丹参-红花配方颗粒制备工艺的优化、TLC鉴别及含量测定  

Optimization of preparation technique,TLC identification and content determination of Salvia miltiorrhiza-Carthamus tinctorius dispensing granules

作　　者：周慧慧 杜少兵 高速 李菁 白吉庆[1] 王小平[1,2] ZHOU Huihui;DU Shaobing;GAO Su;LI Jing;BAI Jiqing;WANG Xiaoping(College of Pharmacy,Shaanxi University of Chinese Medicine,Xianyang,Shaanxi,712046 P.R.China;Shaanxi Key Lab.of Chinese Medicine Fundamentals and New Drugs Research,Shaanxi University of Chinese Medicine,Xianyang,Shaanxi,712046 P.R.China)

机构地区：[1]陕西中医药大学药学院,陕西咸阳712046 [2]陕西中医药大学陕西省中药基础与新药研究重点实验室,陕西咸阳712046

出　　处：《华西药学杂志》2022年第3期292-296,共5页West China Journal of Pharmaceutical Sciences

基　　金：国家自然科学基金资助项目(批准号:81974544);陕西省科技厅社发项目(2019SF-286);陕西省教育厅重点实验室项目(18JS025)。

摘　　要：目的筛选丹参-红花配方颗粒的最佳制备工艺,并对其质量标准进行研究。方法在单因素试验的基础上,筛选了辅料类别、干浸膏粉与辅料的质量比、润湿剂(乙醇)浓度、干燥时间等影响因素,优化其制备工艺;采用TLC法鉴别配方颗粒中的丹参、红花;采用HPLC法测定配方颗粒中主要成分的含量。结果丹参-红花配方颗粒的最佳制备条件为:糊精与干膏粉的质量比为1∶1,70%乙醇为润湿剂,60℃干燥20 min;TLC斑点清晰、专属性、重复性好,简单可行;建立了同时测定丹参-红花配方颗粒中丹参素、丹酚酸B、紫草酸、迷迭香酸和羟基红花黄色素A含量的HPLC法。结论优化后的制备工艺简单、可行,成型率、溶化性、水分等均符合要求,且建立的鉴别和含量测定方法可有效控制丹参-红花配方颗粒的质量,为该制剂质量标准的制定奠定了基础。OBJECTIVE To prepare Salvia miltiorrhiza-Carthamus tinctorius dispensing granules and to study its quality standard.METHODS On the basis of single-factor experiments,taking the accessories category,the mass ratio of dry extract powder and auxiliary materials,the concentration of ethanol and drying time as influencing factors,the preparation process was optimized.TLC was adopted in the qualitative identification of Salvia miltiorrhiza and Carthamus tinctorius in the granules.HPLC was used to determine the content of the main ingredients in the dispensing granules.RESULTS The optimum preparation conditions were as follows:the mass ratio of dextrin to dry paste powder was 1∶1;70%ethanol was used as wetting agent,dried at 60℃for 20 minutes.The TLC spots were clear without negative interference.An HPLC method for the determination of danshensu,salvianolic acid B,shikonic acid,rosmarinic acid and hydroxysafflor yellow A in the dispensing granules was established.CONCUSION The optimized preparation process is simple and feasible,and the molding rate,solubility and moisture content meet the requirements.The established identification and content determination method can effectively control the quality of Salvia miltiorrhiza-Carthamus tinctorius dispensing granules.

关 键 词：丹参 红花 药对 配方颗粒 制备工艺 质量标准 薄层色谱 高效液相色谱 含量测定 单因素试验 

分 类 号：R917[医药卫生—药物分析学] R28[医药卫生—药学]