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Detection method of compound chlorhexidine dyclonine cream

A compound chlorhexidine and detection method technology, which is applied in the detection field of compound preparations, can solve the problem of affecting product process stability investigation and determination of curative effect, identification method specificity and accuracy are not strong, and product quality cannot be well guaranteed To achieve comprehensive and effective quality inspection, stable identification method, and increase the effect of TLC identification

Active Publication Date: 2016-02-17
GUIZHOU JINQIAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] In the original standard, only chlorhexidine hydrochloride is identified by color development, and borneol is identified by thin layer. The quality control method is relatively simple, the content of active ingredients is not clear, and the specificity and accuracy of the identification method are not strong.
In further research, we found that in the thin layer identification method of borneol, the method of heating and cooling the aqueous solution in a water bath and extracting with chloroform was used to prepare the test solution. The extraction is too cumbersome and needs to be replaced by a simple, feasible and accurate identification method; in the prescription of compound chlorhexidine dyclonine cream, chlorhexidine hydrochloride, borneol and dyclonine hydrochloride are the main active ingredients of the product. However, the existing detection method does not measure the content of the above-mentioned ingredients in the prescription, so the product quality cannot be well guaranteed, thereby affecting the process stability inspection of the product and the determination of the curative effect, causing hidden dangers to the product quality

Method used

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  • Detection method of compound chlorhexidine dyclonine cream
  • Detection method of compound chlorhexidine dyclonine cream
  • Detection method of compound chlorhexidine dyclonine cream

Examples

Experimental program
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Effect test

Embodiment 1

[0123] Embodiment 1 compound chlorhexidine dyclonine cream detection method

[0124] 【Properties】This product is light brown to brown cream;

[0125][Identification] (1) Take 3g of this product, put it in a stoppered Erlenmeyer flask, add 20ml of n-hexane, put it in a hot water bath at 65°C to dissolve, let it cool, put it in the refrigerator for 20 minutes, take it out, and filter it immediately. The filtrate was evaporated to dryness in a water bath at 65°C, and the residue was added with 5ml of ethanol to dissolve it as the test solution; another appropriate amount of borneol reference substance was added with ethanol to make a solution containing 1mg per 1ml as the reference substance solution; according to the second appendix of the Chinese Pharmacopoeia 2010 edition VB thin-layer chromatography test, draw 10 μl of each of the above two solutions, point them on the same silica gel G thin-layer plate, use benzene: ethyl acetate = 9:1 as the developer, dry it after developm...

Embodiment 2

[0137] Embodiment 2 compound chlorhexidine dyclonine cream detection method

[0138] 【Properties】This product is light brown to brown cream;

[0139] [Identification] (1) Take 3g of this product, put it in a stoppered Erlenmeyer flask, add 20ml of n-hexane, put it in a hot water bath at 65°C to dissolve, let it cool, put it in the refrigerator for 20 minutes, take it out, and filter it immediately. The filtrate was evaporated to dryness in a water bath at 65°C, and the residue was added with 5ml of ethanol to dissolve it as the test solution; another appropriate amount of borneol reference substance was added with ethanol to make a solution containing 1mg per 1ml as the reference substance solution; according to the second appendix of the Chinese Pharmacopoeia 2010 edition VB thin-layer chromatography test, draw 10 μl of each of the above two solutions, point them on the same silica gel G thin-layer plate, use benzene: ethyl acetate = 5:5 as the developer, dry it after develop...

Embodiment 3

[0151] Embodiment 3 compound chlorhexidine dyclonine cream detection method

[0152] 【Properties】This product is light brown to brown cream;

[0153] [Identification] (1) Take 3g of this product, put it in a stoppered Erlenmeyer flask, add 20ml of n-hexane, put it in a hot water bath at 65°C to dissolve, let it cool, put it in the refrigerator for 20 minutes, take it out, and filter it immediately. The filtrate was evaporated to dryness in a water bath at 65°C, and the residue was added with 5ml of ethanol to dissolve it as the test solution; another appropriate amount of borneol reference substance was added with ethanol to make a solution containing 1mg per 1ml as the reference substance solution; according to the second appendix of the Chinese Pharmacopoeia 2010 edition VB thin-layer chromatography test, draw 10 μl of each of the above two solutions, spot them on the same silica gel G thin-layer plate, use benzene: ethyl acetate = 8:2 as the developer, dry it after developm...

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Abstract

The invention discloses a method for detecting compound chlorhexidine dihydrochloride and dyclonine hydrochloride cream. The method comprises the following steps: respectively measuring content of chlorhexidine hydrochloride and dyclonine hydrochloride in a preparation by adopting an HPLC method, and measuring content of borneol by adopting gas chromatography; performing thin-layer chromatography identification on the borneol and olive fruit water alcohol extract in the preparation, and performing liquid phase retention time identification on chlorhexidine hydrochloride and dyclonine hydrochloride. Compared with the prior art, the method disclosed by the invention is exclusive, feasible and high in reproducibility, and the quality of the compound chlorhexidine dihydrochloride and dyclonine hydrochloride cream can be effectively controlled. According to repeated tests, the detection method is stable, simple, convenient, and high in reproducibility, has accurate results and can serve as a method for detecting the compound chlorhexidine dihydrochloride and dyclonine hydrochloride cream as well as an index for inspecting the stability of the process.

Description

technical field [0001] The invention relates to a detection method of a compound preparation, in particular to a detection method of a compound chlorhexidine dyclonine cream. technical background [0002] Compound chlorhexidine dyclonine cream is a cream made by uniformly dispersing chlorhexidine hydrochloride, olive fruit hydroalcoholic extract, borneol, dyclonine hydrochloride, menthol and stevioside in a suitable matrix , for skin external use, for oral mucosal ulcers, gingivitis, pharyngitis. It is recorded on page 148 of Volume 14 of National Standard of Chemical Drugs, and the standard number is WS-10001-(HD-1354)-2003. [0003] In the original standard, only chlorhexidine hydrochloride is identified by color development, and borneol is identified by thin layer. The quality control method is relatively simple, the content of active ingredients is not clear, and the specificity and accuracy of the identification method are not strong. In further research, we found tha...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 张芝庭张涛涛
Owner GUIZHOU JINQIAO PHARMA
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