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Clevidipine butyrate structured lipid emulsion and preparation method thereof

A kind of technology of clevidipine butyrate and fat emulsion, which is applied in the directions of oil/fat/wax inactive ingredients, pharmaceutical formulations, emulsion delivery, etc.

Inactive Publication Date: 2012-01-18
辽宁中海康生物制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the past 10 years, no new intravenous antihypertensive drugs have been marketed

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] prescription

[0034]

[0035] Process:

[0036] (1) Preparation of water phase: add glycerin to water to dissolve, heat to 75°C, and set aside;

[0037] (2) Preparation of oil phase: heat refined soybean oil to 75°C, add egg yolk lecithin (with a phosphatidylcholine content of more than 80%) to dissolve, add clevidipine butyrate, and stir to dissolve;

[0038] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 75° C., high-speed shear dispersion, shear speed of 8000 rpm, and time of 15 minutes to form colostrum;

[0039] (4) Adjusting the pH value: rapidly cooling the colostrum in step (3) below 30°C, and adjusting the pH value to 6.0-8.0 with sodium hydroxide;

[0040](5) High-pressure homogenization: the colostrum in step (4) is homogenized under high pressure by a microfluidizer 4 times, the pressure is 1000 bar, and the temperature is controlled below 30°C;

[0041] (6) potting and sterilization: ...

Embodiment 2

[0044] prescription

[0045]

[0046] Process:

[0047] (1) Preparation of water phase: add glycerin to water to dissolve, heat to 75°C, and set aside;

[0048] (2) Preparation of oil phase: heat refined soybean oil to 75°C, add egg yolk lecithin (with a phosphatidylcholine content of more than 80%) to dissolve, add clevidipine butyrate, and stir to dissolve;

[0049] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 75° C., high-speed shear dispersion, shear speed of 8000 rpm, and time of 15 minutes to form colostrum;

[0050] (4) Adjusting the pH value: rapidly cooling the colostrum in step (3) below 30°C, and adjusting the pH value to 6.0-8.0 with sodium hydroxide;

[0051] (5) High-pressure homogenization: the colostrum in step (4) is homogenized under high pressure by a microfluidizer 4 times, the pressure is 1000 bar, and the temperature is controlled below 30°C;

[0052] (6) potting and sterilization:...

Embodiment 3

[0055] prescription:

[0056]

[0057] Process:

[0058] (1) Preparation of water phase: add glycerin to water to dissolve, heat to 75°C, and set aside;

[0059] (2) Preparation of oil phase: heat refined soybean oil and medium-chain triglycerides to 75°C, add egg yolk lecithin (more than 80% phosphatidylcholine content) to dissolve, add clevidipine butyrate, and stir to make it dissolve;

[0060] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 75° C., high-speed shear dispersion, shear speed of 8000 rpm, and time of 15 minutes to form colostrum;

[0061] (4) pH value adjustment: quickly cool down the colostrum in step (3) to below 30°C, and adjust the pH value to 4.5-6.5 with sodium hydroxide;

[0062] (5) High-pressure homogenization: the colostrum in step (4) is homogenized under high pressure by a microfluidizer 4 times, the pressure is 1000 bar, and the temperature is controlled below 30°C;

[0063] ...

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Abstract

The invention relates to a clevidipine butyrate structured lipid emulsion which comprises clevidipine butyrate, structured triglyceride, an emulsifier, an isotonic agent, a pH regulator, and injection water, wherein the weight volume percentage of clevidipine butyrate is 0.05-0.1% (w / v); the weight volume percentage of structured triglyceride is 5-30% (w / v); the weight volume percentage of the emulsifier is 1.0-2.0% (w / v); and the weight volume percentage of the isotonic agent is 1.0-5.0% (w / v).

Description

technical field [0001] The invention relates to a clevidipine butyrate structured fat emulsion and a preparation method thereof. Background technique [0002] During heart and brain surgery, it is required to quickly and safely lower blood pressure to a predetermined level and maintain it for a predetermined time, and then quickly restore blood pressure to normal. The drugs currently used for the above indications mainly include sodium nitroprusside, nitroglycerin and nicardipine. But none of them can really effectively control blood pressure. The main disadvantage of sodium nitroprusside is the risk of cyanide poisoning, followed by the effect on regional myocardial blood flow in patients with coronary artery disease. Nitroglycerin is also very short-acting, but the effect is too low and needs to be used in very high doses, which can easily cause a decrease in cardiac output. Nicardipine is a dihydropyridine calcium antagonist with high vascular selectivity, but the dura...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/4422A61K47/44A61K47/14A61K47/24A61K47/34A61K47/26A61P9/12
Inventor 宋华先王娟肖红梅马红萍孙欣黄海秦玉霞
Owner 辽宁中海康生物制药股份有限公司
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