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Two-stage type microneedle array patch capable of simultaneously realizing BCG vaccine inoculation and diagnosis, and preparation method thereof

A microneedle array and needle array technology, applied in the field of biomedical engineering, can solve problems such as unbearable pain, cold chain storage and transportation, and high risk of infection

Pending Publication Date: 2020-12-04
中山大学深圳
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to overcome the disadvantages of the above-mentioned existing intradermal injection of BCG and tuberculin into human skin, such as unbearable pain, difficult operation, easy failure, high risk of infection, cold chain storage and transportation, etc. The two functions of BCG vaccination and the diagnosis of whether the vaccination is successful greatly improve the success rate of BCG vaccination and diagnosis

Method used

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  • Two-stage type microneedle array patch capable of simultaneously realizing BCG vaccine inoculation and diagnosis, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] An embodiment of the microneedle array patch of the present invention, see figure 1 , the microneedle array drug patch described in this embodiment includes a microneedle array and a drug patch, and the microneedle array is placed on the drug patch; the microneedle of the microneedle array includes a soluble drug-loaded microneedle tip 1 and an insoluble microneedle The support end 2; the tip 1 of the soluble drug-loaded microneedle is prepared by mixing BCG, tuberculin microspheres, and soluble excipients through freeze-drying. The microneedle tip 1 is placed on the insoluble microneedle support end 2, the microneedle array base 3 is the insoluble microneedle array base, and the insoluble microneedle support end 2 is located on the surface of the microneedle array base 3; the patch includes a pressure-sensitive adhesive tape 4 and The absorption gasket 5 and the pressure-sensitive adhesive tape 4 are used for pasting the skin and the microneedle array; the hollow part ...

Embodiment 2

[0042] The process of using the microneedle array patch of the present invention is as follows:

[0043] First, remove the sliced ​​medical sponge in the microneedle array patch, and stick the pressure-sensitive tape on the skin, and the whole microneedle array patch is directly pasted on the skin.

[0044] Secondly, press the patch with an appropriate force (no pain is appropriate), stop pressing for 2 minutes, and use the pressure-sensitive tape of the microneedle array patch to fix the depth of the microneedle array piercing into the skin, and the tip of the soluble drug-loaded microneedle Dissolution occurs intradermally.

[0045] Again, tear off the patch after 15 minutes. At this time, the tip of the soluble drug-loaded microneedle completely dissolves and stays in the skin, leaving tiny pores in the stratum corneum of the skin. After about 24 hours, it is completely healed, and the BCG vaccination is completed.

[0046] Finally, in the PPD test, after 3 months, lightly...

Embodiment 3

[0048] Storage stability test of the two-stage microneedle array patch of the present invention

[0049] The two-stage microneedle array patch prepared in Example 1 was placed at room temperature (10-30°C) for 12 months, dissolved in a buffer solution, and the BCG and Mycobacterium tuberculosis contained in the tip of the soluble drug-loaded microneedle were detected Su vitality.

[0050] Among them, BCG was incubated and cultured for 4 weeks, and the number of viable bacteria was detected by a cell counter, and the nucleic acid content of tuberculin was detected by ultraviolet-visible spectrophotometry. The two-stage microneedle array patch just prepared was used as a control to compare the solubility The viable count of BCG contained in the tip of the drug-loaded microneedle and the nucleic acid content of tuberculin.

[0051] The results showed that the number of BCG viable bacteria and the nucleic acid content of tuberculin in the two-stage microneedle array patch that ha...

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Abstract

The invention discloses a two-stage type microneedle array patch capable of simultaneously realizing BCG vaccine inoculation and diagnosis. The two-stage type microneedle array patch comprises a microneedle array and a patch; the microneedle array is arranged on the patch; the microneedle comprises a soluble drug-loaded microneedle tip and an insoluble microneedle supporting end; the soluble drug-loaded microneedle tip is prepared by mixing a BCG vaccine, tubercle bacillus element microspheres and soluble auxiliary materials and performing freeze drying; and the tubercle bacillus element microspheres are prepared by combining slow-release auxiliary materials and tubercle bacillus elements. The BCG vaccine and the tubercle bacillus elements are gathered at the soluble microneedle drug-loaded tip at the same time; and the release time of the tubercle bacillus elements is controlled through a slow-release microsphere technology, so that two drug administration purposes of inoculating theBCG vaccine and diagnosing whether the BCG vaccine is successfully inoculated or not can be achieved through one-time drug administration. The invention further discloses a preparation method of the patch.

Description

technical field [0001] The invention relates to the technical field of biomedical engineering, and more specifically, relates to a two-stage microneedle array patch for simultaneously realizing BCG vaccination and diagnosis thereof and a preparation method thereof. Background technique [0002] BCG is currently the only vaccine approved for use against tuberculosis. The prevalence of tuberculosis can be well controlled by expanding the scope of BCG vaccination of newborns. BCG vaccination is currently administered to newborns by intradermal injection with a syringe. This intradermal injection usually requires skilled medical personnel and is often unreliable. , usually about 5% of BCG vaccinations are injected subcutaneously, resulting in vaccination failure and purulent infection. This intradermal injection method is also a risk for BCG vaccinators or medical staff. In addition, whether the BCG vaccination is successful usually requires intradermal injection of tuberculin ...

Claims

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Application Information

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IPC IPC(8): A61K39/04A61K9/70A61K47/36A61P31/06A61K49/00A61M37/00A61B5/00
CPCA61K39/04A61K9/7023A61K9/0021A61K47/36A61P31/06A61K49/0006A61M37/0015A61B5/4848A61M2037/0046A61M2037/0053A61M2037/0061Y02A50/30
Inventor 刘彬江克刚蒋乐伦
Owner 中山大学深圳
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