降糖消脂片成型工艺考察及熊果酸的含量测定  

Investigation of Molding Process of Jiangtang Xiaozhi Tablets and Determination of Ursolic Acid in This Tablets

作　　者：任烨[1] 葛争艳[1] 金龙[1] 郭宇洁[1] 刘建勋[1] 

机构地区：[1]中国中医科学院西苑医院基础医学研究所,中药药理北京市重点实验室,北京100091

出　　处：《中国实验方剂学杂志》2015年第8期13-16,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家"重大新药创制"科技重大专项(2010ZX09102-213);国家自然科学基金青年基金项目(81202950)

摘　　要：目的：优选降糖消脂片的成型工艺并建立熊果酸的含量测定方法,为该制剂的工业化生产与质量控制提供参考。方法：以外观、脆碎度、崩解时限等为指标,采用单因素试验优选降糖消脂片的成型工艺。采用HPLC测定降糖消脂片中熊果酸含量,流动相甲醇-0.05%磷酸水（90∶10）,柱温2℃,检测波长215 nm。结果：以15%预胶化淀粉＋5%乳糖为填充剂,92%乙醇为润湿剂,内外各加3%交联聚维酮为崩解剂,0.3%硬脂酸镁为润滑剂。熊果酸进样量在0.398-3.980μg与峰面积呈良好线性关系,平均回收率96.96%;样品中熊果酸质量分数2.22 mg·g^-1。结论：优选的成型工艺稳定可行,建立的含量测定方法操作简便、准确、灵敏、重复性好。Objective： To provide a reference for industrial production and quality control of Jiangtang Xiaozhi tablets by optimizing its molding process and establishing determination of ursolic acid in this preparation. Method： With appearance, friability, disintegration time and others as indexes, molding process of Jiangtang Xiaozhi tablets was optimized by single-factor tests. HPLC was employed to determine the content of ursolic acid in Jiangtang Xiaozhi tablets with mobile phase of methanol-0.05% phosphoric acid water （90： 10）, column temperature of 2 ℃and detection wavelength at 215 nm. Result： With 15% pregelatinized starch and 5% lactose as filling agent, 92% ethanol as wetting agent, adding 3% crosslinking polyvinylpolypyrrolidone internally and externally as disintegrant, 0. 3% magnesium stearate as lubricant. A good linearity of ursolic acid was in the range of 0.398-3.980 μg, the average recovery was 96.96%, the mass fraction of ursolic acid in samples was 2.22 mg ·g^-1 Conclusion： This optimized molding process is stable and feasible. This determination is simple, accurate, sensitive with a good reproducibility.

关 键 词：降糖消脂片 成型工艺 熊果酸 包衣工艺 崩解时限 

分 类 号：R283.6[医药卫生—中药学] R284.1[医药卫生—中医学]