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目的:筛选刺槐花总黄酮缓释片的最佳配方,考察其释放度。方法:以刺槐花总黄酮的释放度为考察指标,采用单因素试验法,考察3种规格的羟丙基甲基纤维素(HPMC-K4M,K15M,K100M)和乳糖的用量对刺槐花总黄酮释放度的影响;采用正交设计实验对刺槐花总黄酮缓释片的处方进行优化,确定最佳处方。结果:最佳配方为HPMC-K4M的用量为15%,乳糖用量为15%,聚乙烯吡咯烷酮(PVP)的用量为4%,微晶纤维素的用量为20%。按此配方制成的缓释片2 h平均累积释药量约为30%,6 h平均累积释药量约为65%,12 h平均累积释药量超过90%。结论:按筛选的最佳配方制备的刺槐花总黄酮缓释片有较好的控释行为,基本上可以达到控制药物释放速率的要求。
OBJECTIVE: To screen the best formulation of total flavonoids sustained-release tablets of Robinia pseudoacacia and study its release. Methods: Taking the release of total flavonoids from acacia flower as test index, the effects of three kinds of hydroxypropyl methylcellulose (HPMC-K4M, K15M, K100M) and lactose on the total flavonoids The orthogonal test was used to optimize the formulation of the total flavonoids sustained-release tablets of acacia flower to determine the best prescription. Results: The optimal formula was HPMC-K4M 15%, lactose 15%, PVP 4%, and microcrystalline cellulose 20%. According to this formula, the sustained-release tablets in 2 h average cumulative release of about 30%, 6 h average cumulative release of about 65%, 12 h average cumulative release of more than 90%. CONCLUSION: According to the optimal formulation, the total flavonoid sustained-release tablets prepared by the optimized formula have a better controlled-release behavior and basically meet the requirements of controlling the drug release rate.