Desonide cream and preparation method thereof

A technology of desonide and cream, applied in the field of medicine, can solve problems such as poor stability

Active Publication Date: 2021-09-21
FRONT PHARM PLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the defects of the prior art, the invention provides a kind of desonide emulsifiable paste and preparation method thereof, which overcomes the problem of poor stability of the desonide emulsifiable paste preparation, and obtains a long-term storage which can keep the paste uniform and stable, Desonide cream that can keep the paste properties and active ingredients stable under different environments (including temperature, humidity, and light), and is convenient for transportation and storage

Method used

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  • Desonide cream and preparation method thereof
  • Desonide cream and preparation method thereof
  • Desonide cream and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024]

[0025]

[0026] Preparation:

[0027] 1) Preparation of the water phase: heat the purified water to 70°C to 75°C, add buffered p-phosphate-sodium phosphate buffer pair (pH=5), dextrin, nonylphenol polyoxyethylene ether and methylparaben and stir to mix Evenly, keep warm for later use;

[0028] 2) Preparation of the oil phase: heating the oil base, including light liquid paraffin, cetostearyl alcohol, white petrolatum, and beeswax to melt to obtain the oil phase material, and keeping it warm at 70°C to 75°C for later use;

[0029] 3) Preparation of main drug dispersion: disperse desonide in glycerin to obtain main drug dispersion suspension;

[0030] 4) Total mixing: the oil phase material and the water phase material are mixed evenly, and the dispersion suspension of the main ingredient is added;

[0031] 5) Cooling: Mix evenly and cool to room temperature to obtain desonide cream.

Embodiment 2

[0033] composition Dosage Desonide 55.0g Citric Acid-Sodium Citrate 110.0g Castor oil polyoxyethylene ether 1.1kg dextrin 22.0g Methylparaben 110.0g glycerin 4.40kg cetostearyl alcohol 13.2kg White Vaseline 16.5kg purified water 74.5kg total 110kg

[0034] Preparation:

[0035] 1) Preparation of water phase: heat purified water to 70°C-75°C, add buffered p-citric acid-sodium citrate buffer pair (pH=5.5), dextrin, castor oil polyoxyethylene ether and paraben Stir the ester to mix well and keep warm for later use;

[0036] 2) Preparation of the oil phase: heat up the oil base, including cetostearyl alcohol and white petrolatum, to melt to obtain the oil phase material, and keep it warm at 70°C to 75°C for later use;

[0037] 3) Preparation of main drug dispersion: disperse desonide in glycerin to obtain main drug dispersion suspension;

[0038] 4) Total mixing: the oil phase material and the water...

Embodiment 3

[0041] composition Dosage Desonide 55.0g Citric Acid-Disodium Hydrogen Phosphate 220.0g Oleyl alcohol polyoxyethylene ether 1.1kg Octylphenol polyoxyethylene ether 1.1kg dextrin 11.0g Methylparaben 220.0g glycerin 6.60kg light liquid paraffin 2.2kg cetostearyl alcohol 16.5kg White Vaseline 13.2kg beeswax 6.6kg purified water 62.2kg total 110kg

[0042] Preparation:

[0043] 1) Preparation of water phase: heat purified water to 70°C to 75°C, add buffered pcitric acid-disodium hydrogen phosphate buffered pair (pH=4.5), dextrin, oleyl alcohol polyoxyethylene ether, octylphenol Polyoxyethylene ether and methylparaben are stirred and mixed, and kept warm for subsequent use;

[0044] 2) Preparation of the oil phase: heating the oil base, including light liquid paraffin, cetostearyl alcohol, white petrolatum, and beeswax to melt to obtain the oil phase material, and keeping it warm a...

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PUM

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Abstract

The invention provides desonide cream and a preparation method thereof. The desonide cream comprises desonide serving as an active component, a polyoxyethylene ether emulsifier, a buffer pair, dextrin, glycerol, an antibacterial agent and an oily matrix. The buffer pair is dissolved in water to achieve a pH value of 4.5-5.5. The desonide cream has no obvious change in character after being exposed to high temperature, high humidity, low temperature, freeze thawing and illumination, has no obvious increase in maximum single impurity and total impurity, and can adapt to various environmental conditions encountered in storage and transportation. Meanwhile, the desonide cream disclosed by the invention is simple in preparation process and easy for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a desonide cream and a preparation method thereof. Background technique [0002] Topical glucocorticoids have the advantages of high curative effect, quick effect, good compliance, and easy acceptance by patients. They are one of the drugs commonly prescribed by dermatologists. Desonide is a weak hormone with anti-inflammatory, anti-allergic, anti-itching and reducing exudation effects. It can reduce the response of tissue inflammation and eliminate congestion and edema caused by local inflammation. It has good safety and effectiveness. [0003] At present, the approved dosage forms of desonide preparations are all external preparations, especially cream dosage forms, which are widely used. Cream preparations are usually stored in an airtight, cool place. The stability of cream formulations is also worse than other solid formulations. Therefore, cream preparations...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/58A61K47/10A61P7/10A61P17/04A61P29/00A61P37/08
CPCA61K31/58A61K9/06A61K47/10A61K9/0014A61P29/00A61P37/08A61P17/04A61P7/10Y02A50/30
Inventor 陈俊宁杰刘营营
Owner FRONT PHARM PLC
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