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Preparation method of clevidipine butyrate injection fat emulsion

A technology of clevidipine butyrate and fat for injection, which is applied in the field of preparation of fat emulsion for clevidipine butyrate injection, can solve problems such as few detailed reports, and achieves stable quality, stable preparation process and convenient use. Effect

Inactive Publication Date: 2016-08-24
NANJING HEALTHNICE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] There are few detailed reports on the preparation process of fat emulsion for clevidipine butyrate injection in published literature reports

Method used

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  • Preparation method of clevidipine butyrate injection fat emulsion
  • Preparation method of clevidipine butyrate injection fat emulsion
  • Preparation method of clevidipine butyrate injection fat emulsion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Single-dose prescription composition

[0025] Element

Dosage (mg)

Clevidipine Butyrate

25

Soybean oil

10000

egg yolk lecithin

600

Oleic acid

15

glycerin

1125

Edetate Disodium

2.5

sodium hydroxide

5

Water for Injection

up to 50ml

[0026] Preparation:

[0027] Dosing process:

[0028] Oil phase preparation: under the protection of nitrogen, add the prescribed amount of soybean oil, egg yolk lecithin and oleic acid into the liquid mixing tank A, stir and heat to 60°C, keep warm, add the prescribed amount of clevidipine butyrate, and high-speed (2500r / min) and stir until the clevidipine butyrate is completely dissolved.

[0029] Water phase preparation: Add the prescribed amount of glycerin, edetate disodium and water for injection into the liquid mixing tank B, stir to completely dissolve and mix evenly, control the liquid mixing temperature at 60°C, and keep warm.

[...

Embodiment 2

[0037] Single-dose prescription composition

[0038] Element

Dosage (mg)

Clevidipine Butyrate

25

Soybean oil

10000

egg yolk lecithin

600

Oleic acid

15

glycerin

1125

Edetate Disodium

2.5

sodium hydroxide

5

Water for Injection

up to 50ml

[0039] Preparation:

[0040] Dosing process:

[0041] Oil phase preparation: under the protection of nitrogen, add the prescribed amount of soybean oil, egg yolk lecithin and oleic acid into the liquid mixing tank A, stir and heat to 60°C, keep warm, add the prescribed amount of clevidipine butyrate, and high-speed (2500r / min) and stir until the clevidipine butyrate is completely dissolved.

[0042] Water phase preparation: Add the prescribed amount of glycerin, edetate disodium and water for injection into the liquid mixing tank B, stir to completely dissolve and mix evenly, control the liquid mixing temperature at 60°C, and keep warm.

[...

Embodiment 3

[0050] Single-dose prescription composition

[0051] Element

Dosage (mg)

Clevidipine Butyrate

25

Soybean oil

10000

egg yolk lecithin

600

Oleic acid

15

glycerin

1125

Edetate Disodium

2.5

sodium hydroxide

5

Water for Injection

up to 50ml

[0052] Preparation:

[0053] Dosing process:

[0054] Oil phase preparation: under the protection of nitrogen, add the prescribed amount of soybean oil, egg yolk lecithin and oleic acid into the liquid mixing tank A, stir and heat to 60°C, keep warm, add the prescribed amount of clevidipine butyrate, and high-speed (2500r / min) and stir until the clevidipine butyrate is completely dissolved.

[0055] Water phase preparation: Add the prescribed amount of glycerin, edetate disodium and water for injection into the liquid mixing tank B, stir to completely dissolve and mix evenly, control the liquid mixing temperature at 60°C, and keep warm.

[...

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Abstract

The invention provides a preparation method of a clevidipine butyrate injection fat emulsion, wherein the fat emulsion consists of a main drug, an oil phase, an emulsifier, an antioxidant, an isoosmotic regulating agent, a chelating agent, a pH value regulating agent and injection water, wherein the oil phase is soybean oil; the emulsifier is egg yolk lecithin; the antioxidant is oleic acid; the isoosmotic regulating agent is glycerol; the chelating agent is edetate disodium; and the pH value regulating agent is sodium hydroxide. In the preparation, an emulsifying temperature is controlled at 60 DEG C, a stirring speed is at 2500r / min, a stirring duration is 10min, pH value is regulated to 8.5-9.0 by virtue of the sodium hydroxide, high-pressure homogeneous pressure is controlled at 700bar and the preparation method includes 6-8 cycle times. The clevidipine butyrate injection fat emulsion prepared by the technology disclosed by the invention is more stable in quality and convenient to use; and moreover, the preparation method is stable in process and suitable for mass production.

Description

technical field [0001] The invention relates to a preparation method of fat emulsion for clevidipine butyrate injection, which belongs to the technical field of medicinal chemistry. Background technique [0002] Clevidipine butyrate, the chemical name is (±) methyl butyl 2,6-dimethyl-4-(2,3-dichlorophenyl)-1,4-dihydro-3,5-pyridinedicarboxylate Acid oxymethyl ester. [0003] Molecular formula is C 21 h 23 Cl 2 NO 6 [0004] The molecular weight is 456.32 [0005] The structural formula is: [0006] [0007] This product is easily soluble in dimethylformamide, acetone and dimethyl sulfoxide; soluble in acetonitrile; slightly soluble in methanol; slightly soluble in ethanol and isopropanol; insoluble or almost insoluble in water. The melting point is 136°C to 139°C. [0008] Clevidipine butyrate (Clevidipine butyrate) is researched by British AstraZeneca company, and in August, 2008 by U.S. Medicines company through the new type of intravenous injection dihydropyrid...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/4422A61P9/12
Inventor 张蓓蓓王华娟
Owner NANJING HEALTHNICE MEDICAL TECH
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