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Nicorandil lipid microsphere preparation and preparation method thereof

A technology of nicorandil grease and nicorandil, which is applied in the field of nicorandil lipid microsphere preparation and its preparation, can solve the problem of low dosage form stability and achieve the effect of improving stability

Active Publication Date: 2022-01-25
太阳升(亳州)生物医药科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] The main purpose of the embodiments of the present invention is to provide a Nicorandil lipid microsphere preparation and its preparation method to solve the technical problem of low stability of existing dosage forms

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 aforementioned nicorandil lipid microsphere preparation, an embodiment of the present invention also provides a preparation method of the nicorandil lipid microsphere preparation, and the method includes the following steps.

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

[0033] In this step, the specific process parameters are not limited, and it is better to be able to dissolve and mix uniformly. For example, the formulated amount of oil for injection can be preheated to 60-70°C, and the formulated amount of emulsifier and stabilizer can be added in sequence under stirring, and mixed evenly to form a homogeneous oil phase.

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

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

Embodiment 1

[0042] Nicorandil formulations were prepared in accordance with the following formula quantities.

[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, dissolve and add the formulated amount of linoleic acid, and mix evenly to obtain a homogeneous oil phase. Continue to use a water bath to keep the temperature of the homogeneous oil phase at 65°C. Under high-speed stirring at 8000 rpm, add the prescribed amount of Nicorandil raw material into the homogeneous oil phase, and stir for 3 minutes to make it evenly dissolve in the soybean oil , to obtain the drug-containing oil phase. Continue to use a water bath to keep the temperature of the medicated oil phase at 65° C., 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 evenly dispersed colostrum. Add water for injection to the...

Embodiment 2

[0046] Nicorandil formulations were prepared in accordance with the following formula quantities.

[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, dissolve and add the formulated amount of linoleic acid, and mix evenly to obtain a homogeneous oil phase. Continue to use a water bath to keep the temperature of the homogeneous oil phase at 65°C. Under high-speed stirring at 8000 rpm, add the prescribed amount of Nicorandil raw material into the homogeneous oil phase, and stir for 3 minutes to make it evenly dissolve in the soybean oil , to obtain the drug-containing oil phase. Continue to use a water bath to keep the temperature of the medicated oil phase at 65° C., 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 evenly dispersed colostrum. Add water for injection to th...

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Abstract

The embodiments of the present invention provide a nicorandil lipid microsphere preparation and a preparation method thereof, which relate to the field of pharmaceutical dosage forms and are invented to solve the technical problem of low stability of the existing nicorandil dosage forms. The nicorandil lipid microsphere preparation comprises nicorandil, oil for injection, emulsifier and water for injection, wherein nicorandil is wrapped in the oil for injection with a particle diameter of 10-900nm, and the oil for injection is dispersed in in 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 effects of nitrates to expand coronary blood vessels and continuously increase coronary blood flow, but also prevents the dissociation of intracellular calcium ions and increases the permeability of cell membranes to potassium ions. [0003] But the physical properties of Nicorandil are not stable enough. When the conditions such as humidity, temperature, oxygen, light, and acidity are not suitable for the solid dosage form of Nicorandil, it is easy to cause the degradation of the active drug. Contents of the invention [0004] The main purpose of the embodiments of the present invention is to provide a nicorandil lipid microsphere preparation and ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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