Macromolecular soluble microneedle used for cutaneous penetration of polypeptide and protein medicines and preparation method of macromolecular soluble microneedle

Abstract

The invention discloses a macromolecular soluble microneedle used for polypeptide and protein medicines. The macromolecular soluble microneedle comprises a base as well as a needle body on the base and a needle point on the needle body, wherein the base and the needle body are made of a mixture of a high polymer material and a stabilizer; and solid active peptide or protein medicines are embedded into the needle point. The concentration degree of the medicines embedded in the needle point of the macromolecular soluble microneedle is relatively high, and nearly no residual medicines exist on the bottom of the needle body, so that the administration efficiency and the administration accuracy are greatly improved; in addition, the part entering the subcutaneous tissue of the needle body can rapidly dissolve, and further degrade to be completely absorbed by the tissues without toxic or side effects, so that the possible needle breaking risk existing in the microneedle made of other materials such as metal, glass and silicon is avoided. The preparation method of the macromolecular soluble microneedle is carried out under simple technological conditions, is low in price, and suitable for volume production, and the macromolecular soluble microneedle can be widely applied to the field of cutaneous penetration of macromolecular medicines.

Description

technical field [0001] The invention belongs to the technical field of microneedle preparation, and specifically relates to a polymer soluble microneedle for transdermal administration of polypeptide and protein drugs and a preparation method thereof. Background technique [0002] The molecular weight of peptides and proteins is usually thousands to hundreds of thousands, and the particle size is between 1 and 100nm. Generally, they cannot diffuse through the stratum corneum of the skin and enter the subcutaneous tissue like small molecule drugs. Due to the instability of peptide and protein drugs in vivo and in vitro, the main clinical dosage forms are solution injections and freeze-dried powder injections. Protein drugs may undergo a variety of complex chemical degradation and physical changes in the in vivo and external environments, and are easily inactivated in the body. Destruction of enzymes, bacteria and body fluids, low bioavailability for non-injection administrati...

AI Technical Summary

Problems solved by technology

Compared with soluble drug-loaded microneedles, coated microneedles have a smaller drug load, and the drug coating is not easy to control; solid microneedles and hollow microneedles can increase the amount of drug delivery, combined with ion osmosis and ultrasonic enhancement. , electrophoresis and other methods can improve the efficiency of drug delivery, but there is a risk of broken needles, causing irreversible damage to the skin

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