Desonide film coating agent and preparation method thereof

A coating agent, desonide technology, applied in anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc., can solve adverse effects on product quality and stability, easy hydrolysis or degradation by other means, desonide To avoid problems such as unstable chemical properties, to prevent short drug adhesion time and loss, easy to control, and ensure drug efficacy

Inactive Publication Date: 2017-03-08
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But there are the following problems in the development of desonide coating agent: (1) the chemical property of active ingredient desonide is unstable, and it is easily hydrolyzed or degraded by other pathways under the condition of water, which will affect the quality and quality of the product adverse effects on stability; (2) in other marketed products of desonide [such as desonide gel and desonide lotion ] found in the quality research that due to the early launch of the original research product, the related substances of the product have not been controlled. According to the requirements of the latest technical guidelines for chemical drug stability research, the related substances have far exceeded the control limit

Method used

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  • Desonide film coating agent and preparation method thereof
  • Desonide film coating agent and preparation method thereof
  • Desonide film coating agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The prescription of desonide coating agent of the present invention consists of:

[0031] Desonide 0.5g Polyvinyl alcohol 05-88 100.0g Titanium dioxide 3.0g Carbomer 981 5.0g glycerin 50.0g Dimethyl sulfoxide 50.0g 2-Phenoxyethanol 5.0g

[0032] citric acid 0.4g sodium hydroxide 0.1g Water for Injection Fixed weight to 1000g

[0033] Preparation:

[0034] 1) Weigh the prescribed amount of polyvinyl alcohol 05-88 and add a certain amount of water for injection to swell for 24 hours to make a gel;

[0035] 2) Carbomer 981 was swollen with a certain amount of water for injection for 4 hours, and the active ingredient desonide was dissolved in dimethyl sulfoxide and 2-phenoxyethanol, then added to the carbomer solution and stirred to mix and disperse;

[0036] 3) Titanium dioxide (over 180 mesh) was added to 2) with glycerin to stir and moisten, fully stirred to mix and disperse, and added the p...

Embodiment 2

[0039] The prescription of desonide coating agent of the present invention consists of:

[0040] Desonide 0.5g Polyvinyl alcohol 17-88 90.0g Titanium dioxide 3.0g Sodium carboxymethyl cellulose 15.0g glycerin 50.0g dimethylformamide 20.0g Benzyl alcohol 5.0g ethanol 50.0g citric acid 0.35g sodium citrate 1.0g Water for Injection Fixed weight to 1000g

[0041] Preparation:

[0042] 1) Weigh the prescribed amount of polyvinyl alcohol 17-88, add a certain amount of water for injection to swell for 24 hours to make a gel;

[0043] 2) First dissolve the pH regulator with water for injection; then disperse carboxymethylcellulose sodium with a certain amount of water for injection above 80°C, add it to the pH regulator solution, stir and swell for 4 hours to form a gel;

[0044] 3) The active ingredient desonide is added to dimethylformamide and benzyl alcohol, stirred and dissolved, then added to 2), fully s...

Embodiment 3

[0048] The prescription of desonide coating agent of the present invention consists of:

[0049] Desonide 0.5g Polyvinyl alcohol 124 90.0g Zinc oxide 5.0g Hydroxypropylmethylcellulose 20.0g Propylene Glycol 50.0g Laurocaprazine 20.0g 2-Phenoxyethanol 7.0g ethanol 30.0g citric acid 0.35g sodium citrate 1.0g Water for Injection Fixed weight to 1000g

[0050] Preparation:

[0051] The preparation method refers to Example 2.

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Abstract

The invention belongs to the field of medicinal preparation, and relates to a desonide film coating agent and a preparation method thereof. The desonide film coating agent is composed of an active component namely desonide and a non-active component. The non-active component comprises a film forming material, a thickening agent, a humectant, a transdermal absorption promoter, an antiseptic, a pH adjuster, and water. The desonide film coating agent is painted on an affected part, a film is formed on the affected part, drugs can be slowly released, the loss of active components is prevented, the effect can last for a long time, the dosing frequency is reduced, the effect of drugs is better exerted; at the same time, the physical and chemical properties of the desonide film coating agent are stable and are accord with the requirements of related guiding principles; compared with ointment with large viscosity, the breathability and water absorbing performance of the film coating agent are better, and the film coating agent is more comfortable. Furthermore, an opacifier is added to reduce the photosensitivity of the desonide film coating agent. At the same time, the operation of the preparation method is simple and easy to control, and the preparation method is suitable for massive industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a desonide preparation, in particular to a desonide coating agent and a preparation method thereof. Background technique [0002] Desonide is a non-halogenated weak steroid hormone drug, which has anti-inflammatory, anti-allergic, antipruritic and anti-exudation effects; it can reduce and prevent tissue responses to inflammation, and can eliminate local non-infectious inflammation caused by fever, Redness and swelling, thereby reducing the manifestations of inflammation; has an immunosuppressive effect: prevents or suppresses cellular immune responses, and suppresses primary immune responses. The topical preparations of desonide can be used for the treatment of various hormone-sensitive skin diseases such as contact dermatitis, neurodermatitis, seborrheic dermatitis, eczema, psoriasis, lichen planus, lichen simplex, sweat blisters and pruritus Wait. Because of its low p...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/58A61P29/00A61P37/08A61P17/04A61P37/06
Inventor 蒋海龙陈李平管璐晗陈博赵静
Owner CHONGQING HUAPONT PHARMA
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