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Preparation containing calcipotriol and betamethasone dipropionate

A technology of betamethasone dipropionate and calcipotriol, which is applied in the directions of medical preparations containing active ingredients, aerosol delivery, organic active ingredients, etc., can solve problems such as poor stability, and achieve the stability and saving of related substances. The effect of production cost and economic burden reduction

Active Publication Date: 2015-06-03
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Calcipotriol anhydrate is less stable than monohydrate

Method used

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  • Preparation containing calcipotriol and betamethasone dipropionate
  • Preparation containing calcipotriol and betamethasone dipropionate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] (1) Prescription

[0050] Raw materials

Prescription amount 1g

Prescription ratio (%)

[0051] betamethasone dipropionate

0.643mg

0.0643

Calcipotriol (anhydrous)

0.05mg

0.005

Triethanolamine

0.1mg

0.01

Benzyl alcohol

5mg

0.5

White Vaseline

944mg

94.4

liquid paraffin

50mg

3

total

1g

100

[0052] (2) Preparation process

[0053] Prepare 50 ointments according to the loading of 15g / bottle.

[0054] Melt 708g of white vaseline in a water bath at 75-85°C, cool to 55-60°C and keep it warm for later use.

[0055] Add 0.482 g of betamethasone dipropionate with a D90 less than 15 μm into 37.5 g of liquid paraffin, and ultrasonicate for 2 minutes in an ultrasonic cleaner to disperse the betamethasone dipropionate evenly, and obtain evenly dispersed betamethasone dipropionate Measone dispersion.

[0056] Add 0.075g of triethanolamine into...

Embodiment 2

[0059] The preparation method is as follows:

[0060] Prepare according to the content of 0.2% of benzyl alcohol, 0.005% of triethanolamine and 94.7% of white petrolatum in each part, and the ratio of other ingredients is the same as that of Example 1. The preparation process is the same as in Example 1. The above percentages are percentages by weight, and the percentages in other corresponding parts also refer to percentages by weight.

Embodiment 3

[0062] Prepare according to the content of 2% benzyl alcohol, 0.02% triethanolamine, and 92.9% white petrolatum in each part, and the ratio of other ingredients is the same as that of Example 1. The preparation process is the same as in Example 1.

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Abstract

The invention belongs to the field of medicine preparations, and particularly relates to a preparation technology of calcipotriol. According to the preparation technology, the problem of the stability of calcipotriol and betamethasone dipropionate is solved. Benzyl alcohol and triethanolamine are added to auxiliary materials. The paste prepared by the technology is stable in property. Compared with foreign similar products, the cost is lower; and the method is suitable for industrialized production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a preparation process of calcipotriol and betamethasone dipropionate. Background technique [0002] Psoriasis, commonly known as psoriasis, is a chronic inflammatory skin disease with a long course of disease and a tendency to relapse, and some cases are almost unhealed throughout life. Calcipotriol is a vitamin D3 derivative, and betamethasone dipropionate belongs to the class of glucocorticoids, both of which are used for the treatment of psoriasis. [0003] Calcipotriol is a white to off-white crystalline powder, and its stability can be maintained for 2 years at a storage temperature of ~20°C. Calcipotriol is soluble in organic solvents such as ethanol, dimethylsulfoxide and dimethylformamide, and its solubility in water is 1.3±0.7mg / L (25°C). Betamethasone dipropionate is white to off-white odorless powder, easily soluble in acetone and chloroform, slightly solub...

Claims

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Application Information

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IPC IPC(8): A61K31/593A61K9/06A61P17/06A61K31/573
Inventor 李智徐飞林子褀
Owner CHONGQING HUAPONT PHARMA
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