Chinese medicinal composition and preparation method thereof and quality control method

A quality control method and composition technology, which can be applied to drug combinations, pharmaceutical formulas, measuring devices, etc., and can solve problems such as unscientific quality control and unstable curative effect

Active Publication Date: 2009-05-27
BEIJING ASIA EAST BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Long-term use of related chemical drugs such as famotidine, ranitidine, and methiguanide will cause many adverse react...

Method used

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  • Chinese medicinal composition and preparation method thereof and quality control method
  • Chinese medicinal composition and preparation method thereof and quality control method
  • Chinese medicinal composition and preparation method thereof and quality control method

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0063] Experimental Example 1. Screening of Glycyrrhizic Acid Extraction and Separation Process

[0064] Taking the content of glycyrrhizic acid as the investigation index, the parameters of pH value, standing time and washing water consumption during acid precipitation were investigated by orthogonal test. The specific method is as follows:

[0065] Weigh 900 g of licorice extract and divide it into 9 parts. According to the orthogonal table L 9 (3 4 ) Arrangement, carry out orthogonal test, carry out acid precipitation, stand still, wash respectively to 9 samples, the content of glycyrrhizic acid in 9 extracts is measured, the results are shown in Table 1, Table 2, Table 3 respectively.

[0066] Table 1. Level table of decoction process factors

[0067]

[0068] Table 2. Orthogonal test data table for water decoction process screening

[0069]

[0070] Table 3. Analysis of variance table

[0071]

[0072]

[0073] f 0.05 (2, 2) = 19.00; F 0.01 (2, 2) = 99...

experiment example 2

[0075] Experimental example 2. the screening of Chinese medicine group and substance identification method of the present invention

[0076] licorice

[0077]Method 1: Take the preparation of the present invention equivalent to 25 g of raw medicinal materials, add 30 ml of n-butanol, heat and reflux for 1 hour, let cool, filter, evaporate the filtrate to dryness, add 1 ml of methanol to dissolve the residue, and use it as the test solution. Prepare a negative sample solution lacking licorice according to the preparation method of the test product preparation and solution. Take another 1 g of licorice as a reference drug, add 20 ml of n-butanol, and make a solution of the reference drug in the same way. According to the test of thin-layer chromatography (Appendix VI B, Chinese Pharmacopoeia, 2005 edition), draw 5 μl of each of the above three solutions, respectively spot on the same silica gel G thin-layer plate, and mix with chloroform-methanol-water (65:35:10) The solution ...

experiment example 3

[0105] Experimental example 3. Determination of limit inspection method

[0106] Tianxianzi has the functions of relieving spasm and relieving pain, calming the nerves and relieving asthma, and is used for the treatment of stomach spasm pain, wheezing and coughing, and mania. However, it contains hyoscyamine, scopolamine and other atropine alkaloids. These alkaloids are all M-choline receptor blockers. The effect on the peripheral nerves is to inhibit the function of the sympathetic nerves, and the effect on the central nervous system is to excite. , In severe cases, it turns into central depression, causing drowsiness and coma. If the dose is too large, it will often cause poisoning and death, so it is necessary to carry out a limited inspection. The experimental process is as follows:

[0107] 2005 Edition Chinese Pharmacopoeia Part One Zhongtian Xianzi has a maximum daily dose of 0.6 g, and this experiment controls the amount of atropine alkaloids contained in the total a...

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Abstract

The invention provides a traditional Chinese medicine composition for treating stomach and duodenal ulcers, a prepration method thereof and a quality control method, and the pharmaceutical composition is composed of the following raw materials: liquoric root liquid extract, common bletilla pseudobulb, turmeric root-tuber, cuttlebone, baical skullcap root, Indian buead, officinal magnolia bark and henbane seed. The invention carries out the system control of prepration process parameters; the invention effectively carries out the quality control of products by identification, content measurement and limit test of traditional Chinese medicines in the formula; furthermore, the products controlled by using the method are more stable and safer on the pharmacological effects.

Description

technical field [0001] The invention relates to a traditional Chinese medicine composition for treating gastric and duodenal ulcers, a preparation method and a quality control method thereof, and belongs to the technical field of traditional Chinese medicines. Background technique [0002] Gastric and duodenal ulcers are a common disease. Epidemiological surveys show that about 10% of the population has suffered from this disease in their lifetime. The disease can occur at any age, and is most common at the age of 45-55. Various factors related to the pathogenesis, such as gastric acid, pepsin, Helicobacter pylori infection, genetics, physical fitness, environment, diet, living habits, neuropsychiatric factors, etc., lead to the enhancement of the above-mentioned invasion and the weakening of the protective mechanism through different channels or mechanisms , can promote ulceration. Since gastric ulcer is a chronic disease and is prone to relapse, to make it fully heal, i...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61K9/16A61K9/20A61K9/48A61P1/04G01N30/02G01N30/90A61K35/56A61K35/618
Inventor 付立家付建家
Owner BEIJING ASIA EAST BIO PHARMA CO LTD
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