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aminotoluic acid freeze-dried preparation

A technology of aminotoluic acid and freeze-dried powder injection, which is applied in the field of aminotoluic acid freeze-dried preparations, 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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Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0148] Preparation Example 1. Preparation of powder injection containing aminotoluic acid

[0149] formula:

[0150] aminotoluic acid 100mg, Mannitol 95mg, Dextran-20 5mg, pH adjuster to pH 4.0, Water for Injection Appropriate amount, add to 4ml.

[0151] Preparation:

[0152] (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 in 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.

[0153] (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

[0157] Preparation Example 2. Preparation of powder injection containing aminotoluic acid

[0158] formula:

[0159]

[0160]

[0161] Preparation:

[0162] (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 in 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.

[0163] (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 injection, The same below), and then add water for injection to the full amount of the prescription.

[0164] (3) The medicinal liquid is filtered with a 0.45um micr...

preparation example 3

[0167] Preparation Example 3. Preparation of powder injection containing aminotoluic acid

[0168] formula:

[0169] aminotoluic acid 100mg, Mannitol 150mg, Dextran-40 2mg, pH adjuster to pH3.5, Water for Injection Appropriate amount, add to 5ml.

[0170] Preparation:

[0171] (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 in 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.

[0172] (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 freeze-dried preparation of aminotoluic acid. The present invention specifically relates to a method for determining the content of aminotoluic acid in a biological sample of an organism, the method comprising the steps of: providing a high-performance liquid chromatography system for determination; providing a blank biological sample and a drug-containing biological sample, the biological The sample is collected from the organism before and after the drug is administered; a solution for testing is prepared, and the drug-containing biological sample is processed to prepare a test solution for liquid chromatography; in a high-performance liquid chromatography system The test solution and the test solution are measured, and the aminotoluic acid content in the biological sample is calculated according to the measured results. The present invention provides a clinical method for monitoring changes in the concentration of active substances in biological samples such as blood or urine after an aminotoluic acid preparation with good performance is administered into the body, the method is to evaluate the therapeutic effect of aminotoluic acid or its In vivo behavior provides a valid basis.

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): G01N30/06A61K9/19A61K31/195A61K47/18A61K47/26A61P7/04
CPCG01N30/06A61K31/195A61K9/19A61K9/0019A61K47/26A61K47/183A61P7/04
Inventor 姜长通李明慧周雨汐黄楠
Owner 山东北大高科华泰制药有限公司
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