Adjuvant-containing mite allergen soluble microneedle patch

An allergen and soluble technology, which is applied in the direction of allergen antigen components, microneedles, medical preparations containing active ingredients, etc., can solve problems such as difficult to learn, insufficient mechanical strength, limited vaccine volume, etc., and achieve good safety , Appropriate mechanical strength, good therapeutic effect

Pending Publication Date: 2021-10-26
微缔医药科技(杭州)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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 p

Method used

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  • Adjuvant-containing mite allergen soluble microneedle patch
  • Adjuvant-containing mite allergen soluble microneedle patch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1 Preparation of Mite Allergen Soluble Microneedles

[0030] The polydimethoxysiloxane female mold required for mite allergen-soluble microneedles was prepared by the inverted molding method. The mite allergen-soluble microneedles were prepared by centrifuging into a mold in two steps, and the microneedles were dried in an experiment box at 10°C, and demolded to obtain the finished soluble microneedle patch.

Embodiment 2

[0031] The screening of embodiment 2 adjuvant types

[0032] The proportion of the adjuvant in the total mass of the needle body is set to a certain value of 40%, the content of the mite allergen is 10%, and the content of the microneedle matrix material Gantrez AN is 50%. Only change the type of vaccine adjuvant, select microcrystalline tyrosine (MCT), oil emulsion (MF59), chitosan (CS), alfalfa polysaccharide (MSP), and investigate the different combinations of adjuvants shown in Table 1. The influence of microneedles on the therapeutic effect, the preparation method of the soluble microneedles involved in this example refers to Example 1 of the present invention.

[0033] Table 1. Dissolvable microneedle formulations containing different types of adjuvants

[0034] No. MCT MF59 CS MSP 1 - - - - 2 40% - - - 3 - 40% - - 4 - - 40% - 5 - - - 40% 6 20% 20% - - 7 20% - 20% - 8 20% - - 20% 9 - ...

Embodiment 3

[0049] The screening of the content ratio of each component in the compound adjuvant of embodiment 3

[0050] On the basis of Example 2, the difference in the influence of the content ratio of each component in the composite adjuvant on the microneedle performance and therapeutic effect was further investigated.

[0051] Set the proportion of the immune adjuvant in the total mass of the needle body to a certain value of 40%, the components of the composite adjuvant are fixed as MCT and MSP, the content of the mite allergen is 10%; the content of the microneedle matrix material is 50%. Only the content ratio of MCT and MSP was changed, and the effect of compound adjuvants with different content ratios as shown in Table 3 on the mechanical strength of microneedles and the therapeutic effect of mite allergens was investigated.

[0052] For the preparation method of soluble microneedles involved in this example, refer to Example 1 of the present invention. For the detection meth...

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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...

Claims

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Application Information

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IPC IPC(8): A61K39/35A61K39/39A61K9/00A61P37/08A61P11/06A61M37/00
CPCA61K39/35A61K39/39A61K9/0021A61P37/08A61P11/06A61M37/0015A61K2039/55511A61K2039/55583A61M2037/0053A61M2037/0046
Inventor 不公告发明人
Owner 微缔医药科技(杭州)有限公司
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