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Cream contg. doxepin hydrochloride, and its prepn. method

A technology for doxepin hydrochloride and cream, which is applied in ointment delivery, emulsion delivery, skin diseases, etc. It can solve the problems that the stability cannot meet industrial production, the appearance of doxepin hydrochloride cream is yellow, and the cream is rough. , achieve great practical value and economic value, be conducive to industrial production, and have the effect of less drug excipients

Inactive Publication Date: 2006-11-29
湖北科益药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the appearance of doxepin hydrochloride emulsifiable paste prepared according to this method is yellow, emulsifiable paste is rough, dry, with a kind of special smell, and its stability can not meet the requirement of industrialized production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Doxepin hydrochloride 5%

[0019] Cetyl Alcohol 4%

[0020] Vaseline 8%

[0021] Glyceryl monostearate and polyoxyethylene-100 stearate 4%

[0022] Benzyl alcohol 0.5%

[0023] Sodium hydroxide 0.01%

[0024] Water 78.49%

[0025] Cetyl alcohol, petrolatum, glycerol monostearate, polyoxyethylene-100 stearate, and benzyl alcohol were weighed according to the recipe amounts, heated to 65° C., melted, and kept the temperature to form an oil phase. Doxepin hydrochloride is dissolved in water to form an aqueous phase.

[0026] After heating the water phase to 65°C, add it to the oil phase, and stir at a high speed of 3000 rpm while adding. After the mixture is kept warm for 15 minutes, it is naturally cooled to room temperature to prepare the doxepin hydrochloride cream.

[0027] The prepared cream is a milky white cream with suitable consistency, delicate appearance, slightly glossy and easy to apply, centrifuged at 3000 rpm for 30 minutes, no delamination is observe...

Embodiment 2

[0029] Doxepin hydrochloride 5%

[0030] Cetyl Alcohol 6%

[0031] Vaseline 10%

[0032] Glyceryl monostearate and polyoxyethylene-100 stearate 8%

[0033] Benzyl alcohol 1%

[0034] water 70%

[0035] Preparation Process:

[0036] Cetyl alcohol, petrolatum, glycerol monostearate, polyoxyethylene-100 stearate, and benzyl alcohol were weighed according to the recipe quantities, heated to 80° C., melted, and kept the temperature to form an oil phase. Doxepin hydrochloride is dissolved in water to form an aqueous phase.

[0037] After heating the water phase to 80°C, add it to the oil phase, stirring at high speed while adding. After the mixture is kept warm for 15 minutes, it is naturally cooled to room temperature to prepare the doxepin hydrochloride cream.

[0038] The cream prepared is a milky white cream with a low consistency.

Embodiment 3

[0040] Doxepin hydrochloride 5%

[0041] Cetyl Alcohol 8%

[0042] Vaseline 12%

[0043] Glyceryl monostearate and polyoxyethylene-100 stearate 10%

[0044] Benzyl alcohol 1.5%

[0045] Water 63.5%

[0046] Preparation Process:

[0047] Preparation Process:

[0048] Cetyl alcohol, petrolatum, glycerol monostearate, polyoxyethylene-100 stearate, and benzyl alcohol were weighed according to the recipe quantities, heated to 85° C., melted, and the temperature was maintained to form an oil phase. Doxepin hydrochloride is dissolved in water to form an aqueous phase.

[0049] After heating the water phase to 85°C, add it to the oil phase, stirring at high speed while adding. After the mixture is kept warm for 15 minutes, it is naturally cooled to room temperature to prepare the doxepin hydrochloride cream.

[0050] The prepared cream is a milky white cream with higher consistency.

[0051] time (month)

[0052] time (month)

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PUM

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Abstract

A cream of doxepin hydrochloride is prepared proportionally from doxepin hydrochloride, monoglyceride stearate, polyoxyethene-100 stearate, hexadecanol, vaseline, phenylmethanol, and water. Its preparing process is also disclosed.

Description

technical field [0001] The present invention relates to doxepin hydrochloride cream and a preparation method thereof. Background technique [0002] Doxepin HCI is a tricyclic antidepressant with anti-H 1 and H 2 receptor action. In 1994, the FDA approved 5% doxepin hydrochloride cream for the treatment of itching caused by various eczema. There are also domestic drug manufacturers that produce and sell this variety. [0003] According to relevant domestic literature reports (Zhong Huiping, Kang Yinshu, Chen Zhi, etc.: Development of Doxeping Cream and Determination of Its Content, Chinese Journal of Hospital Pharmacy, 1992, 12(7): 311-313), stearic acid was used , solid paraffin, liquid paraffin, Tween-80, glycerol monostearate, ethyl paraben, glycerin, distilled water, etc. can also be made into doxepin hydrochloride cream. However, the doxepin hydrochloride cream prepared according to the method has yellow appearance, roughness, dryness, and a special odor, and its st...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/335A61K47/34A61K47/14A61P17/04A61K47/06A61K47/10
Inventor 余修祥周利娟邱银生刘红
Owner 湖北科益药业股份有限公司
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