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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 optimize the forming process of hypoglycemic tablet and establish the method of determination of ursolic acid, which can provide reference for the industrialized production and quality control of the preparation. Methods: The appearance, friability, disintegration time as an index, the use of single factor optimization of hypoglycemic foam tablet molding process. The content of ursolic acid in Jiangtang Xiaozhi tablet was determined by HPLC. The mobile phase consisted of methanol-0.05% phosphoric acid water (90:10) and the column temperature was 2 ℃. The detection wavelength was 215 nm. Results: 15% pregelatinized starch + 5% lactose as filler, 92% ethanol as wetting agent, both inside and outside plus 3% crospovidone as disintegrating agent and 0.3% magnesium stearate as lubricant. The injection volume of ursolic acid showed a good linear relationship with the peak area of 0.398 ~ 3.980μg, the average recovery was 96.96%. The content of ursolic acid in the sample was 2.22 mg · g-1. Conclusion: The preferred molding process is stable and feasible. The established assay method is simple, accurate, sensitive and reproducible.