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Desonide cream and preparation method thereof

A desonide and cream technology, applied in the field of biomedicine, can solve the problems of desonide cream to be improved, the type and quantity of impurities are increased, and the stability of the preparation is poor, and the appearance is good, the growth of impurities is suppressed, and the high temperature is improved. The effect of stability

Active Publication Date: 2021-02-09
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, existing desonide emulsifiable paste and preparation method thereof still need to be improved

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

[0034] Example 1 Acidic regulator influence investigation on the high temperature stability of desonide emulsifiable paste

[0035] 1.1 Prescription 1

[0036]

[0037]

[0038] 1.2 Preparation method of prescription 1:

[0039] 1.2.1 Weigh stearyl alcohol, beeswax, liquid paraffin, vaseline, polyethylene glycol stearate and methylparaben in the prescribed amount, heat and stir to 75°C to completely melt, and obtain oil phase A, keep warm for later use.

[0040] 1.2.2 Weigh the prescribed amount of purified water and citric acid, stir to dissolve and adjust the pH to 4.0-5.0 with 0.1M sodium hydroxide solution, then heat and stir to 75°C to completely melt to obtain aqueous phase B, keep it warm for later use.

[0041] 1.2.3 Disperse desonide in glycerin and heat to 55°C to obtain aqueous phase C, keep it warm for later use.

[0042] 1.2.4 Add water phase B to oil phase A, turn on vacuum homogenization, homogenize at a speed of 2400rpm, homogenize for 10 minutes, stir ...

Embodiment 2

[0048] Embodiment 2 in vitro transdermal experiment

[0049] 2.1 Prescription 2

[0050]

[0051]

[0052] 2.2 Preparation method of prescription 2:

[0053] 2.2.1 Weigh the prescription amount of stearyl alcohol, beeswax, liquid paraffin, vaseline, polyethylene glycol stearate and methylparaben, heat and stir to 85°C to completely melt, and obtain oil phase A, keep it warm for later use.

[0054] 2.2.2 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 85°C to obtain the aqueous phase B, keep it warm for later use.

[0055] 2.2.3 Disperse desonide in glycerin and heat to 55°C to obtain aqueous phase C, keep it warm for later use.

[0056] 2.2.4 Add water phase B into oil phase A, turn on vacuum homogenization, homogenize at a speed of 2400rpm, homogenize for 10 minutes, then add water phase C when the temperature is lowered to 55°C with stirring, continue ...

Embodiment 3

[0066] 3.1 Introduce tartaric acid, malic acid, citric acid, fumaric acid or lactic acid into the prescription, the specific prescription is as follows:

[0067] Prescription 3:

[0068] Element Dosage / g Desonide 0.05 stearyl alcohol 5.0 beeswax 5.0 polyethylene glycol stearate 10.0 liquid paraffin 6.0 vaseline 8.0 glycerin 5.0 tartaric acid 0.03 0.1M sodium hydroxide solution Appropriate amount Methylparaben 0.05 purified water up to 100g

[0069] Prescription 4-Prescription 7 are the same as Prescription 3, except that the acid regulators used are malic acid, citric acid, fumaric acid and lactic acid.

[0070] 3.2 Preparation method:

[0071] 3.2.1 Weigh stearyl alcohol, beeswax, liquid paraffin, petrolatum, polyethylene glycol stearate and methylparaben in the prescribed amount, heat and stir to 80°C to completely melt to obtain oil phase A, keep it warm for later use.

[0072] 3.2.2 Weigh...

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Abstract

The invention provides a desonide cream and a preparation method thereof. The desonide cream contains desonide as an active ingredient and a stability enhancer, wherein the stability enhancer is an acid regulator. The high-temperature stability of the desonide cream is significantly improved, and the growth of impurities is significantly inhibited.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to desonide cream and a preparation method thereof. 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. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K31/58A61K47/12A61P17/00A61P17/04
CPCA61K9/0014A61K9/06A61K31/58A61K47/12
Inventor 王学海郑妮许勇陈海靓杨以平黄松范昭泽刘哲黄璐
Owner HUBEI HUMANWELL CHENGTIAN PHARMA
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