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Modified fat-soluble composition and preparation method thereof

A composition and fat-soluble technology, applied in the direction of drug combination, pharmaceutical formula, organic active ingredients, etc., can solve the problems of poor stability, achieve the effects of improving stability, ensuring content uniformity, and improving safety and effectiveness

Inactive Publication Date: 2018-11-16
昆山普瑞凯纳米技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the hydrolysis tendency of betamethasone ester during storage, the hydrolyzed products are free betamethasone and organic acid. Adding appropriate triethanolamine to the system can increase the alkalinity and reduce the risk of calcipotriol degradation. environment, so betamethasone has a higher risk of hydrolysis and poorer stability

Method used

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  • Modified fat-soluble composition and preparation method thereof
  • Modified fat-soluble composition and preparation method thereof
  • Modified fat-soluble composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] An improved fat-soluble composition, its formula is as shown in the following table:

[0025] Name of raw material

1000g formula quantity (g)

Formula ratio (%)

effect

Calcipotriol anhydrous

0.05

0.005

active ingredient

Betamethasone valerate

0.5

0.05

active ingredient

liquid paraffin

50

5

Fat-soluble base, consistency regulator

cetyl alcohol

40

4

Fat-soluble base, consistency regulator

di-tertiary hydroxyanisole

0.01

0.001

Antioxidants

Di-tert-butyl-p-cresol

0.01

0.001

Antioxidants

White Vaseline

add up to 1000

add up to 100

fat soluble matrix

[0026] A preparation method of an improved fat-soluble composition, comprising the following steps:

[0027] 1) Pretreatment: transfer cetyl alcohol to liquid paraffin with about 70% of the formulation amount, add antioxidant, heat to 40°C and stir to dissolve, add calcipotriol anhydrou...

Embodiment 2

[0031] An improved fat-soluble composition, its formula is as shown in the following table:

[0032] Name of raw material

1000g formula quantity (g)

Formula ratio (%)

effect

Calcipotriol anhydrous

0.05

0.005

active ingredient

Betamethasone acetate

0.5

0.05

active ingredient

liquid paraffin

40

4

Fat-soluble base, consistency regulator

cetyl alcohol

60

6

Fat-soluble base, consistency regulator

Racemic α-tocopherol

0.5

0.05

Antioxidants

White Vaseline

add up to 1000

add up to 100

fat soluble matrix

[0033] A preparation method of an improved fat-soluble composition, comprising the following steps:

[0034] 1) Pretreatment: transfer cetyl alcohol to liquid paraffin with about 50% of the formulation amount, add antioxidant, heat to 60°C and stir to dissolve, add calcipotriol anhydrous, stir until completely dissolved, and obtain calcipo Triol solution; t...

Embodiment 3

[0038] An improved fat-soluble composition, its formula is as shown in the following table:

[0039] Name of raw material

1000g formula quantity (g)

Formula ratio (%)

effect

Calcipotriol anhydrous

0.05

0.005

active ingredient

Betamethasone dipropionate

0.5

0.05

active ingredient

liquid paraffin

100

10

Fat-soluble base, consistency regulator

cetyl alcohol

80

8

Fat-soluble base, consistency regulator

Di-tert-butyl-p-cresol

0.02

0.002

Antioxidants

Racemic α-tocopherol

0.05

0.005

Antioxidants

White Vaseline

add up to 1000

add up to 100

fat soluble matrix

[0040] A preparation method of an improved fat-soluble composition, comprising the following steps:

[0041] 1) Pretreatment: transfer cetyl alcohol to liquid paraffin with about 60% of the formulation amount, add antioxidant, heat to 50°C and stir to dissolve, add calcipotriol anhydrou...

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Abstract

The invention discloses a modified fat-soluble composition and a preparation method thereof. In the composition, an effective component comprises a vitamin D derivative and a betamethasone ester; an adjuvant material comprises a fat-soluble matrix and an antioxidant. In the composition, the fat-soluble matrix is selected, and the water content of the matrix is controlled, so that the hydrolysis risk of the betamethasone ester is reduced, the stability of calcipotriol anhydride is prevented from being affected by hydrolysed acid, and the stability of the modified fat-soluble composition is alsoimproved. In the composition, the more reasonable betamethasone ester is optimized and is used for drug combination treatment for plaque psoriasis, so that more clinical selections are provided for patients. The invention provides an optimized pretreatment method of the calcipotriol anhydride, so that the content uniformity of calcipotriol in a product is ensured, and the safety and the effectiveness of the product are further improved. The invention provides the stable composition through the optimization of the formula and the process.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an improved fat-soluble composition. Background technique [0002] Psoriasis is a common chronic inflammatory skin disease. It is a disease of polygenic inheritance, which can be induced by various triggering factors, such as trauma, infection, drugs, etc., in susceptible individuals. The typical cutaneous appearance is well-demarcated erythematous plaques with silvery white scales. In mild cases, it may manifest as several silver coin-sized plaques on the elbow and knees, and in severe cases, the skin of the whole body may also be involved. Its pathophysiological mechanism is mainly the abnormality of epidermal hyperplasia and differentiation and the activation of immune system. The traditional Chinese medicine name is white boils, and the folks generally call it psoriasis. The disease mainly occurs in young and middle-aged people, and has a great impact on the phy...

Claims

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Application Information

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IPC IPC(8): A61K31/593A61K31/573A61K47/06A61K47/10A61K47/08A61K47/22A61P17/06
CPCA61K31/573A61K31/593A61K47/06A61K47/08A61K47/10A61K47/22A61P17/06A61K2300/00
Inventor 刘坤罗文豪谢林峰
Owner 昆山普瑞凯纳米技术有限公司
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