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Hydrocortisone butyrate semihydrate zinc oxide pharmaceutical composition

A technology of hydrocortisone butyrate and hemihydrate, which is applied in the field of hydrocortisone butyrate hemihydrate zinc oxide pharmaceutical composition, and can solve the problems of curative effect influence, product stability interference, ester hydrolysis speed influence and the like

Inactive Publication Date: 2014-06-25
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Table 3 on the second page of the US patent application US20040152682A1 also discloses hydrocortisone-21-butyrate (HCB-21) produced by the transesterification of the main impurity in the stability test of hydrocortisone butyrate preparations. Due to the presence of a large amount of water in the process and formula of the preparation, the transesterification reaction of the existing hydrocortisone-21-butyrate occurs faster, and the impurity hydrocortisone-21-butyrate produced is more , which has increased interference to the stability of the product, and at the same time, the production of impurities has also had a certain impact on the curative effect of the product
[0004] is well known (Ma Junying, types and influencing factors of carboxylic acid ester hydrolysis, "Journal of Xinyang Normal University: Natural Science Edition", 1998, Volume 11, Issue 4, 417- 421) Tertiary alcohol ester hydrocortisone butyrate can be hydrolyzed under acidic or alkaline conditions, but different pH values ​​will have a greater impact on the rate of ester hydrolysis

Method used

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  • Hydrocortisone butyrate semihydrate zinc oxide pharmaceutical composition
  • Hydrocortisone butyrate semihydrate zinc oxide pharmaceutical composition
  • Hydrocortisone butyrate semihydrate zinc oxide pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Dissolve 1 kg of hydrocortisone butyrate in 25 L of tetrahydrofuran: ethanol (2:8) mixed solution, add 2.5 L of water, freeze at -70 to -60 ° C for 3 hours, and the solution freezes into a solid . Vacuumize the system until the vacuum degree is below 18Pa, heat up gradually to -40°C, and keep the temperature for 3 hours; raise the temperature to -20°C, and keep the temperature for 6 hours; hour, naturally rise to room temperature, keep the temperature for 5 hours, and dry at 50±5°C until the difference in weight per gram of the compound is less than or equal to 0.5 mg at intervals of 1 hour to obtain hydrocortisone butyrate hemihydrate.

Embodiment 2

[0033]Dissolve 1 kg of hydrocortisone butyrate in 30 L of tetrahydrofuran: ethanol (1.5:8.5) mixed solution, add 3.9 L of water, freeze at -70 to -60 °C for 3 hours, and the solution freezes into a solid . Vacuumize the system until the vacuum degree is below 18Pa, heat up gradually to -40°C, and keep the temperature for 3 hours; raise the temperature to -20°C, and keep the temperature for 6 hours; hour, naturally rise to room temperature, keep the temperature for 5 hours, and dry at 50±5°C until the difference in weight per gram of the compound is less than or equal to 0.5 mg at intervals of 1 hour to obtain hydrocortisone butyrate hemihydrate.

Embodiment 3

[0035] Dissolve 1 kg of hydrocortisone butyrate in 20 L of tetrahydrofuran: ethanol (2.5:7.5) mixed solution, add 1.4 L of water, freeze at -70 to -60 ° C for 3 hours, and the solution freezes into a solid . Vacuumize the system until the vacuum degree is below 18Pa, heat up gradually to -40°C, and keep the temperature for 3 hours; raise the temperature to -20°C, and keep the temperature for 6 hours; hour, naturally rise to room temperature, keep the temperature for 5 hours, and dry at 50±5°C until the difference in weight per gram of the compound is less than or equal to 0.5 mg at intervals of 1 hour to obtain hydrocortisone butyrate hemihydrate.

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Abstract

The invention relates to a hydrocortisone butyrate semihydrate zinc oxide pharmaceutical composition and in particular relates to a preparation method of hydrocortisone butyrate semihydrate and a preparation method of the hydrocortisone butyrate semihydrate zinc oxide pharmaceutical composition.

Description

technical field [0001] The invention relates to a pharmaceutical composition of hydrocortisone butyrate hemihydrate zinc oxide, in particular to a preparation method of hydrocortisone butyrate hemihydrate and a pharmaceutical composition of hydrocortisone butyrate hemihydrate zinc oxide method of preparation. Background technique [0002] Hydrocortisone-17-butyrate (Hydrocortisone-17-butyrate, CAS: 13609-67-1) is a kind of steroid corticosteroid, which can inhibit the reaction of inflamed and allergic skin, and also inhibit the reaction associated with the accelerated regeneration of cells This leads to symptoms such as erythema, edema, skin thickening, subsidence of skin surface roughness, and relief of itching, burning, and pain. Due to the introduction of 17-butyrate on the hydrocortisone molecule, the fat solubility of hydrocortisone butyrate is better, so that better curative effect can be achieved during external treatment, while the side effects of hydrocortisone are...

Claims

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Application Information

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IPC IPC(8): A61K33/30A61K9/06A61K47/34A61K47/28A61K47/20A61P29/00A61K31/573
Inventor 孙亮赵琳
Owner TIANJIN JINYAO GRP