Fludrocortisone acetate oral cavity instant film agent and preparation method thereof

Abstract

The present invention discloses a fludrocortisone acetate oral cavity instant film agent. The fludrocortisone acetate oral cavity instant film agent comprises a fludrocortisone acetate clathrate, a film forming material and a filler. The fludrocortisone acetate clathrate is prepared by clathration of cyclodextrin or / and cyclodextrin derivatives and fludrocortisone acetate. Aiming at problems thata fludrocortisone acetate liquid preparation is poor in stability, and marketed tablets are large in volume and slow in dissolution, and unfavorable for use of patients in neonatal period, infants andyoung children, etc., the oral cavity instant film agent is designed to solve problems that in common oral instant film agents, the fludrocortisone acetate is relatively slow in dissolution rate andpoor in stability is poor. The fludrocortisone acetate instant film agent is small in volume and light in mass, can be dissolved once placed at the tip of the tongue, is pleasant in mouthfeel, quick in onset and good in absorption, and satisfies drug administration requirements of the patients in the neonatal period, infants and young children, etc.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an oral instant film of fludrocortisone acetate and a preparation method thereof. Background technique [0002] Congenital adrenal hyperplasia is mainly due to defects in the enzymes necessary for the biosynthesis of adrenocortical hormones, resulting in abnormal synthesis of corticosteroids. In most cases, the adrenal gland secretes insufficient sugar hormones and salt hormones and excessive male hormones, so different degrees of adrenal cortical insufficiency appear clinically, accompanied by virilization in girls, and precocious puberty in boys. Addison's syndrome is primary chronic adrenal insufficiency, which refers to a series of symptoms caused by the destruction of most of the bilateral adrenal glands due to various reasons, resulting in insufficient secretion of adrenal cortex hormones, including systemic Hyperpigmentation of the skin, hyponatremia, hypotension, elevat...

AI Technical Summary

Problems solved by technology

For infants and young children, especially those in the neonatal period, it is very difficult to swallow ordinary tablets, and it may even be dangerous

Because fludrocortisone acetate is sensitive to light, humidity and temperature, there are many difficulties in the development of new oral preparations of fludrocortisone acetate

Images