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Benvitimod cream as well as preparation method and application thereof

A technology of Benvimod and ointment, which is applied in anti-inflammatory agents, pharmaceutical formulations, ointment delivery, etc. It can solve the problems affecting the appearance and stability of nanoemulsions, the emulsification area and particle size, and the large particle size of nanoemulsions. and other problems, to achieve the effect of convenient medication, stable quality and good smearability

Inactive Publication Date: 2021-12-17
SUMMIT GD BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The application discloses that it is necessary to strictly control the weight ratio of the compound surfactant and the co-surfactant to 3-5:1. If it is less than or exceeds this range, it will cause problems with the emulsification area and particle size, and affect the appearance and stability of the nanoemulsion. At the same time, it is also necessary to control the total amount of compound surfactant and co-surfactant to the weight ratio of oil phase to 8-9:1, less than or exceeding this range will also lead to the problem of excessive particle size of nanoemulsion
[0006] CN108066279A discloses a cream composition for external use containing Benvimod, which uses liposome and ethosome technology to prepare the cream, and the preparation process is complicated; and the preparation system needs to add antioxidants and transdermal accelerators ; At the same time, in the preparation steps of the examples, the raw material drug is first ultrafinely pulverized, and the average particle size is strictly required to be less than 10 microns, which increases the process steps and is difficult to operate

Method used

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  • Benvitimod cream as well as preparation method and application thereof
  • Benvitimod cream as well as preparation method and application thereof
  • Benvitimod cream as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061]

[0062]

[0063] The preparation method of the cream is as follows:

[0064] (1) Bulk drug dissolution: Weigh ethanol, add the raw material drug, stir and dissolve at 50°C;

[0065] (2) Oil phase preparation: weigh white vaseline, light liquid paraffin, stearic acid, glyceryl monostearate, lanolin, polyoxyethylene (40) monostearate and di-tert-butyl p-formaldehyde Phenol, heat up to 65°C, stir to dissolve, slowly add the raw material drug dissolved in ethanol, continue to stir, mix evenly, and set aside;

[0066] (3) Water phase preparation: Weigh purified water, raise the temperature to 70°C, add ethylenediaminetetraacetic acid and potassium sorbate, adjust the pH value to 5.0 with glacial acetic acid / sodium acetate, stir and dissolve for later use;

[0067] (4) Emulsification: Slowly add the water phase to the oil phase, keep at 65°C, homogenize, and continue to stir for 30 minutes;

[0068] (5) Cool down, stop heating, continue to stir, gradually lower to ro...

Embodiment 2

[0072] ingredients weight percentage Ben Vimod 2.0％ White Vaseline 15.0％ light liquid paraffin 6.0％ cetyl alcohol 5％ Glyceryl monostearate 5.0％ Ethylparaben 0.15％ Tween 80 10.0％ Propylene Glycol 8.0％ Disodium edetate 0.1％ Butylated Hydroxyanisole (BHA) 0.1％ Citric Acid / Sodium Citrate Appropriate amount water margin co-production 100％

[0073] The preparation method of the cream is as follows:

[0074] (1) Bulk drug dissolution: Weigh propylene glycol, add the raw material drug, stir and dissolve at 50°C;

[0075] (2) Oil phase preparation: Weigh white vaseline, light liquid paraffin, glyceryl monostearate, cetyl alcohol, and ethylparaben, heat up to 65°C, stir to dissolve, and slowly add the dissolved raw materials , continue to stir, mix evenly, set aside;

[0076] (3) Water phase preparation: Weigh purified water, add Tween 80, heat up to 70°C, add disodium edetate and butyl hydr...

Embodiment 3

[0082] ingredients weight percentage Ben Vimod 2.0％ White Vaseline 15.0％ glyceryl monooleate 2.0％ Glyceryl monolinoleate 6.0％ white beeswax 5.0％ stearyl alcohol 9.0％ sodium benzoate 1.0％ Polyethylene glycol cetostearyl ether 8.0％ Sodium Calcium EDTA 0.1％ Di-tert-butyl-p-cresol (BHT) 0.1％ glycerin 8.0％ hydrochloric acid Appropriate amount water margin co-production 100％

[0083] The preparation method of the cream is as follows:

[0084] (1) Oil phase preparation: weigh white vaseline, white beeswax, stearyl alcohol, glyceryl monooleate, glycerol monolinoleate, polyethylene glycol cetostearyl ether and di-tert-butyl p-cresol, Heat up to 70°C, stir to dissolve, set aside;

[0085] (2) Water phase preparation: Weigh purified water, raise the temperature to 70°C, add sodium calcium edetate and sodium benzoate, adjust the pH value to 5.0 with hydrochloric acid, stir and dissolve fo...

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Abstract

The invention relates to cream containing Benvitimod as well as a preparation method and application of the cream. A pharmaceutical composition is used for treating inflammatory skin diseases such as psoriasis, eczema, palmoplantar pustulosis and atopic dermatitis. The pharmaceutical composition comprises the Benvitimod, an oil-soluble matrix, an emulsifier, a solvent, a preservative, a pH regulator, water, an optional chelating agent and an optional antioxidant. The preparation method comprises the following steps: separately preparing an oil phase and a water phase, adding the water phase into the oil phase, carrying out full emulsifying, then, adding dissolved Benvitimod into the emulsified oil-water two-phase matrix, carrying out cooling, and carrying out uniform stirring and mixing. Optionally, the dissolved Benvitimod is added to the oil phase, and then, emulsification is performed. The cream disclosed by the invention is moist in cream body, good in smearing property, convenient to take, small in skin irritation, good in curative effect and stable in quality.

Description

technical field [0001] This article relates to the field of medical technology, and relates to a Benvimod cream and its preparation method and application. Background technique [0002] Benvitimod (Benvitimod, WBI-1001, also known as Benvitimod, called Tapinarof abroad) is a natural small molecule compound produced by entomopathogenic nematode symbiotic bacteria, and its molecular formula is C 17 h 18 o 2 , the molecular weight is 254.32, and the structural formula is: [0003] [0004] Benvimod acts as an aryl hydrocarbon receptor (AhR) agonist and mediates its anti-inflammatory properties through activation of the aryl hydrocarbon receptor (AhR). Benvimod binds and activates the aryl hydrocarbon receptor (AhR) in a variety of cells, including target tissue human skin cells; in addition, in stimulating peripheral blood CD4+ T cells and human skin in vitro, Benvimod inhibited the Expression of inflammatory cytokines and effects on barrier gene expression in primary hu...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/05A61P17/00A61P29/00A61P17/06
CPCA61K9/0014A61K31/05A61K9/06A61P17/00A61P29/00A61P17/06
Inventor 申娟刘迪鲍文静曹博侯怀信尤臻
Owner SUMMIT GD BIOTECH
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