Isosorbide mononitrate sodium chloride injection

Abstract

The invention relates to isosorbide mononitrate sodium chloride injection which belongs to the field of medical preparation. The isosorbide mononitrate sodium chloride injection is prepared from 10-40mg of isosorbide mononitrate, 450-1800mg of sodium chloride, an amount of pH regulator which regulates the pH to 4.0-7.0 and water for injection, wherein the volume of the water for injection is fixed to 100ml. The isosorbide mononitrate sodium chloride injection has high stability and simple preparation process.

Description

technical field [0001] The invention relates to an injection of isosorbide mononitrate and sodium chloride, which belongs to the field of pharmaceutical preparations. Background technique [0002] Isosorbide mononitrate is a commonly used drug for the treatment of coronary heart disease and angina pectoris. It was first developed by BoehringerMannheim GmbH in Germany and launched in the market in 1981. It has been clinically used for many years and has a definite curative effect. Its main mechanism of action is to expand venous volume vessels and peripheral resistance vessels, reduce cardiac preload and postload, and reduce myocardial oxygen consumption. The drug has the characteristics of high bioavailability, small individual differences, long half-life, and remarkable curative effect, and is better than indigestion and nitroglycerin in the prevention of coronary heart disease and angina pectoris. [0003] Recent studies have shown that the crown-expanding effect of isoso...

AI Technical Summary

Problems solved by technology

Oral preparations such as tablets, dripping pills, and capsules of isosorbide mononitrate are taken orally, and the blood drug concentration rises rapidly to 400ng / ml, which greatly exceeds the minimum effective dose (100ng / ml), causing patients to experience severe headaches, Nausea, vomiting, circulatory collapse and other side effects have an incidence rate of about 14%, and when taken for a long time, tolerance often occurs and the curative effect is reduced

[0005] Although isosorbide mononitrate aqueous injection overcomes the shortcomings of oral preparations such as slow drug effect, low bioavailability, and is not suitable for patients who cannot be administered orally, it needs to be added to sodium chloride injection or glucose injection for use. It brings operational troubles and the possibility of errors to medical staff, and it is easy to cause contamination of medicinal liquid during operation

[0006] In addition, in the prescription of isosorbide mononitrate injection in the prior art, there is no mention of the optimum precipitation pH value, stable pH value and pH value for exerting the best curative effect of isosorbide mononitrate in large-volume injections. The appropriate pH regulator selected

[0007] Chinese patent CN 1679537A only discloses a kind of isosorbide mononitrate sodium chloride injection for the treatment of coronary heart disease and angina pectoris, does not disclose the pH regulator selected by it, and does not disclose the optimum precipitation pH value, stable pH value and The pH value for the best therapeutic effect, and its injection has the disadvantage of instability

Images