Cetrorelix preparation and preparation method thereof

A technology of cetrorelix and cetrorelix acetate, which is applied in the field of biomedicine, can solve problems such as poor stability, and achieve the effects of ensuring stability, shortening drying time, and reducing production costs

Pending Publication Date: 2021-05-18
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

Because most cetrorelix acetate for injection on the market has long-term storage, poor stability in accelera

Method used

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  • Cetrorelix preparation and preparation method thereof
  • Cetrorelix preparation and preparation method thereof
  • Cetrorelix preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0049]Example 1

[0050]The present invention provides a method of preparing a Westlaik formulation comprising the steps of:

[0051](1) Mixed solution containing mannitol and Xiqikik,

[0052]Table 1 raw material ratio

[0053]

[0054]Follow the components shown in Table 1 and their ratio acquired raw materials;

[0055]The acetic acid was dissolved in 30% acetic acid (100 mL), and 600 ml of injection was mixed with water; then, then add mannitol dissolved and mixed; add water to the total volume of 1000ml, acquiring mannitol and acetic acid Qu Rick's mixed solution. The solution was filtered through a 0.2 μm filter.

[0056](2) Freezing:

[0057]The mannitol obtained by step (1) is subjected to (1.0 ml / score) to the container, and perform the following steps:

[0058]The first stage: the cooling rate is 0.5 ° C / min, and the temperature of the plate layer is lowered to -30 ° C, and the holding time is 1 hour;

[0059]The second stage: Tip at the temperature of the plate layer to -10 ° C with the temperatur...

Example Embodiment

[0063]Example 2

[0064]The present invention provides a method of preparing a Westlaik formulation comprising the steps of:

[0065](1) Preparation of mannitol, western acetic acid solution:

[0066]Follow the components shown in Table 1 and their ratio acquired raw materials;

[0067]The acetic acid was dissolved in 30% acetic acid solution (100 mL), and then 600 ml of water was mixed with water; then, then the mannitol dissolved and mixed; the injection water to a total volume of 1000 ml, acquired mannitol and acetic acid Western Rick mixed solution. The solution was filtered through a 0.2 μm filter.

[0068](2) Freezing:

[0069]The obtained mannitol, the western Ryracaviraic acid solution is dispensed (in 1.0 ml / score) to the container, and the following steps are performed:

[0070]The first stage: the cooling rate is 0.5 ° C / min, and the temperature of the plate layer is lowered to -40 ° C, and the holding time is 1 hour;

[0071]The second stage: Tip at the temperature of the plate layer to -10...

Example Embodiment

[0075]Example 3

[0076]The present invention provides a method of preparing a Westlaik formulation comprising the steps of:

[0077](1) Preparation of mannitol, western acetic acid solution:

[0078]Follow the components shown in Table 1 and their ratio acquired raw materials;

[0079]The acetic acid was dissolved in 30% acetic acid (100 mL), and 600 ml of injection was mixed with water; then, then add mannitol dissolved and mixed; add water to the total volume of 1000ml, acquiring mannitol and acetic acid Qu Rick's mixed solution. The solution was filtered through a 0.2 μm filter.

[0080](2) Freezing:

[0081]The obtained mannitol, the western Ryracaviraic acid solution is dispensed (in 1.0 ml / score) to the container, and the following steps are performed:

[0082]The first stage: cooling rate is 1 ° C / min, and the temperature of the plate layer is lowered to -30 ° C, and the holding time is 1 hour;

[0083]The second stage: Tip at the temperature of the plate layer to -10 ° C with the temperature r...

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Abstract

The invention discloses a cetrorelix preparation and a preparation method thereof, and relates to the technical field of biological medicines. The preparation method comprises the steps that a mixed solution containing mannitol and cetrorelix acetate is subjected to first-stage freezing, second-stage freezing and third-stage freezing, wherein the conditions of the first stage are that after the temperature is decreased to -20 DEG C to -40 DEG C, heat preservation is conducted for 0.1-2 h; the conditions of the second stage are as follows are that the temperature is raised to -20 DEG C to -5 DEG C, heat preservation is performed for 0.1-2 hours; and the conditions of the third stage are that after the temperature is reduced to -20 DEG C to -40 DEG C, heat preservation is performed for 0.1-2 hours. According to the method, the temperature is lowered to be close to the glass transition temperature of the solution, the temperature is kept for a period of time, and the temperature is lowered again until the solution is completely frozen after the temperature is raised to a certain temperature, so that the stability of the cetrorelix preparation product can be ensured to the greatest extent. Meanwhile, after the freezing treatment, a relatively high drying temperature can be selected for drying in the drying stage, so that the product quality is not influenced, the drying time is shortened, and the production cost is reduced.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a cetrorelix preparation 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. [0003] The existing patent CN94101378.2 discloses a preparation method of cetrorelix freeze-dried pharmaceutical composition. The disclosed preparation method is to dissolve cetrorelix with acetic acid, dilute with water for injection, and then add mannitol to obtain manna Alcohol, cetrorelix solution, filter the solution, and freeze-dry. The preparation method mainly solves t...

Claims

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Application Information

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IPC IPC(8): A61K38/08A61K9/19A61K47/26A61P5/24A61P15/08
CPCA61K38/08A61K9/19A61K47/26A61P5/24A61P15/08
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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