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Preparation for external use having improved temporal stability of steroid

A technology of external preparations and steroids, applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, non-central analgesics, etc., can solve problems such as poor feeling of use, separation, poor ductility of preparations, etc. To achieve the effect of improving the stability over time

Inactive Publication Date: 2009-01-07
KOWA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, if polar oil is mixed, the polar oil and water may sometimes separate
In addition, crotamiton may cause skin irritation and worsen the feeling of use, so it is not preferable to mix it in a large amount
In addition, in an anhydrous external preparation composition, for example, because it does not contain water, the spreadability of the preparation may be poor, and the feeling of use may be poor.

Method used

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  • Preparation for external use having improved temporal stability of steroid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] 0.025 g of dexamethasone acetate and 0.5 g of lidocaine were added to 45 g of ethanol to dissolve to prepare an ethanol solution. Next, 2 g of diphenhydramine hydrochloride and 0.25 g of citric acid were added to 30 g of purified water and stirred to prepare an aqueous solution. After that, the above-mentioned aqueous solution and ethanol solution were mixed, and purified water was added to make the total amount 100 mL to obtain the liquid preparation of Example 1 (pH 6.0).

Embodiment 2

[0062] 0.025 g of dexamethasone acetate and 0.5 g of lidocaine were added to 45 g of ethanol to dissolve to prepare an ethanol solution. Next, 2 g of diphenhydramine hydrochloride and 0.32 g of malic acid were added to 30 g of purified water and stirred to prepare an aqueous solution. After that, the aqueous solution and the ethanol solution were mixed, and purified water was added to make the total amount 100 mL to obtain the liquid preparation of Example 2 (pH 6.06). The pH was 6.09 after storage at 60°C for 10 days. The residual rate of dexamethasone acetate (content after storage at 60°C for 10 days / content immediately after preparation×100) was 96.6%, and the stability of dexamethasone acetate was significantly improved. It should be noted that in the determination of the content of dexamethasone acetate, HPLC was used in the same manner as in Test Example 1.

preparation example 1

[0063] [Preparation Example 1] (Liquid preparation)

[0064] Dexamethasone acetate 0.025% w / v

[0065] Diphenhydramine hydrochloride 2.0%w / v

[0066] Lidocaine 0.5%w / v

[0067] l-menthol 3.0%w / v

[0068] dl-camphor 2.0%w / v

[0069] Citric acid 0.3%w / v

[0070] Ethanol 30%w / v

[0071] Pure water

[0072]

[0073] Total 100mL

[0074] Dexamethasone acetate, l-menthol, dl-camphor and lidocaine are added to ethanol to dissolve to make an ethanol solution. In addition, diphenhydramine hydrochloride and citric acid are added to purified water and stirred to prepare an aqueous solution. After that, the above-mentioned aqueous solution and ethanol solution are mixed to obtain a liquid preparation for external use.

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PUM

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Abstract

It is intended to provide a preparation for external use which is prepared by adding a benzoic ester-based local anesthetic drug and an oxycarboxylic acid to a steroid-containing preparation for external use to thereby improve the temporal stability of the steroid and impart a favorable feel in using.

Description

Technical field [0001] The present invention relates to an external preparation that improves the stability of steroids over time and has a good feeling of use in a steroid-containing external preparation. More specifically, it relates to an external preparation that further contains a benzoate-based local anesthetic and a hydroxycarboxylic acid in a steroid-containing external preparation to improve the stability of the steroid over time and provide a good feeling of use. Background technique [0002] For a long time, compounds having a steroid skeleton have been widely used as active ingredients of medicines. For example, in the treatment of inflammatory skin diseases such as inflammation and dermatitis caused by insect bites, external preparations containing adrenal corticosteroids with anti-inflammatory effects are used. Examples of adrenal corticosteroids used in the above external preparations include hydrocortisone or dexamethasone. In addition, steroid-containing external...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/573A61K9/06A61K9/08A61K9/10A61K47/10A61K47/12A61P17/00A61P43/00
CPCA61K47/12A61K47/10A61K31/573A61K9/0014A61K45/06A61P17/00A61P29/00A61P43/00A61K9/70
Inventor 竹前和久
Owner KOWA CO LTD
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