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Thermostable epidemic encephalitis B vaccine soluble microneedle delivery system

A delivery system and thermally stable technology, which can be applied in the direction of microorganisms, drug delivery, and resistance to vector-borne diseases. It can solve the problems of small drug loading, harmful residues, and difficulty in controlling the dosage of coated microneedles, and achieve vaccine stability. Excellent performance, good thermal stability, and good mechanical strength

Pending Publication Date: 2021-07-16
LIAONING CHENGDA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although solid solid microneedles and hollow microneedles are relatively simple to prepare, they will cause harmful residues if they are accidentally broken in the skin; coated microneedles have a small drug load and are difficult to control the dosage; in contrast, soluble microneedles have It has been extensively studied due to its advantages of large dose, self-dissolution when pierced into the skin, and no harmful residues.

Method used

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  • Thermostable epidemic encephalitis B vaccine soluble microneedle delivery system

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1 JE vaccine soluble microneedle preparation

[0023] The JE vaccine soluble microneedle to be prepared in the present invention includes a needle body and a backing, and the needle body is composed of the JE vaccine, a vaccine stabilizer and a suitable matrix material.

[0024] The preparation method of Japanese encephalitis vaccine soluble microneedle of the present invention is as follows:

[0025] The Japanese encephalitis vaccine, the vaccine stabilizer and the matrix material are mixed according to the prescription ratio, and deionized water is added to fully dissolve it to form a uniform needle body liquid. Take an appropriate amount of needle body liquid and pour it into the polydimethylsiloxane female mold, so that the needle body liquid is completely immersed in the hole of the female mold, and then put it into a high-speed centrifuge, set the speed at 4000r / min, and centrifuge for 5 minutes to make the microneedle solution fully Enter the female m...

Embodiment 2

[0026] Example 2 Relevant tests of JE vaccine soluble microneedles

[0027] 1. Characterization method of JE vaccine stability

[0028] The prepared microneedles were dissolved in 10 mL of deionized water, and the vaccine antigen content in the solution was detected by ELISA (enzyme-linked immunosorbent assay) method, which was recorded as the initial 0-month vaccine antigen content (vaccine stability was regarded as 100%) In addition, the various microneedles prepared in the same batch as above were stored in an environment with a temperature of 37°C for 1 month, and then the same ELISA method was used to detect the percentage of the antigen content of each microneedle vaccine relative to the initial time, and recorded is the percentage of vaccine antigen content.

[0029] When the Japanese encephalitis vaccine is stored in an environment with a temperature of 37°C for 1 month, the percentage of vaccine antigen content is still higher than 70%, which is considered to meet th...

Embodiment 3

[0036] The type of vaccine stabilizer of embodiment 3 is investigated on the influencing factors of vaccine stability

[0037] Set the mass ratio of microneedle matrix material and JE vaccine to a certain value, only change the type of vaccine stabilizer, and explore the influence of different vaccine stabilizers on the protective effect of JE vaccine in soluble microneedles.

[0038] The type of vaccine stabilizer is selected as one or more combinations of human albumin, polyvinylpyrrolidone (PVP), arginine, trehalose, and dextran, corresponding to experimental groups 2-11.

[0039] In this example, the preparation process of JE vaccine soluble microneedles is the same as Example 1. The test method for the stability of JE vaccine is shown in Example 2, and the test results are shown in Table 1.

[0040] Table 1. The impact of the type of vaccine stabilizer on vaccine stability (mean%±SD%, n=6)

[0041] No. vaccine stabilizer Antigen content percentage of JE vac...

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Abstract

The invention discloses a thermostable epidemic encephalitis B vaccine soluble microneedle delivery system, which comprises a needle body and a backing, the needle body is composed of an epidemic encephalitis B vaccine, a matrix material and a vaccine stabilizer, the vaccine stabilizer is a mixture of arginine and trehalose, and the content ratio of the epidemic encephalitis B vaccine to the vaccine stabilizer is 1:3. According to the epidemic encephalitis B vaccine soluble microneedle delivery system, the needle body medicine is excellent in thermal stability and good in mechanical strength, the skin barrier can be effectively punctured, and percutaneous delivery of the epidemic encephalitis B vaccine is achieved.

Description

technical field [0001] The invention relates to the technical field of JE vaccine administration, in particular to a thermally stable JE vaccine soluble microneedle delivery system and a preparation method thereof. Background technique [0002] Japanese encephalitis is an acute infectious disease caused by Japanese encephalitis virus and transmitted by mosquitoes. JE has a high mortality rate and disability rate, and is one of the main infectious diseases that threaten the health of the population, especially children. my country is a high-endemic area of ​​JE. In the 1960s and early 1970s, a large-scale epidemic occurred across the country. After the 1970s, with the widespread vaccination of JE vaccine, the incidence of JE has dropped significantly, and it has remained at a relatively low incidence in recent years. Level. It can be seen that the JE vaccine plays an important role in the prevention of JE epidemics. [0003] At present, inactivated whole virus vaccine produ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/12A61K9/00A61K47/18A61K47/26A61P31/14
CPCA61K9/0021A61K39/12A61K47/183A61K47/26A61P31/14C12N2770/36034Y02A50/30
Inventor 张庶民周荔葆马凤森廖辉刘苗苗修雪亮吴铮徐国标王一平杨文腰张伟
Owner LIAONING CHENGDA BIOTECH
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