A pharmaceutical composition for external use

A technology of externally used drugs and compositions, applied in the field of medicine, which can solve problems such as unstable ointment formulations, uneven content, and increased impurities

Active Publication Date: 2020-06-26
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Studies have shown that when using polyoxypropylene-15-S-stearyl alcohol ether as a solvent, there are the following problems in the preparation process: due to the immiscibility of hydrocarbons such as ethers and petrolatum, phase separation occurs, resulting in long-term high-temperature conditions When stored under low conditions, the ointment dosage form is unstable, impurities increase, and the content is uneven

Method used

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  • A pharmaceutical composition for external use
  • A pharmaceutical composition for external use
  • A pharmaceutical composition for external use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] prescription:

[0037]

[0038] Preparation Process:

[0039] (1) Weigh the prescription amount of white petrolatum, heat it in a 60℃ water bath until it melts completely, and cool it down to 45-50℃ for use;

[0040] (2) Weigh the prescription amount of liquid paraffin, add the prescription amount of racemic α-tocopherol, and stir until the dissolution is complete; add the prescription amount of betamethasone dipropionate (90% particle size <15μm), stir until the dispersion is uniform, and set aside;

[0041] (3) Weigh the prescription amount of medium-chain triglycerides, add the prescription amount of calcipotriol, heat it in a water bath at 50°C until it is completely dissolved, and set aside;

[0042] (4) Add the products of steps (2) and (3) to the product of step (1) and emulsify for 15 minutes at a speed of 4000 rpm;

[0043] (5) After emulsification is finished, the temperature is lowered to 25-35°C, and the product is divided into aliquots and ready to be obtained.

Embodiment 2

[0045] prescription:

[0046]

[0047] Preparation Process:

[0048] (1) Weigh the prescription amount of white petrolatum, heat it in a 60℃ water bath until it melts completely, and cool it down to 45-50℃ for use;

[0049] (2) Weigh the prescription amount of liquid paraffin, add the prescription amount of racemic α-tocopherol, and stir until the dissolution is complete; add the prescription amount of betamethasone dipropionate (90% particle size <15μm), stir until the dispersion is uniform, and set aside;

[0050] (3) Weigh the prescription amount of medium-chain triglycerides, add the prescription amount of calcipotriol, heat it in a water bath at 50°C until it is completely dissolved, and set aside;

[0051] (4) Add the products of steps (2) and (3) to the product of step (1) and emulsify for 15 minutes at a speed of 4000 rpm;

[0052] (5) After emulsification is finished, the temperature is lowered to 25-35°C, and the product is divided into aliquots and ready to be obtained.

Embodiment 3

[0054] prescription:

[0055]

[0056] Preparation Process:

[0057] (1) Weigh the prescription amount of white petrolatum, heat it in a 60℃ water bath until it melts completely, and cool it down to 45-50℃ for use;

[0058] (2) Weigh the prescription amount of liquid paraffin, add the prescription amount of racemic α-tocopherol, and stir until the dissolution is complete; add the prescription amount of betamethasone dipropionate (90% particle size <15μm), stir until the dispersion is uniform, and set aside;

[0059] (3) Weigh the prescription amount of medium-chain triglycerides, add the prescription amount of calcipotriol, heat it in a water bath at 50°C until it is completely dissolved, and set aside;

[0060] (4) Add the products of steps (2) and (3) to the product of step (1) and emulsify for 15 minutes at a speed of 4000 rpm;

[0061] (5) After emulsification is finished, the temperature is lowered to 25-35°C, and the product is divided into aliquots and ready to be obtained.

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PUM

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Abstract

The invention mainly relates to a pharmaceutical composition for external use, which belongs to the technical field of medicines. The pharmaceutical composition for external use contains 0.05 g of calcipotriol (anhydrous), 0.643 g of betamethasone dipropionate, 30 to 75 g of medium-chain triglyceride, 20 to 60 g of liquid paraffin and 0.01 to 0.1 g of racemized alpha-tocopherol. Compared with the prior art, the pharmaceutical composition provided by the invention has better stability, so medication safety is better guaranteed.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a more stable pharmaceutical composition for external use. Background technique [0002] Calcipotriol is a derivative of VD3. In vitro data show that calcipotriol can induce differentiation and inhibit the reproduction of keratinocytes, which is the basis for the treatment of psoriasis. Betamethasone dipropionate is a highly effective halogen-containing corticosteroid drug. Similar to other local corticosteroids, betamethasone dipropionate has anti-inflammatory, antipruritic, vasoconstriction and immunosuppressive properties. Both are first-line topical psoriasis treatment drugs. Authoritative clinical data show that the compound preparation of calcipotriol and betamethasone dipropionate is significantly more effective in treating psoriasis than when they are used alone. [0003] The calcipotriol betamethasone ointment developed by LEO Pharma Inc. was launched in the Unite...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/593A61K31/573A61K47/06A61K47/14A61K47/44A61P17/06
Inventor 杨平蒋德军龚成余悦东冯卫何志均
Owner SICHUAN HAISCO PHARMA CO LTD
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