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Vaccine protective agent premixing auxiliary material and preparation method thereof

A technology of vaccine protective agent and premixed auxiliary materials, which is applied in the field of vaccine production technology and biomedicine, can solve the problems such as no reports of vaccine protective agent premixed auxiliary materials, and achieve the effect of convenient use

Active Publication Date: 2014-10-08
HUNAN ER KANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, there are no relevant reports on premixed excipients of vaccine protective agents

Method used

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  • Vaccine protective agent premixing auxiliary material and preparation method thereof
  • Vaccine protective agent premixing auxiliary material and preparation method thereof
  • Vaccine protective agent premixing auxiliary material and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Preparation of sugar solution: Weigh 60g of trehalose, 10g of sucrose, and 10g of lactose respectively, add 200ml of purified water to dissolve, then add 0.4g of activated carbon, stir for 30min, then filter through a 0.22μm filter membrane, and then filter the filtrate through a filter with a molecular cut-off range of 5000-10000d hollow fiber ultrafiltration membrane ultrafilter ultrafiltration.

[0030] Preparation of salt solution: Weigh 8.5g of sodium chloride, 3.5g of disodium hydrogen phosphate dodecahydrate, and 0.25g of sodium dihydrogen phosphate dihydrate, add 50ml of purified water to dissolve, then add 0.1g of activated carbon, stir for 30min, and pass through 0.22 The filter membrane of μm is filtered, and the filtrate is ultrafiltered by an ultrafilter equipped with a hollow fiber ultrafiltration membrane with a molecular cut-off range of 5000-10000d.

[0031] Concentrate and crystallize the sugar solution and salt solution obtained above under the condit...

Embodiment 2

[0034] Take 10 g of the premixed auxiliary material of the vaccine protection agent of Example 1, add 100 ml of water for injection, sterilize by 0.1 um filter, and set aside at 4°C. According to the volume of 0.6ml per person, the virus content is 7.00-7.38 lgCCID 50 / ml, add the stock solution of hepatitis A virus live virus, stir and mix the resulting vaccine mixture and pre-cool at the temperature of -20°C- -50°C for 3-5 hours, and the shelf temperature of the freeze-drying box is -35°C- -50°C , turn on the vacuum, sublimate, and the shelf temperature of the secondary freeze-drying box is 15°C-30°C, and the freeze-dried live attenuated hepatitis A vaccine is made.

Embodiment 3

[0036] After getting and mixing each adjuvant of the same amount as the premixed adjuvant of the vaccine protection agent of Example 1, add 100ml of water for injection, and make the freeze-dried live attenuated hepatitis A vaccine by the method of embodiment 2.

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Abstract

The invention provides a vaccine protective agent premixing auxiliary material and a preparation method thereof. The vaccine protective agent premixing auxiliary material comprises the following components in parts by weight: 50-100 parts of trehalose, 5-50 parts of cane sugar, 5-40 parts of lactose, 8.5 parts of sodium chloride, 3.5 parts of sodium phosphate dibasic dodecahydrate and 0.25 part of sodium dihydrogen phosphate dehydrate. The premixing auxiliary material does not contain gelatin and human serum albumin, the components do not react with one another, and the vaccine protective agent premixing auxiliary material is convenient to use, can be directly used for vaccine preparation and can effectively achieve a protective effect in the vaccine preparation and storage process.

Description

technical field [0001] The invention relates to a vaccine protective agent premixed auxiliary material and a preparation method thereof, belonging to the field of vaccine production technology and biomedicine. Background technique [0002] In order to facilitate the transportation and storage of live bacterial vaccines, they are usually made into freeze-dried preparations. In order to ensure the live bacteria rate of the live bacterial vaccine during the freeze-drying process and during the transportation and storage process, the prior art generally uses a lyoprotectant during the preparation of the live bacterial vaccine. Traditional lyoprotectant formulations often contain gelatin or human serum albumin, but the use of gelatin and human serum albumin has certain safety hazards and is also subject to certain restrictions. [0003] Gelatin or gelatin derivatives can directly cause allergic reactions in recipients. Gelatin can cause both cell-mediated and non-cell-mediated ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/36A61K39/29A61K39/25A61P31/22A61P31/14
Inventor 帅放文王向峰章家伟曾三平
Owner HUNAN ER KANG PHARMA
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