Sublingual temperature-sensitive gel containing mite allergen and preparation method of sublingual temperature-sensitive gel

Abstract

The invention discloses a sublingual temperature-sensitive gel containing mite allergen. The sublingual temperature-sensitive gel is composed of mite allergen, a cationic monomer and a temperature-sensitive gel material, wherein the content ratio of the cationic monomer to the temperature-sensitive gel material is (1:2)-(1:1). According to the sublingual temperature-sensitive gel containing mite allergen, the sublingual temperature-sensitive gel is provided on the basis of a common sublingual drop containing mite allergen, the advantage of convenience in administration of the sublingual drop is maintained, the retention time of a vaccine under the tongue is prolonged, and the drug effect is improved; the gelling time of the temperature-sensitive gel is shortened, the loss caused by swallowing in the administration process is reduced, and the dosage is reduced; and the thermo-sensitivity of the temperature-sensitive gel to adsorb protein is overcome, the adsorption of the gel to the protein in a liquid state is improved, and then the dosage is reduced.

Description

technical field [0001] The invention relates to the technical field of administration of mite allergens, in particular to a sublingual thermosensitive gel containing mite allergens and a preparation method thereof. Background technique [0002] Allergy is considered by the World Health Organization (WHO) to be a major global health problem at present, and the incidence rate of allergy is very high. According to literature reports, about 1 / 3 of people have suffered from allergic diseases in their lifetime. According to the data of WHO, 22% to 25% of people in the world suffer from allergic diseases at present, and the rate of increase is 23 times every 10 years. At present, there are more than 200 million people in my country alone suffering from allergic diseases. Therefore, allergy and anti-allergy are unavoidable serious problems faced by modern people. The allergens that cause allergic reactions mainly include dust mites, pollen, dust, catkins, animal dander, etc., and m...

AI Technical Summary

Problems solved by technology

[0006] The Chinese patent with publication number CN102014954A discloses a mucosal allergen-specific immunotherapy using seasonal allergens, and proposes the idea of ​​developing pollen allergens into solid dosage forms (including sublingual gel preparations), However, the disadvantages of this patent are: ① only the pollen allergen sublingual gel is proposed, and the retention problem of the gel has not yet been solved; ② whether quantitative administration can be achieved when the gel is administered , have no way of knowing

[0007] The Chinese patent with the publication number CN1840190A discloses a pharmaceutical composition for treating allergic diseases. The composition contains dust mite allergens, pollen allergens and pharmaceutically acceptable carriers. The composition can be developed into sublingual But the weak point of this technology is: from the preparation of the sublingual buccal preparation of its embodiment 4, it can be known that it is a drop, and there is the defect of "the residence time of sublingual mucosa is short, and the treatment effect of mite allergen is poor".

However, the technical deficiencies of this literature are as follows: ① DmLT is used as the adjuvant of polio vaccine, which has large side effects and low level of immune response; ② the pH value of the thermosensitive gel has not been studied, and there is uncertainty

The technical deficiencies of this document are as follows: ① Chitosan must be dissolved in an acidic solution with a pH value lower than 6.2, and the pH value of the gel solution will affect the rheological properties, while the antigen Der p1 can be dissolved in a neutral pH The activity is the strongest, so there is uncertainty about whether cationic polymers can be used to develop sublingual thermosensitive gels for mite allergens; ②The retention of dust mite allergens in the sublingual mucosa is also unknown

Therefore, whether there is an interaction and influence between the thermosensitive gel matrix material and the allergen is still uncertain, and needs to be explored and verified

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