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Stable cetrorelix medicinal composition and preparation method thereof

A technology for cetrorelix and composition, which is applied in the field of polypeptide pharmaceutical compositions and their preparation, can solve the problems of difficult filtration, loss of content, inability to prepare lyophilized pharmaceutical compositions of trorelix, etc., and achieves convenient transportation and process. simple effect

Active Publication Date: 2012-04-25
辉凌制药中国有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This technology mainly solves the problems of difficulty in filtration and loss of content, and practice has proved that this technology cannot prepare stable Trerelix lyophilized pharmaceutical compositions
The lyophilized pharmaceutical composition of cetrorelix acetate for injection that is now on the market is a powder injection, and the trade name is Si Ze Its stability is not ideal
Cetrorelix acetate for injection, which is currently on the market, has poor stability in long-term storage and accelerated tests, and the number of related substances has increased significantly. Therefore, the US FDA requires its storage temperature to be 2-8°C

Method used

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  • Stable cetrorelix medicinal composition and preparation method thereof
  • Stable cetrorelix medicinal composition and preparation method thereof
  • Stable cetrorelix medicinal composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Prescription (1000 sticks)

[0023]

[0024] Weigh the raw and auxiliary materials according to the prescription amount, dissolve cetrorelix with 30% acetic acid solution, add water for injection and mix well. Then add mannitol to dissolve and mix well, and continue to add injection to the total volume. 0.2μm filter, with 1.0ml / package.

[0025] Lower the temperature of the plate layer to -25°C at 0.5°C / min and keep it warm for 2 hours. Then continue to cool down, let the product drop below -40°C, and keep it warm for 3 hours. Turn on the vacuum and start heating until the product is completely dry.

Embodiment 2

[0027] Prescription (1000 sticks)

[0028]

[0029] Weigh the raw and auxiliary materials according to the prescription quantity, dissolve the cetrorelix with 30% acetic acid solution, add water for injection and mix well, then add mannitol to dissolve and mix well. Continue adding water for injection to total volume. 0.2μm filter, with 1.0ml / package.

[0030] Reduce the temperature of the plate layer to -40°C at 1°C / min and keep it warm for 1.5 hours. Then continue to cool down, let the product drop below -40°C, and keep it warm for 2 hours. Turn on the vacuum and start heating until the product is completely dry.

Embodiment 3

[0032] Prescription (1000 sticks)

[0033]

[0034] Lower the temperature of the plate layer to -37°C at 1°C / min and keep it warm for 1.5 hours. Then continue to cool down, let the product drop below -40°C, and keep it warm for 2 hours. Turn on the vacuum and start heating until the product is completely dry.

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Abstract

The invention relates to a stable cetrorelix medicinal composition and a preparation method thereof. The medicinal composition is obtained through the preparation method which comprises the following steps: 1, preparing a solution of mannitol and cetrorelix acetate, and filtering the solution; 2, packaging the solution obtained in step 1 to a container, and cooling step by step according to a case which comprises the following stages: a, cooling a plate layer to -25--40DEG C according to a cooling rate of not greater than 3DEG C / min and keeping the temperature for not less than 1h, and b, continuously cooling to -40DEG C or below and keeping the temperature of not less than 1h; and 3, drying to obtain the lyophilized medicinal composition. The stability of the medicinal composition obtained through the preparation method is good, so the medicinal composition still has definite curative effects when the medicinal composition is preserved for a long time.

Description

technical field [0001] The invention relates to a polypeptide pharmaceutical composition and a preparation method thereof, in particular to a cetrorelix freeze-dried pharmaceutical composition and a preparation method thereof. Background technique [0002] Cetrorelix is ​​a gonadotropin-releasing hormone (LHRH) antagonist developed by Germany's ASTA MEDICA company, which can control the stimulation of the ovary, prevent premature discharge of immature follicles, and help conception. It is mainly used for patients undergoing controlled ovarian stimulation to prevent premature ovulation, and then perform egg collection and assisted reproductive technology treatment. In clinical trials, this product is usually used in combination with human menopausal gonadotropin (HMG). The limited experience with this product, usually in combination with recombinant human follicle-stimulating hormone (r-hFSH), suggests that its efficacy is similar to that of the former. [0003] This produc...

Claims

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Application Information

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IPC IPC(8): A61K38/08A61K9/19A61P15/08A61P35/00A61P15/00A61P13/08A61J3/02
Inventor 郑春莲唐洋明刘建马亚平袁建成
Owner 辉凌制药中国有限公司
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