Crisaborole ointment and preparation method thereof

A technology of criborole and ointment, applied in the field of pharmaceutical preparations, can solve problems such as incomplete elucidation of the mechanism of action, and achieve the effects of solving stability, good uniformity and uniform dispersion

Pending Publication Date: 2019-11-19
SHANGHAI JIANHE PHARM & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its active ingredient, Crisaborole, is a phosphodiesterase-4 (phosphodiesterase-4, PDE-4) inhibitor whose mechanism of action has not been fully elucidated

Method used

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  • Crisaborole ointment and preparation method thereof
  • Crisaborole ointment and preparation method thereof
  • Crisaborole ointment and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1 Criborole ointment prescription (100, 60g / ) and preparation process

[0043]

[0044] Preparation Process:

[0045] (1) Take 4740g of white petroleum jelly, 318g of liquid paraffin, and 210g of emulsifier glyceryl monostearate and put them into a 10L stainless steel vacuum emulsification tank, turn on the jacket to heat and start stirring, and heat the substrate temperature to 65°C Insulation, as the oil phase;

[0046] (2) Take 600g of the prescribed amount of propylene glycol and place it in a 2L beaker, heat it in a water bath to 45°C and keep it warm, add 6g of the prescribed amount of 2,6-di-tert-butyl-p-cresol and 6g of calcium disodium edetate, and stir until it is completely dissolved, then add 120g of the prescribed amount of crisborole, and stir until the raw materials are completely dissolved;

[0047] (3) Turn on the chilled water jacket to lower the temperature of the material in the oil phase to 45°C and keep it warm. When the temperature o...

Embodiment 2

[0063] Embodiment 2 grams of Riborole ointment prescription (100, 60g / ) and preparation process

[0064]

[0065] Preparation Process:

[0066] (1) Take 4870g of white vaseline, 318g of liquid paraffin, and 230g of emulsifier glyceryl monostearate, and add them into a 10L stainless steel vacuum emulsification tank, turn on the jacket to heat and start stirring, and heat the substrate temperature to 65°C Insulation, as the oil phase;

[0067] (2) Take 450g of the prescribed amount of dimethyl sulfoxide and place it in a 2L beaker, heat it in a water bath to 45°C and keep it warm, add the prescribed amount of 2,6-di-tert-butyl-p-cresol 6g, disodium edetate 6g, stir until completely dissolved, then add 120g of the prescribed amount of crisborole, stir until the raw materials are completely dissolved;

[0068] (3) Turn on the chilled water jacket to lower the temperature of the material in the oil phase to 45°C and keep it warm. When the temperature of (1) drops to about 45°C...

Embodiment 3

[0084] Embodiment 3 grams of Riborole ointment prescription (100, 60g / ) and preparation process

[0085]

[0086] Preparation Process:

[0087] (1) Take 4930g of white vaseline, 318g of liquid paraffin, and 170g of polyoxyethylene fatty acid ester in the prescribed amount, add them to a 10L stainless steel vacuum emulsification tank, turn on the jacket to heat and start stirring, and heat the substrate temperature to 65°C to keep it warm. oil phase;

[0088] (2) Take 600g of the prescribed amount of propylene glycol and place it in a 2L beaker, heat it in a water bath to 45°C and keep it warm, add 6g of the prescribed amount of 2,6-di-tert-butyl-p-cresol and 6g of calcium disodium edetate, and stir until it is completely dissolved, then add 120g of the prescribed amount of crisborole, and stir until the raw materials are completely dissolved;

[0089] (3) Turn on the chilled water jacket to cool the material in the oil phase to 45°C and keep it warm. When the temperature ...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and specifically relates to an external Crisaborole preparation; and especially, the invention relates to Crisaborole ointment and a preparation technology thereof. The Crisaborole ointment disclosed by the invention contains no water in the components, and comprises the following ingredients in percentage by weight:

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an external preparation of crisborole, in particular to a crisborole ointment and a preparation process thereof. Background technique [0002] Crisaborole, trade name Eucrisa, chemical name 5-(4-cyanophenoxy)-1,3-dihydro-1-hydroxy-[2,1]-benzoxazole. Criborole is easily soluble in common organic solvents, such as isopropyl alcohol and propylene glycol, but insoluble in water. Its structural formula is as follows: [0003] [0004] Atopic dermatitis is a chronic, relapsing, inflammatory skin disease. Patients often have severe itching, which seriously affects the quality of life. The disease usually first occurs in infancy, and the onset before 1 year old accounts for about 50% of all patients. The disease is a chronic process, and some patients can be delayed to adulthood, but there are also adults with onset. According to the survey, the incid...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/69A61K47/18A61K47/06A61P17/00
CPCA61K9/06A61K31/69A61K47/183A61K47/06A61P17/00
Inventor 张锐
Owner SHANGHAI JIANHE PHARM & TECH CO LTD
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