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目的:制备葛根黄酮速释微丸,并对其制备工艺进行研究。方法:首先以熔融法将葛根黄酮组分制备成固体分散体,考察了载体及其比例对溶出度的影响。以葛根黄酮固体分散体作为主药制备微丸,考察了处方中润湿剂、载药量、辅料等因素对葛根黄酮微丸收率、圆整度、溶出度的影响;采用正交试验设计,筛选出葛根黄酮速释微丸的最佳制备工艺。结果:葛根黄酮速释微丸处方为主药20 g,乳糖5 g,微晶纤维素25 g,润湿剂为30%的乙醇。采用挤出滚圆法制备,最佳工艺条件为挤出频率25 Hz,滚圆频率30 Hz,滚圆时间6 min。结论:葛根黄酮速释微丸制备工艺科学合理,制剂稳定,为通脉复方微丸多元释药系统的制备奠定了基础。
OBJECTIVE: To prepare Pueraria flavone fast-release pellets and study its preparation process. Methods: Firstly, the flavonoids of Pueraria lobata was prepared into a solid dispersion by melting method. The effect of the carrier and its proportion on the dissolution was investigated. Pellets of Pueraria flavonoids solid dispersions were used as the main drug to investigate the effects of the wetting agent, drug loading, excipients and other factors on the yield, roundness and dissolution of Pueraria flavonoids pellets. The orthogonal experimental design , The optimum preparation process of kudzu flavonoids immediate-release pellets was screened out. Results: Pueraria flavonoids immediate-release pellets prescription for the main drug 20 g, lactose 5 g, microcrystalline cellulose 25 g, wetting agent 30% ethanol. Prepared by extrusion spheronization method, the optimum conditions for the extrusion frequency 25 Hz, spheronization frequency 30 Hz, spheronization time 6 min. Conclusion: The preparation process of Gegen flavonoids immediate-release pellets is scientific and reasonable and the preparation is stable, which lays a foundation for the preparation of Tongmai compound pellets multi-drug delivery system.