Preparation method of soluble microneedle patch for rabies vaccine

A rabies vaccine and micro-needle sticker technology, applied in the directions of micro-needles, needles, and medical devices, can solve the problems of easy breakage of the needle body, increased manufacturing costs, residues, etc., and achieves flexible assembly methods, excellent mechanical properties, and flexible shapes. control effect

Inactive 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 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 mic

Method used

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  • Preparation method of soluble microneedle patch for rabies vaccine
  • Preparation method of soluble microneedle patch for rabies vaccine
  • Preparation method of soluble microneedle patch for rabies vaccine

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0038] Example 1 Preparation of Rabies Vaccine Soluble Microneedle Patch

[0039] (1) Preparation of PDMS horizontal mold by UV-LIGA method

[0040] First, mix PDMS and curing agent uniformly at a mass ratio of 10:1, place them in a vacuum drying oven, and vacuum for 5 minutes at a vacuum degree of 0.08Mpa to remove bubbles in the solution, and then stand for use;

[0041] Second, prepare a silicon substrate, sputter a layer of nickel on the silicon substrate, and pre-process it to ensure absolute cleanliness;

[0042] Then, a layer of 100μm thick SU-8 glue is thrown on the pre-processed silicon substrate, and the mask is used for photolithographic development. The shape of the mask is the same as the shape of the needle body of the microneedle;

[0043] Finally, pour the previously evacuated PDMS solution, place it in an oven, dry it at 60°C for 5 hours and then take it out, and then demold the PDMS horizontal mold.

[0044] The shape of the needle in the present invention can be such a...

Example Embodiment

[0056] Example 2 Comparison of needle types of microneedles prepared by different preparation methods

[0057] The soluble microneedles were prepared according to the method of Example 1 of the present invention and the traditional reverse mold method, and the prepared soluble microneedles were all placed under a scanning electron microscope to measure and calculate the average height of the microneedles after demolding, and obtain the high uniformity Under the premise (no significant difference, P greater than 0.05) the percentage of microneedles, the height of the two molds are both 500μm, the number of needles are both 50, and there are 20 parallel. The calculation results are shown in Table 1.

[0058] Table 1 Investigation of the high uniformity of microneedles with different preparation methods

[0059] Preparation Traditional moulding Method of the invention Average height of microneedle (μm)446.5*486.7* Highly uniform acquisition rate (%)65100

[0060] *Refers to the h...

Example Embodiment

[0062] Example 3 Comparison of microneedles prepared by different preparation methods in skin penetration and peeling experiments

[0063] Prepare rabies vaccine soluble microneedle patches with the same number of needles and the same backing area according to the down-mold method, 3D printing method, and the method of Example 1 of the present invention. The soluble microneedle patches prepared by the three methods are pierced with an applicator. Into the isolated pig skin to ensure that all three microneedles have penetrated the skin. One minute after the administration, the backing layer of the microneedles was peeled off, and the conditions of the microneedles and the backing layer after peeling were observed.

[0064] The observation results are shown in Table 2. It can be seen from Table 2 that all the needles are left in the skin only by the method of the present invention, indicating that the rabies vaccine can be completely vaccinated.

[0065] Table 2 Summary table of solu...

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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...

Claims

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Application Information

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IPC IPC(8): A61M37/00
CPCA61M37/0015A61M2037/0053
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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