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Antihypertensive drug fat milk injection and preparation method thereof

A technology of emulsion injection and fat, which is applied in the field of antihypertensive drug fat emulsion injection and its preparation, can solve the problems of needing strengthening and poor stability, and achieve the effect of stable quality and high safety

Active Publication Date: 2018-02-06
WUHAN CONFORM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, existing literature reports that due to the instability of clevidipine butyrate, degradation may occur during the processing and storage of pharmaceutical preparations, and the current clevidipine butyrate fat emulsion injection has poor stability.
Therefore, the research on current clevidipine butyrate fat emulsion injection and preparation method thereof still needs to be strengthened

Method used

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  • Antihypertensive drug fat milk injection and preparation method thereof
  • Antihypertensive drug fat milk injection and preparation method thereof
  • Antihypertensive drug fat milk injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0177] Example 1 Clevidipine Butyrate Fat Emulsion Injection Prescription Screening

[0178] The inventor sets the prescription composition of clevidipine butyrate fat emulsion injection of the present invention as follows: clevidipine butyrate, oil phase medium, emulsifier, osmotic pressure regulator, stabilizer, metal chelating agent, pH value adjustment medicaments, and water for injections. Furthermore, the specific prescription of clevidipine butyrate fat emulsion injection was screened, as follows:

[0179] 1. Prescription screening and basic process:

[0180] (1) Take the mixture of soybean oil for injection and medium-chain triglycerides (the weight ratio of the two is 1:1) and heat it to 70°C~75°C, add egg yolk lecithin, stabilizer, clevidipine butyrate, mix , shear until all are dissolved and dispersed evenly, so as to obtain the first mixture containing clevidipine butyrate oil phase.

[0181] (2) Heat water for injection to 70°C, add glycerin for injection and s...

Embodiment 2

[0206] The preparation of embodiment 2 clevidipine butyrate fat emulsion injection

[0207] prescription:

[0208]

[0209] Preparation method:

[0210] (1) Take the mixture of soybean oil for injection and medium-chain triglycerides (the weight ratio of the two is 1:1) and heat it to 70°C~75°C, add egg yolk lecithin E-80, phosphatidylglycerol, and butyric acid chloride Vidipine, mixed, sheared until completely dissolved and dispersed evenly, so as to obtain the first mixture containing clevidipine butyrate oil phase.

[0211] (2) Heat water for injection to 70°C, add glycerin for injection and stir evenly, add disodium edetate and stir until dissolved, so as to obtain the second mixture forming an aqueous phase.

[0212] (3) Mix the first mixture and the second mixture, and shear while mixing, at a rotation speed of 8000 rpm, for 10 minutes, so as to obtain a third mixture forming colostrum.

[0213] (4) Use 1 mol / L sodium hydroxide solution to adjust the pH of the thir...

Embodiment 3

[0228] The preparation of embodiment 3 clevidipine butyrate fat emulsion injection

[0229] prescription:

[0230]

[0231] Preparation method:

[0232] (1) Take the mixture of soybean oil for injection and medium-chain triglycerides (the weight ratio of the two is 1:1) and heat it to 70°C~75°C, add egg yolk lecithin E-80, phosphatidylglycerol, and butyric acid chloride Vidipine, mixed, sheared until completely dissolved and dispersed evenly, so as to obtain the first mixture containing clevidipine butyrate oil phase.

[0233] (2) Heat water for injection to 70°C, add glycerin for injection and stir evenly, add disodium edetate and stir until dissolved, so as to obtain the second mixture forming an aqueous phase.

[0234] (3) Mix the first mixture and the second mixture, and shear while mixing, at a rotation speed of 2000 rpm, for 30 minutes, so as to obtain a third mixture forming colostrum.

[0235] (4) Use 1 mol / L sodium hydroxide solution to adjust the pH of the thir...

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Abstract

The invention discloses an antihypertensive drug fat milk injection and a preparation method thereof. The antihypertensive drug fat milk injection is a clevidipine butyrate fat milk injection and contains clevidipine butyrate and a pharmacologically acceptable medical excipient; the medical excipient comprises an oil-phase medium, an emulsifier, an osmotic pressure regulator, a stabilizer, a metalcheating agent, a pH value regulator and injection water. The antihypertensive drug fat milk injection has stable quality and high safety and is not irritant to blood vessels.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. Specifically, the invention relates to an antihypertensive drug fat emulsion injection and a preparation method thereof. Background technique [0002] Clevidipine butyrate is an antihypertensive drug, a new short-acting dihydropyridine calcium channel antagonist developed by AstraZeneca. Clevidipine Butyrate Emulsion for Intravenous Injection was first launched in the U.S. in August 2008 under the trade name Cleviprex (its published prescription information uses soybean oil as the injection oil and oleic acid as the stabilizer), and it was approved for marketing within the past 10 years. The only new intravenous antihypertensive drug. The drug is used to treat high blood pressure that is not suitable for orally administered orally ineffective, and it can also be used to treat acutely elevated blood pressure after surgery. [0003] However, according to existing literature re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K47/14A61K47/44A61K31/4422A61P9/12
CPCA61K9/0019A61K9/107A61K31/4422A61K47/14A61K47/44
Inventor 周小顺牟东升李进贺容丽汪哲多
Owner WUHAN CONFORM PHARMA CO LTD
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