A kind of rupatadine fumarate nanoemulsion and its preparation method and application
A technology of rupatadine fumarate and nanoemulsion, which is applied in the field of medicine and can solve problems such as tooth damage in children
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[0049] In a second aspect, an embodiment of the present invention provides a method for preparing a rupatadine fumarate nanoemulsion according to the first aspect, comprising the following steps:
[0050] Weigh the cosurfactant and rupatadine fumarate in the formula amount, and mix them evenly to obtain the first mixture;
[0051] Weigh the surfactant and the oil phase of the formula, and mix them uniformly to obtain the second mixture;
[0052] The first mixture is added to the second mixture, mixed uniformly, and water is added dropwise while stirring, until a stable clear emulsion is formed;
[0053] A pH adjuster is added to the stable and clear emulsion, the pH is adjusted to 5-6, and water is added to make up the volume to obtain a rupatadine fumarate nanoemulsion.
[0054] The preparation method of the rupatadine fumarate nanoemulsion provided by the invention can maximize the drug loading by mixing in stages, the method is simple, reliable, and has good repeatability,...
Embodiment 1
[0062] The components of the rupatadine fumarate nanoemulsion provided in this example are shown in Table 1.
[0063] The preparation method of the rupatadine fumarate nanoemulsion provided in this embodiment is:
[0064] (1) weigh 10g of propylene glycol and 128mg of rupatadine fumarate, mix and stir to obtain a first mixture;
[0065] (2) take by weighing 15g Tween 80, 5g Span 80 and 50g ethyl oleate, mix and stir to obtain the second mixture;
[0066] (3) the first mixture is added to the second mixture, mixed and stirred, and distilled water is added dropwise while stirring, until a stable clear and transparent emulsion is formed;
[0067] (4) Add 0.397g of citric acid and 0.568g of disodium hydrogen phosphate to the above stable, clear and transparent emulsion, adjust the pH to 5.2, add distilled water to dilute to 100mL, and filter to obtain rupatadine fumarate nanoemulsion.
Embodiment 2
[0069] The components of the rupatadine fumarate nanoemulsion provided in this example are shown in Table 1.
[0070] The preparation method of the rupatadine fumarate nanoemulsion provided in this embodiment is:
[0071] (1) weigh 10g of propylene glycol and 128mg of rupatadine fumarate, mix and stir to obtain a first mixture;
[0072] (2) take by weighing 20g Tween 80, 5g Span 80 and 45g ethyl oleate, mix and stir to obtain the second mixture;
[0073] (3) the first mixture is added to the second mixture, mixed and stirred, and distilled water is added dropwise while stirring, until a stable clear and transparent emulsion is formed;
[0074] (4) Add 0.320g of citric acid and 0.568g of disodium hydrogen phosphate to the above stable, clear and transparent emulsion, adjust the pH to 5.5, add distilled water to dilute to 100mL, and filter to obtain rupatadine fumarate nanoemulsion.
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