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W/O vaccine oil adjuvant formulation and preparation method thereof

An oil adjuvant and preparation technology, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, viral antigen components, etc., can solve the differences in antigen release behavior, poor repeatability between batches, and uneven particle size of emulsions, etc. problem, to achieve uniform milk droplet size, improve the level and persistence of immune response, and improve storage stability

Active Publication Date: 2015-12-16
INST OF PROCESS ENG CHINESE ACAD OF SCI
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that the difference in particle size distribution will lead to the difference in antigen release behavior
And this difference will further lead to the difference in the immune effect in the body
The present invention aims to establish a new type of emulsion preparation method, that is, the rapid membrane emulsification method in veterinary vaccine oil adjuvant vaccine preparations, to prepare oil adjuvant vaccine preparations with uniform particle size and controllability, and to overcome the traditional high-speed stirring, homogeneous emulsification, The particle size of the emulsion prepared by ultrasound and other methods is not uniform, uncontrollable, and poor repeatability between batches; at the same time, an efficient and continuous immune response effect is obtained on the basis of uniform particle size

Method used

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  • W/O vaccine oil adjuvant formulation and preparation method thereof
  • W/O vaccine oil adjuvant formulation and preparation method thereof
  • W/O vaccine oil adjuvant formulation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Measure 20mL of the solution containing inactivated Newcastle disease and avian influenza virus as the water phase (W), measure 60mL of white oil containing Span80 and stabilizer aluminum stearate as the oil phase (O), add the oil phase to the In the pulper, under the condition of 3500 rpm, add the water phase (W) to the oil phase (O), homogenize for 3 minutes, then adjust the number of revolutions to 10000 rpm, and continue to emulsify for 5 minutes , to obtain the W / O type oil adjuvant Newcastle disease-avian influenza dual vaccine preparation. Optical microscope photographs such as figure 2 As shown, the results show that there are relatively large droplets in the prepared emulsion; the prepared emulsion is measured for particle size and particle size distribution, and the ZetaPlus with particle size analysis function is used to measure, and 1 drop of the above-mentioned droplet is taken with a pipette. The prepared emulsion was added to 1mL of the oil phase, trans...

Embodiment 2

[0057] A microporous membrane with a pore size of 2.8 μm was used to prepare an oil adjuvant preparation containing Newcastle disease-avian influenza dual vaccine. Measure 20 mL of a solution containing inactivated Newcastle disease and avian influenza virus as the water phase (W), and measure 60 mL containing The white oil of Span80 and stabilizer aluminum stearate is used as the oil phase (O), the water phase (W) is poured into the oil phase (O) under mechanical stirring, and the W / O pre-emulsion is prepared by stirring at a low speed, and subsequently, this The pre-emulsion is transferred to a storage tank for rapid membrane emulsification, and is repeatedly passed through the membrane 3 times under a nitrogen pressure of 0.45 MPa to obtain a W / O oil adjuvant vaccine preparation. Optical microscope photographs such as image 3 As shown, the result shows that the uniformity of the particle size of the prepared emulsion is good; the measurement of the particle size and partic...

Embodiment 3

[0059] Since the inactivated Newcastle disease-avian influenza virus vaccine used is not purified, it is difficult to accurately quantify the amount of antigen, which makes it impossible to conduct research on the release behavior of antigen in vitro. To this end, bovine serum albumin (BSA) was used as the model antigen to prepare the emulsion and study the release behavior of the antigen in vitro. Accurately weigh a certain amount of BSA, dissolve it in a certain volume of deionized water, prepare a BSA solution with a concentration of 500mg / mL, measure 20mL of BSA solution as the water phase (W), and measure 60mL of white oil containing Span80 and the stabilizer aluminum stearate as the oil phase (O), the oil phase is added to the homogenizer, and the water phase (W) is added to the oil phase (O) under the condition of 3500 rpm, and the homogeneous Slurry for 3 minutes, then adjust the number of rotations to 10000 rpm, and continue to emulsify for 5 minutes to obtain the W / O...

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Abstract

The invention relates to a W / O vaccine oil adjuvant formulation and a preparation method thereof. The formulation is a W / O emulsion, which comprises an aqueous phase containing a solution of antigen and an oil phase containing white oil, an emulsifier, and a stabilizing agent. The W / O emulsion has the average particle size in a range of 0.1-8.22 [mu]m and the coefficient of dispersion less than 0.1. The preparation method comprises: transferring a pre-emulsion into a storage tank for quick membrane emulsification, and allowing the obtained product to pass through a microporous membrane under the pressure in a range of 0.1-2.5 MPa to obtain the W / O vaccine oil adjuvant formulation. The W / O vaccine oil adjuvant formulation is uniform and controllable in size. The improved uniformity of the emulsion benefits enhancement of stability of emulsion droplets. Compared with an emulsion prepared through a conventional process, the emulsion in the invention is slower in the Ostwald ripening, so that when the formulation is injected into a human body, the burst release of antigen is at a low speed, and antigen can be continuously released later, thereby inducing a quick, efficient and continuous immune response level.

Description

technical field [0001] The invention relates to the technical field of vaccines, in particular to a uniform and controllable W / O vaccine oil adjuvant preparation in the field of veterinary vaccines and a preparation method thereof, which can be used to improve the stability of the preparation, induce a rapid immune response, and increase the intensity and intensity of the immune response. Level. Background technique [0002] With the acceleration of the process of economic globalization, the circulation of animals and animal products is becoming more and more frequent, the vectors of animal diseases are increasing, and the probability of disease and disease epidemics is significantly increasing, which not only causes economic losses, but also seriously endangers human health. health and life safety. According to incomplete statistics, in the past 20 years, there have been more than 10 new animal diseases, among which pig blue ear disease, porcine pseudorabies, circovirus an...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K9/107A61P37/04A61K39/145A61K39/17A61K39/135A61K39/12
Inventor 马光辉王连艳苏志国刘媛杨婷媛周炜清
Owner INST OF PROCESS ENG CHINESE ACAD OF SCI
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