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Calcipotriol betamethasone ointment and preparation method thereof

A technology of calcipotriol and betamethasone, applied in the field of medicine, can solve the problems of increased impurities, phase separation, uneven content and the like

Inactive Publication Date: 2013-05-22
JIANGSU SEMPOLL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Studies have shown that when polyoxypropylene-15-S-stearyl alcohol ether is used as the solvent of ointment, there are following problems in the preparation process: due to the immiscibility of hydrocarbons such as ethers and petrolatum, phase separation occurs, resulting in long-term Storage under high temperature conditions: unstable ointment dosage form, increased impurities, uneven content
In the stability study of calcipotriol betamethasone ointment produced by LEO, the ointment will produce irreversible phase separation when placed at high temperature (50°C), resulting in ointment destruction

Method used

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  • Calcipotriol betamethasone ointment and preparation method thereof
  • Calcipotriol betamethasone ointment and preparation method thereof
  • Calcipotriol betamethasone ointment and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Recipe for Ointment 1

[0052]

[0053] making process:

[0054] (a) Micronizing calcipotriol and betamethasone until 90% of the particle size is less than 15 microns, and the particle size range is between 5-110 microns.

[0055] (b) Add (a) to caprylic capric acid macrogol glyceride under high-speed cutting and homogenization, and the temperature is controlled at 40-60°C

[0056] (c) Melt white vaseline at 80°C and keep warm at 70°C

[0057] (d) While stirring continuously, mix the material obtained in step (b) and (c) homogeneously, and control the temperature at 55-70°C

[0058] (e) Cool down to 25-35° C., and pack to obtain calcipotriol-betamethasone ointment.

[0059] The ointment was placed at 40°C and 50°C for 10 days respectively, and the properties of the ointment and the related substances and contents of betamethasone dipropionate were investigated. See Table 1 and Table 2 for the results.

Embodiment 2

[0061] Recipe for ointment 2

[0062]

[0063] making process:

[0064] (a) Micronizing calcipotriol and betamethasone until 90% of the particle size is less than 15 microns, and the particle size range is between 5-50 microns.

[0065] (b) Add (a) to caprylic capric acid macrogol glyceride under high-speed cutting and homogenization, and the temperature is controlled at 40-60°C

[0066] (c) Melt white vaseline at 80°C and keep warm at 70°C

[0067] (d) Add vitamin E to (c) and stir well.

[0068] (e) While stirring continuously, mix the material obtained in step (b) and (d) homogeneously, and control the temperature at 55-70°C

[0069] (f) cooling down to 25-35° C., and dispensing to obtain calcipotriol-betamethasone ointment.

[0070] The ointment was placed at 40°C and 50°C for 10 days respectively, and the properties of the ointment and the related substances and contents of betamethasone dipropionate were investigated. See Table 1 and Table 2 for the results.

Embodiment 3

[0072] Recipe for ointment 3

[0073]

[0074] making process:

[0075] (a) Micronizing calcipotriol and betamethasone until 90% of the particle size is less than 15 microns, and the particle size range is 5-15 microns.

[0076] (b) Add (a) to caprylic capric acid macrogol glyceride under high-speed cutting and homogenization, and the temperature is controlled at 40-60°C

[0077] (c) Melt white vaseline at 80°C and keep warm at 70°C

[0078] (d) Add vitamin E and ethylparaben to (c) and stir well.

[0079] (e) While stirring continuously, mix the material obtained in step (b) and (d) homogeneously, and control the temperature at 55-70°C

[0080] (f) cooling down to 25-35° C., and dispensing to obtain calcipotriol-betamethasone ointment.

[0081] The ointment was placed at 40°C and 50°C for 10 days respectively, and the properties of the ointment and the related substances and contents of betamethasone dipropionate were investigated. See Table 1 and Table 2 for the res...

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Abstract

The invention a calcipotriol betamethasone ointment prepared from caprylocaproyl macrogolglycerides. Under the conditions of high speed cutting and a homogeneous state, calcipotriol micronized particles with particle size range being 5-110 microns and the micronized particles of betamethasone dipropionate are uniformly dispersed to caprylocaproyl macrogolglycerides, affinities of caprylocaproyl macrogolglycerides and a commonly used ointment matrix are utilized to obtain the uniform ointment with uniformly distributed particle size. Furthermore, the stability of resisting high temperature (50 DEG C) is better, and is beneficial to improving the quality and the stability of a medicine.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a calcipotriol-betamethasone ointment for treating psoriasis caused by abnormal keratosis. Background technique [0002] Calcipotriol is a VD3 derivative, and betamethasone propionate is a high-efficiency halocorticoid drug, both of which are first-line topical psoriasis treatment drugs. Authoritative clinical data show that the effective rate of compound preparations in the treatment of psoriasis is significantly better than that of their single use. [0003] According to the patent of LEO, the patent No. ZL00807667.7 relates to the solvent C represented by polyoxypropylene-15-S-stearyl ether to dissolve calcipotriol (dissolved, in the form of non-fine powder particles), and to polyoxygen Propylene-15-S-stearyl ether has been patented. The patent adopts micronized calcipotriol particles dispersed in caprylic capric acid macrogol glyceride, and the particle size ra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/593A61K31/573A61K9/06A61K47/34A61P17/06A61K47/14
Inventor 周越强李超陈玉兰惠洁
Owner JIANGSU SEMPOLL PHARMA
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