结果通过比较制剂溶出度一时间曲线及有关物质数据，得到溶出曲线相似性五因子均能合格的粉碎工艺，即用球磨机粉碎3min所得原料制得的制剂与原研一致。结论筛选出了与原研药品一致的工艺方法。OBJECTIVE To compare the in vitro dissolution of ursodeoxycholic acid capsules prepared by different grinding methods and screen the best grinding method. METHODS Using the large cup method, HPLC was used to investigate the simi- larity of dissolution behaviors between the reference preparation Ursofalk ~ （the original drug） and the self-made ursodeoxycholic acid capsules in four dissolution media. The grinding method which obtained product with qualified similarity factor f2 was deter- mined as the best technology. RESULTS The ursodeoxycholic acid capsules made with raw material micronized by ball grinder for 3 rain had similar dissolution curve to the original drug. CONCLUSION Rational preparation process is established for ursodeoxycholic acid capsules.

关 键 词：熊去氧胆酸 粉碎方法 溶出度试验 一致性评价 

分 类 号：R944.5[医药卫生—药剂学]