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Freeze-dried powder injection of aminomethylbenzoic acid for injection

A technology of freeze-dried powder for injection and aminotoluic acid, which is applied in the field of freeze-dried powder of aminotoluic acid for injection, and can solve the problems of inapplicable powder for injection and inapplicable powder for injection, etc.

Active Publication Date: 2021-03-19
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, this invention did not pay attention to the impurity p-toluic acid in the preparation, and it has been found that the quality detection method recorded in the prior art is not suitable for the powder injection involved in ZL201510150322.9, especially not suitable for the powder containing Dextran powder injection

Method used

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  • Freeze-dried powder injection of aminomethylbenzoic acid for injection
  • Freeze-dried powder injection of aminomethylbenzoic acid for injection
  • Freeze-dried powder injection of aminomethylbenzoic acid for injection

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0112] Preparation Example 1, Preparation of Powder Injection Containing Aminotoluic Acid

[0113] formula:

[0114] Aminomethylbenzoic acid 100mg, Mannitol 95 mg, Dextran-20 5 mg, pH regulator to pH4.0, Water for Injection Appropriate amount, add to 4ml.

[0115] Preparation:

[0116] (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.

[0117] (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 2

[0121] Preparation Example 2, Preparation of Powder Injection Containing Aminotoluic Acid

[0122] formula:

[0123]

[0124]

[0125] Preparation:

[0126] (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.

[0127] (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 injection into a solution containing 10 mg / ml of the active ingredient, The same below), and then add water for injection to the full amount of the prescription.

[0128]...

preparation example 3

[0131] Preparation Example 3, Preparation of Powder Injection Containing Aminotoluic Acid

[0132] formula:

[0133] Aminomethylbenzoic acid 100mg, Mannitol 150mg, Dextran-40 2 mg, pH regulator to pH3.5, Water for Injection Appropriate amount, add to 5ml.

[0134] Preparation:

[0135] (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.

[0136] (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 injec...

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Abstract

The invention relates to a freeze-dried powder injection of aminomethylbenzoic acid for injection, the powder injection comprises aminomethylbenzoic acid, a freeze-drying excipient and an optional acidifying or alkalizing agent, and the freeze-drying excipient is selected from sucrose, glucose, mannitol, lactose, sorbitol and glycine; wherein the acidifying or alkalizing agent is selected from sodium hydroxide, potassium hydroxide, sodium dihydrogen phosphate, dibasic sodium phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, hydrochloric acid, phosphoric acid, nitric acid, sulfuric acid or a combination thereof. The invention also relates to a method for preparing the freeze-dried powder injection of the aminomethylbenzoic acid for injection and a method for qualitydetection of the freeze-dried powder injection of the aminomethylbenzoic acid for injection, and the method for quality detection comprises the operation of determining the content of p-toluic acid serving as an impurity in the freeze-dried powder injection by using a high performance liquid chromatography. The method provided by the invention can accurately determine related substances in the freeze-dried powder injection, and the powder injection has excellent pharmaceutical properties such as excellent stability and preparation safety.

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, more particularly relates to aminomethylbenzoic acid freeze-dried powder injection quality testing methods. The freeze-dried powder injection pharmaceutical composition of the present invention has expected good properties. Background technique [0002] Aminomethylbenzoic acid (Aminomethylbenzoic Acid), p-aminomethylbenzoic acid monohydrate, also known as anti-blood fibrinolytic aromatic acid, p-carboxybenzylamine, 4-(aminomethyl)b...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/195A61K47/26A61K47/36A61K47/02A61K47/04A61P7/04G01N30/02G01N30/06
CPCA61K9/0019A61K9/19A61K31/195A61K47/26A61K47/36A61K47/02A61P7/04G01N30/02G01N30/06
Inventor 张庚伦李明慧周雨汐黄楠宋晓燕
Owner 山东北大高科华泰制药有限公司
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