Alprostadil liposome combination medicine and industrial preparation and quality control and application

Abstract

The invention discloses an alprostadil liposome composite medicine, which is a composite medicine comprising the main ingredients, i.e., high-purity alprostadil liposome and a mixture of Aspisol and soldium salicylate with the weight ratio of (85-95): (5-15), and discloses the weight ratio of the raw materials of the ingredients in the composite medicine; the invention further provides a preparation method and quality control of the alprostadil liposome composite medicine; a freeze-dried injection, or an oral preparation, or a spraying agent, or a suppository or an enema of the alprostadil liposome composite medicine is prepared; the chromatographic conditions of the contents of the alprostadil, the prostaglandin A1 and the prostaglandin B1 are measured, and three retention peaks before and after the alprostadil retention peak are the characteristic retention peaks of the supplementary materials of the alprostadil liposome composite medicine provided by the invention; the alprostadil liposome composite medicine is used for treating and preventing the diseases such as coronary heart disease and myocardial infarction, cerebral infarction, hypertension, hyperlipidemia, arteriosclerosis, vasculitis, tumor, hepatitis, aiabetic angiopathy and renal insufficiency, bronchial asthma, pancreatitis, gastric ulcer and vertebrobasilar insufficiency and the like.

Description

technical field [0001] The invention relates to an alprostadil liposome combination medicine, its industrial preparation, quality control and application. Background technique [0002] Alprostadil, formerly known as prostaglandin E 1 , referred to as PGE 1 . It is an endogenous drug with wide physiological activity and high efficiency. It is used to treat and prevent coronary heart disease, myocardial infarction, cerebral infarction, hypertension, hyperlipidemia, arteriosclerosis, vasculitis, tumor; it can also treat hepatitis, diabetic vascular disease and renal insufficiency; it can treat refractory bronchial asthma, Pancreatitis, gastric ulcer, and vertebral fundus insufficiency have miraculous effects. It has the characteristics of small dosage, broad-spectrum drug with definite curative effect, short half-life, no accumulation in the body, and no harmful side effects. It will be a good medicine for a century. However, due to its active chemical properties, the qual...

AI Technical Summary

Problems solved by technology

However, due to its active chemical properties, the quality stability of the preparation is poor, and the content decline affects the curative effect and produces side effects, so the content decline, injection pain, and refrigerator storage and transportation are the three major international problems of alprostadil preparations

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