参草宁心颗粒干法制粒处方筛选及工艺参数优化

Prescription Screening and Optimization of Process Parameter of Dry Granulation of Shencao Ningxin Granules

目的考察参草宁心颗粒干法制粒的最佳药辅配比及工艺参数。方法以乳糖、麦芽糊精、可溶性淀粉分别与浸膏粉的配比为考察因素,以一次成型率、堆密度、休止角为考察指标,采用L9(34)正交试验进行药辅配比优选;以送料速度、滚压速度和滚压压力为考察因素,以一次成型率、堆密度、休止角为考察指标,采用Box-Behnken效应曲面法进行工艺参数优化。结果优选的药辅配比为乳糖∶麦芽糊精∶可溶性淀粉∶浸膏粉=0.50∶0.25∶0.25∶1。优化的工艺参数为:送料速度59.51r/min,滚轮转速11.47r/min,滚轮压力60.13MPa。验证试验结果表明,采用优选的药辅配比及工艺参数制备的颗粒具有比较稳定的一次成型率、堆密度和休止角,且粒度、水分、溶化性检查符合颗粒剂制剂通则要求。结论采用正交试验优选的药辅配比及效应曲面法优化的工艺参数可以保证参草宁心颗粒的工艺稳定,物理特性符合要求。

Objective To investigate the optimal dosages and process parameters of dry granulation of Shencao Ningxin Granules.Methods Taking the proportion of lactose,maltodextrin,soluble starch and extract powder as investigation factors,taking the primary molding rate,bulk density and rest angle as investigation indexes,L9(34)orthogonal experiment was used to optimize the proportion of drug and auxiliary.With the feeding speed,roll speed and roll pressure as the investigation factors,and the primary shaping rate,bulk density and rest angle of the particles as investigation indexes,Box-Behnken effect surface method was adopted to optimize the process parameters.Results The optimal proportion was lactose:maltodextrin:soluble starch:extract powder=0.50:0.25:0.25:1.The optimal process conditions were as follows:feeding speed was 59.51 r/min;roller speed was 11.47 r/min;roller pressure was 60.13 MPa.The experimental results showed that the particle prepared by the optimal mixture ratio and technological parameters had stable primary molding rate,bulk density and resting angle.The particle size,water content and solubility test met the general requirements of granule preparation.Conclusion The optimized proportion of drug and auxiliary by the orthogonal experiment and the optimal process parameters through the effect surface method can ensure the stability of the process of Shencao Ningxin Granules,and physical characteristics meet the requirements.