High-stability compound fluocinonide tincture and preparation method thereof

A technology of fluocinolone acetate and compound acetic acid, which is applied in pharmaceutical formulations, organic active ingredients, active ingredients of salicylic acid, etc., can solve the problems of reduced efficacy and unstable active ingredients, and achieves good stability and high stability. Effect

Pending Publication Date: 2020-12-04
INNER MONGOLIA SHENG TANG INT MONGOLIAN MEDICINE RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, during the storage of the compound fluocinolone acetate tincture, the active ingredients in i

Method used

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  • High-stability compound fluocinonide tincture and preparation method thereof
  • High-stability compound fluocinonide tincture and preparation method thereof
  • High-stability compound fluocinonide tincture and preparation method thereof

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preparation example Construction

[0033] The present invention provides the preparation method of above-mentioned highly stable compound fluocinolone acetate tincture, comprising the following steps:

[0034] (1) Take 700 parts by volume of absolute ethanol, then add salicylic acid and glycerin in sequence, stir until dissolved, then add a pH regulator to adjust the pH to 5.3-5.7, add resorcinol and borneol, stir until dissolved, and obtain the first mixture;

[0035] (2) Take fluocinolone acetate, add dimethyl sulfoxide, and mix well to obtain the second mixed solution;

[0036] (3) Add the first mixed solution obtained in step (1) to the second mixed solution obtained in step (2), stir, then add the remaining dehydrated alcohol and mix well to obtain the high-stability compound fluorine acetate Easy tincture.

[0037] Preferably, in step (1), the speed of the first stirring is 60-70 rpm, and the stirring time is 50-70 min.

[0038] Preferably, in step (1), the speed of the second stirring is 60-70 rpm, an...

Embodiment

[0042] A highly stable fluocinolone acetate tincture prepared from the following raw materials per 1000ml: 0.4g fluocinonide acetate, 50g salicylic acid, 100g resorcinol, 20g borneol, 50ml glycerin, 20ml dimethyl sulfoxide, pH Regulator sodium hydroxide 16 ~ 26g or triethylamine 40 ~ 82ml, the balance is absolute ethanol.

[0043] The preparation method of above-mentioned highly stable fluocinolone acetate tincture comprises the following steps:

[0044] (1) Take 700mL of absolute ethanol, then add salicylic acid and glycerin in sequence, stir at a stirring rate of 60-70rpm for 50-70min until dissolved, then add a pH regulator to adjust the pH to 5.3-5.7, add m-phthalic acid Phenol and borneol were stirred at a stirring rate of 60-70rpm for 15-25min until dissolved to obtain the first mixed solution;

[0045] (2) Take fluocinolone acetate, add dimethyl sulfoxide, and mix well to obtain the second mixed solution;

[0046] (3) Add the first mixed solution obtained in step (1) ...

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Abstract

The invention provides a high-stability compound fluocinonide tincture which takes sodium hydroxide or triethylamine as a pH regulator, and the pH of the compound fluocinonide tincture is 5.3-5.7. Thecompound fluocinonide tincture system provided by the invention is good in stability; and in a long-time storage process, impurities generated by effective components including fluocinolone acetonide, salicylic acid, resorcinol and borneol are few, and the content of the key effective component fluocinolone acetonide can be kept at a relatively high level.

Description

technical field [0001] The invention belongs to the technical field of chemical industry and pharmacy, and in particular relates to a highly stable compound fluocinolone acetate tincture and a preparation method thereof. Background technique [0002] The main components of compound fluocinonide acetate include fluocinonide acetate, salicylic acid, borneol and resorcinol. Fluocinonide tincture has a strong anti-inflammatory effect, among which salicylic acid has the effect of dissolving skin cutin and fungicide, and borneol It has analgesic effect after local rubbing. However, during the storage of the compound fluocinolone acetate tincture, the active ingredients in it are not stable, and long-term storage may easily lead to a decrease in the efficacy of the medicine. Contents of the invention [0003] In order to solve the above technical problems, the present invention provides a compound fluocinolone acetate tincture with stable performance and long-term efficacy and a...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/02A61K47/10A61K47/18A61K31/045A61K31/05A61K31/58A61K31/60A61P29/00A61P31/10
CPCA61K31/60A61K31/58A61K31/045A61K31/05A61K9/08A61K47/10A61K47/02A61K47/18A61P29/00A61P31/10A61K2300/00
Inventor 刘卫东梁国栋娜黑芽
Owner INNER MONGOLIA SHENG TANG INT MONGOLIAN MEDICINE RES INST CO LTD
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