NANOBODY BIOMEDICINE TRANSDERMAL ADMINISTRATION FORMULATION SYSTEM AND PREPARATION METHOD AND USE THEREOF

摘要

The invention discloses a transdermal drug delivery scheme for preparing a specific nanobody biopharmaceutical through penetrating skin tissue, and its preparation method and application. Due to biological characteristics such as unstable activity of traditional antibodies or protein macromolecules, the administration of biopharmaceuticals is basically limited to injections. Nanobodies are the smallest units currently known to bind target antigens. The three-dimensional structure of nanobodies determines the relative stability of their structure and biological activity and their biological properties. Nanobodies have the characteristics of high temperature resistance, activity in a certain acid-base environment, good water solubility, and strong tissue penetration. Therefore, by optimizing the formulation of the carrier, the stability of the nanobody and the penetration of the skin tissue can be maintained and increased, so as to achieve a transdermal delivery formulation of the nanobody biopharmaceutical. The transdermal delivery of nanobody can be used for the specific nanobody to play a role in the local application area, and can also be used for the nanobody to penetrate the skin and enter the blood circulation to reach the site of a predetermined lesion. Nanobodies in the transdermal delivery system include specific nanobodies for different lesion targets, such as, but not limited to, dermatological targets, inflammation and rheumatism targets, cancer targets, viral bacteria targets, cardiovascular disease targets, diabetes targets, Alzheimer's disease targets, brain tumor targets. The carrier for transdermal delivery of the nanobody has the advantages of stabilizing the structure and efficacy of the nanobody, releasing the drug via the skin, and having good transdermal effect; the comfort of skin application is high; and the skin irritation and allergic reaction characteristics are basically absent. The carrier system components include, but not limited to, soluble polymer macromolecular carbohydrate matrix, polyethylene glycol (PEG), dextran, polyamino acid, optimized formulation, stirred mixture. The invention discloses a preparation method and application of the transdermal drug delivery system. Transdermal administration is a safe and effective method of administration. Less content of proteolytic enzymes in the skin tissue is conducive to maintaining the stability of such biological drugs. The nanobody biomedical transdermal drug delivery preparation system has the advantages of being non-toxic, stable, controllable, convenient for administration, and easy to operate, etc., and opens up new dosage forms of nanobody biopharmaceuticals, and its application prospect is very broad.