Emulsion for clevidipine butyrate intravenous injection and preparation method thereof

A technology of clevidipine butyrate and clevidipine butyrate, which is applied in the direction of emulsion delivery, cardiovascular system diseases, oil/fat/wax non-active ingredients, etc., can solve the problems of short activity in the body, and achieve remarkable effects, The effect of low cost and simple preparation method

Inactive Publication Date: 2013-06-05
董慧芳
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Clevidipine butyrate is a new generation of calcium ion antagonist, which is an ester drug, which is easily metabolized by esterases in blood and tissues, and hydrolyzed into inactive metabolites, so the activity in vivo is extremely short

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] 50ml 0.5mg / ml specification

[0017] Clevidipine butyrate: 25mg

[0018] Refined soybean oil: 200mg / ml

[0019] High-purity egg yolk phospholipid: 12mg / ml

[0020] Oleic acid: 0.3mg / ml

[0021] Glycerin: 22.5mg / ml

[0022] Sterile water for injection: appropriate amount (generally used in solution with EDTA-2Na)

[0023] EDTA-2Na: 0.05mg / ml

[0024] 0.1% sodium hydroxide: appropriate amount of pH regulator

[0025] The preparation method comprises the following steps:

[0026] (1) Preparation of oil phase: high-speed stirring with high-speed shearing machine to dissolve high-purity lecithin in refined soybean oil, adding clevidipine butyrate raw material after dripping oleic acid, and stirring with high-speed shearing machine The raw material drug is completely dissolved in the oil phase and kept warm for later use;

[0027] (2) Prepare the water phase: add glycerin to the EDTA-2Na sterilized aqueous solution for injection, and after the dissolution is complete,...

Embodiment 2

[0033] 100ml 0.5mg / ml specification

[0034] Clevidipine butyrate: 50mg

[0035] Refined soybean oil: 200mg / ml

[0036] High-purity egg yolk phospholipid: 12mg / ml

[0037] Oleic acid: 0.3mg / ml

[0038] Glycerin: 22.5mg / ml

[0039] Sterile water for injection: appropriate amount (generally used in solution with EDTA-2Na)

[0040] EDTA-2Na: 0.05mg / ml

[0041] 0.1% sodium hydroxide: appropriate amount of pH regulator

[0042] The preparation method comprises the following steps:

[0043] (1) Preparation of oil phase: high-speed stirring with high-speed shearing machine to dissolve high-purity lecithin in refined soybean oil, adding clevidipine butyrate raw material after dripping oleic acid, and stirring with high-speed shearing machine The raw material drug is completely dissolved in the oil phase and kept warm for later use;

[0044] (2) Prepare the water phase: add glycerin to the EDTA-2Na sterilized aqueous solution for injection, and after the dissolution is complete...

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PUM

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Abstract

The invention discloses an emulsion for clevidipine butyrate intravenous injection and a preparation method thereof. The emulsion comprises the following components: 0.5mg / mL of clevidipine butyrate, 200mg / mL of refined soybean oil, 12mg / mL of high-purity lecithin, 0.3mg / mL of oleic acid, 22.5mg / mL of glycerol and 0.05mg / mL of ethylene diamine tetraacetic acid (EDTA)-2Na. Each bottle of emulsion contains 0.5mg / mL or 1.0mg / ml of an active ingredient of clevidipine butyrate.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a clevidipine butyrate emulsion for intravenous injection and a preparation method thereof. Background technique [0002] Clevidipine butyrate is a new generation of calcium antagonists, which belongs to ester drugs, and is easily metabolized by esterases in blood and tissues, and is hydrolyzed into inactive metabolites, so the activity in vivo is extremely short. At the same time, it has a rapid onset of action and can selectively dilate arteries without affecting venous volume vessels. Research data show that for perioperative hypertensive patients, clevidipine butyrate is better than sodium nitroprusside and nitroglycerin in adjusting blood pressure during surgery, and the effect of blood pressure adjustment after surgery is equivalent to that of nicardipine; The therapeutic effect and safety of patients with acute severe hypertension are better than sodium nitropru...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/4422A61K47/44A61P9/12
Inventor 董慧芳
Owner 董慧芳
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