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Rh-FSH preparation and preparing method thereof

A technology of rh-fsh and preparation, applied in the field of human reproduction, can solve the problems of poor freeze-drying effect, poor reconstitution effect of freeze-dried preparations, etc., and achieves the effect of easy freeze-drying process and good freeze-drying process

Inactive Publication Date: 2019-05-10
CHANGCHUN SHENGJINNUO BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] The purpose of this patent is to solve the technical problems of poor freeze-drying effect of rh-FSH (freeze-dried powder) and poor reconstitution effect of freeze-dried preparations. Easier process control, better freeze-drying of preparations and better reconstitution technical effects

Method used

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  • Rh-FSH preparation and preparing method thereof
  • Rh-FSH preparation and preparing method thereof
  • Rh-FSH preparation and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] A rh-FSH preparation consisting of:

[0051]

[0052] The above components were further processed as follows.

[0053] Step 1: Dosing

[0054] (1) Take an appropriate amount of water for injection, slowly add other ingredients except rh-FSH into the water for injection, and stir until completely dissolved.

[0055](2) Finally, add the rh-FSH stock solution and mix well, and adjust the pH value to pH 7.0 ± 0.5 with phosphoric acid / sodium hydroxide. At this time, the rh-FSH content is about 5.5 μg / ml.

[0056] (3) Pass the prepared solution through a 0.2 μml filter membrane to sterilize and filter, put 1ml ± 0.02ml into 2ml vials in a sterile environment, and freeze-dry according to the following steps.

[0057] Step 2: Freeze drying

[0058] (1) Pre-freezing step: gradually lower the temperature to -35 degrees, pre-freeze for 40 minutes, then raise the temperature to -25 degrees, keep for 100 minutes, then lower the temperature to -45 degrees, and keep for 180 minu...

Embodiment 2

[0063] A rh-FSH preparation consisting of:

[0064]

[0065] The above components were further processed as follows.

[0066] Step 1: Dosing

[0067] (1) Take an appropriate amount of water for injection, slowly add other ingredients except rh-FSH into the water for injection, and stir until completely dissolved.

[0068] (2) Finally, add the rh-FSH stock solution and mix well, and adjust the pH value to pH 7.0 ± 0.5 with phosphoric acid / sodium hydroxide. At this time, the rh-FSH content is about 5.5 μg / ml.

[0069] (3) Pass the prepared solution through a 0.2 μml filter membrane to sterilize and filter, put 1ml ± 0.02ml into 2ml vials in a sterile environment, and freeze-dry according to the following steps.

[0070] Step 2: Freeze drying

[0071] (1) Pre-freezing step: gradually lower the temperature to -35 degrees, pre-freeze for 40 minutes, then raise the temperature to -25 degrees, keep for 100 minutes, then lower the temperature to -45 degrees, and keep for 180 min...

Embodiment 3

[0076] A rh-FSH preparation consisting of:

[0077]

[0078] The above components were further processed as follows.

[0079] Step 1: Dosing

[0080] (1) Take an appropriate amount of water for injection, slowly add other ingredients except rh-FSH into the water for injection, and stir until completely dissolved.

[0081] (2) Finally, add the rh-FSH stock solution and mix well, and adjust the pH value to pH 7.0 ± 0.5 with phosphoric acid / sodium hydroxide. At this time, the rh-FSH content is about 5.5 μg / ml.

[0082] (3) Pass the prepared solution through a 0.2 μml filter membrane to sterilize and filter, put 1ml ± 0.02ml into 2ml vials in a sterile environment, and freeze-dry according to the following steps.

[0083] Step 2: Freeze drying

[0084] (1) Pre-freezing step: gradually lower the temperature to -35 degrees, pre-freeze for 40 minutes, then raise the temperature to -25 degrees, keep for 100 minutes, then lower the temperature to -45 degrees, and keep for 180 min...

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Abstract

The invention provides a rh-FSH preparation and a preparing method thereof. Poloxamer 188 is added into a freeze-drying formula of the rh-FSH, and is used for assisting in freeze drying, the whole freeze-drying process is easier, and the freeze form after the preparation is subjected to freeze drying is better; different from other kinds of drugs, the poloxamer 188 is added into the rh-FSH preparation, the re-dissolving speed is obviously increased, insoluble particles are also not increased, and the pharmacopeia requirement is completely met; the quality of the rh-FSH after re-dissolving is subjected to content detection of dissociation subunit, oxidation subunit and polymers; test results show that the quality of the target protein rh-FSH is not influenced by the freeze-drying preparation after the poloxamer 188 is added, and the purity of the target protein rh-FSH is not influenced.

Description

technical field [0001] The present invention relates to the field of human reproduction, more specifically, the present invention relates to gonadotropin and its preparation method. Background technique [0002] According to the World Health Organization (WHO) report: about 1 of every 7 couples in the world has reproductive disorders, and infertility affects about 10% to 15% of the world's population. The incidence of infertility in my country is increasing year by year, and in some economically developed coastal areas, due to environmental pollution, work pressure and other factors, more than 20% of infertility patients are affected, especially in those with In the representative Guangdong area, more than two and a half couples out of 10 suffer from infertility due to various reasons. Statistics show that among the causes of female infertility, follicular dysplasia syndrome caused by endocrine dysfunction accounts for 48.42% of all causes of infertility, ranking first among...

Claims

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Application Information

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IPC IPC(8): A61K38/24A61K9/19A61K47/10A61P15/08
Inventor 张军付中岳徐婷杜研周彦航李少华楚志洋王聪
Owner CHANGCHUN SHENGJINNUO BIOLOGICAL PHARMA
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