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Method for detecting related substances in preparation containing hydrophilic gel framework material

A detection method, a technology of hydrophilic gel, which is applied in the field of drug detection and can solve problems such as detection difficulties

Active Publication Date: 2015-03-25
CHENGDU KANGHONG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the application of its hydrophilic gel material, and these hydrophilic gels form a gel state when they meet water, it is difficult to dissolve them in the pretreatment process of drug detection, so that the content of raw materials in pharmaceutical preparations and The detection of related substances becomes more difficult

Method used

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  • Method for detecting related substances in preparation containing hydrophilic gel framework material
  • Method for detecting related substances in preparation containing hydrophilic gel framework material
  • Method for detecting related substances in preparation containing hydrophilic gel framework material

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 4

[0059]Example 4 Comparison of sample processing methods for Gliclazide sustained-release tablets

[0060] 1.1 Powder preparation: Take 20 tablets of 30 mg gliclazide sustained-release tablets (Chengdu Hengrui Pharmaceutical Co., Ltd., batch number 130509) in a mortar and grind to fine powder.

[0061] 1.2 Preparation of the test product:

[0062] Diluent 1: Purified water: Methanol = 98:2

[0063] Diluent 2: Saturated sodium sulfate solution: Methanol = 98:2

[0064] Conventional technique: Weigh about 1g of sample into a 10ml measuring bottle. Add diluent 1 directly to the mark, and the sample becomes gelatinous, unable to be centrifuged and filtered.

[0065] The method of this application: Weigh 1g sample into a 10ml measuring bottle, add diluent 2 solution to the mark, the sample has good fluidity.

Embodiment 5

[0066] Embodiment 5 Metformin Hydrochloride Sustained-release Tablet Sample Processing Method Comparison

[0067] 1.1 Powder preparation: Take 10 0.5g Metformin Hydrochloride Sustained Release Tablets (Chengdu Hengrui Pharmaceutical Co., Ltd., batch number 130502) in a mortar and grind to fine powder.

[0068] 1.2 The preparation of the test product is as follows:

[0069] Diluent 1: Purified water: Methanol = 98:2

[0070] Diluent 2: Saturated sodium sulfate solution: Methanol = 98:2

[0071] Conventional technique: Weigh about 1g of sample into a 10ml measuring bottle. Add diluent 1 directly to the mark, and the sample becomes gelatinous, unable to be centrifuged and filtered.

[0072] The method of this application: Weigh 1g sample into a 10ml measuring bottle, add diluent 2 solution to the mark, the sample has good fluidity.

Embodiment 6

[0073] Example six Ibuprofen sustained-release tablet sample processing method comparison

[0074] 1.1 Preparation of medicinal powder: Take 10 0.3g ibuprofen sustained-release tablets (Taiji Southwest Pharmaceutical Co., Ltd., batch number 10802) in a mortar and grind to fine powder.

[0075] 1.2 Preparation of the test product:

[0076] Diluent 1: Purified water: Methanol = 98:2

[0077] Diluent 2: Saturated sodium sulfate solution: Methanol = 98:2

[0078] Conventional technique: Weigh about 1g of sample into a 10ml measuring bottle. Add diluent 1 directly to the mark, and the sample becomes gelatinous, unable to be centrifuged and filtered.

[0079] The application method: take 1g sample in a 10ml measuring bottle, add diluent 2 solution to the scale, the sample has good fluidity.

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Abstract

The invention relates to the field of medicine detection, and provides a method for detecting related substances in a preparation containing a hydrophilic gel framework material. The preparation containing the hydrophilic gel framework material is treated with a solution containing sodium sulfate or sodium chloride and dissolved into a solution with good fluidity; and the solution is filtered, and a clear solution is injected into a high performance liquid chromatograph for detection. The method can effectively form the hydrophilic gel skeleton material into the solution with good fluidity, and can carry on the effective detection of related substances; when the content of hydrophilic gel framework material is up to 90%, the solution with good fluidity can still be formed to achieve the purpose of separation and detection.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a method for detecting related substances in preparations containing hydrophilic gel skeleton materials. Background technique [0002] Impurities in chemicals are a general term for ingredients other than active ingredients. According to the physical and chemical properties of impurities, impurities in pharmaceuticals can be divided into organic impurities, inorganic impurities and residual solvents. Among them, organic impurities come from: ① impurities introduced during the production process of raw materials; ② degradation products produced during storage of raw materials; ③ degradation products produced during the production and storage of preparations. The chemical structures of such impurities are generally similar to or related to the active ingredients, so they are usually called related substances [China Journal of Pharmaceutical Industry, 2010, 41(4): 305-308]. Impurity ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 柯潇邬智刚林楠
Owner CHENGDU KANGHONG PHARMA GRP