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A docosanol cream

A technology of alcohol cream and emulsifier, which is applied in the direction of emulsion delivery, antiviral agents, active ingredients of hydroxyl compounds, etc. It can solve the problems of high price, unstable quality of excipients, affecting the quality and stability of preparations, etc., and achieve production costs Reduced, stable and controllable quality, the effect of stable quality

Active Publication Date: 2016-01-06
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

There are few domestic manufacturers of these two emulsifiers, and due to the production process and other reasons, sucrose monostearate and sucrose distearate cannot be separated well, resulting in unstable quality of excipients, which in turn affects the quality and quality of preparations. Stability; In addition, sucrose fatty acid esters are expensive, which increases the production cost of medicines; due to the defects of sucrose fatty acid esters, it hinders the large-scale production and application of products

Method used

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  • A docosanol cream
  • A docosanol cream
  • A docosanol cream

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A behenyl alcohol cream, the composition of raw materials is as follows: behenyl alcohol 10g, benzyl alcohol 1g, liquid paraffin 5g, white petrolatum 3g, stearic acid 1g, propylene glycol 10g, glyceryl monostearate 1g, Span- 602g, Tween-603g, add purified water to 100g.

[0026] The preparation method is as follows: oil phase (behenyl alcohol, benzyl alcohol, liquid paraffin, white petrolatum, stearic acid, glyceryl monostearate, Span-60), water phase (propylene glycol, Tween-60, purified Water) were mixed separately, heated to 75°C under stirring, then the water phase was added to the oil phase, kept stirring for 15-20 minutes, then stopped heating, continued to stir to room temperature, filled, and packaged.

[0027] The prepared cream is milky white, moderate in viscosity and easy to spread and administer. The pH of the cream is 6.3, and the particle size of the milk droplets is less than 8μm. Centrifuged at 3000rpm for 30 minutes, it will not separate or break the ...

Embodiment 2

[0029] A kind of behenyl alcohol emulsifiable paste, raw material composition is as follows: benzyl alcohol 10g, benzyl alcohol 1g, liquid paraffin 3g, white petrolatum 1.5g, stearic acid 0.5g, propylene glycol 10g, glyceryl monostearate 0.5g, Span-601g, Tween-602g, add purified water to 100g.

[0030] The preparation method is the same as in Example 1.

[0031] The prepared emulsifiable paste is milky white, low in viscosity, and is easy to be lost when applied for administration; the emulsifiable emulsifiable pH is 6.5, and the particle size of emulsion droplets is all less than 8 μm, and centrifuged at 3000 rpm for 30 minutes, without delamination or demulsification.

Embodiment 3

[0033] A kind of behenyl alcohol emulsifiable paste, raw material composition is as follows: benzyl alcohol 10g, benzyl alcohol 1g, liquid paraffin 7g, white petrolatum 4.5g, stearic acid 3g, propylene glycol 10g, glyceryl monostearate 1.5g, Pan - 603g, Tween - 604g, purified water to 100g.

[0034] The preparation method is the same as in Example 1.

[0035] The prepared emulsifiable paste is milky white with high viscosity, and it is more difficult to spread evenly when coating and administering; milk.

[0036] The behenyl alcohol emulsifiable paste that embodiment 1-3 is made has carried out toxicological research, and research result shows that behenyl alcohol emulsifiable paste of the present invention has no obvious stimulating action and sensitization, does not have clinically relevant toxic and side effects, Clinical application safety:

[0037] (1) Skin irritation

[0038] Refer to the "Technical Guidelines for the Irritation, Allergy and Hemolysis Research of Che...

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Abstract

The invention belongs to the technical field of pharmaceutical preparation, and particularly discloses a docosanol emulsifiable paste. The main improvement is the emulgator; due to the improvement of the formula of the existing docosanol emulsifiable paste, the product has stable quality and good safety. The docosanol emulsifiable paste is a mixture of span-60, tween-60 and glycerin monostearate, wherein the optimum weight ratio of glycerin monostearate to span-60 to tween-60 is 1:2:3. Among multiple emulgators, the compound docosanol emulsifiable paste adopts glycerin monostearate, span-60 and tween-60 which have wide source of feed and stable quality and are cheap, achieves a good effect, has stable and controllable quality, greatly lowers the production cost, and is very beneficial to industrial production and popularization and application of the product.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a behenyl alcohol cream. The main improvement of the present invention lies in the emulsifier. By improving the existing formula of behenyl alcohol cream, the obtained product has stable quality and good safety. Background technique [0002] Docosanol is a new antiviral drug first developed by Lidakol Company of the United States, and later produced by Avanir Pharmaceutical Company of the United States. The trade name is abreva. The marketed docosanol cream has a concentration of 10% and is used to treat lips and faces. herpes. Excipients include light mineral oil, propylene glycol, sucrose monostearate, sucrose distearate, and benzyl alcohol. It is an oil-in-water emulsion type matrix, which has a certain affinity for oil and water, and can exudate with the wound surface. Mixed with ingredients, it has little effect on the normal function of the skin. In t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K31/045A61K47/34A61K47/14A61K47/26A61P31/12A61P31/22
Inventor 舒志元余修祥刘胜文史自东方征远李旻王登美戴正琳王强
Owner 湖北科益药业股份有限公司