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Clevidipine butyrate injection

A technology of clevidipine butyrate and dipine injection, which is applied in the fields of emulsion delivery, cardiovascular system diseases, organic active ingredients, etc., can solve the problems of easy aggregation and merging of emulsion droplets, thermodynamic instability, demulsification and floating oil, etc., and achieves Reduce the lipid peroxidation problem in the body, prolong the storage time, and reduce the oil phase content

Active Publication Date: 2013-05-22
BEIJING DELI FURUI MEDICAL SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The problems of stability and safety in the emulsion prepared by this formula and method: fat emulsion belongs to submicron emulsion, belongs to thermodynamically unstable system, and it is in the long-term storage process, and the emulsion droplets are easy to aggregate and merge, and the particle size grows up. There may even be partial demulsification and floating oil

Method used

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  • Clevidipine butyrate injection
  • Clevidipine butyrate injection
  • Clevidipine butyrate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The clevidipine butyrate injection provided in this embodiment includes clevidipine butyrate, oil phase, phospholipid and organic solvent, and the weight percentages of each component are as follows:

[0044] Clevidipine butyrate 0.01-10%,

[0045] Oil phase 0.1-10%,

[0046] Phospholipids 5-50%,

[0047] Organic solvent 40-90%.

[0048] In the above prescription, the oil phase includes at least one of the following: soybean oil, corn oil, castor oil, olive oil, coconut oil, peanut oil, fish oil, cottonseed oil, glyceryl monostearate, glyceryl monooleate, sesame oil , safflower oil, C 6 -C 8 Fatty acid triglycerides, ethyl oleate.

[0049] The phospholipids include at least the following: natural phospholipids and synthetic phospholipids.

[0050] The organic solvent includes at least the following: ethanol, glycerol, propylene glycol, polyethylene glycol, wherein ethanol is preferred.

[0051] The preparation method of above-mentioned injection comprises the fol...

Embodiment 2

[0073] prescription:

[0074]

[0075] Preparation:

[0076] Accurately weigh the prescribed quantity of clevidipine butyrate, dissolve it in part of absolute ethanol, then add lecithin E-80, soybean oil and the remaining prescribed amount of absolute alcohol, stir to dissolve each component and mix well Clevidipine Acid Injection.

[0077] In clinical application, the above prescription is diluted 5-100 times (0.1-2 mg / mL) for better effect, more preferably 0.5 mg / mL.

Embodiment 3

[0080] prescription:

[0081]

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Abstract

The invention belongs to the field of a pharmaceutical preparation, and in particular relates to a clevidipine butyrate injection. The injection comprises 0.01-10% of clevidipine butyrate, 0.1-10% of oil phase, 5-50% of phospholipid and 40-90% of organic solvent in percentage by weight. According to the invention, the clevidipine butyrate injection with good stability can be obtained, and the clevidipine butyrate can be used for lowering blood pressure during a surgery and after the surgery and when an oral therapy is not feasible or desirable. In comparison with the prior art, the clevidipine butyrate injection is always an anhydrous system in a storage process of the injection, the injection can be prepared on spot during use, thereby being capable of preventing an oxidation reaction of phospholipids and a degradation reaction of medicines, prolonging the preservation time of the preparation and improving the stability of the injection provided by the invention.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to clevidipine butyrate injection. Background technique [0002] In heart, brain, eye surgery and microsurgery, it is very important to control the patient's blood pressure. In these cases, it is necessary to quickly, accurately and safely lower the blood pressure to a predetermined level and maintain it for a certain period of time. After the operation, the blood pressure should be quickly restored to a normal level. [0003] Clevidipine butyrate, the chemical name is 4-(2',3'-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate butyryloxy Methyl methyl ester (C21H23Cl2NO6), a new generation of short-acting dihydropyridine vascular selective calcium antagonists, has been shown to reduce mean arterial blood pressure, but has little effect on venous volume vessels. Clinically, it is often used to control blood pressure during or after surgery, and it can als...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/4422A61P9/12
Inventor 吴翠栓马风中朱啸
Owner BEIJING DELI FURUI MEDICAL SCI & TECH
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