Method for preparing tacrolimus ointment

Abstract

The invention provides a method for preparing a tacrolimus ointment. The method comprises the following steps of: 1, weighing purified tacrolimus, white beeswax, liquid paraffin, paraffin, white Vaseline, propene carbonate and propanediol in the mass ratio of 1:30:40:30:520:10:10; 2, mixing the white beeswax with the liquid paraffin and the paraffin, heating for melting, mixing uniformly to obtain a mixed solution I, and preserving heat at the temperature of 70 DEG C for later use; 3, heating white Vaseline for melting to obtain a white Vaseline solution, and preserving heat at the temperature of 70 DEG C for later use; 4, mixing propanediol and propene carbonate uniformly in the ratio of 1:1 to obtain a mixed solution 2; 5, dissolving tacrolimus into the mixed solution of propanediol and propene carbonate to obtain a mixed solution 3, and preserving heat at the temperature of 70 DEG C for later use; and 6, dispersing the mixed solution 3 into the white Vaseline solution to obtain a mixed solution 4, adding the mixed solution 4 into the mixed solution I to obtain a solution 5, stirring at the temperature of 70 DEG C for 10 minutes, cooling, and continually stirring till the solution 5 is condensed into an ointment.

Description

technical field [0001] The invention belongs to a method for preparing ointment for use, in particular to a method for preparing tacrolimus ointment. Background technique [0002] Tacrolimus ointment is indicated for short-term or intermittent long-term treatment of 0.03% and The 0.1% concentration of this product can be used for adults, but only the 0.03% concentration of this product can be used for children 2 years old and above. [0003] The matrix of traditional tacrolimus ointment is liquid paraffin, white beeswax, white petrolatum and paraffin, and the solvent is propylene carbonate; the matrix in the prescription is a non-polar solvent, and the density is less than 1g / ml; and propylene carbonate is extremely Sexual solvent, density greater than 1g / ml. This prescription compatibility makes the tacrolimus ointment easy to separate the solvent in the high temperature and freeze-thaw cycle test, sinking to the bottom, and it is difficult to obtain a uniformly distribut...

AI Technical Summary

Problems solved by technology

This prescription compatibility makes the solvent of tacrolimus ointment easy to separate in high temperature and freeze-thaw cycle tests, sinking to the bottom, and it is difficult to obtain a uniformly distributed pharmaceutical preparation

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