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Clevidipine butyrate emulsion and preparation method thereof

A technology of clevidipine butyrate and dipine emulsion, which is applied in the direction of pharmaceutical formula, emulsion delivery, medical preparations containing active ingredients, etc., can solve the problems of poor storage stability, achieve less adverse reactions, ensure stability, and eliminate impurities The effect of low content

Active Publication Date: 2014-11-19
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The technical problem to be solved by the present invention is to overcome the defect of poor storage stability of the existing clevidipine butyrate injection emulsion, and a kind of clevidipine butyrate emulsion and preparation method thereof are provided

Method used

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  • Clevidipine butyrate emulsion and preparation method thereof
  • Clevidipine butyrate emulsion and preparation method thereof
  • Clevidipine butyrate emulsion and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0043] A kind of clevidipine butyrate emulsion, its component and content are as follows:

[0044]

[0045] The preparation method of the clevidipine butyrate emulsion of the present embodiment may further comprise the steps:

[0046] (1) Under a nitrogen atmosphere, mix clevidipine butyrate, soybean oil and oleic acid uniformly at 60°C according to the above formula to obtain an oil phase; mix egg yolk lecithin, glycerin, EDTA and water for injection in Mix evenly at 60°C to obtain the water phase; add the oil phase to the water phase evenly at a rate of 10-20g / min, shear and emulsify at 60°C, the shear speed is 10,000rpm, and the shear time is 30 minutes to obtain the water package oil emulsion;

[0047] (2) Under a nitrogen atmosphere, after the oil-in-water emulsion is cooled to below 25°C, adjust the pH to 7.0 with sodium hydroxide, homogenize under high pressure, the homogenization pressure is 1000bar, and the number of homogenization is 4 times. The temperature is ...

Embodiment 2

[0049] A kind of clevidipine butyrate emulsion, its component and content are as follows:

[0050]

[0051] The preparation method of the clevidipine butyrate emulsion of the present embodiment may further comprise the steps:

[0052] (1) Under a nitrogen atmosphere, mix clevidipine butyrate, fish oil and oleic acid uniformly at 40°C according to the above formula to obtain an oil phase; mix soybean lecithin, sodium chloride, ethylenediaminetetraacetic acid and water for injection Mix evenly at 40°C to obtain the water phase; add the oil phase to the water phase evenly at a speed of 40-60g / min, shear and emulsify at 40°C, the shear speed is 4000rpm, and the shear time is 50 minutes to obtain the water phase oil-in-emulsion;

[0053] (2) Under a nitrogen atmosphere, after the oil-in-water emulsion is cooled to below 25°C, adjust the pH to 9.0 with sodium hydroxide, homogenize under high pressure, the homogenization pressure is 1500bar, and the number of times of homogenizat...

Embodiment 3

[0055] A kind of clevidipine butyrate emulsion, its component and content are as follows:

[0056]

[0057] The preparation method of the clevidipine butyrate emulsion of the present embodiment may further comprise the steps:

[0058] (1) Under a nitrogen atmosphere, mix clevidipine butyrate, castor oil, and trans-oleic acid at 90°C according to the above formula to obtain an oil phase; mix egg yolk lecithin, glycerin, aminotriacetic acid, and water for injection in Mix evenly at 90°C to obtain the water phase; add the oil phase to the water phase evenly at a rate of 90-100g / min, shear and emulsify at 90°C, the shear speed is 12000rpm, and the shear time is 10 minutes to obtain the water package oil emulsion;

[0059] (2) Under a nitrogen atmosphere, after the oil-in-water emulsion is cooled to below 25°C, adjust the pH to 4.0 with hydrochloric acid, homogenize under high pressure, the homogenization pressure is 500bar, and the homogenization times are 6 times, and the hom...

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Abstract

The invention discloses a clevidipine butyrate emulsion and a preparation method thereof. The clevidipine butyrate emulsion includes an oil phase and a water phase. The oil phase comprises clevidipine butyrate, long-chain oil and a stabilizer. The water phase comprises an emulsifier and water. A mass ratio of the oil phase and the water phase is 1:11-1:1. The clevidipine butyrate accounts for 0.05-0.5% of the total mass of the clevidipine butyrate emulsion; the long-chain oil accounts for 10-50% of the total mass of the clevidipine butyrate emulsion; the stabilizer accounts for 0.01-0.5% of the total mass of the clevidipine butyrate emulsion; and the emulsifier accounts for 0.5-5.0% of the total mass of the clevidipine butyrate emulsion. The water phase can also include a metal ion chelating agent and / or an isotonic agent. The emulsion can also include a pH adjusting agent. The clevidipine butyrate emulsion is safe and effective, is less in adverse reactions, is high in drug encapsulation efficiency, is good in storage stability, is controllable in preparation processes and is low in contents of impurities. The method is easy to industrially control.

Description

technical field [0001] The invention relates to a clevidipine butyrate emulsion and a preparation method thereof. Background technique [0002] A hypertensive emergency is a severe clinical manifestation caused by a sharp rise in blood pressure. The "Guidelines for the Prevention and Treatment of Hypertension in China" revised in 2005 pointed out that hypertensive emergencies are severely elevated blood pressure, greater than 180 / 120mmHg, accompanied by progressive target organ dysfunction. The 2007 ESC / ESH European Hypertension Guidelines included perioperative hypertension as a hypertensive emergency. According to the epidemiological data of the United States, 1 / 3 of the patients who come to the emergency department due to hypertensive crisis are hypertensive emergencies. Hypertensive emergencies occur in about 5% of Chinese hypertensive patients. According to literature, the incidence of target organ damage in hypertensive emergencies: encephalopathy 16.3%, intracrania...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/4422A61P9/12
Inventor 唐文燕房秋雨施海斌史建国孙宁云张军东
Owner SHANGHAI SINE PHARMA LAB
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