Four-strain flu vaccine soluble microneedle patch and preparation method thereof

An influenza virus, soluble technology, applied in the field of quadrivalent influenza virus vaccine soluble microneedle patch and its preparation, can solve the mechanical properties of vaccine soluble microneedle, the difference in intradermal dissolution performance, the inability of microneedle tip to effectively pierce the skin, the physical and chemical properties of vaccine There are differences in properties, etc., to achieve the effects of good stability, fast onset, and moderate mechanical strength of the needle body

Pending Publication Date: 2019-09-03
LIAONING CHENGDA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantage of this technical solution is that since both PVA and sucrose are ductile materials, the mechanical strength may be insufficient compared to brittle materials, so there is a hidden danger that the tip of the microneedle cannot effectively puncture the skin. Matrix materials and their composite materials" (Zhang Jie, Ma Fengsen, Zhan Haohui, etc., Materials Herald, 2017, 31(19): 129-134.)
[0008] It is well known that the composition of the quadrivalent influenza virus vaccine has changed compared with the trivalent influenza vaccine, resulting in differences in the physical and chemical properties of the vaccine. According to the literature "Matrix materials an

Method used

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  • Four-strain flu vaccine soluble microneedle patch and preparation method thereof
  • Four-strain flu vaccine soluble microneedle patch and preparation method thereof
  • Four-strain flu vaccine soluble microneedle patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0036] Example 1 The negative mold preparation of quadrivalent influenza virus vaccine microneedles

[0037] like figure 1 , the present invention adopts the laser drilling method to prepare the negative mold of the quadrivalent influenza virus vaccine microneedle, and the steps are as follows:

[0038] 1) Preparation of PDMS mold

[0039] After mixing the polydimethoxysiloxane (PDMS) and the curing agent in a mass ratio of 10:1, pour it into a rectangular parallelepiped container; place the container in a vacuum drying box, and vacuumize for 5 minutes at a vacuum degree of 0.08 MPa to make the mixing The air bubbles in the liquid are removed; then put in an oven, dried at 60° C. for 5-10 hours, and then taken out to obtain a formed PDMS mold.

[0040] 2) Laser drilling PDMS mold

[0041] Use a carbon dioxide laser engraving machine to drill holes on the PDMS mold obtained in step 1) to obtain a negative mold that can be used for preparing quadrivalent influenza virus vacci...

Example Embodiment

[0043] The preparation of embodiment 2 quadrivalent influenza virus vaccine microneedle

[0044] like figure 2 In the present invention, the quadrivalent influenza virus vaccine microneedle is prepared by a secondary vacuum mold-in method, and the steps are as follows:

[0045] 1) After mixing Gantrez S-97, CS, trehalose, and quadrivalent influenza virus vaccine according to the prescribed proportion, dissolve and mix with solvent (deionized water) respectively to form a uniform needle body fluid, take an appropriate amount of needle body fluid and put it into a centrifuge tube, Placed in a centrifugal precipitation device, centrifuged to remove air bubbles in the needle fluid, and set aside for later use.

[0046] 2) Take the needle body fluid obtained after centrifugation in step 1), pour it on the PDMS mold prepared in the implementation 1 of the present invention, and then place the PDMS mold in a vacuum drying box, and vacuumize for 5 minutes at a vacuum degree of 0.08 MP...

Example Embodiment

[0050] Example 3 Experiment on the influence of the components of the matrix material on the performance of the microneedles

[0051] Assuming that the proportion of the matrix material in the total mass of the needle body is a certain value, only the composition of the matrix material is changed, and the influence of different combinations of matrix materials on the performance of the microneedle as shown in Table 1 is investigated. The microneedle involved in this example For the negative mold, the preparation method thereof refers to Example 1 and Example 2 of the present invention.

[0052] Table 1 Microneedle formulations composed of different matrix material components

[0053] No Matrix material trehalose Quadrivalent influenza virus vaccine 1 40% PVP 15％ 45％ 2 40% Gantrez S-97 15％ 45％ 3 40% CS 15％ 45％ 4 40% PVA 15％ 45％ 5 20% PVP + 20% Gantrez S-97 15％ 45％ 6 20% CS+20% PVA 15％ 45％ 7 20% Gantrez S-97 +...

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Abstract

The invention provides a four-strain flu vaccine soluble microneedle patch comprising a needle body and a backing. The needle body is composed of a matrix material, a heat-resistant protective agent,a four-strain flu vaccine and a solvent. The matrix material is a mixture of at least two of a methyl vinyl ether-maleic anhydride copolymer, chondroitin sulfate, polyvinyl alcohol and polyvinyl pyrrolidone; the heat-resistant protective agent is trehalose, the solvent is deionized water. The prepared four-strain flu vaccine soluble microneedle patch has moderate mechanical strength of the needlebody and can effectively penetrate skin, and the vaccine is dissolved quickly in the skin; moreover, the prepared microneedle has good long-term stability of the vaccine in the needle body.

Description

technical field [0001] The invention relates to the technical field of microneedle administration of vaccines, and provides a quadrivalent influenza virus vaccine soluble microneedle patch and a preparation method thereof. Background technique [0002] Influenza is an acute respiratory infection caused by influenza, and it is also a highly contagious and fast-spreading disease. It is mainly spread through airborne droplets, person-to-person contact or contact with contaminated objects. The current influenza vaccines are generally administered by needle injection, and patient compliance is poor. Therefore, a new type of vaccine administration route is urgently needed. Human skin is the largest organ of the human body, and the epidermis is rich in antigen-presenting cells. For example, Langerhans cells in the epidermis account for 3%-5% of all epidermal cells. However, the stratum corneum barrier of the skin makes the delivery of macromolecular drugs and water-soluble small ...

Claims

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Application Information

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IPC IPC(8): A61K39/145A61K39/295A61K9/00A61K47/26A61K47/36A61K47/32A61P31/16
CPCA61K39/12A61K9/0021A61K47/26A61K47/36A61K47/32A61P31/16C12N2760/16134C12N2760/16234A61K2039/70
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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