乌索酸滴丸剂的制备及其体外溶出度研究

Preparation of Usolic Acid Dropping Pills and Study on its Dissolution in Vitro

目的经过筛选处方和优化工艺,将乌索酸制成滴丸剂,同时考察其体外溶出度。方法采用滴制法制备乌索酸滴丸。以滴丸的圆整率、重量差异及硬度等作为综合评定指标,优选出滴丸的最佳处方和成型工艺,采用反相高效液相色谱(RP-HPLC)法测定含量。结果筛选出了最佳的处方和成型工艺,合理可行,制备的乌索酸滴丸质量稳定,质控方法准确可靠。结论制备的乌索酸滴丸外观性状好,丸重差异小,含量准确,溶出度得到了显著提高,45m in内乌索酸滴丸的体外溶出度比片剂提高229.2%,比乌索酸胶囊提高13.4%。

Objective To prepare Ursolic Acid Dropping Pills by choosing prescriptions and dropping conditions and to assay its dissolution in vitro. Methods Ursolic Acid Dropping Pills were prepared by dropping method. Optimum prescription and dropping conditions were selected by using spherical degree, weight variation and hardness as comprehensive evaluation indicator. RP - HPLC method was used to determine the content of ursolic acid in dropping pills. Results Optimum prescription and dropping con- ditions which had been selected were simple and feasible. Ursolic Acid Dropping Pills prepared had good quality and stability, and the method for quality control was accurate. Conclusion Ursolic Acid Dropping Pills had good appearance, little weight variation and accurate content, and its dissolution had been improved significantly. Furthermore, the dissolution rate of Ursolic Acid Dropping Pills in vitro increased 229.2 % and 13.4 % than that of its tablet and capsule within 45 min, respectively.