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Method for determining the in vivo behavior of lyophilized preparations of aminotoluic acid

A technology of aminotoluic acid and a determination method, which is applied in the directions of freeze-drying delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve problems such as inability to block, and achieve the effect of excellent methodological characteristics.

Active Publication Date: 2022-08-02
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 the in vivo behavior of lyophilized preparations of aminotoluic acid
  • Method for determining the in vivo behavior of lyophilized preparations of aminotoluic acid
  • Method for determining the in vivo behavior of lyophilized preparations of aminotoluic acid

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0201] Preparation Example 1. Preparation of powder injection containing aminotoluic acid

[0202] formula:

[0203] aminotoluic acid 100mg, Mannitol 95mg, Dextran-20 5mg, pH adjuster to pH 4.0, Water for Injection Appropriate amount, add to 4ml.

[0204] Preparation:

[0205] (1) Weigh the main drug and auxiliary materials of the recipe, place them in a stainless steel bucket, add about 80% of the water for injection of the recipe, dissolve each component, and then add 0.1% (w / v) of activated carbon by solution volume, Stir for 30 minutes, filter and decarbonize, and add water for injection to the full amount of the prescription.

[0206] (2) Sampling the filtrate, measure the pH value, and adjust it to a specified value with a pH regulator if necessary (the specified value is the pH value measured by diluting the dry powder obtained by freeze drying into a solution containing 10 mg / ml of active ingredient with water for injecti...

preparation example 2

[0210] Preparation Example 2. Preparation of powder injection containing aminotoluic acid

[0211] formula:

[0212] aminotoluic acid 100mg, Mannitol 50mg, Dextran-20 10mg, pH adjuster to pH 4.5, Water for Injection Appropriate amount, add to 6ml.

[0213] Preparation:

[0214] (1) Weigh the main drug and auxiliary materials of the recipe, place them in a stainless steel bucket, add about 80% of the water for injection of the recipe, dissolve each component, and then add 0.1% (w / v) of activated carbon by solution volume, Stir for 30 minutes, filter and decarbonize, and add water for injection to the full amount of the prescription.

[0215] (2) Sampling the filtrate, measure the pH value, and adjust it to a specified value with a pH regulator if necessary (the specified value is the pH value measured by diluting the dry powder obtained by freeze drying into a solution containing 10 mg / ml of active ingredient with water for inject...

preparation example 3

[0219] Preparation Example 3. Preparation of powder injection containing aminotoluic acid

[0220] formula:

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

[0222] Preparation:

[0223] (1) Weigh the main drug and auxiliary materials of the recipe, place them in a stainless steel bucket, add about 80% of the water for injection of the recipe, dissolve each component, and then add 0.1% (w / v) of activated carbon by solution volume, Stir for 30 minutes, filter and decarbonize, and add water for injection to the full amount of the prescription.

[0224] (2) Sampling the filtrate, measure the pH value, and adjust it to a specified value with a pH regulator if necessary (the specified value is the pH value measured by diluting the dry powder obtained by freeze drying into a solution containing 10 mg / ml of active ingredient with water for injecti...

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Abstract

The present invention relates to a method for determining the in vivo behavior of lyophilized preparations of aminotoluic acid. Specifically, it relates to a method for determining the content of aminotoluic acid in the urine of biological samples of living organisms, including the following steps: providing a high-performance liquid chromatography system; drug biological samples, and the drug-containing biological samples are processed to prepare a test solution for liquid chromatography; the test solution and the test solution are measured in a chromatographic system, and the biological samples are calculated according to the measurement results. The aminotoluene content in the. The medicament comprises aminotoluic acid and a freeze-dried excipient; the medicament is a freeze-dried powder injection of aminobenzoic acid; the freeze-dried excipient is selected from sucrose, glucose, mannitol, lactose, sorbitol, glycine, Dextran. The method of the invention provides an effective tool for evaluating the in vivo behavior of the aminotoluic acid preparation, and can be used to investigate the pharmacokinetic behavior of the preparation in the subject.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a kind of hemorrhage that can be used for hyperfibrinolysis caused by primary fibrinolysis, including acute and chronic, localized or systemic hyperfibrinolysis, and the latter is commonly seen in cancer, leukemia, Freeze-dried powder injection pharmaceutical composition for obstetrics and gynecology accident, severe liver disease hemorrhage, etc., particularly relates to a freeze-dried powder injection pharmaceutical composition containing aminotoluic acid, and the present invention also relates to a reliable method for the determination of organisms For example, the content of the above-mentioned aminotoluic acid in biological samples such as blood, urine, etc. after the above-mentioned lyophilized powder injection containing aminotoluic acid is administered to a human or rat, and then to evaluate the therapeutic effect of aminotoluic acid or its in vivo behavior. in accordance wi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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