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Quality control method for Chinese medicine preparation

A cold-clearing heat-clearing and detection method technology, which is applied to medical formulas, medical preparations containing active ingredients, plant raw materials, etc., can solve problems such as ineffective control of the quality of cold-clearing heat preparations, affecting product production and quality assurance

Inactive Publication Date: 2009-12-23
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 method can't effectively control the quality of Ganmao Qingre preparation, thereby will influence the production of product and guarantee quality

Method used

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  • Quality control method for Chinese medicine preparation
  • Quality control method for Chinese medicine preparation
  • Quality control method for Chinese medicine preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0116] The quality control of embodiment 1 Ganmao Qingre syrup

[0117] The quality control method of the present invention comprises the following steps:

[0118] The observation of traits, the steps are:

[0119] 【Properties】This product is a brownish-yellow to brown liquid; sweet, slightly bitter.

[0120] Content identification, the steps are:

[0121] [Identification] (1) Take 15ml of this product, dilute with 5ml of water, add ethyl acetate and shake and extract twice, 20ml each time, combine the ethyl acetate solution, evaporate to dryness, add 0.5ml of methanol to dissolve the residue, and use it as the test sample solution. Take another puerarin reference substance, add methanol to make a solution containing 1mg per 1ml, as the reference substance solution. According to the test of thin-layer chromatography (Appendix VI B, Chinese Pharmacopoeia, 2005 edition), draw 5 μl of each of the above two solutions, respectively spot on the same silica gel G thin-layer plate...

Embodiment 2

[0137] The quality control of embodiment 2 Ganmao Qingre Oral Liquid

[0138] The quality control method of the present invention comprises the following steps:

[0139] The observation of traits, the steps are:

[0140] 【Properties】This product is brown to brown translucent liquid; sweet, slightly bitter.

[0141] Content identification, the steps are:

[0142] [Identification] (1) Take 15ml of this product, dilute with 5ml of water, add ethyl acetate and shake and extract twice, 20ml each time, combine the ethyl acetate solution, evaporate to dryness, add 0.5ml of methanol to dissolve the residue, and use it as the test sample solution. Take another puerarin reference substance, add methanol to make a solution containing 1mg per 1ml, as the reference substance solution. According to the test of thin-layer chromatography (Appendix VI B, Chinese Pharmacopoeia, 2005 edition), draw 5 μl of each of the above two solutions, respectively spot on the same silica gel G thin-layer...

Embodiment 3

[0158] Example 3 Quality Control of Ganmao Qingre Granules

[0159] The quality control method of the present invention comprises the following steps:

[0160] The observation of traits, the steps are:

[0161] 【Properties】This product is granules, brown to brown powder or granules; sweet, slightly bitter.

[0162] Content identification, the steps are:

[0163][Identification] (1) Take 15g of this product, dilute with 5ml of water, add ethyl acetate and shake and extract twice, 20ml each time, combine the ethyl acetate solution, evaporate to dryness, add 0.5ml of methanol to dissolve the residue, and use it as the test sample solution. Take another puerarin reference substance, add methanol to make a solution containing 1mg per 1ml, as the reference substance solution. According to the test of thin-layer chromatography (Appendix VI B, Chinese Pharmacopoeia, 2005 edition), draw 5 μl of each of the above two solutions, respectively spot on the same silica gel G thin-layer p...

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Abstract

The invention discloses a quality control method of a traditional Chinese medicine preparation, in particular to a quality control method of a cold-clearing and heat-clearing preparation. The method adopts thin-layer chromatography for identification, and high-performance liquid phase for content determination. The quality control method has good precision, sensitivity and stability, ensuring the product quality is "safe, uniform, stable, effective and controllable", and can be used for preparations such as syrups, oral liquids, capsules, tablets and granules. Quality Control.

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 cold and heat-clearing preparation. Background technique: [0002] Cold and heat-clearing preparations are prepared from 100g nepeta panicle, 30g mint, 50g fangfeng, 50g bupleurum, 30g perilla, 50g kudzu root, 30g bellflower, 40g bitter almond, 30g angelica, 100g kudiding, and 80g reed rhizome. Wind-dissipating, exogenous and heat-clearing medicines are used for wind-cold and cold, headache and fever, aversion to cold and body pain, runny nose, cough and dry throat. The existing Ganmao Qingre Granules are on the market. [0003] The Ganmao heat-clearing preparation of the present invention is a variety developed through reformation on the basis of the original dosage form. The existing Ganmao heat-clearing preparation has the disadvantages of backward quality control methods and difficult control of product qu...

Claims

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Application Information

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IPC IPC(8): A61K36/899
Inventor 王泽坤陈孜孜杨义牟兰进郭璐
Owner GUIZHOU YIBAI PHARMA CO LTD
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