Multiple emulsion type adjuvant for foot-and-mouth disease vaccine and preparation method of multiple emulsion type adjuvant

A foot-and-mouth disease vaccine and foot-and-mouth disease technology, which is applied in the double-emulsion adjuvant of the foot-and-mouth disease vaccine and its preparation field, can solve the problems of large side effects and easy inflammation, and achieve the effects of avoiding inflammation, reducing toxic and side effects, and low preparation cost

Active Publication Date: 2017-03-22
南京国创生物技术研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, water-in-oil-in-water (W / O / W) type double emulsion includes ISA 206 adjuvant (SEPPIC, France) and adjuvants containing a large amount of mineral oil. Although the vaccines containing these adjuvants have high immune activity, they can be completely absorbed by animals after a long time after immunization, and the inoculation site is prone to inflammation, so side effects bigger

Method used

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  • Multiple emulsion type adjuvant for foot-and-mouth disease vaccine and preparation method of multiple emulsion type adjuvant
  • Multiple emulsion type adjuvant for foot-and-mouth disease vaccine and preparation method of multiple emulsion type adjuvant
  • Multiple emulsion type adjuvant for foot-and-mouth disease vaccine and preparation method of multiple emulsion type adjuvant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1 prepares double emulsion type adjuvant

[0025] In this example, Emulsogen EL360 was purchased from Clariant Chemical Co., Ltd., product number CNP1004847; stearyl polyoxyethylene (21) ether was purchased from Shanghai Meihao Fine Chemical Co., Ltd., product number PCN / 4500713528.

[0026] Compound emulsion adjuvant 1 formula:

[0027]

[0028]

[0029] Compound emulsion adjuvant 2 formula:

[0030]

[0031] Compound emulsion adjuvant 3 formula:

[0032]

[0033] Control adjuvant 1 formula:

[0034]

[0035] Contrast adjuvant 2 formula (it is the oil phase 3 of Example 1 in the invention patent application with the publication number CN 104398478 A and the title "Double-emulsion carrier of veterinary medicine and its application"):

[0036]

[0037]

[0038] Preparation of double emulsion adjuvant 1-3 and control adjuvant 1, 2, the specific method is as follows: weigh each component according to the formula, mix, stir evenly, and ste...

Embodiment 2

[0039] The preparation of embodiment 2 foot-and-mouth disease vaccine (W / O / W type)

[0040] Pig foot-and-mouth disease inactivated virus liquid (O type, Mya98 strain) is provided by Jinyu Baoling Biological Pharmaceutical Co., Ltd., and the virus content in every 0.2 ml of virus liquid before inactivation is 10 7.17 LD 50 .

[0041] Mix double-emulsion adjuvant 1-3 and control adjuvant 1 with porcine foot-and-mouth disease inactivated virus solution at a mass ratio of 1:1, shake by hand for 5-10 minutes or stir at 250rpm for 30 minutes to make each component Mix evenly to obtain the foot-and-mouth disease vaccine. The corresponding relationship between the number of the foot-and-mouth disease vaccine and the adjuvant is shown in Table 1. It is best to preheat the adjuvant and virus solution to 15-30°C before mixing. According to the publication number CN 104398478 A, the title "multi-emulsion type carrier of veterinary medicine and its application" method in Example 3 of th...

Embodiment 3

[0044] Safety inspection of embodiment 3 foot-and-mouth disease vaccine A, B, C

[0045] The safety of the foot-and-mouth disease vaccines A-E in Example 2 on mice and pigs was examined.

[0046] (1) Mouse safety test

[0047] Take 60 clean-grade mice of 16-22g, and randomly divide them into 6 groups, one of which is not vaccinated as a control, and the other five groups are respectively immunized with foot-and-mouth disease vaccine A, B, C, D or E, and each mouse is subcutaneously injected with 1 / 2 head portion (0.5ml, 1 / 2 head portion here is relative to pig) foot-and-mouth disease vaccine. 1 week, 2 weeks, and 3 weeks after vaccination, 3 mice were randomly dissected in each group, and the absorption of the injection site was observed. The results are shown in Table 2. It can be seen from Table 2: the injection site of the inoculated mice was dissected, and 3 / 3 of the vaccine groups A, B, and C were completely absorbed 2 weeks after injection; only 1 / 3 of the vaccine was...

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Abstract

The invention provides a multiple emulsion type adjuvant for a foot-and-mouth disease vaccine and a preparation method of the multiple emulsion type adjuvant and relates to the field of medicine preparation. The multiple emulsion type adjuvant for the foot-and-mouth disease vaccine is composed of the following components including, by mass, 50-65 parts of mineral oil, 10-35 parts of vitamin E, 3-5 parts of castor oil ethyl oxide, 2-8 parts of tween 80, 2-6 parts of n-amyl alcohol, 1-4 parts of stearyl alcohol polyoxyethylene ether and 1-5 parts of deionized water. The invention further provides the foot-and-mouth disease vaccine containing the multiple emulsion type adjuvant and a preparation method of the foot-and-mouth disease vaccine. The foot-and-mouth disease vaccine containing the adjuvant can be completely absorbed by animals in short time on the premise of good stability and immunological enhancement effect, inflammation of the inoculation position is avoided, and therefore, side reaction is reduced remarkably.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a double emulsion adjuvant for foot-and-mouth disease vaccine and a preparation method thereof. Background technique [0002] Oily adjuvants are the most widely used in animal vaccines and have the best immune enhancing effect. There are three types of oil-containing adjuvant vaccines: water-in-oil (W / O), water-in-oil-in-water (W / O / W) and oil-in-water (O / W). [0003] At present, W / O (oil emulsion) is the most common oil-containing adjuvant vaccine, which has the best immune-enhancing effect, but has the disadvantages of high content of non-metabolizable mineral oil, high viscosity, and strong toxic and side effects. Animals such as pigs, dogs, and cats are particularly sensitive to this formulation, which limits the practical application of W / O formulations. The O / W dosage form overcomes the shortcomings of W / O, but the adjuvant activity is too weak, the ability to im...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K39/135A61P31/14
Inventor 邓碧华卢宇吕芳张金秋赵艳红侯继波
Owner 南京国创生物技术研究院有限公司
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