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目的:制备丹参酚酸速释微丸,并对制备工艺进行研究。方法:考察了处方中润湿剂、载药量、辅料、乳糖用量、崩解剂、羧甲基淀粉钠用量以及润湿剂用量等因素对丹参酚酸微丸收率、圆整度、溶出度的影响;采用正交试验设计,筛选出丹参酚酸速释微丸的最佳制备工艺。结果:丹参酚酸速释微丸处方以总量50 g计算,主药22.5g,乳糖5 g,羧甲基淀粉钠2 g,微晶纤维素20.5 g,润湿剂为30%的乙醇27 mL。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50 Hz,滚圆时间4 min。结论:丹参酚酸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 rapid-release pellets of salvianolic acid, and to study the preparation process. Methods: The effects of wetting agent, drug loading, excipients, lactose dosage, disintegrant, sodium carboxymethyl starch dosage and wetting agent dosage on the yield, roundness and dissolution of salvianolic acid pellets were studied. Degree of influence; using orthogonal design, screening out the optimum preparation process of salvianolic acid phenolic acid immediate release pellets. Results: The dosage of Danshen phenolic acid immediate release pellets was calculated as 50 g, the main drug was 22.5 g, lactose 5 g, sodium carboxymethyl starch 2 g, microcrystalline cellulose 20.5 g and wetting agent 30% ethanol 27 mL. The optimum conditions were extrusion frequency of 25 Hz, spheronization frequency of 50 Hz and spheronization time of 4 min. CONCLUSION: The preparation process of salvianolic acid phenolic acid immediate release pellets is scientific and reasonable and the preparation is stable, which lays a foundation for the preparation of multimodal drug delivery system of Tongmai compound pellets.