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Thermally-stable hepatitis A vaccine soluble microneedle patch and preparation method thereof

A thermally stable and soluble technology, applied in biochemical equipment and methods, microneedles, medical preparations of non-active ingredients, etc., to achieve moderate mechanical strength and good thermal stability

Pending Publication Date: 2020-01-14
LIAONING CHENGDA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, there are still many uncertainties in the development of hepatitis A vaccine soluble microneedles by referring to the prescription of hepatitis B vaccine soluble microneedles

Method used

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  • Thermally-stable hepatitis A vaccine soluble microneedle patch and preparation method thereof
  • Thermally-stable hepatitis A vaccine soluble microneedle patch and preparation method thereof
  • Thermally-stable hepatitis A vaccine soluble microneedle patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1 Preparation method of hepatitis A vaccine soluble microneedle female mold

[0030] Such as figure 1 , the present invention adopts photolithography and etching process in conjunction with inverted mold method to prepare the negative mold of hepatitis A vaccine microneedle, and the steps are as follows:

[0031] 1) Preparation of monocrystalline silicon positive mold microneedles

[0032] The positive mold microneedles were prepared by photolithography and etching processes. The microneedles are listed as 5*5, the height of each microneedle is 400 μm, the diameter of the bottom of the needle is 200 μm, and the diameter of the tip is 20 μm.

[0033] 2) Preparation of polysiloxane mold

[0034] Mix the polysiloxane and the curing agent at a mass ratio of 6:1, and pour it into a cuboid container with a single crystal silicon positive mold microneedle; place the container in a vacuum drying oven, and evacuate it for 3 minutes at a vacuum degree of 0.1MPa , so th...

Embodiment 2

[0035] The preparation of embodiment 2 hepatitis A vaccine microneedles

[0036] Such as figure 2 , the present invention adopts secondary vacuum molding method to prepare hepatitis A vaccine microneedles, and the steps are as follows:

[0037] 1) After mixing the matrix material, vaccine stabilizer and hepatitis A vaccine according to the prescription ratio, dissolve it with an appropriate amount of solvent (deionized water) to form a uniform mixture (i.e. needle body fluid), take an appropriate amount of needle body fluid into a centrifuge tube, and place in a centrifuge Precipitator, centrifuge to remove the air bubbles in the needle body fluid, and let it stand for later use.

[0038] 2) Take the needle body fluid obtained after centrifugation in step 1), pour it on the polysiloxane mold prepared in Embodiment 1 of the present invention, then place the polysiloxane mold in a vacuum drying oven, and put it in a vacuum degree of 0.1 MPa for 3 minutes, so that Inject the n...

Embodiment 3

[0041] The impact of embodiment 3 different vaccine stabilizers on the stability of hepatitis A vaccine

[0042] Assuming that the proportion of the vaccine stabilizer in the total mass of the needle is a certain value, only the components of the vaccine stabilizer are changed, and the effects of single or different combinations of the vaccine stabilizer on the stability of the hepatitis A vaccine in the microneedles are investigated. Influence, the preparation method of the microneedle and negative mold involved in this embodiment refers to Embodiment 1 and Embodiment 2 of the present invention.

[0043] Characterization method of vaccine stability in microneedles: the microneedles prepared according to the prescriptions in Table 1 were dissolved in 10 mL of deionized water at 37° C., and the vaccine antigen content in the solution was detected by ELISA (enzyme-linked immunosorbent assay). Record it as the vaccine antigen content in the initial month 0 (vaccine stability is r...

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Abstract

The invention provides a thermally-stable hepatitis A vaccine soluble microneedle patch, which includes a needle body and a backing. The needle body is composed of a hepatitis A vaccine, a matrix material and a vaccine stabilizer, wherein the vaccine stabilizer is a mixture of polyvinylpyrrolidone and dextran; and the content ratio of the vaccine stabilizer to the hepatitis A vaccine is (2: 1)-(5:1). The hepatitis A vaccine soluble microneedle patch prepared in the invention has good thermal stability of the needle body medicine and moderate mechanical strength, and can effectively penetratethe skin.

Description

technical field [0001] The invention relates to the technical field of vaccine microneedle administration, and provides a thermally stable hepatitis A vaccine soluble microneedle patch and a preparation method thereof. Background technique [0002] Viral hepatitis A, referred to as hepatitis A, is caused by hepatitis A virus and is an infectious disease mainly caused by liver inflammation. , the current effective measure to prevent the disease is the use of hepatitis A vaccine. The current hepatitis A vaccine is generally administered through needle injection, which has poor patient compliance. Therefore, a new route of vaccine administration is urgently needed. Compared with the injection route, oral administration still has limitations, especially for biomacromolecular drugs, which are easily affected by proteases in the gastrointestinal tract and the first-pass effect of the liver, resulting in reduced bioavailability. In addition to injection and oral routes, the field...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/12A61K9/70A61K47/32A61K47/26A61P31/14A61M37/00
CPCA61K9/0021A61K9/703A61K39/12A61K47/32A61K47/26A61P31/14A61M37/0015C12N2770/32434A61M2037/0053
Inventor 张庶民马凤森周荔葆廖辉陈中秋刘苗苗吴铮辛小韵
Owner LIAONING CHENGDA BIOTECH
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