Recombinant human interferon alpha2a suppository and preparation method

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 compliance of injection, protein instability, high price, etc., and achieve good antiviral effect, The production process is simple and easy, and the biological activity is stable

Inactive Publication Date: 2017-07-28
长春生物制品研究所有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The invention provides a recombinant human interferon α2a suppository, which solves the problems of traditional recombinant human interferon α2a suppository such as high price, 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 and glycerin gelatin matrix evenly

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Preparation of recombinant human interferon α2a plug

[0030] (1) Matrix preparation and initial dissolution

[0031] 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, exhaust valve, circulating water valve and steam valve, heat the temperature to 80-90°C, and stir continuously to dissolve it, the stirring speed is 20-40 rpm;

[0032] (2) Matrix sterilization

[0033] Keep the stirring speed at 20-40 rpm. 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 air intake valve of the matrix tank, open the interlayer exhaust valve, drain the interlayer condensate, and close the interlayer exhaust valve ; After the pressure in the matrix tank reaches 0.10-0.13 Mpa, open the exhaust valve in the matrix tank, drain the...

Embodiment 2

[0039] Study on Stability of Recombinant Human Interferon α2a Plug

[0040] 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 (production batch numbers: S20130201, S20130202, and S20130203) produced continuously in 2013 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.

[0041] 1. Accelerated stability investigation test of recombinant human interferon α2a suppository of the present invention at 36.5-37.5°C:

[00...

Embodiment 3

[0061] Quality Control Evaluation

[0062] 1. Identification test

[0063] The result was positive by immunoblotting ("Pharmacopoeia of the People's Republic of China" (2015 edition) three general rules 3401) or immunospot method ("People's Republic of China Pharmacopoeia" (2015 edition) three general rules 3402) assay.

[0064] 2. Visual inspection

[0065] This product should be a light yellow to brown suppository, with a complete, uniform, smooth and firm appearance.

[0066] 3. The weight difference shall be determined according to the method of "Pharmacopoeia of the People's Republic of China" (2015 Edition) Three General Rules 0107), the weight difference shall be ±5% of the labeled amount, and the result is qualified.

[0067] 4. The melting time limit is determined according to the method of the third general rule 0922 of the Pharmacopoeia of the People's Republic of China (2015 edition), and it should be qualified.

[0068] 5. The PH value is measured according to ...

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Abstract

The invention discloses a recombinant human interferon alpha2a suppository and a preparation method thereof. A main effective ingredient of a recombinant human interferon alpha2a stock solution is a recombinant plasmid containing a recombinant human interferon alpha2a gene which is built by utilizing a bacillus coli expression technique and is converted into the bacillus coli to obtain stable engineering bacteria; after the engineering bacteria are fermented, the recombinant human interferon alpha2a stock solution is obtained by a series of purification process; the stock solution is subjected to aseptic filtration and is used as the recombinant human interferon alpha2a suppository which is prepared by mixing glycogelatin matrixes for protecting the bio-activity of the effective ingredient. The problems that the conventional recombinant human interferon alpha2a suppository is high in price, unstable in protein, difficult to store, and poor in injection use compliance for patients are solved.

Description

technical field [0001] The invention provides a recombinant human interferon alpha 2a plug, and provides a preparation method thereof, belonging to the technical field of biopharmaceuticals. 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 disea...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): A61K9/02A61K38/21A61P15/00A61P15/02A61P31/22A61P31/20
CPCA61K9/0036A61K9/02A61K38/212A61K47/42Y02A50/30
Inventor刘景会刘琳琳李利王宇
Owner长春生物制品研究所有限责任公司