治郁颗粒的成型工艺及质量控制  

Molding Process and Quality Control of Zhiyu Granules

作　　者：李婷[1] 叶豆丹[1] 鲍慧玮[1] 高巍[1] 张炜煜[1] 

机构地区：[1]长春中医药大学,长春130117

出　　处：《中国实验方剂学杂志》2014年第6期19-22,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：吉林省中医药管理局中医药科技项目(2012-075)

摘　　要：目的：优选治郁颗粒的成型工艺并建立其质量标准.方法：以成型性、溶化性为指标,通过单因素试验优选治郁颗粒的成型工艺;采用TLC对处方中栀子、郁金和黄连进行定性鉴别;运用HPLC测定栀子苷含量,流动相乙腈-水（10∶90）,检测波长238 nm.结果：最佳成型工艺为药材提取物-甜菊糖苷-糊精（10∶1∶1）,加入65％乙醇制软材,干燥温度55℃.栀子、郁金和黄连的TLC鉴别斑点清晰且阴性无干扰;栀子苷在3.28 ～ 16.40 mg·L-1呈良好线性关系,平均回收率101.02％（RSD1.67％）,栀子苷含量不得少于24.0mg·g-1.结论：优选的成型工艺简单、稳定、可行,建立的质量控制方法专属性强、重复性好,能用于控制治郁颗粒的质量.Objective：To optimize molding process of Zhiyu granules and establish its quality standards.Method：With formability and dissolubility as indexes,molding technology of Zhiyu granules was optimized by single factor tests; TLC was used for qualitative identification of Gardeniae Fructus,Curcumae Radix and Coptidis Rhizoma; HPLC was adopted to determine the content of gardenoside with mobile phase of acetonitrile-water （10∶ 90） and detection wavelength of 238 nm.Result：Optimal molding process was as following：ratio of herbs extract-stevioside-dextrin （10∶ 1∶1）,added 65 ％ ethanol for made of soft materials,drying temperature at 55 ℃.Spots of Gardeniae Fructus,Curcumae Radix and Coptidis Rhizoma on TLC plates were clear without interference by the blank reference; Gardenoside showed a good linear relationship at the range of 3.28-16.40 mg ·L-1,average recovery was 101.02％ with RSD of 1.67％,the content of gardenoside should not less than 24.0 mg ·g-1 Conclusion：Optimized process was simple,feasible and suitable for industrial production; This established quality control method was specific and reproducible,which could be adopted to quality control of Zhiyu granules.

关 键 词：治郁颗粒 成型工艺 质量标准 辅料 成型性 单因素试验 栀子 郁金 黄连 

分 类 号：R283.6[医药卫生—中药学]