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目的:制备难溶性药物新藤黄酸的羟丙基-β-环糊精包合物,并对包合物进行鉴定及质量控制。方法:采用冷冻干燥法制备包合物,并经差示量热扫描、红外光谱、扫描电镜、相溶解度等方法对其进行表征;高效液相色谱法测定包合物中新藤黄酸的含量。结果:新藤黄酸和羟丙基-β-环糊精形成了包合物,且形成的包合物的主客分子物质的量比为1:1,表观稳定常数为Ka=117L.mol-1;新藤黄酸线性范围为4.12～24.72μg.mL-1(r=0.9999),平均回收率为100.1%,RSD为0.48/%。结论:冷冻干燥法制备包合物方法简单可行,增加了药物的溶解度。
OBJECTIVE: To prepare hydroxypropyl-β-cyclodextrin inclusion complex, which is a poorly soluble drug, of gambogic acid. The inclusion complex was identified and quality controlled. Methods: The inclusion complex was prepared by freeze-drying and characterized by differential scanning calorimetry, infrared spectroscopy, scanning electron microscopy and phase solubility. The content of neo gambogic acid in the inclusion complex was determined by high performance liquid chromatography. Results: The new inclusion compounds were formed by the new gambogic acid and hydroxypropyl-β-cyclodextrin, and the ratio of host-guest material to the inclusion complex was 1: 1. The apparent stability constant was Ka = 117L.mol- 1. The linear range of new Gambogic acid was 4.12 ~ 24.72μg.mL-1 (r = 0.9999). The average recovery was 100.1% and the RSD was 0.48%. Conclusion: The method of freeze-drying preparation of inclusion compound is simple and feasible, increasing the solubility of the drug.