葛根素分散片的处方设计优化及溶出度研究

A Study on the Optimization of Preparation Technology and Dissolution of Puerarin Dispersible Tablets

目的:对葛根素分散片的制备工艺进行优化,并对其溶出进行考察。方法:采用单因素及正交实验,以崩解时间为指标对工艺进行优化,确定辅料的种类及用量,并对工艺确证后的样品进行溶出度研究。结果:得到最佳处方组成:每片中含葛根素磷脂复合物固体分散体0.35g,微晶纤维素0.45g,交联羧甲纤维素钠0.09g,微粉硅胶0.07g,其他由矫味剂补足处方量。同时测得葛根素分散片在0.1mol/L的盐酸溶液中15min的累积溶出已达90%。结论:本研究工艺制备的葛根素分散片溶出速率快、分散均匀,值得进一步开展工业化生产。

Objective: The preparation technology of puerarin dispersible tablets was optimized and its dissolution was investigated. Methods: Single factor and orthogonal experiments were used to optimize the process with disintegration time as the index, so as to determine the types and dosage of excipients, and to study the dissolution of the samples after the process was confirmed. Results: The optimum prescription composition was obtained as follows: solid dispersion containing puerarin phospholipid complex 0.35g, microcrystalline cellulose 0.45g, croscarmellose sodium 0.09g, aerosol 0.07g in each tablet, and other prescriptions were supplemented by flavor modifiers. At the same time, the cumulative dissolution of puerarin dispersible tablets in 0.1 mol/L hydrochloric acid solution for 15 minutes reached 90%. Conclusion: The puerarin dispersible tablets prepared by this technology have fast dissolution rate and uniform dispersion, which is worthy of further industrial production.