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Tacrolimus ointment and preparation method thereof

A technology of tacrolimus and ointment, applied in the field of pharmaceuticals, can solve the problems of low industrialization, need for improvement, uneven ointment content, etc.

Inactive Publication Date: 2014-11-05
HUMANWELL HEALTHCARE GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the tacrolimus ointment obtained by this method is easily separated by solvent in high temperature or long-term storage, so that the content of the ointment is uneven
Patent CN102885761A mentions that the liquid medicine is first dispersed in the melted white vaseline, and then the obtained mixed liquid is dispersed in the rest of the ointment base. This method still has the problem of uneven mixing
Patent CN103271826A mentions adding the ointment base into the liquid medicine in stages, which can solve the problem of uneven mixing, but the operation process is not easy to control, and the degree of industrialization is not strong
[0005] Thereby, the method for preparing tacrolimus ointment still needs to be improved at present

Method used

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  • Tacrolimus ointment and preparation method thereof
  • Tacrolimus ointment and preparation method thereof
  • Tacrolimus ointment and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0186] prescription:

[0187]

[0188] Preparation method:

[0189] (1) Heat and stir 140g of liquid paraffin, 50g of white beeswax and 30g of paraffin to 75°C to melt, keep warm for subsequent use, so as to obtain the first solution;

[0190] (2) heating and stirring 729g of white petrolatum to 75°C to make it melt, keep warm for subsequent use, so as to obtain white petrolatum solution;

[0191] (3) Heat and stir 1 g of tacrolimus and 50 g of N-methylpyrrolidone to 75° C. to dissolve, so as to obtain a second solution;

[0192] (4) Add the first solution into the vacuum homogenization emulsification tank, turn on the vacuum homogenization, and carry out the first vacuum homogenization treatment for 5 minutes under the homogenization speed of 2400 rpm, so as to obtain the first solution of the vacuum homogenization treatment;

[0193] (5) Add the second solution to the first solution that has undergone the first vacuum homogenization treatment, and carry out the second v...

Embodiment 2

[0200] prescription:

[0201]

[0202] Preparation method:

[0203] (1) Heat and stir 140g of liquid paraffin, 50g of white beeswax and 30g of paraffin to 70°C to melt, keep warm for subsequent use, so as to obtain the first solution;

[0204] (2) heating and stirring 730g of white petrolatum to 70° C. to make it melt, keep warm for subsequent use, so as to obtain white petrolatum solution;

[0205] (3) Heat and stir 0.3 g of tacrolimus and 50 g of diethylene glycol monoethyl ether to 70° C. to dissolve, so as to obtain a second solution;

[0206] (4) Add the first solution into the vacuum homogenization emulsification tank, turn on the vacuum homogenization, and perform the first vacuum homogenization treatment for 10 minutes under the homogenization speed of 2400 rpm, so as to obtain the first vacuum homogenization treatment;

[0207] (5) Add the second solution to the first solution that has undergone the first vacuum homogenization treatment, and carry out the second ...

Embodiment 3

[0211] prescription:

[0212]

[0213] Preparation method:

[0214] (1) Heat and stir 140g of liquid paraffin, 50g of white beeswax and 30g of paraffin to 80°C to melt, keep warm for subsequent use, so as to obtain the first solution;

[0215] (2) heating and stirring 729.5 g of white petrolatum to 80° C. to melt it, and keep it warm for subsequent use, so as to obtain a white petrolatum solution;

[0216] (3) Heat and stir 0.5 g of tacrolimus and 50 g of propylene glycol to 80° C. to dissolve, so as to obtain a second solution;

[0217] (4) Add the first solution into the vacuum homogenization emulsification tank, turn on the vacuum homogenization, and perform the first vacuum homogenization treatment for 15 minutes under the homogenization speed of 2400 rpm, so as to obtain the first vacuum homogenization treatment;

[0218] (5) Add the second solution to the first solution that has undergone the first vacuum homogenization treatment, and carry out the second vacuum hom...

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Abstract

The invention provides a tacrolimus ointment and a preparation method, the tacrolimus ointment comprises tacrolimus and an ointment matrix; the ointment matrix comprises liquid paraffin, cera alba, paraffin and albolene, and an absorption promoter. The medicine content uniformity and quality stability of the tacrolimus ointment are good.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to tacrolimus ointment and a preparation method thereof. Background technique [0002] Atopic Dermatitis (AD) is an allergic skin disease with a genetic predisposition, characterized by chronic, recurrent, itchy, and inflammatory conditions. The incidence rate of children worldwide is about 10% to 20%, and the incidence rate of adults is about 1% to 3%, and the incidence rate has an increasing trend year by year. AD is prone to recurrent attacks and is not easy to cure, which has a great impact on patients' physical and mental health and quality of life. [0003] Tacrolimus ointment is a macrolide antibiotic extracted from Actinomycetes, which has strong immunosuppressive properties, and its drug strength is 10 to 100 times that of cyclosporine A. Developed by Stellite, it was first listed in Japan in June 1993. It is the world's first approved non-corticosteroid external immunomodulator. ...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/436A61P17/00A61P37/08
Inventor 王学海郑妮李莉娥范昭泽许勇王伟申际丽黄松余艳平黄璐田华肖强于静何珩
Owner HUMANWELL HEALTHCARE GRP
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