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Injection composition containing dolasetron mesylate

A technology of dolasetron mesylate and a composition, applied in the field of medicine, can solve problems such as reducing the quality of dolasetron preparations, and achieve the effects of enhancing storage stability, simple method and inhibiting degradation

Inactive Publication Date: 2017-11-21
天津双硕医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] The formation of impurities will greatly reduce the quality of dolasetron preparations, and will also bring unpredictable side effects

Method used

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  • Injection composition containing dolasetron mesylate
  • Injection composition containing dolasetron mesylate
  • Injection composition containing dolasetron mesylate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0098] Example 1 Preparation of 12.5mg / 0.625ml Dolasetron Mesylate Injection

[0099] .

[0100] The preparation method is as follows:

[0101] 1) Take dolasetron mesylate crude drug, pulverize it into fine powder, and set aside;

[0102]2) Take 80% of the total volume of water for injection, dissolve sodium glutamate, glycerin, and 0.1M HCl in sequence to adjust the pH value of the solution to 3.0-4.0;

[0103] 3) Take the solution obtained in step 2), add the dolasetron mesylate bulk drug powder obtained in step 1), stir, and dissolve to obtain the drug-containing solution ①;

[0104] 4) Take the drug-containing solution ① obtained in step 3), add water for injection to the full amount, and adjust the pH value to 3.0-4.0 with 0.1M HCl or NaOH aqueous solution to obtain the drug-containing solution ②;

[0105] 5) Take the drug-containing solution ② obtained in step 4), adsorb the pyrogen with 0.2% activated carbon, and filter to obtain the drug-containing solution ③;

...

Embodiment 2

[0108] Example 2 Preparation of 100mg / 5ml Dolasetron Mesylate Injection

[0109] .

[0110] The preparation method is as follows:

[0111] 1) Take dolasetron mesylate crude drug, pulverize it into fine powder, and set aside;

[0112] 2) Take 80% of the total volume of water for injection, dissolve sodium glutamate, glycerin, and 0.1M HCl in sequence to adjust the pH value of the solution to 3.0-4.0;

[0113] 3) Take the solution obtained in step 2), add the dolasetron mesylate bulk drug powder obtained in step 1), stir, and dissolve to obtain the drug-containing solution ①;

[0114] 4) Take the drug-containing solution ① obtained in step 3), add water for injection to the full amount, and adjust the pH value to 3.0-4.0 with 0.1M HCl or NaOH aqueous solution to obtain the drug-containing solution ②;

[0115] 5) Take the drug-containing solution ② obtained in step 4), adsorb the pyrogen with 0.2% activated carbon, and filter to obtain the drug-containing solution ③;

[011...

Embodiment 3

[0118] Example 3 Preparation of 500mg / 25ml Dolasetron Mesylate Injection

[0119] .

[0120] The preparation method is as follows:

[0121] 1) Take dolasetron mesylate crude drug, pulverize it into fine powder, and set aside;

[0122] 2) Take 80% of the total volume of water for injection, dissolve sodium glutamate, glycerin, and 0.1M HCl in turn to adjust the pH value of the solution to 3.0-4.0; 3) Take the solution obtained in step 2) and add the obtained methanesulfonic acid in step 1) Lasetron bulk drug powder, stirred, dissolved, to obtain the drug-containing solution ①;

[0123] 4) Take the drug-containing solution ① obtained in step 3), add water for injection to the full amount, and adjust the pH value to 3.0-4.0 with 0.1M HCl or NaOH aqueous solution to obtain the drug-containing solution ②;

[0124] 5) Take the drug-containing solution ② obtained in step 4), adsorb the pyrogen with 0.2% activated carbon, and filter to obtain the drug-containing solution ③;

[0...

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Abstract

The invention provides an injection composition containing dolasetron mesylate for enhancing the stability of the dolasetron mesylate injection in a long-term storage process, reducing degradation of a raw material drug dolasetron mesylate in the storage process and generating impurities A and B. By adding glutamic acid and sodium salt thereof into the injection, degradation of dolasetron mesylate is effectively inhibited. Meanwhile, the invention provides a stable pH value environment, so that the storage stability of a final preparation is further enhanced. Meanwhile, the raw material drug is easy to separate out as the injection is in the long-term storage process to generate insoluble microparticles to lead to unqualified visible foreign matters. By applying a crystallizing inhibitor glycerinum in the injection, the problem is effectively solved. Glycerinum as small molecules also plays a role of osmotic regulation. The preparation method of the obtained dolasetron mesylate injection is simple, and the dolasetron mesylate injection can be produced by means of a conventional preparation method, so that the injection composition has remarkable advantages of being easy to industrialize, high in production efficiency, good in stability, controllable in quality and the like.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an injection composition containing dolasetron mesylate, a preparation method and application thereof. Background technique [0002] With the changes of human living environment, living standards and lifestyles and the advancement of medicine, the spectrum of diseases has undergone significant changes, general infectious diseases have been gradually controlled, and malignant tumors have become common major diseases that seriously affect human life and living standards one. According to the World Health Organization, there are more than 10 million new cancer patients and more than 6 million deaths in the world every year. In my country, more than 1.6 million new cases are added every year, and more than 1.3 million deaths are caused. At present, cancer has become another major cause of death in China and even in the world. [0003] In the past few decades, there ha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/18A61K47/10A61K31/439A61P35/00
CPCA61K9/0019A61K9/08A61K31/439A61K47/10A61K47/183
Inventor 不公告发明人
Owner 天津双硕医药科技有限公司
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