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目的:优化藤黄酸羟丙基-β-环糊精(HP-β-CD)包合物冻干粉针的制备工艺。方法:采用冷冻干燥法制备藤黄酸羟丙基-β-环糊精包合物冻干粉针,HPLC法测定藤黄酸的含量,应用正交设计法优化制备工艺。结果:优化的制备工艺为50℃包合8h,反应物质量配料比为50:3;制备的包合物包合率达到90%,90min体外释放百分数小于20%;包合物冻干粉色泽均匀、粉末蓬松、溶解性好。结论:工艺优化合理、重现性好。
OBJECTIVE: To optimize the preparation process of HP-β-CD inclusion complex freeze-dried powder injection. Methods: Lyophilized powder of gambogic acid hydroxypropyl-β-cyclodextrin inclusion complex was prepared by freeze-drying method. The content of gambogic acid was determined by HPLC. The orthogonal design method was used to optimize the preparation process. Results: The optimized preparation process was that the inclusion ratio of the reactants was 50: 3 at 50 ℃ for 8h, the inclusion rate of the inclusion complex was 90% and the percentage of in vitro release was less than 20% after 90min. Uniform, fluffy powder, good solubility. Conclusion: process optimization reasonable, reproducible.