蓬子菜总黄酮颗粒剂的制备工艺研究  

Formulation Process of Galium Verum L.Granules

作　　者：朱慧[1] 董坤[1] 于子慧[1] 马英丽[1] 

机构地区：[1]黑龙江中医药大学,黑龙江中医药大学北药基础与应用研究省部共建教育部重点实验室,黑龙江哈尔滨150040

出　　处：《中医药学报》2013年第3期53-56,共4页Acta Chinese Medicine and Pharmacology

基　　金：黑龙江中医药大学新药研究基金(No.X201001)

摘　　要：目的:优选蓬子菜总黄酮颗粒剂最佳成型工艺条件并建立其质量控制方法。方法:在对辅料筛选的基础上,采用正交试验,以颗粒的粗粒及细粉总和的百分率为指标,优选蓬子菜总黄酮颗粒成型工艺。采用TLC对蓬子菜总黄酮颗粒剂进行鉴别;采用UV法测定颗粒剂中总黄酮的含量。结果:最佳成型工艺为浸膏粉:辅料(糊精:甘露醇=1∶1)=1∶1.5比例混合,95%乙醇为润湿剂,所制颗粒各项指标均符合《中国药典》(2010年版一部附录I C)颗粒剂项下相关规定。TLC鉴别图谱斑点清晰;总黄酮在0.008～0.024mg/mL范围内线性关系良好。结论:该成型工艺稳定可控,建立的定性及含量测定方法可有效控制该颗粒剂质量。Objective：To ascertain the best formulation process of Galium verum L.granule and to establish the quality standard of the granule.Methods：On the basis of complementary makings screening,orthogonal experiment was used to optimize the best formulation process of Galium verum L.granules with the index of the percentage of coarse particle and fine powder.The Galium verum L.granules were identified by TLC;the total flavonoids of Galium verum L.granule were tested by UV.Results：The best optimum process conditions were that the ratio of dry extract powder and accessories（dextrin：mannitol=1：1）was 1：1.5.The wetting agent was 95% alcohol.All the various indexes of the granules conformed to the relevant regulations of ChP.The spots of TLC were clear;Flavonoids in 0.008~0.024mg/ml scope inside had a good linear range.Conclusion：The optimum moulding process is stable and can be controlled.Established qualitative and content determination method can effectively control the quality of the granules.

关 键 词：蓬子菜 总黄酮 颗粒剂 成型工艺 质量控制 

分 类 号：R283.6[医药卫生—中药学]