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Quality control method for Chinese medicine preparation

A quality control method and preparation technology, which is applied in the direction of pharmaceutical formulations, non-central analgesics, antipyretics, etc., can solve problems that affect product production and quality assurance, and cannot effectively control the quality of compound Yuanhu analgesic preparations, etc.

Active Publication Date: 2006-11-08
GUIZHOU YIBAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, existing quality control methods cannot effectively control the quality of compound Yuanhu analgesic preparation, which will affect the production and quality assurance of products

Method used

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  • Quality control method for Chinese medicine preparation

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Experimental program
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Effect test

Embodiment 1

[0108] The quality control of embodiment 1 compound Yuanhuzhitong capsule

[0109] The quality control method of the present invention comprises the following steps:

[0110] The observation of traits, the steps are:

[0111] 【Properties】This product is a capsule, the content is gray-yellow powder or granule; taste bitter.

[0112] Content identification, the steps are:

[0113] 【Identification】(1) Take 4g of the content of this product, add 50ml of methanol, ultrasonically treat for 30 minutes, filter, evaporate the filtrate to dryness, add 10ml of water to dissolve the residue, add concentrated ammonia test solution to adjust to alkaline (pH8~9), Shake and extract with diethyl ether three times, 10ml each time, combine the diethyl ether extracts, evaporate to dryness, add 1ml of methanol to the residue to dissolve, and use it as the test solution. In addition, take 1 g of Corydalis Corydalis as reference medicinal material, add 50 ml of methanol, and prepare the reference...

Embodiment 2

[0124] Example 2 Quality Control of Compound Yuanhu Zhitong Granules

[0125] The quality control method of the present invention comprises the following steps:

[0126] The observation of traits, the steps are:

[0127] 【Properties】This product is granules, grayish yellow powder or granules; bitter in taste.

[0128] Content identification, the steps are:

[0129] [Identification] (1) Take 4g of this product, add 50ml of methanol, sonicate for 30 minutes, filter, evaporate the filtrate to dryness, add 10ml of water to dissolve the residue, add concentrated ammonia test solution to make it alkaline (pH8~9), and use diethyl ether Shake and extract 3 times, 10ml each time, combine the ether extracts, evaporate to dryness, add 1ml methanol to the residue to dissolve, and use it as the test solution. In addition, take 1 g of Corydalis Corydalis as reference medicinal material, add 50 ml of methanol, and prepare the reference medicinal material solution in the same way. Take an...

Embodiment 3

[0139] The quality control of embodiment 3 Compound Yuanhu Zhitong Tablets

[0140] The quality control method of the present invention comprises the following steps:

[0141] The observation of traits, the steps are:

[0142] 【Properties】This product is tablet, the content is grayish yellow powder or granule; taste bitter.

[0143] Content identification, the steps are:

[0144] [Identification] (1) Take 40 tablets of this product, add 50ml of methanol, ultrasonically treat for 30 minutes, filter, evaporate the filtrate to dryness, add 10ml of water to dissolve the residue, add concentrated ammonia test solution to adjust to alkaline (pH8~9), use Diethyl ether was shaken and extracted 3 times, 10ml each time, the diethyl ether extract was combined, evaporated to dryness, and the residue was dissolved by adding 1ml of methanol as the test solution. In addition, take 1 g of Corydalis Corydalis as reference medicinal material, add 50 ml of methanol, and prepare the reference ...

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Abstract

The present invention relates to quality control method for Chinese medicine preparation, and is especially the quality control method for compound pain-relieving corydalis preparation. The quality control method includes thin layer chromatography process for material identification and weight process for content measurement. The quality control method is precise, sensitive and stable, can ensure the high and stable product quality, and may be used for tablet, syrup, granule and other compound pain-relieving corydalis preparation.

Description

Technical field: [0001] The invention relates to a quality control method of a traditional Chinese medicine preparation, in particular to a quality control method of a compound Yuanhu analgesic preparation. Background technique: [0002] The compound Yuanhu analgesic preparation is prepared from Corydalis Corydalis (made from vinegar) 98g, Rhizoma Cyperi (made from vinegar) 98g, Toosendan 98g, and Xu Changqing 98g. For pain in the liver and stomach, epigastric pain, sternocostal pain, and menstrual pain. The existing Compound Yuanhu Pain Relief Tablets are on the market. [0003] The compound Yuanhu analgesic preparation of the present invention is a variety developed through reformation on the basis of the original dosage form. The existing compound Yuanhu analgesic preparation has the disadvantages of backward quality control methods and difficult control of product quality. In the existing quality control methods, there is no identification of its ingredients, or conten...

Claims

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Application Information

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IPC IPC(8): A61K36/8905A61K9/00A61K9/08A61K9/10A61K9/16A61K9/20A61K9/48A61P29/00G01N30/90
Inventor 王泽坤田淑华唐鹏杨坤闫文超
Owner GUIZHOU YIBAI PHARMA CO LTD
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