Method for using amino acid analyzer to determine tranexamic acid content

A technology of tranexamic acid and amino acids, applied in the field of analysis, can solve problems such as low specificity, low sensitivity, and many influencing factors

Active Publication Date: 2019-07-02
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 using amino acid analyzer to determine tranexamic acid content
  • Method for using amino acid analyzer to determine tranexamic acid content
  • Method for using amino acid analyzer to determine tranexamic acid content

Examples

Experimental program
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Effect test

Embodiment 1

[0060] Embodiment 1, use amino acid analyzer to measure the tranexamic acid in the product

[0061] Test samples: drugs, tranexamic acid tablets, market sampling products, and the composition of excipients is unknown.

[0062] (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);

[0063] (2) Provide the chromatographic column as the prewash column and the analysis column, all are ion exchange resin columns, the prewash column used in this embodiment has a length of 10cm and a diameter of 4.6mm and a particle size of 4 μm, and an analysis column has a length of 20cm and a diameter of 4.6mm and a particle size 8μm, the ion exchange resin of the chromatographic column is a special resin for Biochrom30+ high-efficiency amino acid automatic analyzer;

[0064...

Embodiment 2

[0078] Embodiment 2, use amino acid analyzer to measure the tranexamic acid in the product

[0079] Test samples: drugs, tranexamic acid powder injection for injection, market sampling products, the excipient is mannitol, and its weight ratio to the main drug is 1:5.

[0080] (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);

[0081] (2) Provide the chromatographic column as the prewash column and the analysis column, all are ion exchange resin columns, the prewash column used in this embodiment has a length of 10cm and a diameter of 4.6mm and a particle size of 4 μm, and an analysis column has a length of 20cm and a diameter of 4.6mm and a particle size 8μm, the ion exchange resin of the chromatographic column is a special resin for Biochrom30+ high-...

Embodiment 3

[0094] Embodiment 3, use amino acid analyzer to measure the tranexamic acid in the product

[0095] Test samples: drugs, tranexamic acid capsules, market sampling products, and unknown excipients.

[0096] (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);

[0097] (2) Provide the chromatographic column as the prewash column and the analysis column, all are ion exchange resin columns, the prewash column used in this embodiment has a length of 10cm and a diameter of 4.6mm and a particle size of 4 μm, and an analysis column has a length of 20cm and a diameter of 4.6mm and a particle size 8μm, the ion exchange resin of the chromatographic column is a special resin for Biochrom30+ high-efficiency amino acid automatic analyzer;

[0098] (3) Provide mobile ...

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Abstract

The invention provides a method for using an amino acid analyzer to determine the tranexamic acid content. The method for determining the tranexamic acid content through ion exchange chromatography and a standard curve method is used. The chromatographic conditions are a 4-micron prewash column and an 8-micron analytical column. Ion exchange resin is resin dedicated to the Biochrom30+ high efficiency amino acid automatic analyzer. The detection wavelength is 570nm. The pump flow rate is 35ml / h. A gradient elution procedure comprises a 0 to 1min buffer 1, a 1 to 2min buffer 2, a 2 to 20min buffer 5, a 20 to 21.5min buffer 6 and a 21.5 to 23.5min buffer 1. The column temperature is 44 DEG C. The reaction temperature is 135 DEG C. The injection volume is 20 mu l. The amino acid analyzer usedfor determining the tranexamic acid content has the characteristics of high commercialization and automation. The method for determining the tranexamic acid content by using the amino acid analyzer has the advantages of simple operation, strong standardization, high sensitivity, being fast and efficient and the like.

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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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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