Adjuvant-containing mite allergen soluble microneedle patch

Abstract

The invention discloses an adjuvant-containing mite allergen soluble microneedle patch. The adjuvant-containing mite allergen soluble microneedle patch comprises a needle body and a backing, wherein the needle body comprises a mite allergen, a composite adjuvant and a matrix material; the composite adjuvant is a mixture of microcrystalline tyrosine and alfalfa polysaccharide; and the content ratio of the microcrystalline tyrosine to the alfalfa polysaccharide is (2:1)-(1:2). According to the mite allergen soluble microneedle patch provided by the invention, by selecting the appropriate type and content of the composite adjuvant and the mass ratio of the matrix material in the needle body, the prepared mite allergen soluble microneedle patch is appropriate in mechanical strength, good in treatment effect and excellent in safety.

Description

technical field [0001] The invention relates to the technical field of administration of mite allergens, in particular to an adjuvanted mite allergen soluble microneedle patch. Background technique [0002] Allergic asthma is a relatively stubborn disease, mostly onset in infants and young children. Chronic bronchitis, pulmonary interstitial fibrosis, obstructive emphysema and chronic pulmonary heart disease may be complicated by allergic asthma for a long time Wait. If neglected, it can last a lifetime. The prevalence of asthma in China is about 1%, and children can reach 3%. According to estimates, there are more than 10 million asthma patients in the country. The main allergies that cause allergic asthma include pollen, house dust, mites, animal dander, etc. Among them, mite allergen is one of the most widely distributed and typical allergens in the world. [0003] At present, desensitization treatment mainly includes subcutaneous injection desensitization and sublingu...

AI Technical Summary

Problems solved by technology

[0008] For example, the Chinese patent with publication number CN 1733299A has prepared a sublingual mite allergen vaccine with chitosan as an adjuvant, but the disadvantages of this scheme are: 1. sublingual preparation and microneedle preparation The preparation method is very different, it is difficult to learn from; ② the patent only mentions in Example 5 that the chitosan-Dermatophagoides farinae allergen treatment group has a good immunotherapy asthma effect, but there is no experimental data or chart ③The applicant found in the preliminary experiment that chitosan was used as an adjuvant to load mite allergens, and the prepared soluble microneedles had "insufficient mechanical strength and could not effectively penetrate into the skin of experimental animals (pigs). "Defects

[0012] For example, in the patent of Publication No. JP 2014156433A, soluble microneedles are used as a tool for allergen testing such as mites, but there is no specific example to prepare soluble microneedles for mite allergens, so it is difficult to learn from

[0013] Another example is the document "Coated microneedle-based cutaneous immunotherapy prevents Der p 1-induced airway allergy in mice" which coats the dust mite allergen Der p 1 and the adjuvant CpG on the microneedles, but the disadvantages of this scheme are: ① coating The drug loading capacity of the microneedle is small, so that the amount of vaccine loaded into the microneedle is very limited; ②The coated microneedle is easy to passivate the microneedle as the number of coatings increases, so there is a problem that the microneedle cannot penetrate effectively ③ Although the adjuvant CpG enhanced the immunogenicity of Der p1, there was no significant difference, see Figure 1H of this document (Akhilesh, Kumar, Shakya, et al. Coated microneedle-based cutaneous immunotherapy prevents Der p 1-induced airway allergy in mice. [J]. Journal of Allergy & Clinical Immunology, 2018.)

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