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葛根等四种中药配方颗粒的制备工艺和质量标准研究

A Study on the Preparation and Quality Control of Radix Puerariae and Other Three TCM Refined Granules

【作者】 邓轶渊

【导师】 崔承彬; 高文远;

【作者基本信息】 天津大学 , 药物化学, 2005, 硕士

【摘要】 本文研究了葛根、白芍、甘草、菊花等四种中药配方颗粒的制备工艺,并对质量标准进行了探讨。针对葛根、白芍、甘草等三种中药的主要有效成分均为水溶性成分,在提取工艺设计中采用水煎提取,对提取次数、加水量、提取时间等因素进行了条件优选。本文采用L9(34)正交试验表安排试验,以出膏率及主要有效成分的提取率作为考察指标,最终得到最佳提取工艺。葛根配方颗粒的最佳提取工艺为:10倍量水,微沸回流1.5小时,回流提取3次;白芍配方颗粒的最佳提取工艺为:12倍量水,微沸回流1小时,回流提取3次;甘草配方颗粒的最佳提取工艺为:10倍量水,微沸回流1小时,回流提取3次。针对菊花中同时含有水溶性成分和挥发油类成分的特点,本实验采取L9(34)正交试验考察,兼顾挥发油提取率、绿原酸提取率和出膏率同时提取挥发油和水溶性物质的方案。综合考察三项指标后得出菊花最佳提取工艺为12倍量水,提取3次,每次1.5小时,同时收集水提液和挥发油。质量标准研究中对上述四种中药配方颗粒的指标成分用HPLC进行了含量测定研究。通过对不同批次的样品考察,制订了各味中药配方颗粒的含量标准,其中葛根配方颗粒中葛根素含量不得低于24mg/g;白芍配方颗粒中芍药苷含量不得低于16mg/g;甘草配方颗粒中甘草酸含量不得低于30mg/g;菊花配方颗粒中绿原酸含量不得低于17mg/g。此外,本实验对各味药均进行了TLC定性鉴别研究,对菊花配方颗粒中的挥发油,采用紫外扫描方法进行质量控制。本文对产品样品的水分、粒度和溶化性等指标进行了检查。

【Abstract】 The herbs in cut, such as Radix puerariae, Radix paeoniae, Radix glycyrrhizae, were extracted with water because their main bio-active substances were found to have good solubility in water. The optimum process was determined by a L9(34)orthogonal test with extraction rate of the main bio-active substances and paste-forming rate as determination markers. The optimum parameters were obtained as the results. There are not only water-solvable substances but also volatile oil in flos chrysanthemi. So, all the three determination makers such as extraction rate of chlorogenic acid, paste-forming rate and oil extraction rate were taken into consideration. The optimal water-extraction processes were as follows: for Radix puerariae, the water amount was 10 times of the herb in cut, decocted 3 times and each time was sustained for 1.5 hours; for Radix paeoniae, the water amount was 12 times of the herb in cut, decocted 3 times and each time was sustained for 1 hour; for Radix glycyrrhizae, the water amount was 10 times of the herb in cut, decocted 3 times and each time was sustained for 1 hour; for flos chrysanthemi, all the three factors such as extraction rate of chlorogenic acid, paste-forming rate and oil extraction rate were taken into consideration, and the optimum was: the water amount was 12 times of the herb in cut, decocted 3 times and each time was sustained for 1.5 hours. Both water solution and the volatile oil were collected simultaneously.In the experiment of quality standards, all the four refined granules were determined with the active composition contents by HPLC. The limited contents of puerarin(≥24mg/g), paeoniflorin(≥16mg/g), glycyrrhizic acid(≥30mg/g) and chlorogenic acid(≥17mg/g) were fixed by analyzing the different samples separately. In addition, TLC method was used to identify the four refined granules and the UV spectra method was used to identify the volatile oil in flos chrysanthemi. Moreover, such check-procedures as the moisture, granularity and water-solvability were carried out.

  • 【网络出版投稿人】 天津大学
  • 【网络出版年期】2007年 05期
  • 【分类号】TQ461
  • 【被引频次】5
  • 【下载频次】1359
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