Meningococcal polysaccharide conjugate vaccine soluble microneedle patch and preparation method thereof

A combined vaccine and soluble technology, applied in the field of transdermal drug delivery, can solve the problems of inaccurate dosing and uncontrollable drug release rate, and maximize drug utilization efficiency, controllable drug release rate, and simple and convenient use. Effect

Active Publication Date: 2017-09-15
GUANGZHOU NEWORLD PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the application of microneedle transdermal immune patches mainly uses microneedle arrays to pierce the skin to form channels and then remove them, and then apply vaccine liquid or ordinary transdermal preparations on the treatment site; or wrap the surface of microneedles The film coating with drugs will bring the drugs into the body when the microneedles penetrate the skin to improve the absorption rate of the drugs; the above two methods have problems such as inaccurate dosage and uncontrollable drug release speed, so it is necessary for a The study of a dissolvable microneedle immune patch with accurate dosage and controllable drug release rate is very prospective

Method used

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  • Meningococcal polysaccharide conjugate vaccine soluble microneedle patch and preparation method thereof
  • Meningococcal polysaccharide conjugate vaccine soluble microneedle patch and preparation method thereof
  • Meningococcal polysaccharide conjugate vaccine soluble microneedle patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] The preparation of embodiment 1 microneedle mold

[0055] (1) Preparation of the male mold: use computer-aided design (CAD) to design the shape, height, spacing, and density of the microneedle arrays of the male mold. The specific specifications of the mold are: the height of the microneedles is 800 μm, and the pitch 900μm, needle bottom diameter 300μm, array 10×10 rows, 100 tapered microneedles, microneedle array size 1cm×1cm, the number of microneedle arrays can be adaptively designed according to the size of the mold. Transform design drawings into digital information of digital machine tools through digital-to-analog conversion, and select brass and stainless steel as processing materials to process and shape according to the design size; figure 1 shown.

[0056] (2) Preparation of the female mold: Place the prepared brass and stainless steel male molds in absolute ethanol, ultrasonically clean the organic cooling liquid remaining on the surface during the preparat...

Embodiment 2

[0058] In this example, the effect of different contents of the A+C meningococcal meningitis polysaccharide conjugate vaccine on the mechanical properties of the microneedles was investigated.

[0059] (1) Preparation of different doses of meningococcal polysaccharide-conjugated vaccine microneedle needle tip liquid: take A+C group meningococcal polysaccharide-conjugated vaccine and dilute it with deionized water to be 50mg / ml, 40mg / ml, 30mg / ml, 20mg / ml respectively , 15mg / ml, 10mg / ml, 5mg / ml of seven different concentrations of A+C meningococcal meningococcal polysaccharide conjugated vaccine, draw 2.0ml of the vaccine solution of the above six concentrations respectively, add sodium hyaluronate 0.55g, dextran 40 (DEX40) 0.40g, povidone K30 (PVP K30) 0.05g, vortex and mix well, after fully swelling, let stand overnight to dissolve, and then get soluble microneedle tip liquid (sodium hyaluronate: dextran 40: povidone The mass ratio of K30:water is 11:8:1:40). The added sodium...

Embodiment 3

[0087] In this example, through the comparative study of two different administration methods of soluble microneedle transdermal immunization and injection immunization, the difference in immune effect between the soluble microneedle transdermal immunization method and the subcutaneous injection immunization method was evaluated. At the same time, the influence of soluble microacupuncture with different needle heights on the immune effect is investigated, which mainly includes the following steps:

[0088] In this embodiment, the molecular weight of sodium hyaluronate is 7775, the molecular weight of dextran 40 is 37000, and the molecular weight of povidone K30 is 40000.

[0089] (1) Preparation of a control group injected with meningitis polysaccharide conjugated vaccine:

[0090] Group A+C meningococcal polysaccharide conjugated vaccine injection control group (CI1): take 5 bottles each of group A meningococcal polysaccharide conjugated vaccine freeze-dried powder and group ...

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Abstract

The invention relates to a meningococcal polysaccharide conjugate vaccine soluble microneedle patch and a preparation method thereof. The soluble microneedle patch comprises a soluble microneedle substrate and soluble microneedle bodies, wherein the soluble microneedle substrate is prepared from an aqueous solution of a first water-soluble high-polymer material, and the soluble microneedle bodies are prepared from an aqueous solution of a second water-soluble high-polymer material and a group A+C meningococcal polysaccharide conjugate vaccine; the percentage by weight of the group A+C meningococcal polysaccharide conjugate vaccine in the soluble microneedle bodies is not greater than 8 percent, and is not 0; the second water-soluble high-polymer material is prepared from sodium hyaluronate, dextran and povidone, and the molecular weight of the water-soluble high-polymer material is 7000 to 630000. The soluble microneedle patch has good mechanical properties and solubility, and the effect of regulating the immune response of the vaccine is better than the effect of a subcutaneous injection immunization method under the same condition.

Description

technical field [0001] The invention relates to the technical field of transdermal administration, in particular to a soluble microneedle patch and a preparation method thereof. Background technique [0002] Vaccination has become the most effective and main means to prevent and treat large-scale infectious diseases, hypersensitivity diseases and autoimmune diseases. Polysaccharide-conjugated vaccines are currently the most advanced component vaccines and are a hot spot in vaccine research. Meningococcal meningitis is a purulent meningitis caused by Neisseria meningitides (Nm)bacteria. It is a serious public health problem worldwide. The problem is that it can cause epidemic meningitis, which has a high fatality rate and disability rate. It is widely distributed and the number of meningitis cases in the world can reach 300,000 to 350,000 per year. The pathogen has been discovered for more than 100 years. According to different geographical distributions and epidemic potent...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/095A61K39/116A61K9/70A61K47/36A61K47/32A61P31/04A61M37/00
CPCA61K39/095A61K47/32A61K47/36A61M37/0015A61K9/0021A61K9/7023A61K2039/70A61M2037/0023A61M2037/0046A61M2037/0053A61M2037/0061Y02A50/30
Inventor 陈航平李革任春艳张敏敏郑腾羿
Owner GUANGZHOU NEWORLD PHARMA CO LTD
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