Quality control method of isatis root preparation

A quality control method, the technology of Banlangen, applied in the field of medicine, can solve the problems of not judging the Banlangen granule, judging the wine sinking process, and being unable to control the authenticity of the product, etc., to achieve a simple and easy quality control method, standardization, stability and consistency, and quality consistent effect

Inactive Publication Date: 2006-04-05
GUANGZHOU BAIYUSN HUTCHISON WHAMPOA CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the production process of Banlangen Granules (1990-2000 Edition) stipulated in the Pharmacopoeia, it is impossible to identify whether alcohol precipitation is used in the existing standards, and it is impossible to control the authenticity of the product, and there is no judgment on Banlangen Granules. It is also impossible to judge whether the wine sinking process has been implemented in the process to ensure the quality of the product.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] (1) Take 0.5Kg of medicinal Radix isatidis and add 1.0Kg of green leaves, decoct twice with water, filter and concentrate to a relative density of 1.1, add sucrose to granulate, and dry to make sugar-containing Radix isatidis granules. Take 5 g of granule powder, accurately weigh, accurately add 20 ml of 80% methanol, weigh, and make 3 parallel portions. Ultrasonic extraction for 20 minutes, make up the lost weight with 80% methanol, filter, and take the subsequent filtrate as the test solution. In addition, accurately weigh 10 mg of adenosine, put it in a 50ml measuring bottle, add methanol to dilute to the scale, and shake well; accurately measure 2ml, put it in a 10ml measuring bottle, add methanol to dilute to the mark, and shake well to obtain (each 1ml contains Adenosine 40 μg). Accurately draw each 10 μl of reference substance solution and need testing solution respectively, inject high-performance liquid chromatograph, be filler with octadecyl bonded silica gel...

Embodiment 2

[0019] (1) Take the isatidis granules from a factory in Beijing (one batch number for sugar-containing type and one sugar-free type), and measure the adenosine content in it according to the method of "Example 1". The content of glucoside is 142μg / g; the content of adenosine in the sugar-free type Banlangen granules is 236μg / g.

[0020] (2) Experiments were carried out in the same manner as in "(2)" in "Example 1". Result: a. Check under 365nm fluorescence, in the chromatogram of the test solution, there is no yellow-green fluorescent spot at the same position (about Rf0.4) as the chromatogram of Folium Isatidis, which shows that there is no admixture in the isatidis granule Folium Folium Extract. B. Spray with 0.1% bromocresol green ethanol solution, heat at 100°C for 5-10 minutes, until the spots are clear in color. In the chromatogram of the test product, there are yellow spots on the corresponding position of the chromatogram of the Radix isatidis control medicinal mater...

Embodiment 3

[0023] (1) Get the Radix Isatidis Granules (sugar-containing type) of a pharmaceutical factory in Guangzhou, and measure the adenosine content therein according to the method of "Example 1". As a result, the content of adenosine in the Radix Radix Granules is 298 μg / g.

[0024](2) Experiments were carried out in the same manner as in "(2)" in "Example 1". Result: a. Check under 365nm fluorescence, in the chromatogram of the test solution, there is no yellow-green fluorescent spot at the same position (about Rf0.4) as the chromatogram of Folium Isatidis, which shows that there is no admixture in the isatidis granule Folium Folium Extract. b. Spray with 0.1% bromocresol green ethanol solution and heat at 100°C for 5-10 minutes until the spots are clearly colored. In the chromatogram of the test product, there are yellow spots on the corresponding position of the chromatogram of the Radix isatidis control medicinal material. It shows that the isatidis granule contains the extra...

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Abstract

The present inven relates to an isatis root preparation and its quality control method. First of all, said invention creates the following method and steps: using TCL to examine the isatis root preparation for that said isatis root medicinal material has the judgement method related to isatis leaf or not and isatis root preparation production process has the judgement standard for implementing alcohol precipition step or not; adopting HPLC quantitative analysis method of adenosine in isatis root medicinal material and isatis root preparation and providing quality control standard, and providing the adenosine content range in the isatis root medicinal materials from different sources and isatis root granules, said adenosine content range is 50-400 micrograms, so that said invention ensures normalization of production process and stable uniformity of quality.

Description

technical field [0001] The invention relates to the field of medicine, and is a quality control method for medical products derived from plants as raw materials, in particular to a quality control method for Radix isatidis preparations. Background technique [0002] Radix isatidis is the root of Isatis indigotica Fort., a cruciferous plant. The Banlangen granules recorded in "Chinese Pharmacopoeia" (1995 edition, 2000 edition) is to get the water decoction of Radix Radix Radix and add ethanol to make its concentration 60%, after precipitation removes polysaccharides, the supernatant is concentrated and added auxiliary materials and made; Banlangen tea is The water decoction of Radix Radix isatidis is added with ethanol to make the concentration 60%, the polysaccharide is removed by precipitation, the supernatant is concentrated, sucrose and dextrin are added, pressed and dried. There are many chemical components isolated from Radix isatidis, including indigo, indirubin, org...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/31A61K31/7076A61P31/12G01N30/00G01N33/15A61K125/00
Inventor 曾令杰李楚源陈矛梁惠瑜杨东升陈松光王德勤
Owner GUANGZHOU BAIYUSN HUTCHISON WHAMPOA CHINESE MEDICINE
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