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Self-emulsifying composition of beta-11 betamethasone, preparation process and application thereof

A technology for betamethasone and a composition is applied in the field of self-emulsifying technology and drug preparation, which can solve the problems of low biotransformation rate of beta-12 substances and affect the rate of betamethasone, so as to improve the biotransformation rate and improve the competitiveness of products. , the effect of increasing solubility

Active Publication Date: 2007-05-23
SHANGAI PHARMA GRP CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Severely affects the rate of betamethasone synthesis reaction
Therefore, solving the problem of low biotransformation rate of betamethasone β-11 to β-12 caused by insoluble water has become a technical problem that those skilled in the art have been trying to overcome for a long time

Method used

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  • Self-emulsifying composition of beta-11 betamethasone, preparation process and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Betamethasone β-11 80g

[0039] Medium Chain Triglycerides (MCT) 150g

[0040] Absolute ethanol 130g

[0041] 1,2-propanediol 160g

[0042]Polyoxyethylene Hydrogenated Castor Oil RH40 250g

[0043] Hydroxypropyl Methyl Cellulose E15 70g

[0044] Mix the above prescription amount of substances and 80ml of foam enemy, heat, reflux at 80°C for 0.5h, add to the fermented broth where the mold (seed) has grown and transform. After being added to the fermentation broth, the average particle diameter is 200nm, and the cumulative value of 90% particle diameter is 360nm.

Embodiment 2

[0046] Betamethasone β-11 80g

[0047] Medium Chain Triglycerides (MCT) 240g

[0048] Labrafil  M (co-emulsifier) ​​200g

[0049] Tween 80 80g

[0050] Polyoxyethylene Hydrogenated Castor Oil RH40 200g

[0051] Mix the above prescription amount of substances with 80ml of foam enemy, heat, reflux at 80°C for 0.5h, add to the fermentation broth where the mold has grown and transform. After being added to the fermentation broth, the average particle diameter is 227nm, and the cumulative value of 90% particle diameter is 395nm.

Embodiment 3

[0053] Betamethasone β-11 80g

[0054] Castor Oil 230g

[0055] 1,2-propanediol 120g

[0056] Transcutol P 220g

[0057] Polyoxyethylene Hydrogenated Castor Oil RH40 250g

[0058] Mix the above prescription amount of substances with 80ml of foam enemy, heat, reflux at 80°C for 0.5h, add to the fermentation broth where the mold has grown and transform. After being added to the fermentation broth, the average particle diameter is 120nm, and the cumulative value of 90% particle diameter is 198nm.

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Abstract

The invention discloses a self-emulsifying composition of betamethasone beta-11 and its use in preparing betamethasone. The self-emulsifying composition comprises betamethasone beta-11 parts, oil phase 15-55 parts, assistant emulsifier 15-46 and emulsifying agent 15-55 parts.

Description

technical field [0001] The invention relates to the technical fields of self-emulsification technology and medicine preparation, in particular to a self-emulsification composition containing betamethasone β-11, a preparation method of the composition and an application in the preparation process of betamethasone. Background technique [0002] The self-emulsifying system (Self-Emulsifying System) is a technology that has developed rapidly in recent years. It is a solid or liquid containing an oil phase, a surfactant (emulsifier) ​​and a co-surfactant (co-emulsifier). Among them, the oil phase is mostly fatty acid esters and vegetable oils after structural modification or hydrolysis, which have good fluidity, solubility and self-emulsification; the surfactant is usually a nonionic surfactant with a high HLB value. An appropriate amount of auxiliary surfactants can reduce the amount of main surfactants and reduce the safety problems caused by repeated use of surfactants. The m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K47/44A61K47/14A61K31/573
Inventor 甘勇韩建生杨凌风杨怡静甘莉朱春柳刘坤
Owner SHANGAI PHARMA GRP CO LTD
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