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Anti-arrhythmic drug fat emulsion injection and preparation method thereof

A technology for injection and injection, which is applied in the directions of drug combination, drug delivery, pharmaceutical formulation, etc., can solve the problems of poor stability, nephrotoxicity, and high vascular irritation, and achieve non-irritant, stable drug quality, and good compliance. Effect

Active Publication Date: 2016-11-23
WUHAN CONFORM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Later, there was an injection solubilized with sulfobutyl ether β-cyclodextrin. Although the use of Tween 80 and benzyl alcohol was avoided, the cyclodextrin has certain nephrotoxicity
[0003] Making amiodarone into injection emulsion can avoid the use of Tween 80, benzyl alcohol, cyclodextrin and other excipients that are prone to toxic and side effects. However, the current amiodarone injection emulsion has poor stability and high vascular irritation.
[0004] Therefore, relevant research on the formulation of amiodarone hydrochloride fat emulsion injection and its preparation method still needs to be strengthened.

Method used

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  • Anti-arrhythmic drug fat emulsion injection and preparation method thereof
  • Anti-arrhythmic drug fat emulsion injection and preparation method thereof
  • Anti-arrhythmic drug fat emulsion injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0083] Embodiment 1 amiodarone hydrochloride fat emulsion injection prescription screening

[0084] The inventor sets the prescription composition of amiodarone hydrochloride fat emulsion injection of the present invention as follows: amiodarone hydrochloride, oil phase, emulsifier, osmotic pressure regulator, stabilizer, pH value regulator, and water for injection. Furthermore, the specific prescription of amiodarone hydrochloride fat emulsion injection was screened, as follows:

[0085] 1. Prescription screening and basic process:

[0086] (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, amiodarone hydrochloride, mix, Shear until all are dissolved and dispersed evenly, so as to obtain the first mixture containing amiodarone hydrochloride oil phase.

[0087] (2) Heat the water for injection to 70° C., add glycerin for injection and stir evenly, s...

Embodiment 2

[0113] The preparation of embodiment 2 amiodarone hydrochloride fat emulsion injection

[0114] prescription:

[0115]

[0116]

[0117] Preparation method:

[0118] (1) Take soybean oil for injection and medium-chain triglycerides and heat them to 70°C-75°C, add egg yolk lecithin E-80, egg yolk lecithin PL-100M, phosphatidylglycerol, and amiodarone hydrochloride, mix and cut until the whole solution is uniformly dispersed, so as to obtain the first mixture containing the amiodarone hydrochloride oil phase.

[0119] (2) Heat the water for injection to 70° C., add glycerin for injection and stir evenly, so as to obtain the second mixture forming an aqueous phase.

[0120] (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 that forms colostrum.

[0121] (4) Adjust the pH value of the third mixture to 5.0 with citric acid, and make up enough water for injection to obta...

Embodiment 3

[0136] The preparation of embodiment 3 amiodarone hydrochloride fat emulsion injection

[0137] prescription:

[0138]

[0139] Preparation method:

[0140] (1) Take soybean oil for injection and medium-chain triglycerides and heat them to 70°C-75°C, add egg yolk lecithin E-80, egg yolk lecithin PL-100M, phosphatidylglycerol, and amiodarone hydrochloride, mix and cut until the whole solution is uniformly dispersed, so as to obtain the first mixture containing the amiodarone hydrochloride oil phase.

[0141] (2) Heat the water for injection to 70° C., add glycerin for injection and stir evenly, so as to obtain the second mixture forming an aqueous phase.

[0142] (3) Mix the first mixture and the second mixture, and shear while mixing, at a rotation speed of 5000 rpm, for 25 minutes, so as to obtain a third mixture that forms colostrum.

[0143] (4) Adjust the pH value of the third mixture to 4.0 with citric acid, and make up enough water for injection to obtain the fourt...

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Abstract

The invention discloses an anti-arrhythmic drug fat emulsion injection and a preparation method thereof. The anti-arrhythmic drug fat emulsion injection is an amiodarone hydrochloride fat emulsion injection which contains amiodarone hydrochloride and a medicinal excipient acceptable pharmaceutically, wherein the medicinal excipient is prepared from an oil phase, an emulsifier, an osmotic pressure regulator, a stabilizing agent, a pH regulator and water for injection. The anti-arrhythmic drug fat emulsion injection is stable in quality and non-irritant to blood vessels, and the security and compliance of clinical drug application are improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. Specifically, the invention relates to an antiarrhythmic drug fat emulsion injection and a preparation method thereof. Background technique [0002] Amiodarone hydrochloride is currently one of the most clinically used and most widely used antiarrhythmic drugs, and was first listed in the United States by Wyeth. Because amiodarone hydrochloride crude drug is insoluble in water, a certain amount of cosolvent Tween 80 and benzyl alcohol have been added in the existing injections, but these cosolvents have relatively large side effects, often easily causing fulminant hepatitis, hypotension, phlebitis and Neonatal fatal asphyxia syndrome and other toxic side effects. In addition, amiodarone itself can cause damage to the lungs. Later, there was an injection solubilized with sulfobutyl ether β-cyclodextrin. Although the use of Tween 80 and benzyl alcohol was avoided, the cyclodex...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/44A61K47/14A61K47/24A61K31/343A61P9/06
CPCA61K9/0019A61K9/107A61K31/343A61K47/14A61K47/24A61K47/44
Inventor 牟东升周小顺贺容丽李进汪哲多吴欢
Owner WUHAN CONFORM PHARMA CO LTD
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