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A kind of preparation method of anti-hepatitis B immune ribonucleic acid freeze-dried powder injection

A freeze-dried powder injection and ribonucleic acid technology, applied in the field of preparation of anti-hepatitis B immune RNA freeze-dried powder injection, can solve the problems of small loss of active ingredients, long sealed storage period, caking or incomplete dissolution, etc., and achieve control Homogeneity, the effect of reducing reconstitution time

Active Publication Date: 2020-02-21
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the freeze-drying process, the water directly sublimes without going through the liquid state, so that the physical and chemical properties and shape of the dried material are basically unchanged, the loss of active ingredients is small, and the sealed storage period is long
[0004] However, the existing preparation method cannot control the uniformity of the anti-hepatitis B immune ribonucleic acid in the product, so that the product is agglomerated or incompletely dissolved during use, so that the obtained product has the problem of long reconstitution time, which is not conducive to the production of the product. Clinical application

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0024] The invention provides a kind of preparation method of anti-hepatitis B immune ribonucleic acid freeze-dried powder injection, comprising the following steps:

[0025] a) mixing anti-hepatitis B immune ribonucleic acid, excipients and water for injection to obtain mixed solution A;

[0026] b) filtering, freezing and drying the mixed solution A in sequence to obtain the anti-hepatitis B immune ribonucleic acid freeze-dried powder injection;

[0027] The mass ratio of the anti-hepatitis B immune ribonucleic acid, excipients and water for injection is 1:(2-15):(200-600).

[0028] In the present invention, the anti-hepatitis B immune ribonucleic acid, excipients and water for injection are mixed to obtain mixed solution A. In the present invention, the anti-hepatitis B immune ribonucleic acid is the main drug, and the source of the anti-hepatitis B immune ribonucleic acid is not particularly limited in the present invention, and commercially available products well known ...

Embodiment 1

[0042] The preparation specification is 1000 anti-hepatitis B immune ribonucleic acid freeze-dried powder injections of 4mg / support:

[0043] (1) First, 4 g of anti-hepatitis B immune ribonucleic acid was added to 1000 g of water for injection, and 20 g of dextran was added and stirred for 8 minutes at 25° C. to obtain a mixed solution A.

[0044] (2) The above-mentioned mixed solution A is finely filtered through a 0.45 μm microporous filter element and a 0.22 μm microporous filter element in turn, then filled and half-tamped; then the product is placed in a freeze dryer and frozen at -35°C After 2 hours, control the heating rate at 7°C / h to 38°C, and then dry for 3 hours to obtain the anti-hepatitis B immune ribonucleic acid freeze-dried powder injection. The observed product properties are white freeze-dried loose block or powder.

[0045] The reconstitution time of the anti-hepatitis B immune ribonucleic acid freeze-dried powder injection obtained by the preparation method...

Embodiment 2

[0047] Preparation specification is 1000 anti-hepatitis B immune ribonucleic acid freeze-dried powder injections of 2mg / support:

[0048] (1) First, 2 g of anti-hepatitis B immune ribonucleic acid was added to 1000 g of water for injection, and 20 g of dextran was added and stirred for 8 min at 25° C. to obtain a mixed solution A.

[0049] (2) The above-mentioned mixed solution A is finely filtered through a 0.45 μm microporous filter element and a 0.22 μm microporous filter element in turn, then filled and half-tamped; then the product is placed in a freeze dryer and frozen at -35°C After 2 hours, control the heating rate at 7°C / h to 38°C, and then dry for 3 hours to obtain the anti-hepatitis B immune ribonucleic acid freeze-dried powder injection. The observed product properties are white freeze-dried loose block or powder.

[0050] According to the test method provided in Example 1, the reconstitution time of the anti-hepatitis B immune ribonucleic acid freeze-dried powder ...

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Abstract

The invention provides a preparation method of an anti-hepatitis B immune ribonucleic acid freeze-dried powder injection. The preparation method of the anti-hepatitis B immune ribonucleic acid freeze-dried powder injection comprises the following steps: a) mixing anti-hepatitis B immune ribonucleic acid, an excipient and water for injection, so that a mixed solution A is obtained; b) filtering, and freeze-drying the mixed solution A, so that the anti-hepatitis B immune ribonucleic acid freeze-dried powder injection is obtained, wherein mass ratio of the anti-hepatitis B immune ribonucleic acid to the excipient to the water for injection is 1:(2-15):(200-600). Compared with the prior art, the preparation method provided by the invention has the advantages that uniformity of anti-hepatitis B immune ribonucleic acid in the anti-hepatitis B immune ribonucleic acid freeze-dried powder injection can be effectively controlled, and redissolution time of a product is reduced; and experiment results show that the redissolution time of the anti-hepatitis B immune ribonucleic acid freeze-dried powder injection obtained by adopting the preparation method provided by the invention is within 12 seconds.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of anti-hepatitis B immune ribonucleic acid freeze-dried powder injection. Background technique [0002] Anti-hepatitis B immune ribonucleic acid is a biological preparation obtained by chemically extracting the lymphoid tissue of animals immunized with hepatitis B vaccine as an antigen. At present, the clinical anti-hepatitis B immune ribonucleic acid has the effect of improving the body's cellular immune function, making the hepatitis B antigen negative and promoting the formation of hepatitis B antibodies, and is widely used in hepatitis B, hepatitis B virus carrier, liver cirrhosis, hepatomegaly, liver injury, Treatment of acute and chronic hepatitis, persistent hepatitis, liver cancer and other diseases. The mechanism of action of anti-hepatitis B immune ribonucleic acid is generally believed to be the effect of information ribonucle...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K35/26A61P37/04A61P31/20A61P1/16A61J3/02
Inventor 李全学廖孝曙逯佩荣余泽勇刘志军廖国栋刘思川程志鹏万阳浴葛均友
Owner HUNAN KELUN PHARMA
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