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Clotrimazole cream and preparation method thereof

A clotrimazole and cream technology, applied in the field of clotrimazole cream and its preparation, achieves the effects of simple preparation process, stable quality and stable release

Inactive Publication Date: 2019-09-17
HARVEST PHARMA HUNAN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

2 There are problems in the formulation and production process of the preparation
3 Degradation caused by improper temperature of raw materials and preparations during storage and distribution

Method used

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  • Clotrimazole cream and preparation method thereof
  • Clotrimazole cream and preparation method thereof
  • Clotrimazole cream and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: A kind of clotrimazole cream with slow drug release and stable quality, including the raw and auxiliary materials in the following weight ratio:

[0029] Clotrimazole 30.0g, cetostearyl alcohol 90.0g, isopropyl myristate 100.0g, Tween 60 20.0g, Span 605.0g, benzyl alcohol 10.0g, and deionized water were added to 1000g.

Embodiment 2

[0030] Embodiment 2: a kind of clotrimazole cream with slow drug release and stable quality, including the raw materials and auxiliary materials in the following weight ratio:

[0031] Clotrimazole 30.0g, cetostearyl alcohol 100.0g, isopropyl myristate 120.0g, Tween 60 25.0g, Span 605.0g, benzyl alcohol 10.0g, and deionized water were added to 1000g.

Embodiment 3

[0032] Embodiment 3: a kind of clotrimazole emulsifiable cream that drug release is slow and stable, comprises the raw materials of following weight:

[0033] Clotrimazole 30.0g, cetostearyl alcohol 110.0g, isopropyl myristate 140.0g, Tween 60 35.0g, Span 60 10.0g, benzyl alcohol 10.0g, and deionized water were added to 1000g.

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Abstract

The present invention relates to a quality-stable clotrimazole cream (3%) and a preparation method thereof. The clotrimazole cream is prepared from the following components: clotrimazole, isopropyl myristate, cetanol, octadecanol, Tween 60, Span 60, benzyl alcohol and purified water; and the clotrimazole cream is prepared by heating and melting an oil phase (including the cetanol, octadecanol, isopropyl myristate, partial Tween 60, and Span 60), homogenizing and mixing with an aqueous phase (including the purified water and benzyl alcohol) and a drug phase (including the purified water, Tween 60 and clotrimazole) at a certain temperature, and then conducting rapid cooling. The clotrimazole cream can be slowly and smoothly released in a medium of pH 4.5 (in simulated vaginal conditions) to reduce dose risks, besides, physicochemical stability of the clotrimazole cream is superior to that of other clotrimazole cream products, and the preparation process is simple, short in time consumption, low in energy consumption, and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a clotrimazole cream (3%) and a preparation method thereof. Background technique [0002] Clotrimazole cream is used for candidal vulvovaginal disease, especially for those with vaginal dryness or menopausal women who are inconvenient to use clotrimazole vaginal tablets. Clotrimazole cream is administered vaginally. Generally, an injector is used to squeeze all the cream into the deep part of the vagina, and it is administered once before going to bed. If the condition is complicated, continuous administration for several days is often required. The conventional commercially available clotrimazole cream has a specification of 1%. The droplet dispersion in the cream is large and the drug is released quickly, resulting in short treatment time and poor patient compliance. If the concentration of the main drug is simply increased to 3% specification, ...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/4174A61K47/10A61P15/02A61P31/02A61P31/10
CPCA61K31/4174A61K9/06A61K47/10A61K9/0034A61P15/02A61P31/10A61P31/02
Inventor 袁金桥刘朝勇刘芳洁
Owner HARVEST PHARMA HUNAN CO LTD
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