Cetrorelix acetate for injection and preparation method thereof

A technology of cetrorelix acetate and cetrorelix, applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve problems such as difficulty in long-term storage, and achieve improved preservation Time, improve temperature resistance, reduce the effect of safety

Pending Publication Date: 2022-03-11
福州华为医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although cetrorelix acetate for injection can be stored at about 25°C in an unopened state, the storage time is only 3 months, and it is difficult to store for a long time

Method used

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  • Cetrorelix acetate for injection and preparation method thereof
  • Cetrorelix acetate for injection and preparation method thereof

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preparation example Construction

[0009] The preparation method of cetrorelix acetate for injection comprises the steps of adding hydroxyethyl starch and mannitol into the cetrorelix acetate solution and mixing with ultrasonic wave to obtain solution A;

[0010] And the step of spraying and freeze-drying solution A to obtain cetrorelix acetate for injection.

[0011] Among them, by using ultrasonic wave to mix solution A obtained by mixing hydroxyethyl starch, mannitol and cetrorelix acetate, it can effectively promote the formation of stable colloidal dispersion of hydroxyethyl starch in solution A, and promote the formation of cetrorelix acetate. grams uniformly dispersed in the colloidal dispersion. The mixing and spray freeze-drying are preferably carried out under the protection of nitrogen gas. In order to prevent the hydroxyethyl starch from swelling during mixing or after opening, in one embodiment, an anti-swelling agent, preferably sodium chloride, can also be added during mixing.

[0012] Cetrorel...

Embodiment 1

[0022] The preparation method of cetrorelix acetate for injection comprises the steps:

[0023] S1. Dissolve 3 g of cetrorelix in 30% acetic acid and dilute to volume with water for injection to obtain a 0.3% cetrorelix acetate solution;

[0024] S2. Add hydroxyethyl starch 200 / 0.5, mannitol and 2 g of sodium chloride into the cetrorelix acetate solution, and obtain solution A after mixing with ultrasonic waves;

[0025] Wherein, the mass ratio of hydroxyethyl starch and cetrorelix acetate is 0.4:1, and the mass ratio of cetrorelix acetate and mannitol is 1:300;

[0026] S3. Atomize solution A at 1.35 bar, pre-freeze the atomized particles at -40°C for 2 hours, freeze-dry for the first time at -30~-25°C, refreeze at -35°C for 1 hour, - Freeze-drying for the second time at 30-25°C, freeze-drying for the third time at 25-30°C, and freeze-drying at a heating rate of 5°C / min to obtain cetrorelix acetate freeze-dried granules;

[0027] S4, bottling the cetrorelix acetate freeze-d...

Embodiment 2

[0029] The difference between the preparation method of cetrorelix acetate for injection and Example 1 is that the concentration of the cetrorelix acetate solution is 0.4%, and the hydroxyethyl starch is selected from hydroxyethyl starch 130 / 0.4, hydroxyethyl starch The mass ratio of starch to cetrorelix acetate is 0.2:1.

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Abstract

The invention belongs to the technical field of biological medicine, and particularly relates to cetrorelix acetate for injection and a preparation method thereof.The preparation method specifically comprises the steps that hydroxyethyl starch and mannitol are added into a cetrorelix acetate solution and mixed through ultrasonic waves, and a solution A is obtained; and performing spray freeze-drying treatment on the solution A to obtain cetrorelix acetate for injection. The cetrorelix acetate for injection is prepared by the preparation method. The cetrorelix acetate for injection prepared by the preparation method of the cetrorelix acetate for injection provided by the invention can be effectively prevented from being hydrolyzed after being unsealed, and the temperature resistance of the cetrorelix acetate for injection can be effectively improved after the cetrorelix acetate for injection is unsealed.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, in particular to a preparation method of cetrorelix acetate for injection. Background technique [0002] At present, cetrorelix acetate for injection is usually bottled in the form of freeze-dried powder, such as a cetrorelix acetate injection and its preparation method disclosed in the publication number CN113616775A, which is prepared by pre-freezing, primary drying, and secondary drying. Cetrorelix acetate block freeze-dried powder with suitable structural porosity. Although cetrorelix acetate for injection can be stored at about 25°C in an unopened state, the storage time is only 3 months, and it is difficult to store it for a long time. Contents of the invention [0003] In order to overcome the above-mentioned defects in the prior art, the technical problem to be solved by the present invention is to provide a cetrorelix acetate for injection which can be stored for a long time at 25...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/08A61K9/19A61K47/26A61K47/36
CPCA61K9/19A61K9/0019A61K38/08A61K47/36A61K47/26
Inventor 张娜林桂坤符友伟谢治平
Owner 福州华为医药技术开发有限公司
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