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Fingerprint control method for Jian'er Qinjie oral solution

A technology of fingerprint spectrum and control method, which is applied in the field of fingerprint spectrum control of traditional Chinese medicine compound preparation Jianerqingjie Liquid, and achieves the effects of convenient operation, consistent medicinal properties and curative effects, and basic medicinal properties and curative effects.

Inactive Publication Date: 2010-06-23
SINOPHARM GRP ZHIJUN SHENZHEN PINGSHAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no relevant literature on the establishment of fingerprints for Jianer Qingjieye medicine to control its quality.

Method used

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  • Fingerprint control method for Jian'er Qinjie oral solution
  • Fingerprint control method for Jian'er Qinjie oral solution
  • Fingerprint control method for Jian'er Qinjie oral solution

Examples

Experimental program
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Effect test

preparation example Construction

[0068] 1.3 Preparation of test solution

[0069] 1.3.1 Preparation of Jianer Qingjie Liquid test solution

[0070] Honeysuckle, chrysanthemum, forsythia, and bitter almonds were distilled to extract aromatic water; hawthorn was heated and extracted twice with 80% ethanol for 2 hours each time, filtered, and the filtrate was combined. The ethanol was recovered from the filtrate, concentrated into an extract to obtain the intermediate of hawthorn, and dissolved in water Make hawthorn medicinal solution; tangerine peel is percolated with 60% ethanol, collect percolation liquid, reclaim ethanol, concentrate into extract to obtain tangerine peel intermediate, add water to dissolve and make tangerine peel medicinal solution; then combine the above medicinal solution and aromatic water, add Appropriate amount of citric acid, simple syrup and benzoic acid, add water to make up to 1000ml, stir well, filter to obtain Jianer Qingjie solution Take Jianer Qingjie solution to pass through C...

Embodiment 1

[0191] Acquisition of Jianer Qingjie Liquid Control Fingerprint and Quality Stability Evaluation:

[0192] Fingerprint similarity calculation results:

[0193] Respectively get 10 batches (10ml specification) and 10 batches (100ml specification) of Jianer Qingjie solution, prepare Jianer Qingjie solution test solution according to the following (1) item solution preparation method, press (2) Analysis of chromatographic conditions under the item:

[0194] (1) Preparation method of the test solution: take 1ml of the finished product, pass it through a C18 solid-phase small column (filler specification is 500mg, activate with 3ml of methanol before use, and then wash with 3ml of water), wash with 1ml of water, discard the water washing solution , and then eluted with 1ml of methanol, and the eluate was collected to obtain the obtained product.

[0195] (2) Chromatographic conditions: high performance liquid chromatography conditions are: the chromatographic column uses octadecy...

Embodiment 2

[0205] Acquisition of control fingerprints of hawthorn intermediates and evaluation of quality stability:

[0206] Fingerprint similarity calculation results:

[0207] Get 7 batches of hawthorn intermediates, make the hawthorn intermediates need testing solution according to the following (1) item solution preparation method, analyze by (2) under the chromatographic conditions:

[0208] (1) Preparation method of the test solution: take 1ml of Hawthorn intermediate, dilute to 10ml with methanol, take 1ml, dilute to 10ml with water, pass through C18 solid-phase small column (filling specification is 500mg, activate with 3ml of methanol before use) , and then washed with 3ml of water), washed with 1ml of water, discarded the water washing solution, and then eluted with 1ml of methanol, and collected the eluate.

[0209] (2) Chromatographic conditions: high performance liquid chromatography conditions are: the chromatographic column uses octadecylsilane bonded silica gel as a fil...

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Abstract

The invention discloses a fingerprint control method for Jian'er Qinjie oral solution, comprising: the prepared fingerprint of the test solution of the Jian'er Qinjie oral solution finished product is tested under a certain chromatographic condition, the fingerprint similarity of the of the test solution fingerprint and the comparison fingerprint is calculated through a computer auxiliary similarity evaluation software, and then the similarity value is obtained, and the quality of the Jian'er Qinjie oral solution is controlled according to the quality control standard that the fingerprint similarity should be larger than 0.90. The invention aims at the characteristics of the Jian'er Qinjie oral solution, and establishes the fingerprint system of the Jian'er Qinjie oral solution, and the similarity evaluation of the product fingerprint and the comparison fingerprint is conducted through the computer auxiliary, thereby controlling the quality of the Jian'er Qinjie oral solution product, which leads the quality of the product to be stable and reliable, the potency and efficacy are basically identical, the safety is good, meanwhile, the method is convenient to operate, the precision is high, and the production efficiency is increased.

Description

technical field [0001] The invention relates to a method for controlling the fingerprint of Jianer Qingjie Liquid, a Chinese medicine compound preparation, in particular to a fingerprint technology for controlling the quality of Jianer Qingjie Liquid. Background technique [0002] The Jianer Qingjieye drug involved in this invention is a national standard variety. Jianer Qingjieye is currently one of the drugs that can treat both respiratory and digestive system diseases in clinical practice. Its market share has accounted for 50% of the current children's medicine %above. Jianer Qingjieye currently has 17 domestic companies with production approval documents issued by the State Food and Drug Administration, and about 7 products are sold in the market. Due to historical reasons, these products generally have unclear active substances and uncontrollable quality, which affects the efficacy of the product and even has hidden dangers in drug safety. [0003] Internationally, f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/752A61P1/14A61P11/00G01N30/36G01N30/86
Inventor 孙国英黄超刘力张春丽刘灿群刘强李秋怡殷米来苏丽静金霞陈剑洪
Owner SINOPHARM GRP ZHIJUN SHENZHEN PINGSHAN PHARMA CO LTD
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