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目的:制备茜草总醌固体分散体并考察其体外溶出性能。方法:采用溶剂-熔融法和溶剂法制备茜草总醌固体分散体,考察不同型号辅料对该固体分散体制备工艺的影响,分别以体外溶出度和溶解度为指标,确定该固体分散体的最优处方。结果:最佳处方为聚乙烯吡咯烷酮S-630-茜草总醌提取物(5∶1),采用溶剂法制备茜草总醌固体分散体,所得产物在1%十二烷基硫酸钠中的溶解度285.39 mg·L-1,为原料的3.6倍;60 min体外累积溶出度66.37%,约为原料的2倍。结论:该工艺制备的固体分散体性状良好,较好地改善了茜草总醌的溶解度,为以茜草为原料的相关固体制剂的开发提供参考。
OBJECTIVE: To prepare the solid dispersions of Rubisco and study its in vitro dissolution performance. Methods: The solid dispersions of Rubisco were prepared by solvent-melt method and solvent method. The effects of different types of excipients on the preparation of the solid dispersions were investigated. The optimal dispersions were determined by the dissolution and solubility in vitro prescription. Results: The best prescription was polyvinylpyrrolidone S-630-Rubia cordifolia extract (5:1). The solid dispersions of Rubisco were prepared by solvent method. The solubility of the resulting product in 1% sodium dodecyl sulfate was 285.39 mg · L-1, which is 3.6 times of that of the raw material. The accumulated dissolution rate in vitro is 66.37% after 60 min, which is about twice of the raw material. CONCLUSION: The solid dispersions prepared by the process have good properties, which can improve the solubility of the total quinone of Ruben and provide a reference for the development of related solid preparations based on Rubia.