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Detection method of glycerin phosphoryl choline injecta related material

A technology of glycerophosphorylcholine and a detection method, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve problems such as inability to detect and determine, and achieve good results.

Active Publication Date: 2011-10-12
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, the detection method of related substances of glycerophosphorylcholine adopts thin-layer chromatography, which can control the content of related substances to not exceed 4.0%, but cannot detect a definite value. More accurate detection methods are still needed to detect glycerophosphorylcholine Effectively control the quality of alkali preparations to ensure safer and more effective medication

Method used

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  • Detection method of glycerin phosphoryl choline injecta related material
  • Detection method of glycerin phosphoryl choline injecta related material
  • Detection method of glycerin phosphoryl choline injecta related material

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0116] Example 1: Detection method of related substances in glycerol phosphorylcholine injection

[0117] Preparation of Glycerophosphorylcholine Injection:

[0118] Take 250g of glycerol phosphorylcholine, add water for injection to 800ml, stir to fully dissolve; heat to boil, add 1g of activated carbon and boil for adsorption for 15 minutes; decarbonize and filter, add water for injection to 1000ml; adjust the pH value to 6.5 with sodium hydroxide solution , filtered with a 0.22μm microporous membrane; filled with an ampoule, specification: 4ml / bottle, containing 1.0g glycerol phosphorylcholine; melt-sealed; sterilized at 121°C for 12 minutes, leak detection, light inspection, packaging, instant;

[0119] According to Chinese Pharmacopoeia 2005 edition an appendix VI D high performance liquid chromatography determination;

[0120] Chromatographic conditions and system suitability test: the chromatographic column Hypersil Scx is used as the chromatographic column; water adj...

Embodiment 2

[0127] Example 2: Detection method of related substances in glycerol phosphorylcholine injection

[0128] Preparation of Glycerophosphorylcholine Injection:

[0129] Take 240g of glycerol phosphorylcholine, add water for injection to 900ml, stir to fully dissolve; heat to boil, add 1.1g of activated carbon and boil for adsorption for 10 minutes; decarbonize and filter, add water for injection to 1000ml; adjust the pH value to 6.8 with hydrochloric acid solution, Filter with a 0.20μm microporous membrane; fill with an ampoule, specification: 3ml / bottle, containing 0.72g glycerol phosphorylcholine; melt seal; sterilize at 118°C for 15 minutes, leak detection, light inspection, packaging, that is have to;

[0130] According to the Chinese Pharmacopoeia 2005 edition an appendix VID high performance liquid chromatography determination;

[0131] Chromatographic conditions and system suitability test: the chromatographic column Hypersil Scx is used as the chromatographic column; wa...

Embodiment 3

[0138] Example 3: Detection method of related substances in glycerol phosphorylcholine injection

[0139] Preparation of Glycerophosphorylcholine Injection:

[0140] Take 260g of glycerol phosphorylcholine, add water for injection to 700ml, stir to fully dissolve; heat to boil, add 0.9g of activated carbon and boil for adsorption for 20 minutes; decarburize and filter, add water for injection to 1000ml; adjust the pH value to 6.0, filter with a 0.24μm microporous membrane; fill in an ampoule, specification: 5ml / bottle, containing 1.3g glycerol phosphorylcholine; melt seal; sterilize at 125°C for 10 minutes, leak detection, light inspection, packaging , that is;

[0141] According to the Chinese Pharmacopoeia 2005 edition an appendix VID high performance liquid chromatography determination;

[0142] Chromatographic conditions and system suitability test: the chromatographic column Hypersil Scx is used as the chromatographic column; water adjusted to pH 2.0 with trifluoroaceti...

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Abstract

The invention relates to a detection method of a glycerin phosphoryl choline injecta related material. In the method, high-performance liquid chromatography (HPLC) is adopted for measurement, a chromatographic column SCX (Strong Cation Exchange) is utilized as chromatographic column, and water the pH value of which is regulated to 1.5 by trifluoroacetic acid is utilized as a mobile phase, and theflow velocity is 1.0 ml / min, and an evaporative light-scattering detector is utilized for detection; and by utilizing the method, the detected glycerin phosphoryl choline injecta related material accounts for no more than 4.0%, and a definite value can be calculated. The detection method provided by the invention can be used for accurately detecting the content of the glycerin phosphoryl choline injecta related material, thus better guaranteeing the safety and effective of medications.

Description

technical field [0001] The invention relates to a method for detecting related substances in glycerol phosphorylcholine injection. Background technique [0002] At present, the detection method of related substances of glycerophosphorylcholine adopts thin-layer chromatography, which can control the content of related substances to not exceed 4.0%, but cannot detect a definite value. More accurate detection methods are still needed to detect glycerophosphorylcholine The quality of alkali preparations is effectively controlled to ensure safer and more effective medication. Contents of the invention [0003] The object of the present invention is to provide a method for detecting related substances in glycerol phosphorylcholine injection. [0004] The object of the invention is achieved through the following technical solutions: [0005] The detection method of the related substance of glycerol phosphorylcholine injection of the present invention is: [0006] According to ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 程志鹏梁隆余启波张德奎张煜华胡思玉
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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