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Antifungal flutrimazole ointment preparation and preparation method thereof

The invention relates to a technology for flutramazole and a preparation process, which is applied in the field of pharmaceutical preparations, and can solve the problems of inability to determine the relationship between excipients and the basis for dosage, difficulty in selecting excipients for flutramazole preparations, and inability to obtain excipients and other materials, thereby achieving pharmaceutical safety. High performance, stable freeze-thaw and light conditions, and small functional impact

Active Publication Date: 2014-07-09
JIANGSU YUANHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

3. Drugs that inhibit fungal nucleic acid biosynthesis: the representative is 5-fluorocytosine, which is not widely used in clinical practice due to its relatively poor curative effect and high recurrence rate
However, there are many auxiliary materials for ointment preparations at present, it is difficult to select the preparation auxiliary materials suitable for flutrimazole, the relationship between the auxiliary materials and the basis for dosage cannot be determined, and an ointment preparation and process with few auxiliary materials and simple methods cannot be obtained.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] A preparation process for antifungal flutrimazole ointment preparation, comprising the following steps:

[0020] (1) Ingredients: weighed by weight, 1 part of cetostearyl alcohol, 2 parts of glyceryl monostearate, 2 parts of benzyl alcohol, 0.8 parts of Tween-20, 1 part of liquid paraffin, For 0.05 parts of white petrolatum, put the above oil phase components in a heat preservation tank to heat up and melt, take 1.5 parts of polyethylene glycol 400 and 19 parts of purified water as the water phase, add them to another heat preservation tank and heat up to 82°C for later use;

[0021] (2) Mixing: After the oil phase in step (1) is completely melted, add 0.1 part of flutrimazole, heat and stir until the emulsion is completely dissolved, heat the emulsion to 80°C and pump the emulsion into a vacuum emulsification machine heated to 75°C in the tank;

[0022] (3) Emulsification: During stirring, pump the water phase in step (1) into the vacuum emulsification tank of step (2...

Embodiment 2

[0026] A preparation process for antifungal flutrimazole ointment preparation, comprising the following steps:

[0027] (1) Ingredients: weighed by weight, 1.2 parts of cetostearyl alcohol, 2.3 parts of glyceryl monostearate, 2.3 parts of benzyl alcohol, 1 part of Tween-20, 1.3 parts of liquid paraffin, For 0.1 part of white petrolatum, put the above oil phase components in a thermal insulation tank to heat up and melt, take 1.7 parts of polyethylene glycol 400 and 20 parts of purified water as the water phase, add it to another thermal insulation tank and heat up to 83 °C for later use;

[0028] (2) Mixing: After the oil phase in step (1) is completely melted, add 0.3 part of flutrimazole, heat and stir until the emulsion is completely dissolved, heat to 81°C and pump the emulsion into a vacuum emulsification machine heated to 80°C in the tank;

[0029] (3) Emulsification: During stirring, pump the water phase in step (1) into the vacuum emulsification tank of step (2), stir...

Embodiment 3

[0033] A preparation process for antifungal flutrimazole ointment preparation, comprising the following steps:

[0034] (1) Ingredients: weighed by weight, 1.5 parts of cetostearyl alcohol, 2.7 parts of glyceryl monostearate, 2.7 parts of benzyl alcohol, 1.5 parts of Tween-20, 1.5 parts of liquid paraffin, For 0.2 parts of white petrolatum, put the above oil phase components in a thermal insulation tank to heat up and melt, take 2.0 parts of polyethylene glycol 400 and 20.5 parts of purified water as the water phase, add them to another thermal insulation tank and heat up to 85°C for later use;

[0035] (2) Mixing: After the oil phase in step (1) is completely melted, add 0.5 parts of flutrimazole, heat and stir until the emulsion is completely dissolved, heat to 82°C and pump the emulsion into a vacuum emulsification machine heated to 85°C in the tank;

[0036] (3) Emulsification: During stirring, pump the water phase in step (1) into the vacuum emulsification tank of step (...

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Abstract

The invention discloses an antifungal flutrimazole ointment preparation and a preparation method thereof, and belongs to the field of pharmaceutical preparation. The antifungal flutrimazole ointment preparation comprises following ingredients, by weight, 1 to 1.5 parts of cetostearyl alcohol, 2 to 2.7 parts of glycerin monostearate, 2 to 2.7 parts of phenylcarbinol, 0.8 to 1.5 parts of tween-20, 1 to 1.5 parts of liquid paraffin, 0.05 to 0.2 part of albolene, 0.1 to 0.5 part of flutrimazole, 1.5 to 2.0 parts of polyethylene glycol 400, and 19 to 20.5 parts of purified water. The invention also provides the preparation method of the antifungal flutrimazole ointment preparation. The preparation method comprises following steps: (1) material preparing, (2) mixing, (3) emulsification, (4) emulsifiable paste preparation, and (5) finished product preparation. A few accessory materials are used for preparing the antifungal flutrimazole ointment preparation; the preparation method is simple; and product quality of the antifungal flutrimazole ointment preparation is stable.

Description

technical field [0001] The invention relates to an antifungal flutrimazole ointment preparation and a preparation process thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] With the widespread application of high-efficiency broad-spectrum antibiotics, adrenal cortex hormones and immunosuppressants in recent years, as well as the gradual increase in human organ tissue transplantation, surgical interventional therapy, and the proliferation of many viruses, fungal infections have become increasingly serious. The incidence of regional infections has increased significantly, and the emergence of some drug-resistant strains has also challenged the treatment of fungal diseases. [0003] At present, there are three main categories of drugs for the clinical treatment of fungal infections: 1. Antifungal drugs that act on fungal cell membranes: 1. Polyene antifungal drugs: they combine with ergosterol on the fungal cytoplasmic membra...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/4174A61K47/34A61P31/10A61P17/00
Inventor 王联民段光新范宇何井亮郑涛李棚王悦梅
Owner JIANGSU YUANHENG PHARMA
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