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
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[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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