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Gelatin-free freeze-drying stabilizer used for human Japanese encephalitis vaccine

A technology of live attenuated vaccine and freeze-dried stabilizer, which is applied in the field of vaccine preparations and achieves the effects of good protection, low irritation and good use safety

Inactive Publication Date: 2015-12-02
WUHAN INST OF BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, gelatin is of bovine or porcine origin and therefore has the potential to carry zoonotic viruses

Method used

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  • Gelatin-free freeze-drying stabilizer used for human Japanese encephalitis vaccine
  • Gelatin-free freeze-drying stabilizer used for human Japanese encephalitis vaccine
  • Gelatin-free freeze-drying stabilizer used for human Japanese encephalitis vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1. Formula and preparation method of freeze-dried stabilizer

[0023] Screening and optimizing the suitable formula of gelatin-free freeze-drying stabilizer for live attenuated Japanese encephalitis vaccine for human use, which contains salt, sugar and other ingredients, and is prepared by dissolving in water for injection.

[0024]

[0025] Weigh the ingredients in the above prescription in turn, dissolve them in water for injection, and adjust the pH to 6.5-7.8 after all the ingredients are dissolved.

[0026] The stock solution of live attenuated encephalitis Japanese encephalitis vaccine and the freeze-dried stabilizer are mixed according to a certain volume, and the preparation time is not more than 4 hours, and stirred until uniform.

Embodiment 2

[0027] Embodiment 2. Optimization of freeze-drying curve program

[0028] Optimized the time control from pre-freezing to sublimation drying and finally analytical drying. The freeze-drying effect of the finished product is better, and the formability is better. Turn on the freeze dryer, and when the temperature of the plate layer reaches -30°C to -40°C, the product is allowed to enter the cabinet and keep it until the product enters the cabinet. After the product is put into the cabinet and the cabinet door is closed and confirmed, the product is accelerated to refrigerate, so that all the products in the cabinet are completely frozen (keep below -40°C for more than 2 hours). Create a low-pressure environment (below 10Pa) for the box, so that the product can be dried and vacuumed at low temperature and low pressure. The first stage of drying: Slowly heat the product to -10°C to 0°C and keep it until the appearance of the product is shaped into a light yellow loose body with...

Embodiment 3

[0029] Embodiment 3. Product quality detection after freeze-drying

[0030] According to the relevant regulations of the third part of the Pharmacopoeia of the People's Republic of China, all relevant items are tested.

[0031]

[0032]

[0033] The test results showed that all indicators of the vaccine products freeze-dried without gelatin freeze-drying stabilizer were in line with national regulations and enterprise standards.

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PUM

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Abstract

The invention relates to a gelatin-free freeze-drying stabilizer used for a human Japanese encephalitis vaccine. The freeze-drying stabilizer is free of gelatin; and according to test and detection results, the prepared vaccine has high stability and security and small irritation and is free of known allergic population. A formula for the freeze-drying stabilizer comprises 0.02 to 0.05 M of disodium hydrogen phosphate (including aquo-compounds thereof), 0.08 to 0.15 M of cane sugar, 0.02 to 0.06 M of sodium dihydrogen phosphate (including aquo-compounds thereof), 0.50 to 0.80 M of urea and 0.20 to 0.70 M of lactose, and the pH value of the freeze-drying stabilizer is 6.5 to 7.8.

Description

technical field [0001] The invention belongs to the field of vaccine preparations, in particular to a gelatin-free freeze-drying stabilizer for live attenuated Japanese encephalitis vaccines for humans. Background technique [0002] Japanese encephalitis is caused by Japanese encephalitis virus infection. It is one of the most common vector-borne diseases of the human central nervous system. It is widely distributed in Asia. 50% of patients will leave permanent neurological sequelae, and it is listed as a key prevention and control disease by the World Health Organization (WHO). Vaccination is the most economical and effective means to prevent and control Japanese encephalitis. [0003] At present, the live attenuated Japanese encephalitis vaccine and the inactivated Japanese encephalitis vaccine on the market are all made by freeze-drying technology, which has incomparable advantages: the virus seeds are dried at low temperature, and the activity of various components is l...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K47/18A61K47/04A61K39/12A61K9/19A61P31/14
CPCY02A50/30
Inventor 吕文利张威鄂文娟赵新华田小凤胡志雄张雪朱蓉
Owner WUHAN INST OF BIOLOGICAL PROD CO LTD
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