天蒲清脑颗粒制剂工艺及质量标准研究  

Preparation and quality standard of Tianpu Qingnao granules

作　　者：冯李乐 罗晓曼 栾飞 邹俊波[1] 史亚军[1] 张小飞[1] 郭东艳[1] 翟秉涛 卫培峰[1] 缪峰[2] 王景媛[1] FENG Li-le;LUO Xiao-man;LUAN Fei;ZOU Jun-bo;SHI Ya-jun;ZHANG Xiao-fei;GUO Dong-yan;ZHAI Bing-tao;WEI Pei-feng;MIAO Feng;WANG Jing-yuan(Shaanxi University of Chinese Medicine,Xi’an 712046;The Second Affiliated Hospital of Shaanxi University of Chinese Medicine,Xianyang Shaanxi 712046)

机构地区：[1]陕西中医药大学,西安712046 [2]陕西中医药大学第二附属医院,陕西咸阳712046

出　　处：《中南药学》2024年第12期3259-3263,共5页Central South Pharmacy

基　　金：陕西中医药大学学科创新团队项目(No.2019-YL11)。

摘　　要：目的 筛选天蒲清脑颗粒的最佳制备工艺,并对其质量标准进行研究。方法 以干浸膏得率和提取物中葛根素的含量作为考核指标,通过L_(9)(3^(4))正交试验法确定天蒲清脑颗粒的水提取工艺,进一步确定浓缩工艺、干燥工艺、成型工艺。采用薄层色谱法对川芎、钩藤、羌活进行定性鉴别;采用高效液相色谱法对葛根中葛根素含量进行测定。结果 最佳水提取工艺为提取两次,第一次10倍量水煎煮120 min,第二次8倍量水煎煮90 min;采用减压浓缩、微波干燥获得干膏粉,干膏粉与糊精比例在1∶2湿法制粒时所得颗粒最佳;薄层鉴别斑点清晰,阴性样品无干扰。结论 天蒲清脑颗粒制备工艺稳定可行,并且该制剂质量标准专属性强,重复性好,可用于其质量控制。Objective To determine the optimal preparation of Tianpu Qingnao granules and related quality standard.Methods The dry extract yield and content of puerarin in the extract were used as the indexes.The aqueous extraction of Tianpu Qingnao granules was determined by L_(9)(3^(4)) orthogonal test.The concentration,drying and shaping were further determined.The thin layer chromatography was used to qualitatively identify Chuanxiong Rhizoma,Uncariae ramulus cum uncis,and Notopterygii rhizoma et radix,and the content of puerarin in Puerariae Lobatae radix was determined by high performance liquid chromatography.Results The optimal water extraction was twice.The initial extraction used 10 times of water and 120 min decoction.In the subsequent extraction,8 times of water,and 90 min decoction.The dry paste powder was obtained through vacuum concentration and microwave drying techniques.The particle size was optimal when the ratio of dry paste powder to dextrin was 1∶2,followed by additional wet granulation.The thin layer identification spots were clear,without interference of the negative sample.Conclusion The preparation of Tianpu Qingnao granules is both stable and feasible.Additionally,the quality standards exhibit strong specificity and good repeatability,facilitating effective quality control.

关 键 词：天蒲清脑颗粒 正交试验 制备工艺 质量标准 含量测定 薄层鉴别 

分 类 号：R283[医药卫生—中药学] R285[医药卫生—中医学]