Dexzopiclone oral fast-dissolving film and preparation method thereof
A technology of eszopiclone and oral instant film, which is applied to pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. Simple process, pure sweetness effect
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Embodiment 1
[0038] Prescription composition:
[0039]
[0040]
[0041] The eszopiclone inclusion complex is prepared by spray drying with eszopiclone and β-cyclodextrin in a molar ratio of 1:1.
[0042] Preparation Process:
[0043] (1) Accurately weigh 29.2 g of β-cyclodextrin and 10.0 g of eszopiclone with a molar ratio of 1:1, respectively, heat the β-cyclodextrin with water to 50°C and dissolve it into a saturated solution. The clone was dissolved in 150 ml of acetone and slowly added to the above saturated solution of β-cyclodextrin, stirred in a constant temperature water bath at 65°C for 4-6 hours, and then the solution was spray-dried in a spray dryer to obtain eszopiclone inclusion complex powder;
[0044] (2), accurately weigh the recipe quantity KollicoatProtect, dissolve in purified water under heating and stirring conditions at 60~70 ℃, then add malic acid, sucralose and menthol in turn, and stir to obtain blank glue;
[0045] (3), the eszopiclone clathrate powder in...
Embodiment 2
[0048] Prescription composition:
[0049]
[0050] The eszopiclone inclusion complex is prepared by spray drying with eszopiclone and β-cyclodextrin in a molar ratio of 1:1.
[0051] Preparation Process:
[0052] (1) Accurately weigh 29.2 g of β-cyclodextrin and 10.0 g of eszopiclone with a molar ratio of 1:1, respectively, heat the β-cyclodextrin with water to 70°C and dissolve it into a saturated solution. The clone was dissolved in 150 ml of acetone and slowly added to the above saturated solution of β-cyclodextrin, stirred in a constant temperature water bath at 65°C for 4-6 hours, and then the solution was spray-dried in a spray dryer to obtain eszopiclone inclusion complex powder;
[0053] (2), accurately weigh the recipe quantity PVAMowiol4-88, dissolve in purified water under heating and stirring conditions at 60~70°C, then add sorbitol, PEG400, citric acid, sucralose and lemon essence successively, stir well to obtain blank glue;
[0054] (3), take the eszopiclo...
Embodiment 3
[0057] Prescription composition:
[0058]
[0059] The eszopiclone inclusion complex is prepared by spray drying with eszopiclone and β-cyclodextrin in a molar ratio of 1:1.
[0060] Preparation Process:
[0061] (1), respectively accurately weigh 29.2 g of β-cyclodextrin and 10.0 g of eszopiclone with a molar ratio of 1:1, heat the β-cyclodextrin with water to 60°C to dissolve it into a saturated solution, and eszopiclone The clone was dissolved in 150 ml of acetone and slowly added to the above saturated solution of β-cyclodextrin, stirred in a constant temperature water bath at 65°C for 4-6 hours, and then the solution was spray-dried in a spray dryer to obtain eszopiclone inclusion complex powder;
[0062] (2), accurately weigh the recipe quantity HPMCE5, dissolve in purified water under heating and stirring conditions at 60~70 ℃, then add glycerin, tartaric acid, sucralose and sweet orange essence successively, and stir to obtain blank glue;
[0063] (3), disperse th...
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