葛根素磷脂复合物干混悬剂的制备及质量控制

Preparation and Quality Control of Puerarin Phospholipid Complex Dry Suspension

目的制备葛根素磷脂复合物干混悬剂并建立其质控方法。方法制备葛根素磷脂复合物,以正交设计优化干混悬剂处方,通过沉降体积比指标考察辅料对干混悬剂性能的影响。建立了紫外分光光度法控制制剂中葛根素的含量,从流变学、混悬剂黏度及粒径分布等方面考察制剂稳定性。结果葛根素在4.16~66.56μg/m L范围内线性关系良好,平均回收率为98.76%(RSD为1.81%)。葛根素磷脂复合物干混悬剂为假塑性流体,流动性良好,粒度分布主要集中在4~8μm。制剂在40℃和75%湿度条件下放置6个月含量无明显变化,干混悬剂稳定性良好。结论葛根素磷脂复合物干混悬剂符合2015年版《中国药典》的质量要求,处方工艺简单、制剂质量稳定,所制备制剂符合干混悬剂质量要求。

Objective To prepare puerarin phospholipid complex dry suspension and establish quality control method.Methods The sedimentation rate of puerarin phospholipid complex dry suspension were investigated and optimized by orthogonal experiments.The content of puerarin was determined by ultraviolet spectrophotometry.The stability of suspension was studied by detecting the rheology property,suspension viscosity,and microscopic morphology,respectively.Results puerarin was linear within 4.16~66.56μg/ml(r=0.9998)and the average recovery rate was 98.76%(RSD was 1.81%).Particle size distribution of puerarin suspension mainly concentrated in the 4~8μm.Puerarin phospholipid complex dry suspension is pseudoplastic fluid with good liquidity.Under 40℃,75%humidity conditions for 6 months,puerarin showed no significant change in dry suspension,particle size did not significantly increase.Puerarin dry suspension shows good stability of the dry suspension.Conclusion The quality of the puerarin phospholipid complex dry suspension conforms to the stadndard of Chinese pharmacopoeia 2015 and the optimized formulation is simple,feasible and stable.The preparation is in accordance with the quality requirements of dry suspension.