Nicorandil lipid microsphere preparation and preparation method thereof

A technology of nicorandil lipid and nicorandil, which is applied in the field of nicorandil lipid microsphere preparation and preparation thereof, and can solve the problems of low stability of dosage forms and the like

Active Publication Date: 2019-08-16
太阳升(亳州)生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The main purpose of the embodiments of the present invention is to provide a Nicorandil lipid microsph...

Method used

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  • Nicorandil lipid microsphere preparation and preparation method thereof
  • Nicorandil lipid microsphere preparation and preparation method thereof
  • Nicorandil lipid microsphere preparation and preparation method thereof

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preparation example Construction

[0031] Corresponding to the above-mentioned nicorandil lipid microsphere preparation, an embodiment of the present invention also provides a preparation method of nicorandil lipid microsphere preparation. The method includes the following steps.

[0032] Step 1: Add the emulsifier and stabilizer to the injection oil, mix well to obtain the oil phase.

[0033] This step does not limit the specific process parameters, and it is suitable to be able to dissolve and mix uniformly. For example, it is possible to preheat the formula amount of injection oil to 60-70°C, add the formula amount of emulsifier and stabilizer one by one while stirring, and mix them to form a homogeneous oil phase.

[0034] Step 2: Add Nicorandil to the oil phase and mix well to obtain the medicated oil phase.

[0035] This step does not limit the specific process parameters, and it is better to be able to mix uniformly. For example, at a temperature of 60-70°C and a high-speed stirring of 7000-9000 rpm, the formul...

Embodiment 1

[0042] The nicorandil preparation was prepared according to the following formula.

[0043]

[0044] In a water bath, preheat the formulated amount of soybean oil to 65°C, then add the formulated amount of lecithin under nitrogen protection and stirring, and add the formulated amount of linoleic acid after dissolution, and mix well to obtain a homogeneous oil phase. Continue to keep the temperature of the homogeneous oil phase at 65°C in a water bath, add the formula amount of nicorandil API to the homogeneous oil phase under high-speed stirring at 8000 rpm, and stir for 3 minutes to make it evenly dissolved in soybean oil In, the medicated oil phase is obtained. Continue to keep the temperature of the medicated oil phase at 65°C in a water bath, and add the medicated oil phase to 800 mL of water for injection under high-speed stirring at 8000 rpm. Stir for 10 minutes to obtain uniformly dispersed colostrum. Fill the colostrum with water for injection until the volume reaches 1...

Embodiment 2

[0046] The nicorandil preparation was prepared according to the following formula.

[0047]

[0048] In a water bath, preheat the formulated amount of soybean oil to 65°C, then add the formulated amount of lecithin under nitrogen protection and stirring, and add the formulated amount of linoleic acid after dissolution, and mix well to obtain a homogeneous oil phase. Continue to keep the temperature of the homogeneous oil phase at 65°C in a water bath, add the formula amount of nicorandil API to the homogeneous oil phase under high-speed stirring at 8000 rpm, and stir for 3 minutes to make it evenly dissolved in soybean oil In, the medicated oil phase is obtained. Continue to keep the temperature of the medicated oil phase at 65°C in a water bath, and add the medicated oil phase to 800 mL of water for injection under high-speed stirring at 8000 rpm. Stir for 10 minutes to obtain uniformly dispersed colostrum. Fill the colostrum with water for injection until the volume reaches 1...

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Abstract

An embodiment of the invention provides a Nicorandil lipid microsphere preparation and a preparation method thereof and relates to the field of drug dosage forms, aiming to solve the technical problemthat an existing Nicorandil dosage form is not high in stability. The Nicorandil lipid microsphere preparation comprises Nicorandil, oil for injection, an emulsifier and water for injection, whereinthe Nicorandi is wrapped in the oil for injection in the size of 10-900nm, and the oil for injection is dispersed in the water for injection.

Description

Technical field [0001] The invention relates to the field of pharmaceutical dosage forms, in particular to a nicorandil lipid microsphere preparation and a preparation method thereof. Background technique [0002] Nicorandil is a coronary vasodilator used in the treatment of various cardiovascular diseases. It not only has the effect of nitrate ester drugs to expand coronary blood vessels and continuously increase coronary blood flow, but also prevents the release of calcium ions in cells and increases the permeability of cell membranes to potassium ions. [0003] However, the physical properties of Nicorandil are not stable enough. Nicorandil solid dosage forms are prone to degradation of active drugs when conditions such as humidity, temperature, oxygen, light, acidity, etc. are not suitable. Summary of the invention [0004] The main purpose of the embodiments of the present invention is to provide a nicorandil lipid microsphere preparation and a preparation method thereof to s...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/455A61K47/44A61K47/24A61P9/08
CPCA61K31/455A61K9/107A61K47/44A61K47/24A61P9/08
Inventor 郭鸿旭缪也夫
Owner 太阳升(亳州)生物医药科技有限公司
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