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Hormone emulsifiable paste

A technology of cream and weight percentage, which is applied in the field of methylprednisolone acetate cream, which can solve the problems of insufficient viscosity, too many excipients, and poor control of the range of application of medicine, and achieve the effect of good quality stability and prevention of degradation

Active Publication Date: 2012-09-05
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The existing methylprednisolone acetin cream has high requirements for the matrix, and the matrix requires more excipients, which are relatively complicated, and some excipients have less sources, such as decyl oleate and caprylic acid / capric acid / myristic acid / Triglyceryl stearate / (Softisan 378), these excipients are not available in China at present, and the import price is more expensive
In addition, the existing methylprednisolone acetin cream is not thick enough to apply on the skin. Due to the excessive fluidity, it is difficult to control the range of application of the medicine. When using it, the amount of extrusion is also difficult to control.
[0007] On the Merck index, we can know that as a corticosteroid, acepromethylprednisolone is a compound that is insoluble in water but soluble in organic solvents. In the prior art, it is generally necessary to prepare cream for this type of corticosteroid compound The compound is first dissolved in an organic solvent, such as propylene glycol or dimethyl sulfoxide, such as triamcinolone acetonide urea cream with approval number H44024203, compound dexamethasone cream with approval number H44024204, but for organic solvents The stability of sensitive active ingredients will be affected to a certain extent, especially methylprednisolone acetone, a corticosteroid with 17,21-diester, is prone to transesterification when dissolved in organic solvents, which will seriously Affects the stability of formulated creams

Method used

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  • Hormone emulsifiable paste
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Methylprednisolone Acetate 1g

[0055] White Vaseline 60g

[0056] Octadecanol 30g

[0057] Glyceryl monostearate 50g

[0058] Liquid paraffin 30g

[0059] Pingpingjia A-20 10g

[0060] Glycerin 50g

[0061] Disodium edetate 2g

[0062] Benzyl alcohol 5g

[0063] Polyvinylpyrrolidone 5g

[0064] water 757g

[0065] Accurately weighed according to the above ratio, the water is divided into two parts: 500g and 257g, ready, the cream preparation process is as follows:

[0066] (1) Oil phase preparation: take white petrolatum, stearyl alcohol, glyceryl monostearate, liquid paraffin, and Pingpingjia A-20 in a container, heat to melt, and keep the temperature at 72±2°C;

[0067] (2) Preparation of water phase: Accurately weigh according to the above proportions, take glycerin, disodium edetate and 500g of water, put them in a container, heat, and keep the temperature at 70±2°C;

[0068] (3) Phase combination: Pour the oil phase prepared in step (1) into the water ph...

Embodiment 2

[0072] Methylprednisolone Acetate 1g

[0073] White Vaseline 30g

[0074] Octadecanol 60g

[0075] Cetyl Alcohol 60g

[0076] Glyceryl monostearate 20g

[0077] Liquid paraffin 10g

[0078] Pingpingjia A-20 50g

[0079] Glycerin 120g

[0080] Disodium edetate 2g

[0081] Benzyl alcohol 5g

[0082] Hydroxypropyl Cellulose 3g

[0083] water 639g

[0084] Accurately weighed according to the above ratio, the water is divided into two parts: 380g and 259g, ready, the cream preparation process is as follows:

[0085] (1) Oil phase preparation: take white petrolatum, stearyl alcohol, cetyl alcohol, glyceryl monostearate, liquid paraffin, and put Pingpingjia A-20 in a container, heat to melt, and keep the temperature at 72±2 ℃;

[0086] (2) Preparation of water phase: Accurately weigh according to the above ratio, take glycerin, disodium ethylenediamine tetraacetate and 380g of water, put them in a container, heat, and keep the temperature at 70±2°C;

[0087] (3) Phase com...

Embodiment 3

[0091] Methylprednisolone Acetate 1g

[0092] White Vaseline 90g

[0093] Octadecanol 60g

[0094] Glyceryl monostearate 10g

[0095] Liquid paraffin 60g

[0096] Pingpingjia A-20 30g

[0097] Glycerin 100g

[0098] Disodium edetate 2g

[0099] Ethylparaben 2g

[0100] Hydroxypropyl Methyl Cellulose 2g

[0101] water 640g

[0102] Accurately weighed according to the above ratio, the water is divided into two parts: 380g and 260g, ready, the cream preparation process is as follows:

[0103] (1) Oil phase preparation: take white petrolatum, stearyl alcohol, glyceryl monostearate, liquid paraffin, and Pingpingjia A-20 in a container, heat to melt, and keep the temperature at 77±2°C;

[0104] (2) Preparation of water phase: Accurately weigh according to the above ratio, take glycerin, disodium ethylenediamine tetraacetate and 380g of water, put them in a container, heat, and keep the temperature at 75±2°C;

[0105] (3) Phase combination: Pour the oil phase prepared in st...

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Abstract

The invention relates to hormone cream with methylprednisolone aceponate as active constituent. The invention consists of following materials: solid matter as oil phase substrate, consistency adjusting agent, moisturizer, emulsifier, stabilizing agent and the balance water. The active constituent is dispersed in the cream as water suspension, and suspension assistant should be added in the water suspension.

Description

technical field [0001] The invention relates to a hormone cream, in particular to a methylprednisolone acetate cream. Background technique [0002] Methylprednisolone Acetate Cream is a type of steroid that suppresses inflammation and allergic skin reactions, and also suppresses reactions associated with accelerated cell regeneration leading to symptoms such as erythema, edema, thickened skin, rough skin surface , and relieve problems such as itching, burning, and pain. Methylprednisolone acetate cream is a current super strong corticosteroid preparation for external use, its curative effect is better than known corticosteroids, and methylprednisolone acetate cream is a high-efficiency corticosteroid without halogen group, and its side effects Light, is a corticosteroid topical preparation that can be used in children. [0003] Methylprednisolone acetate emulsifiable paste trade name is Advantan, is German Schering AG (Schering AG) development listing. Instructions for th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/573A61K9/06A61K47/44A61P17/00A61P37/08A61K47/06A61K47/14A61K47/38
Inventor 李娜张其婉李建马晓勇李宏玲
Owner TIANJIN JINYAO GRP
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