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Method for preparing Desonide cream

A technology for desonide and cream, which is applied in the field of biomedicine, can solve the problems such as the preparation method of desonide cream needs to be improved, the type and quantity of impurities are increased, the stability of preparation is poor, etc. Long and stable effect

Inactive Publication Date: 2018-03-09
HUBEI HUMANWELL CHENGTIAN PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the application dosage form of desonide is mainly cream, but the type and quantity of impurities in the desonide cream of the prior art will increase significantly after long-term or high-temperature storage, and the content will also decrease, and the stability of the preparation is poor
[0004] Thereby, the preparation method of existing desonide cream still needs to be improved

Method used

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  • Method for preparing Desonide cream
  • Method for preparing Desonide cream
  • Method for preparing Desonide cream

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] 1.1 Prescription

[0060] Prescription 1:

[0061]

[0062]

[0063] Prescription 2:

[0064] Element

Dosage / g

Desonide

0.05

stearyl alcohol

1.0

beeswax

10.0

polyethylene glycol stearate

20.0

light liquid paraffin

2.0

White Vaseline

1.0

glycerin

20.0

citric acid

0.01

sodium hydroxide solution

Appropriate amount

Methylparaben

0.01

purified water

up to 100g

[0065] Prescription 3:

[0066]

[0067]

[0068] 1.2 Preparation method:

[0069] 1.2.1 Weigh stearyl alcohol, beeswax, light liquid paraffin, white petrolatum, polyethylene glycol stearate and methylparaben in the prescribed amount, heat and stir to 75-85°C to completely melt to obtain the oil phase A, heat preservation spare.

[0070] 1.2.2 Weigh the prescribed amount of purified water and citric acid / citric acid / malic acid, stir to dissolve and adjust the pH to 4.0-5.0 ...

Embodiment 2

[0074] Embodiment 2 in vitro transdermal experiment

[0075] 2.1 Method:

[0076] The abdominal skin of a small Bama-scented suckling pig was rinsed with normal saline and fixed between the two pools of a vertical diffusion pool, with the horny layer facing the supply pool and the dermis facing the receiving pool. Add 0.3g self-made cream (desonide cream prepared according to prescription 1 in Example 1) or original preparation (desonide cream, Perrigo New York) in the supply pool, add 8ml receiving solution (physiological Saline), stir magnetically in a constant temperature water bath at 32±2°C, take 1ml of samples from the receiving pool at the 4th, 6th, 8th, 12th, and 24th hours respectively, and add an equal amount of isothermal fresh receiving solution at the same time. After the sample was filtered with a 0.45 μm microporous membrane, the concentration of the drug in the receiving solution was determined by HPLC. After the experiment, remove the pigskin, scrub the skin...

Embodiment 3

[0093] prescription

[0094] Desonide

0.05 parts

stearyl alcohol

3 copies

white beeswax

3 copies

liquid paraffin

6 servings

White Vaseline

8 servings

polyethylene glycol stearate

10 copies

Methylparaben

0.05 parts

citric acid

0.05 parts

0.1M sodium hydroxide solution

Appropriate amount

glycerin

5 copies

purified water

up to 100 copies

[0095] Preparation:

[0096] 1. Weigh stearyl alcohol, beeswax, liquid paraffin, vaseline, polyethylene glycol stearate and methylparaben in the prescribed amount, heat and stir to 75-85°C to completely melt to obtain oil phase A, keep it warm for later use .

[0097] 2. Weigh the prescribed amount of purified water and citric acid, stir to dissolve, adjust the pH to 4.0-5.0 with 0.1M sodium hydroxide solution, then heat and stir to 75-85°C to completely melt to obtain aqueous phase B, keep it warm for later use.

[...

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PUM

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Abstract

The present invention proposes a method for preparing desonide cream, the method comprising: (1) mixing a consistency regulator, an emulsifier, and a preservative to obtain an oil phase A; (2) mixing purified water, an alkaline regulator, and a stabilizer Mix the enhancers to obtain the water phase B; (3) disperse the desonide in the solvent to obtain the water phase C; (4) mix the oil phase A and the water phase B to obtain the first mixed liquid; (5) Mix the first mixed solution with the aqueous phase C under the condition of greater than or equal to 20 degrees Celsius and lower than 50 degrees Celsius, so as to obtain the desonide cream. The method is simple and convenient to operate, and while the prepared desonide cream has good use performance and curative effect, the high-temperature stability is obviously improved, and the growth of impurities is significantly suppressed.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a method for preparing desonide cream. Background technique [0002] Desonide (Desonide) is a halogen-free glucocorticoid, which is listed as an intermediate-effect glucocorticoid in European and American countries. It has anti-inflammatory, anti-allergic, anti-itch and anti-exudation effects, and is suitable for various skin diseases that are effective for corticosteroid treatment, such as contact dermatitis, neurodermatitis, seborrheic dermatitis, psoriasis, eczema, lichen planus Treatment of skin inflammation and itching caused by lichen simplex and sweat blisters. [0003] At present, the application form of desonide is mainly cream. However, after long-term or high-temperature storage of desonide cream in the prior art, the types and quantities of impurities will increase significantly, and the content will also decrease, and the stability of the preparation is poor. [0004] Th...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/58A61K47/12A61K47/10A61K47/44A61K47/06A61K47/14A61K47/02A61P29/00A61P37/08A61P17/04A61P17/00A61P25/00A61P17/08A61P17/06
CPCA61K9/06A61K31/58A61K47/02A61K47/06A61K47/10A61K47/12A61K47/14A61K47/44
Inventor 郑妮陈海靓王琼洁黄松杨以平袁李芳黄璐
Owner HUBEI HUMANWELL CHENGTIAN PHARMA
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