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目的优化新藤黄酸羟丙基-β-环糊精(HP-β-CD)包合物冻干粉针的制备工艺。方法采用不饱和水溶液法,以L-精氨酸与新藤黄酸成盐助溶,制备新藤黄酸HP-β-CD包合物;采用冷冻干燥法制备新藤黄酸HP-β-CD包合物冻干粉针;HPLC法测定新藤黄酸的量;以包合率为指标,应用正交设计法优化制备工艺。结果优化的制备工艺为HP-β-CD与新藤黄酸质量配料比为10∶1、20℃包合5 h;制备的包合物包合率高;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 of HPG-β-cyclodextrin (HP-β-CD) inclusion complex freeze-dried powder. Methods HP-β-CD inclusion compound of new Gambogic acid was prepared by salt-solubilizing L-arginine and neoxanthic acid by using unsaturated aqueous solution method. HP-β-CD of Gambogic acid was prepared by freeze-drying Freeze-dried powder; HPLC determination of the amount of new gambogic acid; inclusion rate as an indicator, the orthogonal design method to optimize the preparation process. Results The optimized preparation process was that the mass ratio of HP-β-CD to neo gambogic acid was 10:1, and the inclusion ratio was 5 h at 20 ℃. The inclusion ratio of the prepared inclusion compound was high. Fluffy, good solubility. Conclusion Process optimization reasonable, reproducible.