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Freeze-dried live attenuated hepatitis A vaccine not containing gelatin or human albumin protective agent and preparation method for freeze-dried live attenuated hepatitis A vaccine

A technology of human albumin and live attenuated vaccine, which is applied in the field of freeze-dried hepatitis A live attenuated vaccine and its preparation, and can solve the problems of human albumin being prone to allergic reactions and carrying mad cow disease virus, etc.

Active Publication Date: 2012-10-10
ZHEJIANG PUKANG BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Traditional lyoprotectant formulations often contain gelatin or human serum albumin, but due to the high endotoxin content of domestic gelatin, imported gelatin has the potential risk of carrying mad cow disease virus, and human serum albumin is prone to allergic reactions. problem, a range of gelatin alternatives needs to be investigated
[0005] products to improve the traditional formula, at present, there is no literature report

Method used

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  • Freeze-dried live attenuated hepatitis A vaccine not containing gelatin or human albumin protective agent and preparation method for freeze-dried live attenuated hepatitis A vaccine
  • Freeze-dried live attenuated hepatitis A vaccine not containing gelatin or human albumin protective agent and preparation method for freeze-dried live attenuated hepatitis A vaccine
  • Freeze-dried live attenuated hepatitis A vaccine not containing gelatin or human albumin protective agent and preparation method for freeze-dried live attenuated hepatitis A vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 1. According to the volume of 0.6ml per person, the virus content is 7.00-7.38lgCCID 50 / ml, calculate the amount of hepatitis A virus live virus stock solution.

[0019] 2. The formula of vaccine stock solution and protective agent (16-3) is calculated according to the volume ratio of 1:0.7-1.2. Weigh 40-120 grams of trehalose, 40 6-18 grams of dextran, and 1-5 grams of L-cysteine , 2-8 grams of arginine, 4-10 grams of glutamic acid, 5-20 grams of glycine, 1-5 grams of magnesium chloride, 1-5 grams of magnesium sulfate, 10-40 grams of sorbitol, 10-40 grams of mannitol, Appropriate amount of trishydroxymethyl aminomethane.

[0020] 3. Mix the above-mentioned trehalose, dextran 40, L-cysteine, arginine, glutamic acid, glycine, magnesium chloride, magnesium sulfate, sorbitol, mannitol, and trishydroxymethylaminomethane. Add 1000 ml of water for injection in turn, stir and mix well, adjust the pH to 6.8-7.4, sterilize by 0.1um filter, and set aside at 4°C.

[0021] 4. I...

Embodiment 2

[0027] Protectant (16-3) formulation of gelatin-free, human albumin-free freeze-dried live attenuated hepatitis A vaccine, with three batches of vaccine containing gelatin (traditional) formulation, and two batches of sterile water for injection, It can be seen from the test results that the endotoxin content of the 16-3 formula without gelatin is significantly reduced, and its detection value is the same as that of sterile water for injection. see table 2

[0028] Table 2. Comparison of endotoxin content between 16-3 formula and the original production formula containing gelatin

[0029]

Embodiment 3

[0031] Vaccines with the same batch number containing the protective agent (16-3) formula of freeze-dried hepatitis A live attenuated live attenuated vaccine without gelatin and human serum albumin, stored in the refrigerator at 2-8°C, and randomly sampled regularly to determine the infectivity of the vaccine Titer, the result proves that according to the above-mentioned preparation method, freeze-drying makes freeze-dried hepatitis A live vaccine, after 2-8 ℃ of storing 21 months, the virus infectivity titer of vaccine remains unchanged, shows that the stability of vaccine is good. See Table 3.

[0032] Table 3. Stability of 16-3 freeze-dried hepatitis A vaccine stored at 2-8°C

[0033]

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Abstract

The invention belongs to the field of biological products, in particular to a freeze-dried live attenuated hepatitis A vaccine protective agent not containing gelatin or human albumin and used for preventing hepatitis A, and a preparation method for the freeze-dried live attenuated hepatitis A vaccine protective agent. The protective agent comprises trehalose, dextran 40, L-cysteine, arginine, glutamic acid, glycine, magnesium chloride, magnesium sulfate, sorbierite, mannitol and tris(hydroxymethyl)aminomethane. The protective agent with the formula is mixed with a hepatitis A vaccine stock solution to form a semi-finished product, the semi-finished product is packaged and freeze-dried, and virus infectious titers of the vaccine before and after freeze drying and the thermal stability after freeze drying are detected; after the formula is compared with the conventional production formula containing the gelatin, results show that the protective agent has good protective effect, the descent of the virus infectious titers of the vaccine in the freeze drying process is obviously decreased, and the endotoxin content in a finished product is obviously reduced (less than 0.25EU / ml); and after the freeze-dried vaccine with the formula is inoculated into a human body, results indicate that the vaccine has good immune effect and high safety.

Description

technical field [0001] The invention belongs to the field of biological products, in particular to a gelatin-free and human albumin-free protective agent-free freeze-dried hepatitis A live attenuated vaccine for preventing hepatitis A and a preparation method thereof. Background technique [0002] Hepatitis A is one of the most important infectious diseases in my country. With the development of economy, the improvement of living conditions, and the popularization and application of homemade hepatitis A vaccine in the past ten years, the incidence rate of the disease has decreased by an average of 20% per year. However, in some central and western regions, the incidence of hepatitis A remains high. Even in some developed eastern provinces, outbreaks of hepatitis A occur from time to time. [0003] As the country pays more and more attention to "people's livelihood" issues, in March 2007, at the Fifth Session of the Tenth National People's Congress, Premier Wen Jiabao listed...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/29A61K47/36A61P1/16A61P31/14
CPCY02A50/30
Inventor 陈念良毛江森黄卫新忻亚娟陈悦青毛子安张锋庄昉成钱汶陈卓朱莲沈立军唐彩华吴海光陈军
Owner ZHEJIANG PUKANG BIOTECH
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