Ornidazole medicinal composition and preparation method thereof

Abstract

The invention discloses an ornidazole medicinal composition. Each 100 milliliters of ornidazole medicinal composition contains 5 grams of ornidazole, 35 to 60 milliliters of 1,2-propylene glycol and the balance of water for injection. The pH value of the ornidazole medicinal composition is 2.5 to 4.5. The composition can be made into a small-volume injection, wherein the injection can be a 5-milliliter injection containing 0.25 gram of the composition or a 10-milliliter injection containing 0.5 gram of the composition. The invention also provides a preparation method of the ornidazole medicinal composition, which comprises: adding ornidazole into 1,2-propylene glycol, keeping the temperature to be 45 to 60 DEG C and stirring the mixture till the ornidazole dissolves completely; adding disodium ethylenediamintetraacetate aqueous solution at a concentration of 40-70mg / 100ml; and using needle active carbon for absorption and microporous filter membrane for filtration decarbonization, supplying water for injection and adjusting the pH value to 2.5 to 4.5 to obtain the ornidazole medicinal composition. The method provided by the invention has simple process and the prepared product has high stability.

Description

technical field [0001] The invention relates to an ornidazole pharmaceutical composition and a preparation method thereof, in particular to an ornidazole injection and a preparation method thereof. Background technique [0002] There are a large number of normal flora parasitic on the surface of the human body and the mucous membrane surface of the cavity that the human body communicates with the outside world, among which anaerobic bacteria account for a large proportion. They can become conditional pathogens in some cases (such as mechanical damage to anatomical barriers, dysregulation of normal flora, etc.). Infection caused by anaerobic infection involves various clinical departments and various parts of the human body. Anaerobic infection has the following characteristics: First, the infection mostly occurs in the mucous membrane or other adjacent parts, and may also invade distant organs. For example, anaerobic bacteria in the oropharyngeal mucosa can cause stomatiti...

AI Technical Summary

Problems solved by technology

Second, the infection of anaerobic bacteria is mostly chronic infection

However, injections with too low a pH have a stimulating effect on the human body, and are likely to cause pain in patients during the intravenous infusion process, and are prone to phlebitis after long-term use

Moreover, due to the poor safety of sterilization at 100°C for 30 minutes (such as a series of drug safety accidents that have occurred in my country in recent years), it is best to use 115°C for 30 minutes for aseptic sterilization of current injections.

Experiments show that the above-mentioned ornidazole injection is sterilized at 115°C for 30 minutes, its content decreases and related substances are difficult to meet the quality requirements of pharmaceutical injections

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