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Method for determining in-vivo behavior of aminomethylbenzoic acid lyophilized preparation

A technology of aminomethylbenzoic acid and medicaments, which is applied in the field of measuring the in vivo behavior of aminomethylbenzoic acid freeze-dried preparations, and can solve problems such as inability to block

Active Publication Date: 2021-03-26
山东北大高科华泰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these antagonists cannot block the activation of activators (such as urokinase, etc.) that have been adsorbed on the fibrin network to form plasmin

Method used

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  • Method for determining in-vivo behavior of aminomethylbenzoic acid lyophilized preparation
  • Method for determining in-vivo behavior of aminomethylbenzoic acid lyophilized preparation
  • Method for determining in-vivo behavior of aminomethylbenzoic acid lyophilized preparation

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0201] Preparation Example 1, Preparation of Powder Injection Containing Aminotoluic Acid

[0202] formula:

[0203] Aminomethylbenzoic acid 100mg, Mannitol 95 mg, Dextran-20 5 mg, pH regulator to pH4.0, Water for Injection Appropriate amount, add to 4ml.

[0204] Preparation:

[0205] (1) Take the principal agent and auxiliary materials of the prescription quantity, place in a stainless steel bucket, add about 80% of the prescription quantity of water for injection, make each component dissolve, then add 0.1% (w / v) gac by the volume of the solution, Stir for 30 minutes, filter and decarburize, and add water for injection to nearly the full amount of the prescription.

[0206] (2) The filtrate is sampled, and the pH value is measured, and if necessary, it is adjusted to a specified value with a pH regulator (this specified value is the value of the measured pH value of the freeze-dried gained dry powder diluted with water for inj...

preparation example 2

[0210] Preparation Example 2, Preparation of Powder Injection Containing Aminotoluic Acid

[0211] formula:

[0212] Aminomethylbenzoic acid 100mg, Mannitol 50mg, Dextran-20 10mg, pH regulator to pH4.5, Water for Injection Appropriate amount, add to 6ml.

[0213] Preparation:

[0214] (1) Take the principal agent and auxiliary materials of the prescription quantity, place in a stainless steel bucket, add about 80% of the prescription quantity of water for injection, make each component dissolve, then add 0.1% (w / v) gac by the volume of the solution, Stir for 30 minutes, filter and decarburize, and add water for injection to nearly the full amount of the prescription.

[0215] (2) The filtrate is sampled, and the pH value is measured, and if necessary, it is adjusted to a specified value with a pH regulator (this specified value is the value of the measured pH value of the freeze-dried gained dry powder diluted with water for inje...

preparation example 3

[0219] Preparation Example 3, Preparation of Powder Injection Containing Aminotoluic Acid

[0220] formula:

[0221] Aminomethylbenzoic acid 100mg, Mannitol 150mg, Dextran-40 2 mg, pH regulator to pH3.5, Water for Injection Appropriate amount, add to 5ml.

[0222] Preparation:

[0223] (1) Take the principal agent and auxiliary materials of the prescription quantity, place in a stainless steel bucket, add about 80% of the prescription quantity of water for injection, make each component dissolve, then add 0.1% (w / v) gac by the volume of the solution, Stir for 30 minutes, filter and decarburize, and add water for injection to nearly the full amount of the prescription.

[0224] (2) The filtrate is sampled, and the pH value is measured, and if necessary, it is adjusted to a specified value with a pH regulator (this specified value is the value of the measured pH value of the freeze-dried gained dry powder diluted with water for inj...

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Abstract

The present invention relates to a method for determining in-vivo behavior of aminomethylbenzoic acid lyophilized preparation, and specifically relates to a method for determining the content of aminomethylbenzoic acid in the biological sample urine of the living body. The method comprises the following steps: providing a high performance liquid chromatography system; collecting a blank biologicalsample and a drug-containing biological sample from organisms before and after drug application, and treating the drug-containing biological sample to prepare a test solution for liquid chromatography; and determining the solution for testing and the test solution in a chromatographic system, and calculating the aminomethylbenzoic acid content in the biological sample according to the determination result. The medicament comprises aminomethylbenzoic acid and a freeze-drying excipient, wherein the medicament is a freeze-dried powder injection of aminomethylbenzoic acid; the freeze-drying excipient is selected from cane sugar, glucose, mannitol, lactose, sorbitol, glycine and dextran. The method provides an effective tool for evaluating the in-vivo behavior of the aminomethylbenzoic acid preparation, and can be used for investigating the pharmacokinetic behavior of the preparation in a subject.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a hemorrhage that can be used for hemorrhage caused by excessive primary fibrinolysis, including acute and chronic, localized or systemic hyperfibrinolytic hemorrhage, which is common in cancer, leukemia, Freeze-dried powder injection pharmaceutical composition for obstetrics and gynecology accidents, severe liver disease bleeding, etc., especially relates to a freeze-dried powder injection pharmaceutical composition containing aminomethylbenzoic acid, and the present invention also relates to a reliable method for measuring biological For example, the content of the above-mentioned aminomethylbenzoic acid in biological samples such as blood, urine, etc. after the human or rat is given the above-mentioned freeze-dried powder injection pharmaceutical composition comprising aminomethylbenzoic acid, and then provides a basis for evaluating the therapeutic effect of aminomethylbenzoic ac...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/24G01N30/86A61K31/195A61K9/19A61K47/26A61K47/18A61P7/04
CPCG01N30/02G01N30/06G01N30/24G01N30/8675A61K31/195A61K9/19A61K47/26A61K47/183A61P7/04G01N2030/045G01N2030/047
Inventor 满春兰宋晓燕李明慧黄楠
Owner 山东北大高科华泰制药有限公司
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