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Emulsion containing clevidipine and preparation process and application thereof

A technology of clevidipine and preparation process, applied in the field of medicine, can solve problems such as poor water solubility, and achieve the effects of stable quality and uniform particle size distribution

Inactive Publication Date: 2010-07-07
北京利乐生制药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention aims at the poor water solubility of clevidipine, but has the characteristics of moderate fat solubility, and preparing it into an emulsion can overcome the shortcoming of its poor water solubility; meanwhile, in the emulsion preparation process, the step of preparing colostrum is omitted, and water The phase and oil phase are directly homogeneous, and the obtained emulsion has uniform particle size distribution and stable quality

Method used

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  • Emulsion containing clevidipine and preparation process and application thereof
  • Emulsion containing clevidipine and preparation process and application thereof
  • Emulsion containing clevidipine and preparation process and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0017]

[0018] Preparation:

[0019] First, measure 500ml of water for injection, dissolve the prescribed amount of glycerin and edetate disodium calcium in it, and dissolve clevidipine and soybean phosphatidylcholine in soybean oil, and heat appropriately to promote dissolution. Then add the water phase and the oil phase to the high-pressure homogenizer in turn for circulation and homogenization until the particle size distribution is 50-250nm, take it out, adjust the pH value to 6-8 with 0.1mol / L NaOH, and then add the remaining A certain amount of water for injection was filtered 5 times with a 200nm microporous membrane to further homogenize the particle size and remove larger particles.

Embodiment 2

[0021]

[0022] Preparation:

[0023] First, measure 500ml of water for injection, dissolve the prescribed amount of glycerin in it, dissolve clevidipine butyrate and egg yolk lecithin in soybean oil, and heat appropriately to promote dissolution. Then add the water phase and the oil phase to the high-pressure homogenizer in turn for circulation and homogenization until the particle size distribution is 50-250nm, take it out, adjust the pH value to 6-8 with 0.1mol / L NaOH, and then add the remaining A certain amount of water for injection was filtered 5 times with a 200nm microporous membrane to further homogenize the particle size and remove larger particles.

Embodiment 3

[0025]

[0026] Preparation:

[0027] First, measure 500ml of water for injection, dissolve the prescribed amount of mannitol in it, dissolve clevidipine and soybean lecithin in castor oil, and heat to promote dissolution. Then add the water phase and the oil phase to the high-pressure homogenizer in turn for circulation and homogenization until the particle size distribution is 50-250nm, take it out, adjust the pH value to 6-8 with 0.1mol / L NaOH, and then add the remaining A certain amount of water for injection was filtered 5 times with a 200nm microporous membrane to further homogenize the particle size and remove larger particles.

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Abstract

The invention discloses to an emulsion containing clevidipine and a preparation process and application thereof, relating to the emulsion utilizing the clevidipine and pharmaceutically acceptable salt or hydrate as active ingredients and the preparation process and the application thereof. The emulsion used for vein injection, which utilizes the clevidipine and the pharmaceutically acceptable salt or hydrate as the active ingredients, is formed by carrying out a certain preparation process on the active ingredients and pharmaceutically acceptable auxiliary materials, and can be used for rapid depressurization during and after a surgery. In the invention, the clevidipine and the pharmaceutically acceptable salt are taken as the active ingredients and some auxiliary materials with specific varieties and ratios are added, thus the emulsion for vein injection is developed according to the preparation process explained by the patent.

Description

technical field [0001] An emulsion containing clevidipine and its preparation process and application. The invention relates to an emulsion with clevidipine and its pharmaceutically acceptable salt or hydrate as active ingredients, its preparation process and application, and belongs to the technical field of medicine. Background technique [0002] With the improvement of people's living standards and changes in dietary structure and lifestyle, the incidence of hypertension has gradually increased in recent years. Hypertension can cause damage to the heart, brain, kidney and other organs of the patient, and is closely related to sugar and lipid metabolism disorders and diabetes, which can significantly reduce the quality of life of the patient, and even endanger life in severe cases. Therefore, the research on the pathogenesis and therapeutic drugs of hypertension has attracted more and more attention from scholars at home and abroad. [0003] In heart, brain, eye surgery ...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/4422A61P9/12
Inventor 李宝齐
Owner 北京利乐生制药科技有限公司
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