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Butyrate clevidipine lipid microsphere injection and preparation method thereof

A technology of clevidipine butyrate and clevidine butyrate, applied in the directions of liquid delivery, pharmaceutical formulation, emulsion delivery, etc., to achieve the effects of improving stability, improving solubility, and avoiding cracking and bleeding

Active Publication Date: 2010-07-21
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] The purpose of the present invention is to provide a kind of clevidipine butyrate lipid microsphere injection and preparation method thereof for the defects of existing clevidipine butyrate injection emulsion, so as to achieve safe and effective, controlled drug release and selective local blood pressure reduction , reduce adverse drug reactions and increase the storage stability of preparations

Method used

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  • Butyrate clevidipine lipid microsphere injection and preparation method thereof
  • Butyrate clevidipine lipid microsphere injection and preparation method thereof
  • Butyrate clevidipine lipid microsphere injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] prescription:

[0053]

[0054] w / w(%)

[0055]

[0056] Clevidipine butyrate 0.01

[0057] soybean oil 10

[0058] Soy Lecithin 1.5

[0059] Macrogol 1000 Vitamin E Succinate 0.4

[0060] Glycerin 2.3

[0061] Sodium hydroxide to adjust the pH to 5.0-8.0

[0062] water for injection balance

[0063]

[0064] Preparation:

[0065] ① Add clevidipine butyrate and soybean lecithin into soybean oil, stir and dissolve at 35-80°C, and mix evenly to obtain an oil phase.

[0066] ②Add polyethylene glycol 1000 vitamin E succinate and glycerin into water for injection, stir and dissolve at 20-80°C to obtain an aqueous phase.

[0067] ③ At 30-75°C, mix and shear the water phase and oil phase to form colostrum.

[0068] ④ Pass the colostrum through a high-pressure homogenizer, ...

Embodiment 2

[0074] prescription:

[0075]

[0076] w / w(%)

[0077]

[0078] Clevidipine butyrate 0.03

[0079] fish oil 20

[0080] Yolk Lecithin 2.5

[0081] Glycerin 2.0

[0082] Macrogol 2000 Stearate 0.6

[0083] Vitamin E 0.5

[0084] Disodium hydrogen phosphate to adjust the pH to 5.0-8.0

[0085] water for injection balance

[0086]

[0087] Preparation:

[0088] ①Add clevidipine butyrate, egg yolk lecithin and vitamin E into the fish oil, stir and dissolve at 35-80°C, mix well to obtain the oil phase.

[0089] ②Add polyethylene glycol 2000 stearate and glycerin into water for injection, stir and dissolve at 20-80°C to obtain an aqueous phase.

[0090] ③ At 30-75°C, mix and shear the water phase and oil phase to form colostrum.

[0091] ④ Pass the colostrum through a high-pressure homogenizer, adjust ...

Embodiment 3

[0097] prescription:

[0098]

[0099] w / w(%)

[0100]

[0101] Clevidipine butyrate 0.05

[0102] olive oil 10

[0103] Hydrogenated Lecithin 3.0

[0104] Solutol HS 15 2.0

[0105] Glycerin 2.5

[0106] water for injection balance

[0107]

[0108] Preparation:

[0109] ①Add clevidipine butyrate and hydrogenated lecithin into olive oil, stir and dissolve at 35-80°C, and mix evenly to obtain an oil phase.

[0110] ②Add Solutol HS 15 and glycerin to water for injection, stir and dissolve at 20-80°C to obtain an aqueous phase.

[0111] ③ At 30-75°C, mix and shear the water phase and oil phase to form colostrum.

[0112] ④ Pass the colostrum through a high-pressure homogenizer, adjust the pressure to 500-1000 bar, and homogenize for 5-15 times under high pressure to obtain lipid microsphere injection.

...

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Abstract

The invention relates to a lipid microsphere injection of butyrate clevidipine which is a rapid-effect hypotensive medicine and can be intravenously injected and a preparation method thereof. The lipid microsphere injection comprises butyrate clevidipine, oil for injection, an emulsifying agent, polyethylene glycol ester, medical additive and water for injection. The lipid microsphere injection can effectively control the medicine release at the same time of ensuring the curative effect and reduce the occurrence rate of adverse reactions.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a lipid microsphere injection of a short-acting antihypertensive drug clevidipine butyrate and a preparation method thereof. Background technique [0002] Steady blood pressure control is crucial in clinical conditions of many diseases, such as cardiovascular surgery, brain surgery, eye surgery and minimally invasive surgery, where it is necessary to quickly and safely lower the patient's blood pressure to A level that is conducive to surgery, and it quickly returns to normal after surgery. In the above medical conditions, the key is to meet the dual needs of ensuring patient safety and lowering blood pressure at the same time under the condition of giving the minimum injection volume. In addition, rapid and effective control of hypertensive emergencies is important to prevent permanent end-stage organ failure. Attention should be paid to prevent...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/4422A61K47/44A61K47/34A61P9/12A61K47/14A61K47/22A61K47/24
Inventor 杨波耿海明甘勇方春梅黄璐张馨欣
Owner WUHAN WUYAO SCI & TECH
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