Preparation method for mupirocin ointment

Abstract

The invention discloses a preparation method for a mupirocin ointment. The mupirocin ointment is prepared from, by mass, 1-5 parts of a main drug mupirocin, 19-80 parts of polyethylene glycol 3350 and 19-80 parts of polyethylene glycol 400. The preparation method comprises the steps that the polyethylene glycol 3350 is dissolved at 80 DEG C until the solution is clear to obtain a polyethylene glycol 3350 solution; the main drug mupirocin is dispersed with the polyethylene glycol 400, the mixture is added into the polyethylene glycol 3350 solution, 80-DEG C heat preservation is performed for 30 min, low-speed stirring is performed, it is guaranteed that the main drug mupirocin is completely dissolved, and materials are obtained; cooling water is started, high-speed stirring is started at the speed of 600 r / min for 30 min in the cooling process until the materials are cooled to 55 DEG C, then a high-speed emulsification head is started, a 3000-r / min high-speed shearing state is kept until the materials are cooled to 38 DEG C, and the material is discharged and filled. According to the preparation method, the particle size of 95% of the prepared materials is smaller than 50 micrometers, and the problem that filling amount cannot be controlled in the filling process is solved.

Description

Technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of mupirocin ointment. Background technique [0002] Mupirocin (Mupirocin), also known as pseudomonas acid A, is an ideal skin surface antibacterial preparation. It was marketed by GlaxoSmithKline under the trade name of "Bactroban" in 1985 . The US FDA approved the drug to be marketed in the United States in 1987, and my country approved the production and sale of the drug in 1993 by Sino-American Schick. Mupirocin is mainly used to prevent and treat skin bacterial infections caused by Gram-positive cocci, such as impetigo, boils, folliculitis and other primary skin infections, as well as eczema combined infection, ulcer combined infection, trauma combined Infections and other secondary skin infections. The main mechanism of mupirocin's antibacterial effect is to inhibit protein synthesis in bacteria. [0003] The chemical name of mupirocin is 9-{4-[5-(2,3-epo...

AI Technical Summary

Problems solved by technology

Since polyethylene glycol 3350 is solid at normal temperature with a melting point of about 52°C, while polyethylene glycol 400 is liquid at normal temperature, during the preparation and cooling process, when the temperature is lower than 52°C, polyethylene glycol 3350 will first Precipitation in granular form, resulting in rough material and excessive consistency, the filling volume cannot be controlled during the filling process, and finally leads to unqualified properties of the finished product