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Preparation method for freeze-dried b-type haemophilus influenza conjugate vaccines

A Haemophilus influenzae-conjugate vaccine technology, which is applied in the field of preparation of freeze-dried Haemophilus influenzae type b conjugate vaccine, can solve the problems of poor stability, inconvenient storage, transportation and use, limited validity period, etc., and achieve long period of validity, Easy to transport and use, good vaccine stability

Inactive Publication Date: 2012-07-25
CHENGDU OLYMVAX BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to solve the shortcomings of the existing Haemophilus influenzae type b conjugate vaccine, provide a preparation method of freeze-dried Haemophilus influenzae type b conjugate vaccine, overcome the storage and transportation of traditional liquid Haemophilus influenzae type b conjugate vaccine And the disadvantages of inconvenient use, poor stability, limited validity period, etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] [Example 1] The preparation method of freeze-dried Haemophilus influenzae type b conjugate vaccine comprises the following steps:

[0020] (1) Prepare the semi-finished solution of Haemophilus influenzae type b conjugate vaccine by uniformly mixing the sucrose solution and the polysaccharide conjugate, wherein the content of sucrose is 72mg / ml, and the content of polysaccharide conjugate is 12ug / ml;

[0021] (2) Put the vaccine semi-finished product solution into a freeze dryer for freeze drying, first lower the temperature of the freeze dryer plate layer to -40°C for pre-freezing, and the pre-freezing time is 2 hours;

[0022] (3) After the pre-freezing is completed, reduce the shelf temperature to -45°C and start vacuuming;

[0023] (4) After the vacuum treatment is completed, adjust the temperature of the freeze dryer in the vacuum state to -35°C and keep it for 10 hours;

[0024] (5) The shelf is heated to 30°C at a rate of 5°C / hour and maintained at 30°C for 3.8 h...

Embodiment 2

[0026] [Embodiment 2] The preparation method of freeze-dried Haemophilus influenzae type b conjugate vaccine comprises the following steps:

[0027] (1) Prepare a semi-finished solution of Haemophilus influenzae type b conjugate vaccine by uniformly mixing the sucrose solution and the polysaccharide conjugate, wherein the content of sucrose is 90mg / ml, and the content of polysaccharide conjugate is 29ug / ml;

[0028] (2) Put the vaccine semi-finished product solution into a freeze dryer for freeze drying, first lower the temperature of the freeze dryer plate layer to -30°C for pre-freezing, and the pre-freezing time is 4 hours;

[0029] (3) After the pre-freezing is completed, reduce the shelf temperature to -30°C and start vacuuming;

[0030] (4) After the vacuum treatment is completed, adjust the temperature of the freeze dryer in the vacuum state to -30°C and keep it for 10 hours;

[0031] (5) The shelf is heated to 30°C at a rate of 5°C / hour and maintained at 30°C for 4.2 ...

Embodiment 3

[0033] [Embodiment 3] The preparation method of freeze-dried Haemophilus influenzae type b conjugate vaccine comprises the following steps:

[0034] (1) Prepare the semi-finished solution of Haemophilus influenzae type b conjugate vaccine by uniformly mixing the sucrose solution and the polysaccharide conjugate, wherein the content of sucrose is 80mg / ml, and the content of polysaccharide conjugate is 20ug / ml;

[0035] (2) Put the vaccine semi-finished product solution into a freeze dryer for freeze drying, first lower the temperature of the freeze dryer plate layer to -35°C for pre-freezing, and the pre-freezing time is 3 hours;

[0036] (3) After the pre-freezing is completed, reduce the shelf temperature to -38°C and start vacuuming;

[0037] (4) After the vacuum treatment is completed, adjust the temperature of the freeze dryer in the vacuum state to -32°C and keep it for 10 hours;

[0038] (5) The shelf is heated to 30°C at a rate of 5°C / hour and maintained at 30°C for 4 ...

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Abstract

The invention discloses a preparation method for freeze-dried b-type haemophilus influenza conjugate vaccines, which comprises the following steps of: preparing and separately packaging semi-finished product solution of the conjugate vaccine; putting the semi-finished product solution of the conjugate vaccine into a freeze-drying machine to be freeze-dried: firstly prefreezing for 2-4 hours, vacuumizing after prefreezing, regulating the temperature of the vacuum freeze-drying machine to be 30-35 DEG C below zero after vacuumizing, keeping the temperature for 10 hours, raising the temperature of a shelf to 30 DEG C at the speed of 5 DEG C / hour, and keeping the temperature of 30 DEG C for 3.8-4.2 hours; and taking out the freeze-dried conjugate vaccine to obtain a finished product. The vaccine prepared in the method disclosed by the invention meets the requirement, and conventional liquid dosage form is replaced by the freeze-dried Hib conjugate vaccine which has the characteristics of convenience in storage, transportation and use, good stability, long period of validity and the like.

Description

technical field [0001] The invention relates to a preparation method of freeze-dried Haemophilus influenzae type b conjugate vaccine. Background technique [0002] Haemophilus influenzae type b conjugate vaccine is composed of purified capsular polysaccharide of Haemophilus influenzae type b covalently combined with tetanus toxoid. Haemophilus influenzae type b is a common commensal bacterium in the nasopharynx of children. Before the vaccine is applied, most children will carry Hib for a certain period of time, sometimes for several months, but the bacterial colonization rate varies greatly with age and socioeconomic status. Big. In areas with high Hib vaccination rates, bacterial colonization of the nasopharynx is very low due to the herd immunity effect of Hib conjugate vaccines. Although only a small proportion of carriers will develop clinical cases, carriers are significant in spreading the disease because Hib is transmitted through droplets of respiratory secretions...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K39/102A61P31/04
CPCA61K39/102A61P31/04
Inventor 张丽莺李靖陈克平朱冲李洪光关晓峰王子龙
Owner CHENGDU OLYMVAX BIOPHARM
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