枇杷叶胶囊的制备及质量标准研究

目的建立枇杷叶胶囊的制备工艺和质量标准。方法选用湿法制粒,以流动性、吸湿性、辅料用量、成型性为考察指标,优选辅料,确定枇杷叶胶囊的最佳制备工艺;采用薄层色谱法(TLC)定性鉴别熊果酸,高效液相色谱法(HPLC)测定熊果酸和齐墩果酸含量。结果最终选择比例为1:1的微晶纤维素与淀粉作为辅料进行制粒,填充1号胶囊;TLC斑点清晰,阴性无干扰;建立的含量测定方法中,熊果酸在浓度为0.096~1.540 mg/ml范围内线性良好(r=0.9999);齐墩果酸在浓度为0.036~0.580 mg/ml范围内线性良好(r=0.9998);熊果酸和齐墩果酸的平均回收率分别为99.92%,98.47%,RSD分别为2.32%,2.44%。结论枇杷叶胶囊制备工艺合理、可行;其质量控制方法准确、稳定、可靠。

Study on Preparation Technology and Quality Standard of Eriobotryae Folium Capsules

Objective To establish the preparation technology and quality standard of Eriobotryae Folium Capsules.Methods The wet granulation method was used,and the flowability,hygroscopicity,amount of excipients and formability were taken as the indexes to optimize the excipients and preparation process.Ursolic acid was identified by TLC,and the contents of ursolic acid and oleanolic acid were determined by HPLC.Results Microcrystalline cellulose and starch with a ratio of 1:1 were selected as excipients and 1#capsule shell was selected for granule packing.TLC spots were clear,and the negative test solution was of no interference.Ursolic acid and oleanolic acid showed good linearity in the range of 0.096-1.540 mg/ml(r=0.9999)and 0.036-0.580 mg/ml(r=0.9998),respectively.The average recoveries of ursolic acid and oleanolic acid were 99.92%and 98.47%,with RSDs of 2.32%and 2.44%,respectively.Conclusion The preparation technology of Eriobotryae Folium Capsules is reasonable and feasible.The quality control method is accurate,stable and reliable.