Preparation method of soluble microneedle patch for rabies vaccine

Abstract

The invention provides a preparation method of a soluble microneedle patch for a rabies vaccine. A structure of the microneedle patch is composed of a needle body and a back lining. The method comprises the following steps: (1) preparing a PDMS transverse mould by a UV-LIGA method; (2) preparing the needle body by an injection molding drying method; (3) preparing the back lining by the injection molding drying method; and (4) carrying out spliced assembling of the needle body obtained in the step (2) and the back lining obtained in the step (3), and thus obtaining the product. The invention provides the preparation method of the soluble microneedle patch for the rabies vaccine; the assembly method is flexible, the density and shape of the microneedle patch are controllable; the soluble microneedle with a needle body structure with large upper part and small lower part can be prepared, has better mechanical performance, can effectively stab or peel skin, and ensures full vaccination ofthe rabies vaccine.

Description

technical field [0001] The invention relates to the technical field of microneedle administration of vaccines, and provides a preparation method of a rabies vaccine soluble microneedle patch. Background technique [0002] Rabies, also known as hydrophobia, is a zoonotic disease caused by rabies virus. This disease is an acute infectious disease that mainly invades the central nervous system. Once it occurs, the mortality rate is as high as 100%. Rabies poses a serious threat to people's life and health. Human rabies is usually transmitted to the human body through the bite of a sick animal. The clinical manifestations are unique fear of water, sound, wind, fear, pharyngeal muscle spasm, and progressive paralysis. Although it is an ancient disease, humans have not been able to eradicate it to this day. Rabies vaccine is a vaccine with a long history. After rabies vaccination, anti-rabies virus antibodies can appear in human blood. These antibodies can prevent the direct tr...

AI Technical Summary

Problems solved by technology

The disadvantages of microneedles with this type of structure are as follows: ①Since the skin of the human body is elastic, the microneedles will be subjected to multi-directional forces after being inserted into the skin, causing them to be extruded outward, resulting in the small upper and lower large microneedles being easily absorbed by the skin. Squeeze out, which is not conducive to precise drug delivery; ②The drug characteristics of rabies vaccine determine that it must be fully vaccinated, and 100% of the effect can be effective. This type of microneedle structure does not completely penetrate the skin during transdermal administration, and the part of the drug-containing needle body Residual Drug Hazards

Although the patent prepares a two-stage microneedle array, like the traditional one-piece microneedles containing medicine and the substrate, the preparation principle still adopts the inversion method, so there are the following technical deficiencies: ① The mold used in the inversion method belongs to Longitudinal mold, that is, the shape of the needle body on the mold is vertically arranged with a small top and a large bottom, so there must be hidden dangers such as easy breakage of the needle body and uneven height of the microneedle during drying and demoulding; The density and shape of the microneedles are fixed. If you want to increase the drug loading capacity of the microneedles, you can only adjust the number of microneedles on the mold by re-cutting the mold, which is time-consuming and laborious and greatly increases the manufacturing cost.

[0009] Trendy 3D printing methods, such as two Chinese invention patents with publication numbers CN105797266A and CN107320841A, both provide a method for preparing microneedles with 3D printing technology. Although this method can adjust the density of microneedles, it is also There are the following technical deficiencies: ①It is mostly used to prepare upper, lower, and lower large microneedles, and there is also the possibility of drug residues when the rabies vaccine microneedles are pierced or peeled off the skin, which cannot ensure complete vaccination of rabies vaccines; ②The molds used It still belongs to the longitudinal mold, and there are hidden dangers such as easy breakage of the needle body and uneven height of the microneedles like the traditional inverted mold method; ③ only suitable for several specific matrix materials, high manufacturing cost, and poor versatility

[0010] In summary, how to realize a process that can prepare small microneedle structures with upper, lower, and lower parts to solve the technical bottleneck that the existing soluble microneedle patches and their preparation methods are not suitable for loading rabies vaccines is what the present invention intends to solve key problem

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