Propranolol hydrochloride oral administration emulsion and preparation method thereof

Abstract

The invention relates to a propranolol hydrochloride oral administration emulsion for treating infantile hemangioma and a preparation method thereof. The oral administration emulsion is prepared from 0.25 to 40 parts by weight of propranolol hydrochloride, 70 to 300 parts by weight of oil phase, 22 to 200 parts by weight of emulsifiers, 15 to 101.5 parts by weight of co-emulsifiers and 352 to 1570 parts by weight of purified water. The propranolol hydrochloride oral administration emulsion provided by the invention solves the problem that no special oral administration preparation for treating infantile hemangioma exists in China at present. The propranolol hydrochloride oral administration emulsion provided by the invention overcomes the defect of a phenomenon of tablet and capsule taking difficulty due to infant pharyngeal narrowing. The propranolol hydrochloride is used as an effective ingredient to be uniformly dispersed in the emulsion; the administration dosage can be precisely mastered; the excessive treatment or insufficient treatment can be avoided.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a propranolol hydrochloride oral milk preparation and a preparation method thereof. Background technique [0002] Hemangioma, also known as infantile hemangioma (IH), is the most common vascular malformation or tumor in infants and young children. It can occur in any part of the body, and the incidence rate is about 4% to 5%, and it is increasing year by year. . There are obvious racial and gender differences in its incidence. The disease is more common in women, with a male to female incidence ratio of 1:3 to 1:5, and about 60% of the cases occur in the head and neck. The incidence of hemangioma may be higher in low birth weight infants and premature infants. Most of them appear in the neonatal period, and a few appear in infancy and early childhood. They appear as small red spots in the early stage, and then rapidly increase in size. Rapid proliferation occurs at 1 ...

AI Technical Summary

Problems solved by technology

However, the commonly used preparations are tablets at present, and the dosage for infants and young children is very small. Usually, a tablet should be divided into multiple doses, and it is difficult to control the dosage accurately; It is inconvenient for infants and young children to take it, and has gastrointestinal reactions, which affects the curative effect; Chinese patent application CN102657697 discloses a kind of propranolol, clove basil oil nanoemulsion medicine and its preparation method. The surfactant and co-surfactant selected by the milk drug form a nanoemulsion preparation together with the drug, but the oral milk formed by the surfactant, co-surfactant and propranolol hydrochloride disclosed by the invention has poor stability. to be improved

At present, there is no propranolol oral preparation specially provided for infants in China, which cannot meet the current clinical needs

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