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Cetrorelix pharmaceutical composition and preparation method thereof

A technology of cetrelix and cetrelix acetate, applied in the field of cetrerelix pharmaceutical composition and preparation thereof, can solve problems such as increase of related substances, poor stability, etc., achieve high stability, improve safety, shorten the time The effect of reconstitution time

Pending Publication Date: 2021-04-30
南京康舟医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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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  • Cetrorelix pharmaceutical composition and preparation method thereof
  • Cetrorelix pharmaceutical composition and preparation method thereof
  • Cetrorelix pharmaceutical composition and preparation method thereof

Examples

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preparation example Construction

[0014] An embodiment of the present invention provides a method for preparing a cetrorelix pharmaceutical composition, the preparation method comprising: dissolving cetrorelix acetate with hydrochloric acid to obtain a cetrorelix acetate hydrochloride solution;

[0015] In the cetrorelix acetate hydrochloric acid solution, the final concentration of the hydrochloric acid is 0.05-3 mol / L.

[0016] Specifically, cetrorelix acetate is a compound, the English name is Cetrorelix acetate, and the molecular formula is C 70 h 92 CLN 17 o 142 (C 2 h 4 o 2 ), the molecular weight is 1551.16Da, CAS NO.130143-01-0. available through existing channels. Cetrorelix acetate for injection is indicated for patients undergoing controlled ovarian stimulation to prevent premature ovulation, and then to perform egg collection and assisted reproductive technology treatment.

[0017] Hydrochloric acid, the aqueous solution of hydrogen chloride (HCl), belongs to the monobasic inorganic strong ...

Embodiment 1

[0035] The present invention provides a preparation method of a cetrorelix pharmaceutical composition, whose components refer to Table 1.

[0036] Table 1 Drug Components

[0037]

[0038] The preparation method of the cetrorelix pharmaceutical composition is as follows:

[0039] According to the weight or volume shown in Table 1, obtain the raw material components;

[0040] After dissolving cetrorelix acetate with 1mol / L hydrochloric acid solution, add 600mL water for injection and mix well; then add mannitol to dissolve and mix well; add water for injection to a total volume of 1000mL to obtain grams of mixed solution.

[0041] The prepared mixed solution containing mannitol and cetrorelix acetate was sub-packaged and filtered, with 1.0 mL / bottle for sub-packaging, and a 0.2 μm filter was used for filtration.

[0042]After filtering, the plate layer temperature was lowered to -40°C, and then freeze-dried to obtain a freeze-dried pharmaceutical composition.

Embodiment 2

[0044] This embodiment provides a preparation method of a cetrorelix pharmaceutical composition, which is roughly the same as that of Example 1, except that the proportion of the components is different, and the difference is as follows:

[0045] Table 2 Drug Components

[0046]

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Abstract

The invention discloses a cetrorelix pharmaceutical composition and a preparation method thereof, and relates to the technical field of biological medicine. The preparation method comprises the steps that cetrorelix acetate is dissolved with hydrochloric acid, and a cetrorelix acetate hydrochloric acid solution is obtained; wherein in the cetrorelix acetate hydrochloric acid solution, the final concentration of hydrochloric acid is 0.05-3 mol / L. The cetrorelix medicine prepared by the preparation method provided by the invention has higher stability, can be stored for a long time at room temperature or ambient temperature, obviously shortens the redissolution time, and improves the safety during clinical medication.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a cetrorelix pharmaceutical composition and a preparation method thereof. Background technique [0002] It has been found through research that cetrorelix acetate tends to form a gel state when dissolved, resulting in a low filtration efficiency and a very obvious drop in the content after filtration. The existing patent CN94101378.2 describes a preparation method of a cetrorelix freeze-dried pharmaceutical composition. The disclosed technical scheme is: dissolve cetrorelix with acetic acid, transfer it to water, and dilute it with water for injection. Mannitol was added and the resulting solution was aliquoted by filtration and lyophilized. This technology mainly solves the problems of difficult filtration and content loss of cetrorelix acetate solution, but practice has proved that the cetrorelix pharmaceutical composition prepared by this technology has the technical prob...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/09A61K47/04A61P15/08
CPCA61K38/09A61K47/02A61P15/08
Inventor 孙浩张瑾谢应成徐健峰苏晴
Owner 南京康舟医药科技有限公司
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