A kind of vaccine protection agent, measles and Japanese encephalitis combined vaccine and preparation method thereof

A combined vaccine and Japanese encephalitis technology is applied in antiviral agents, pharmaceutical formulas, medical preparations with non-active ingredients, etc. It can solve problems such as poor stability, short validity period, and high adverse reaction rate, and achieve good stability, The effect of extending the shelf life and good protection effect

Active Publication Date: 2016-01-20
CHENGDU INST OF BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the protective agents of measles and Japanese encephalitis combined vaccines reported in the existing literature have many problems, such as poor stability, short validity period, high adverse reaction rate, etc.

Method used

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  • A kind of vaccine protection agent, measles and Japanese encephalitis combined vaccine and preparation method thereof
  • A kind of vaccine protection agent, measles and Japanese encephalitis combined vaccine and preparation method thereof
  • A kind of vaccine protection agent, measles and Japanese encephalitis combined vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The preparation of embodiment 1 protective agent of the present invention

[0027] 1. Preparation method

[0028] (1), gelatin solution: dissolve gelatin in sterilized phenol red-free EBSS balanced salt solution under the condition of 100 ℃ hot water bath to aid dissolution, stir in real time, wait until completely dissolved and clear, then make the gelatin concentration 5% ~25%, sterilized at 0.11MPa for 30 minutes, then dilute to volume with sterilized phenol red-free EBSS balanced salt solution in a sterile environment to obtain a gelatin solution, and store at 37°C until use;

[0029] (2) Sugar solution: Dissolve trehalose and sucrose in sterilized EBSS balanced salt solution under the condition of 100°C hot water bath to aid dissolution, stir in real time, and after being completely dissolved and clear, sterilize at 100°C for 30 minutes, Constant volume, so that the concentration of each sugar in the solution is 20-40%, while hot, sterilize and filter to obtain th...

Embodiment 2

[0032] The screening experiment of embodiment 2 protective agent of the present invention

[0033] 1. Preparation method

[0034] (1), preparation of protective agent

[0035] According to the formula shown in Table 1, the protective agent was prepared according to the following steps:

[0036] a. Gelatin solution: Dissolve gelatin in sterilized phenol red-free EBSS balanced salt solution under the condition of 100°C hot water bath to aid dissolution, stir in real time, wait until it is completely dissolved and clear, and then set the volume to make the gelatin concentration 5% to 25% %, 0.11MPa for 30 minutes to sterilize, then dilute to volume with sterilized phenol red-free EBSS balanced salt solution in a sterile environment to obtain a gelatin solution, and store it at 37°C for later use;

[0037] b. Sugar solution: Dissolve trehalose and sucrose in sterilized EBSS balanced salt solution under the condition of 100°C hot water bath to aid dissolution, stir in real time, ...

Embodiment 3

[0064] Embodiment 3 vaccine stability test of the present invention

[0065] Taking Example 2 MJV20100611 batch number and MJV20100712, MJV20100813 three batches of Japanese encephalitis-measles combined vaccine prepared in accordance with the formula of the protective agent in Example 2, according to ICH's "STABILITY TESTING OF NEW DRUGSUBSTANCES AND PRODUCTS", the 56 ℃ accelerated thermal stability test of the three batches of vaccine products was carried out. The three batches of vaccine combined vaccine finished products were stored at 56°C for 1 hour, 4 hours, 8 hours, 12 hours, 24 hours and 72 hours respectively, and the titers of measles virus and Japanese encephalitis virus in the combined vaccine were measured by sampling. The experimental results are shown in Table 2:

[0066] Table 2 Titers of measles JE vaccine after storage at 56°C for different time

[0067]

[0068] It can be seen from Table 2 that the combined live attenuated measles and Japanese encephalit...

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Abstract

The invention provides a vaccine protection agent which is characterized by comprising the following components by weight: 60 to 200 parts of disaccharides, 3 to 10 parts of gelatin, 0.5 to 10 parts of amino acid, 3 to 10 parts of urea, 3 to 10 parts of sorbitol and 2 to 10 parts of human albumin. The invention also provides a combined measles and Japanese encephalitis vaccine and a preparation method thereof. The vaccine protection agent provided in the invention can effectively enhance stability of the combined measles and Japanese encephalitis vaccine and has a high application value.

Description

technical field [0001] The invention relates to a vaccine protective agent, in particular to a protective agent of measles-Japanese encephalitis combined vaccine. Background technique [0002] Measles and Japanese encephalitis combined vaccine is a dual live vaccine prepared from an attenuated strain of measles virus and an attenuated strain of Japanese encephalitis virus. For live toxin vaccines, the components of the freeze-drying protective agent and the freeze-drying process of the two vaccines are similar. And the ages of immunization of the two are similar (measles: over 8 months old, the age of additional immunization is 18-24 months; Japanese encephalitis: vaccination at 8 months old, booster immunization at 2 years old), the injection method is the same (subcutaneous inoculation of deltoid muscle of upper arm) ), my country has already begun to develop the measles-JE combined vaccine, but due to reasons such as vaccine stability, there has been no finished product o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/42A61K39/295A61K39/165A61K39/12A61P31/14A61K47/18A61K47/26
CPCY02A50/30
Inventor 李玉华吴永林康庄
Owner CHENGDU INST OF BIOLOGICAL PROD
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