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Method for Determination of Tranexamic Acid Content Using Amino Acid Analyzer

A technology of tranexamic acid and amino acids, applied in the field of analysis, can solve problems such as difficult promotion, low sensitivity, complicated operation, etc.

Active Publication Date: 2021-08-17
BEIJING INST FOR DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] However, when there are many compound components in cosmetics, daily chemical products, food, health food and medicine, the above method has one or more bottleneck problems, such as complicated operation, many influencing factors, weak specificity, low sensitivity, Or difficult to promote, etc.

Method used

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  • Method for Determination of Tranexamic Acid Content Using Amino Acid Analyzer

Examples

Experimental program
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Effect test

Embodiment 1

[0059] Embodiment 1, use amino acid analyzer to measure the tranexamic acid in the product

[0060] Test samples: drugs, tranexamic acid tablets, market sampling products, and the composition of excipients is unknown.

[0061] (1) Analytical instrument amino acid analyzer is provided, and what this embodiment uses is Biochrom30+ high-efficiency amino acid automatic analyzer; The chromogenic agent ninhydrin used for detection is produced by British Biochrom Ltd. (specifically used batch number: 20635);

[0062] (2) Provide the chromatographic column as prewash column and analytical column, be ion exchange resin column, the prewash column length 10cm that this embodiment uses and diameter 4.6mm and particle size 4μm, analytical column length 20cm and diameter 4.6mm and particle size 8μm, the ion exchange resin of the chromatographic column is a special resin for Biochrom30+ high-efficiency amino acid automatic analyzer;

[0063] (3) Provide mobile phase for chromatographic elut...

Embodiment 2

[0077] Embodiment 2, use amino acid analyzer to measure the tranexamic acid in the product

[0078] Test samples: medicines, tranexamic acid powder injections for injection, market sampling products, the auxiliary material is mannitol, and its weight ratio to the main drug is 1:5.

[0079] (1) Analytical instrument amino acid analyzer is provided, and what this embodiment uses is Biochrom30+ high-efficiency amino acid automatic analyzer; The chromogenic agent ninhydrin used for detection is produced by British Biochrom Ltd. (specifically used batch number: 20635);

[0080] (2) Provide the chromatographic column as prewash column and analytical column, be ion exchange resin column, the prewash column length 10cm that this embodiment uses and diameter 4.6mm and particle size 4μm, analytical column length 20cm and diameter 4.6mm and particle size 8μm, the ion exchange resin of the chromatographic column is a special resin for Biochrom30+ high-efficiency amino acid automatic analy...

Embodiment 3

[0093] Embodiment 3, use amino acid analyzer to measure the tranexamic acid in the product

[0094] Test samples: drugs, tranexamic acid capsules, market sampling products, and unknown excipients.

[0095] (1) Analytical instrument amino acid analyzer is provided, and what this embodiment uses is Biochrom30+ high-efficiency amino acid automatic analyzer; The chromogenic agent ninhydrin used for detection is produced by British Biochrom Ltd. (specifically used batch number: 20635);

[0096] (2) Provide the chromatographic column as prewash column and analytical column, be ion exchange resin column, the prewash column length 10cm that this embodiment uses and diameter 4.6mm and particle size 4μm, analytical column length 20cm and diameter 4.6mm and particle size 8μm, the ion exchange resin of the chromatographic column is a special resin for Biochrom30+ high-efficiency amino acid automatic analyzer;

[0097] (3) Provide mobile phase for chromatographic elution, which mobile pha...

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Abstract

Disclosed is a method for determining the content of tranexamic acid using an amino acid analyzer, and a method for determining the content of tranexamic acid by using ion-exchange chromatographic separation and a standard curve method. The chromatographic conditions are 4μm prewash column and 8μm analysis column, and the ion exchange resin is Biochrom30+ special resin for high-efficiency amino acid automatic analyzer; detection wavelength is 570nm; pump flow rate is 35ml / h; gradient elution program: 0~1min buffer 1, 1~ 2min buffer 2, 2-20min buffer 5, 20-21.5min buffer 6, 21.5-23.5min buffer 1; column temperature 44°C; reaction temperature 135°C; injection volume 20μl. The amino acid analyzer used in the determination of tranexamic acid content has the characteristics of commercialization and high degree of automation. The method for determining the content of tranexamic acid with an amino acid analyzer has the advantages of simple operation, strong standardization, high sensitivity, rapidity and high efficiency.

Description

technical field [0001] The invention belongs to the technical field of analysis, and relates to a method for determining the content of tranexamic acid, in particular to an analysis method for determining the content of tranexamic acid by using an amino acid analyzer. In particular, an amino acid analyzer is used to determine the content of tranexamic acid in cosmetics, daily chemical products, food, health food, medicine and other products or their raw materials. Background technique [0002] Tranexamic acid is a synthetic amino acid antifibrinolytic drug, and its main mechanism of action is to achieve hemostatic effect by inhibiting the activation of proteolysin and plasminogen. Clinical drugs include tranexamic acid tablets, tranexamic acid injections and tranexamic acid capsules. In addition, studies have found that tranexamic acid can inhibit pigmentation caused by ultraviolet radiation, and achieve the effect of whitening and freckle removal. At present, tranexamic a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/36
CPCG01N30/02G01N30/06G01N30/36G01N2030/067
Inventor 郭洁刘成浩张蓉邬国庆
Owner BEIJING INST FOR DRUG CONTROL
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