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Recombinant human interferon alpha2a suppository and preparation method thereof

A technology of recombinant human interferon and interferon α, which is applied in suppository delivery, drug combination, pharmaceutical formula, etc., can solve the problems of poor patient compliance, protein instability, and high price, and achieve good therapeutic effect and preservation Long-term, stable biological activity

Inactive Publication Date: 2020-04-03
李宇辉
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The invention provides a recombinant human interferon α2a suppository, which solves the problems of high price of traditional recombinant human interferon α2a suppository, unstable protein, difficult storage, and poor compliance of patients for injection. Recombinant human interferon α 2a suppository prepared by mixing the purified recombinant human interferon α 2a stock solution with glycerin gelatin matrix

Method used

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  • Recombinant human interferon alpha2a suppository and preparation method thereof
  • Recombinant human interferon alpha2a suppository and preparation method thereof
  • Recombinant human interferon alpha2a suppository and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Screening of Recombinant Human Interferon α2a Suppository Matrix Formula

[0037] The stock solution of recombinant human interferon α2a was prepared by our company (Changchun Institute of Biological Products Co., Ltd.), and reagents such as glycerin and gelatin were purchased commercially.

[0038] (1) Preliminary selection of suppository base

[0039] According to the literature and our laboratory's experience in the preparation of interferon suppositories, glycerin was initially selected as the excipient and bacteriostatic agent, and gelatin was used as the excipient and protease inhibitor.

[0040] (2) Preparation process of suppository base

[0041] 1) Matrix preparation and initial dissolution

[0042] Add glycerin, gelatin, and water for injection into a sterile and airtight suppository matrix tank according to the ratio of 5:2:1 to 5:3:2. Close the feed inlet valve, open the stirring switch, the exhaust valve, the circulating water valve and the ste...

Embodiment 2

[0055] Example 2 Preparation of Recombinant Human Interferon α2a Plug

[0056] The sources of various raw materials used in this embodiment are the same as those in Example 1.

[0057] (1) Matrix preparation and initial dissolution

[0058] Add glycerin, gelatin, and water for injection into a sterile and airtight suppository matrix tank according to the ratio of 5:2:1 to 5:3:2. Close the feed inlet valve, open the stirring switch, the exhaust valve, the circulating water valve and the steam valve, heat the temperature to 80-90°C, and stir continuously to make it dissolve, and the stirring speed is 20-40rpm.

[0059] (2) Matrix sterilization

[0060] Keep the stirring speed at 20-40rpm. Open the main steam valve of the suppository matrix tank, open the main exhaust valve, drain the condensed water, and close the main exhaust valve. Open the interlayer inlet valve of the matrix tank, open the interlayer exhaust valve, drain the condensed water in the interlayer, and close t...

Embodiment 3

[0071] Example 3 Stability investigation test of recombinant human interferon α2a plug

[0072] In order to further determine the stability of the formula and preparation method of the present invention, it is judged whether the drug is stable at the storage temperature to be changed by summarizing and analyzing the test data, so as to provide a theoretical basis for the determination of product packaging, transportation, storage conditions and expiration date , and reset the expiration date of the product during the stabilization period. Three batches of recombinant human interferon α2a suppositories produced continuously in 2013 (production batch numbers: S20130201, S20130202, and S20130203) were used as the research objects, and the accelerated stability test at 36.5-37.5°C and the long-term stability test at 29-31°C were carried out respectively.

[0073] 1. Accelerated stability investigation test of recombinant human interferon α2a suppository at 36.5-37.5°C:

[0074] A...

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Abstract

The invention relates to a recombinant human interferon alpha2a suppository and a preparation method thereof. Wherein the recombinant human interferon alpha2a is obtained by the following steps: utilizing an escherichia coli expression technology to construct a recombinant plasmid containing a human interferon alpha2a gene, and transforming into escherichia coli to obtain a stable engineering bacterium, fermenting the engineering bacterium, and purifying the engineering bacterium to obtain recombinant human interferon alpha2a, through sterile filtration, and mixing with glycerol and a gelatinmatrix, the recombinant human interferon alpha2a suppository is obtained. The formula of the matrix is characterized in that the matrix does not contain human serum albumin, wherein glycerol is not only an excipient, but also a bacteriostatic agent; the gelatin is also an excipient or a protease inhibitor, can effectively protect the protein of the recombinant human interferon alpha2a from being degraded, ensures the structural integrity of the recombinant human interferon alpha2a, stabilizes the biological activity of the interferon, can interfere with protease released by cells to further destroy damaged mucous membrane tissues of the vagina, and has a mucous membrane protection effect.

Description

technical field [0001] The invention relates to the technical field of biopharmaceuticals, in particular to a recombinant human interferon alpha 2a plug and a preparation method thereof. Background technique [0002] Interferon (interferon, IFN) is controlled by cell genes and produced under the action of specific inducers, a type of highly active, multifunctional protein with broad-spectrum anti-virus, anti-cell division, anti-tumor and cellular immune regulation. biological activity. The anti-viral mechanism of interferon is that it mainly acts on the receptor system on the cell membrane. The anti-viral protein gene in the cell is derepressed and activated, and the anti-viral protein mRNA is synthesized, transferred to the cytoplasmic ribosome, and then translated into several anti-viral proteins. , thereby blocking the propagation of the virus. Interferon is a biological agent currently used clinically at home and abroad to effectively treat more than 30 viral diseases ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/02A61K38/21A61K47/10A61K47/42A61P15/00A61P15/02A61P31/12A61P31/20A61P31/22A61P35/00
CPCA61K9/0034A61K9/02A61K38/212A61K47/10A61K47/42A61P15/00A61P15/02A61P31/12A61P31/20A61P31/22A61P35/00
Inventor 刘景会刘琳琳李利王宇
Owner 李宇辉
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