A kind of method for preparing tacrolimus ointment
A technology of tacrolimus and ointment, applied in the field of preparation of tacrolimus ointment, can solve the problems of difficulty in obtaining uniform distribution of pharmaceutical preparations, easy layering, etc., and achieve the effects of reducing production costs, rapid industrialization, and realization of industrialization
Active Publication Date: 2015-08-05
ZHEJIANG WAN SHENG PHARMA CO LTD
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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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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...
Claims
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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K31/436A61P17/00A61P37/06
Inventor 单瑞平李永和杜军金璐
Owner ZHEJIANG WAN SHENG PHARMA CO LTD
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