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Vaccine protectant, hydrophobia vaccine and preparation method thereof

A kind of technology of rabies vaccine, vaccine protective agent, be applied in: [0001] The present invention relates to a kind of vaccine protective agent, the field of vaccine protective agent, can solve the problems such as promotion and use restriction, vaccine quality discount, unstable rabies vaccine, etc., to improve Stability, extended shelf life, good clinical application prospects

Active Publication Date: 2012-06-27
CHENGDU INST OF BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The stable potency of rabies vaccine in freeze-dried dosage form can theoretically be stored for more than 18 months, but if the freeze-dried protective agent is not ideal, the potency cannot be effectively kept stable, and the quality of the vaccine is greatly reduced
Due to the instability of rabies vaccine, it must be transported, stored and used through cold chain under low-temperature refrigeration conditions, so that the large-scale promotion and use of rabies vaccine, especially in economically underdeveloped regions and tropical and subtropical regions, is widely accepted. limit

Method used

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  • Vaccine protectant, hydrophobia vaccine and preparation method thereof
  • Vaccine protectant, hydrophobia vaccine and preparation method thereof
  • Vaccine protectant, hydrophobia vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The preparation of embodiment 1 protective agent of the present invention

[0031] 1. Preparation method

[0032] Weighing, dissolving and autoclaving are operated in a workshop with a cleanliness level of 100,000, and filtration sterilization is operated under a laminar flow of a level of 100 in a workshop with a cleanliness of 10,000, including the following steps:

[0033] (1) Prepare 1000ml of gelatin with a concentration of 11%: Weigh 110g of gelatin, dissolve it in 750ml of 0.01M PBS (pH 7.6) sterilized solution in a hot water bath at 100°C, stir in real time, and when it is completely clear, set the volume at 1000ml, sterilized at 0.11MPa for 30 minutes, then supplemented with sterilized 0.01M PBS (pH 7.6) solution to make up to 1000ml to obtain 11% gelatin solution, stored at 2-8°C, and used within one week. Used gelatin is the product of Fluka Company;

[0034] (2) Preparation of 1000ml protective agent sugar solution: Weigh 179.9g of pharmaceutical grade mal...

Embodiment 2

[0036] The preparation of embodiment 2 rabies vaccine of the present invention

[0037] 1. Vaccine preparation

[0038] (1), preparation of protective agent

[0039] According to the formula shown in Table 1, the protective agent was prepared according to the following steps:

[0040] a. Prepare 1000ml of 11% gelatin: Weigh 110g of gelatin, dissolve it in 750ml of sterilized 0.01M PBS (pH 7.6) solution in a hot water bath at 100°C, stir in real time, and when it is completely clear, set the volume to 1000ml , 0.11MPa for 30 minutes to sterilize, then supplement the liquid with sterilized 0.01M PBS (pH 7.6) solution to make up to 1000ml to obtain 11% gelatin solution, store at 2-8°C, and use within one week. Used gelatin is the product of Fluka Company;

[0041] b. Prepare 1000ml protective agent sugar solution: weigh pharmaceutical grade polysaccharide and dissolve it in sterilized 750ml 0.01M PBS (pH 7.6) solution under 100°C hot water bath, stir in real time, and wait until...

Embodiment 3

[0067] The quality detection of the vaccine that embodiment 3 protective agent of the present invention prepares

[0068] Get the vaccine that embodiment 2 formula 1 prepares, carry out following detection:

[0069] 1. Vaccine safety test, vaccine intracerebral injection test to observe safety

[0070] The rabies vaccine produced by screening the protective agent was tested for vaccine safety, vaccine intracerebral injection test, allergic test, and vaccine injection site irritation test. The results showed that after the vaccine safety test and intracerebral injection of Kunming mice, The mice showed no abnormal behavior, and all the experimental mice survived after 14 days of observation.

[0071] 2. Vaccine abnormal toxicity test

[0072] Trial freeze-dried rabies vaccine was injected intraperitoneally into mice (18-22g) and guinea pigs (250-350g). The results showed that the mice survived and gained weight after 7 days of observation.

[0073] 3. Vaccine allergy test

...

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Abstract

The invention provides a vaccine protectant, comprising the following components, by percentage composition: 50-80 parts of disaccharide, 20-30 parts of human albumin, 10 parts of gelatin and 1.5-1.65 parts of amino acid. The invention also provides a hydrophobia vaccine and a preparation method thereof. The vaccine protectant of the invention can effectively enhance thermal stability of a hydrophobia vaccine lyophilized preparation and has huge application value.

Description

Background technique [0001] The invention relates to a vaccine protective agent, in particular to a rabies vaccine protective agent. Background technique [0002] Rabies, also known as hydrophobia, is an acute viral infectious disease that affects the central nervous system. Rabies is by far the acute infectious disease with the highest human case fatality rate, once onset, the case fatality rate is as high as 100%. Rabies occurs in 87 countries and regions around the world, but they are mainly distributed in developing countries such as Asia, Africa and Latin America, 98% of which are in Asia. The number of cases in China is second only to India, ranking second in the world. Since 1997, my country's rabies epidemic has maintained an upward trend for more than 10 years, and the number of cases and deaths has continued to increase. From 2006 to 2008, a total of 9,045 cases of rabies were reported nationwide, accounting for 24.9% of the total number of deaths from various inf...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/42A61K39/205A61P31/14
Inventor 李玉华吴永林毛川成刘杰赵宇吴曼萍牟建超刘蓉杨会强孙艳
Owner CHENGDU INST OF BIOLOGICAL PROD
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