Oil-in-water submicron emulsion serving as vaccine adjuvant and preparation method thereof

An oil-in-water vaccine adjuvant technology, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, can solve the problems of antigen titer reduction and inactivation, and achieve stability sex good effect

Inactive Publication Date: 2014-05-14
SHANGHAI INST OF PHARMA IND +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the former, the influenza vaccine needs to undergo high-speed stirring and nano-collision during the preparation process, which may easily lead to a decrease in the antigen titer or even inactivation.
The oil phase isopropyl myristate, ethyl oleate and polyoxyethylene castor oil used in the latter have relatively high toxicity in injection administration.

Method used

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  • Oil-in-water submicron emulsion serving as vaccine adjuvant and preparation method thereof
  • Oil-in-water submicron emulsion serving as vaccine adjuvant and preparation method thereof
  • Oil-in-water submicron emulsion serving as vaccine adjuvant and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Embodiment 1: the preparation of oil-in-water type submicroemulsion

[0051] Under an inert gas environment, 50 g of squalene and 6.0 g of egg yolk lecithin (containing 80% phosphatidylcholine) were weighed, stirred and mixed evenly, as the oil phase.

[0052] Weigh 0.3 g of sodium oleate and 25 g of glycerin, add an appropriate amount of water for injection, stir and mix evenly, and use it as the water phase.

[0053] In an inert gas environment, the oil phase and the water phase are mixed, and the high-speed shear is continued to form colostrum. Add about 0.1ml of 1mol / L NaOH to adjust the pH value of colostrum to 5.0-10.0, and dilute to 1000ml with water for injection. Transfer to a high-pressure homogenizer for homogenization until the emulsion droplet size is reduced to a qualified level, after filtering, filling, autoclaving, and cooling to obtain the submicroemulsion vaccine adjuvant.

Embodiment 2

[0054] Embodiment 2: the preparation of oil-in-water type submicroemulsion

[0055] Under an inert gas environment, 50 g of squalene and 6.0 g of egg yolk lecithin (containing 80% phosphatidylcholine) were weighed, stirred and mixed evenly, as the oil phase.

[0056] Weigh 25g of glycerin, add an appropriate amount of water for injection, stir and mix evenly, and use it as the water phase.

[0057] In an inert gas environment, the oil phase and the water phase are mixed, and the high-speed shear is continued to form colostrum. Add about 0.1ml of 1mol / L NaOH to adjust the pH value of colostrum to 5.0-10.0, and dilute to 1000ml with water for injection. Transfer to a high-pressure homogenizer for homogenization until the emulsion droplet size is reduced to a qualified level, after filtering, filling, autoclaving, and cooling to obtain the submicroemulsion vaccine adjuvant.

Embodiment 3

[0058] Embodiment 3: the preparation of oil-in-water type submicroemulsion

[0059] Under an inert gas environment, 10 g of squalene and 0.5 g of egg yolk lecithin (containing 80% phosphatidylcholine) were weighed, stirred and mixed evenly, and used as the oil phase.

[0060] Weigh 20 g of glycerin, add an appropriate amount of water for injection, stir and mix evenly, and use it as the water phase.

[0061] In an inert gas environment, the oil phase and the water phase are mixed, and the high-speed shear is continued to form colostrum. Add an appropriate amount of 1mol / L KOH to adjust the pH value of the colostrum to 5.0-10.0, and dilute to 1000ml with water for injection. Transfer to a high-pressure homogenizer for homogenization until the emulsion droplet size is reduced to a qualified level, after filtering, filling, autoclaving, and cooling to obtain the submicroemulsion vaccine adjuvant.

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Abstract

The invention discloses an oil-in-water (O / W) submicron emulsion serving as a vaccine adjuvant. The O / W submicron emulsion is characterized by comprising (1) squalene or squalane, (2) an emulsifier and (3) auxiliary materials for injection, wherein the emulsifier is one or a mixture of soybean lecithin, egg yolk lecithin, hydrogenated soybean lecithin, hydrogenated egg yolk lecithin, polyethylene glycol-12-hydroxystearate, oleic acid and sodium oleate in any ratio. The invention further discloses a preparation method of the O / W submicron emulsion. By using the O / W submicron emulsion, the dosages of vaccines can be reduced, and adverse reactions are reduced. Moreover, the O / W submicron emulsion can be sterilized in an autoclaving manner, can be stored for a long time at 2-8 DEG C or at the room temperature, and is superior to the conventional O / W submicron emulsion adjuvant in safety and stability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oil-in-water submicroemulsion used as a vaccine adjuvant and a preparation method thereof. Background technique [0002] An adjuvant refers to a substance that is used simultaneously or in advance with an antigen and has no antigenicity itself, but can non-specifically enhance the immunogenicity of the antigen or change the type of immune response, thereby enhancing the immune response. In 1925, Ramon conducted a systematic study on this for the first time, and confirmed that in addition to the antigen itself, various components added to the vaccine are also important factors that cause immune responses. It was found that metal salts, starch, oil, vitamins, etc. Toxoid immune response. [0003] The mechanism of action of adjuvants has not been fully elucidated, and it is generally believed that they mainly work through the following mechanisms: (1) Targeting. By ta...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K9/107A61K47/24A61K47/34A61P37/04
Inventor 金方蔡伟惠邓家华
Owner SHANGHAI INST OF PHARMA IND
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