Molding Process and Quality Control of Zhiyu Granules

LI Ting; YE Dou-dan; BAO Hui-wei; GAO Wei; ZHANG Wei-yu

doi:10.11653/syfj2014060019

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Molding Process and Quality Control of Zhiyu Granules

更新时间：2024-01-04

- Molding Process and Quality Control of Zhiyu Granules
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 20, Issue 6, Pages: 19-22(2014)
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- DOI：10.11653/syfj2014060019
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- Published：2014
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LI Ting, YE Dou-dan, BAO Hui-wei, et al. Molding Process and Quality Control of Zhiyu Granules[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(6): 19-22.
DOI：

LI Ting, YE Dou-dan, BAO Hui-wei, et al. Molding Process and Quality Control of Zhiyu Granules[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(6): 19-22. DOI： 10.11653/syfj2014060019.

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%（RSD 1.67%），栀子苷含量不得少于24.0 mg·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。

Abstract

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.

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