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Method for measuring content of cysteine in compound amino acid injection

A compound amino acid, cysteine ​​technology, applied in the field of determination of cysteine ​​content in compound amino acid injection, can solve the problems of many derivatization steps, inability to accurately measure cysteine ​​content, interference of other amino acids, etc. Good performance, high recovery rate, quality control effect

Active Publication Date: 2017-07-14
武汉一半天科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has been reported in the prior art that cysteine ​​is derivatized using iodoacetic acid-o-phthalaldehyde, iodoacetic acid-PICO TAG and N-ethylmaleimide as derivatizing agents, but there are many derivatization steps, Due to the interference of other amino acids, the content of cysteine ​​in the compound amino acid injection cannot be accurately determined

Method used

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  • Method for measuring content of cysteine in compound amino acid injection
  • Method for measuring content of cysteine in compound amino acid injection
  • Method for measuring content of cysteine in compound amino acid injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Determination of Cysteine ​​Hydrochloride in Compound Amino Acid Injection 18AA-V

[0065] (1) Taking the compound amino acid 18AA-V injection prepared by Hubei Bantian Pharmaceutical Co., Ltd. as a sample, the method for measuring the content of cysteine ​​hydrochloride in the compound amino acid injection 18AA-V comprises the following steps:

[0066] (11) Accurately weigh cysteine, mix it with water, and prepare a 0.06 mg / mL cysteine ​​aqueous solution as a reference solution;

[0067] Prepare compound amino acid injection according to the formula of compound amino acid injection 18AA-V, dilute 5 times with water, as need testing solution;

[0068] N-(1-pyrene)maleimide was mixed with acetonitrile to obtain a N-(1-pyrene)maleimide acetonitrile solution with a mass concentration of 0.2 mg / mL as a derivative solution;

[0069] (12) Mix 0.5mL of the reference substance solution and 0.5mL of the test solution with 1mL of the derivatizer solution in the step (11), and de...

Embodiment 2

[0130] Determination of Cysteine ​​Content in Compound Amino Acid Injection 18AA-Ⅶ

[0131] (1) Taking the compound amino acid 18AA-Ⅶ injection prepared by Hubei Bantian Pharmaceutical Co., Ltd. as a sample, the method for measuring the content of cysteine ​​in the compound amino acid injection 18AA-Ⅶ comprises the following steps:

[0132] (11) Accurately weigh cysteine, mix it with water, and prepare a 0.07 mg / mL cysteine ​​aqueous solution as a reference solution;

[0133] Prepare the compound amino acid injection according to the formula of the compound amino acid injection 18AA-Ⅶ, dilute it 5 times with water, and use it as the test solution;

[0134] N-(1-pyrene)maleimide was mixed with acetonitrile to obtain a N-(1-pyrene)maleimide acetonitrile solution with a mass concentration of 0.2 mg / mL as a derivative solution;

[0135] (12) Mix 0.5mL of the reference substance solution and 0.5mL of the test solution with 1mL of the derivatizer solution in the step (11), and deri...

Embodiment 3

[0195] Determination of Cysteine ​​Content in Compound Amino Acid Injection 18AA-IX

[0196] (1) Taking the compound amino acid 18AA-IX injection prepared by Hubei Bantian Pharmaceutical Co., Ltd. as a sample, the method for measuring the content of cysteine ​​in the compound amino acid injection 18AA-IX comprises the following steps:

[0197] (11) Accurately weigh cysteine, mix it with water, and prepare a 0.05 mg / mL cysteine ​​aqueous solution as a reference solution;

[0198] Prepare compound amino acid injection according to the formula of compound amino acid injection 18AA-IX, dilute 5 times with water, as need testing solution;

[0199] N-(1-pyrene)maleimide was mixed with acetonitrile to obtain a N-(1-pyrene)maleimide acetonitrile solution with a mass concentration of 0.2 mg / mL as a derivative solution;

[0200] (12) Mix 0.5mL of the reference substance solution and 0.5mL of the test solution with 1mL of the derivatizer solution in the step (11), and derivatize for 20m...

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Abstract

The invention provides a method for measuring content of cysteine in a compound amino acid injection. The method comprises preparing a cysteine aqueous solution as a reference substance solution, taking a compound amino acid injection as a sample solution, carrying out derivation on cysteine in the reference substance solution and the sample solution through N-(1-pyrene)maleimide, carrying out high performance liquid chromatography on the derived reference substance solution and sample solution, and according to the liquid chromatogram of the derived reference substance solution and sample solution, acquiring content of cysteine in a compound amino acid injection through an external standard method. The method can realize accurate determination of content of cysteine in a compound amino acid injection, and has good specificity, high precision and a high recovery rate.

Description

technical field [0001] The invention relates to the technical field of medical detection, in particular to a method for measuring the content of cysteine ​​in compound amino acid injection. Background technique [0002] At present, there are more than a dozen varieties of compound amino acid injections approved by the state, such as 18AA, 18AA-I, 18AA-II, 18AA-IV, 18AA-V, etc. Among the 20 kinds of amino acids that synthesize proteins, cysteine ​​is the most unstable, and is easily oxidized into water-insoluble cystine and other substances. Therefore, in the compound amino acid injection, whether the cysteine ​​content complies with the regulations directly reflects the product quality and technological level. [0003] It has been reported in the prior art that a colorimetric method is used to measure the content of cysteine, specifically, a colorimetric reaction is carried out with a chromogenic agent and a cysteine ​​amino acid at a certain pH value, and the UV method is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 胡文杰刘振东甘周阳饶斌甘文飞甘丰瑞
Owner 武汉一半天科技开发有限公司