Rabies vaccine stabilizer and application thereof

A rabies vaccine and stabilizer technology, applied in the field of biopharmaceuticals, can solve problems such as allergic reactions or other stress reactions, complex animal serum components, and animal death, and achieve scientific and reasonable results in compatibility and ratio

Inactive Publication Date: 2015-03-04
常州同泰生物药业科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, in the production of inactivated rabies vaccine, it is usually necessary to add a certain proportion of animal serum to prolong the shelf life of the vaccine. Due to the complex composition of animal serum, allergic reactions or other stress reactions often occur after injection of animals, and even animal death occurs. And existing various stabilizer can only guarantee the stability of rabies vaccine at low temperature at most, and can't play stabilizing effect under normal temperature, high temperature environment, is unfavorable for rabies vaccine in some low temperature storage conditions and the economic backwardness of imperfect equipment Country and region promotion application

Method used

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  • Rabies vaccine stabilizer and application thereof
  • Rabies vaccine stabilizer and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Configure the rabies vaccine stabilizer according to the following components and proportions:

[0033] Bovine serum albumin 1.1% (W / V);

[0034] Amino acid composition 2.1% (W / V);

[0035] Mannitol 0.8% (W / V);

[0036] Phosphate buffer 20mmol / L, pH7.2;

[0037] Protopanaxatriol 1.5% (W / V)

[0038] The amino acid composition is configured according to the following weight ratio: L-lysine: 4-hydroxyisoleucine: L-proline tert-butyl ester hydrochloride=1:1.2:0.6.

[0039] Calculate and accurately weigh the above-mentioned components according to the total volume of 100ml of the solution, keep them mixed evenly at room temperature, make up to 100ml with water for injection, and place in a sterilized container.

Embodiment 2

[0041] Configure the rabies vaccine stabilizer according to the following components and proportions:

[0042] Bovine serum albumin 1.2% (W / V);

[0043] Amino acid composition 2.7% (W / V);

[0044] Sorbitol 0.2% (W / V);

[0045] Phosphate buffer 50mmol / L, pH7.2;

[0046] Protopanaxatriol 1.2% (W / V)

[0047] The amino acid composition is configured according to the following weight ratio: L-lysine: 4-hydroxyisoleucine: L-proline tert-butyl ester hydrochloride=1.5:0.8:0.3.

[0048] Calculate and accurately weigh the above-mentioned components according to the total volume of 100ml of the solution, keep them mixed evenly at room temperature, make up to 100ml with water for injection, and place in a sterilized container.

Embodiment 3

[0050] Configure the rabies vaccine stabilizer according to the following components and proportions:

[0051] Bovine serum albumin 1.0% (W / V);

[0052] Amino acid composition 2.5% (W / V);

[0053] Sorbitol 0.6% (W / V);

[0054] Phosphate buffer 30mmol / L, pH7.0;

[0055] Protopanaxatriol 1.4% (W / V)

[0056] The amino acid composition is configured according to the following weight ratio: L-lysine: 4-hydroxyisoleucine: L-proline tert-butyl ester hydrochloride=1.2:0.9:0.5.

[0057] Calculate and accurately weigh the above-mentioned components according to the total volume of 100ml of the solution, keep them mixed evenly at room temperature, make up to 100ml with water for injection, and place in a sterilized container.

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Abstract

The invention discloses a rabies vaccine stabilizer. The rabies vaccine stabilizer is prepared from the following components by weight: 1-1.2 percent (W/V) of bovine serum albumin, 2.1-2.7 percent (W/V) of amino acid composition, 0.2-0.8 percent (W/V) of sorbitol or mannitol, 20-50mmol/L of buffer solution, 1.2-1.5 percent (W/V) of proto-panaxatriol and the balance of water, wherein a pH value of the buffer solution is 7.0-7.2. An application method of the rabies vaccine stabilizer comprises the following steps: (1) BSR cell passage, culture and extension; (2) virus inoculation, culture and harvest; (3) virus inactivation; and (4) vaccine preparation: after virus inactivation passes inspection, adding a virus in the rabies vaccine stabilizer. Without containing animal serum, the rabies vaccine stabilizer can not have harmful effects in an immune animal body and can ensure the stability of a rabies vaccine at low, normal and high temperatures.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a rabies vaccine stabilizer and its application. Background technique [0002] Because rabies is a fatal disease, the mortality rate after the onset is almost 100%, so far, there is still no effective treatment in the world. Therefore, anyone who is bitten by a rabies or an animal that is unclear whether it is poisonous or not should be injected with a rabies vaccine immediately. Pregnant women who are bitten should also be vaccinated against rabies in time. The rabies vaccine currently manufactured in our country is inoculated into the primary hamster kidney cells with the fixed rabies virus virus. After cultivation, the venom is harvested, concentrated, purified, refined and added with aluminum hydroxide adjuvant. After passing the comprehensive test, it is the prevention of rabies. vaccine. At present, in the production of inactivated rabies vaccine, it is usually necessar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/42A61K39/205A61P31/14
Inventor 张传明冷雪梅虞华芳
Owner 常州同泰生物药业科技股份有限公司
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