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

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 ...

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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 and composite materials for the construction of soluble microneedles" (Zhang Jie, Ma Fengsen, Zhan Haohui et al., Materials Herald, 2017,31(19):129-134.) It can be seen that the matrix materials for constructing soluble microneedles can be divided into tough materials and brittle materials according to the mechanical properties of the materials. The combination will lead to differences in the mechanical properties and intradermal dissolution properties of the vaccine soluble microneedles. Therefore, it is still full of uncertainties to use the existing trivalent influenza vaccine microneedle prescriptions for the development of quadrivalent influenza virus vaccine microneedles.

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