A kind of granule of lamotrigine solid dispersion and preparation method thereof
A technology of solid dispersion and lamotrigine, which is applied in the directions of non-active ingredients such as medical preparations, pharmaceutical formulations, and active ingredients of heterocyclic compounds, can solve the problems of low solubility of lamotrigine and improve the bioavailability , rapid and easy to take effect
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[0041] The preparation method of the lamotrigine solid dispersion provided by the invention comprises the steps of: according to the amount of the formula recorded in Table 1 for each embodiment, it is added in the hot-melt extruder, and the barrel temperature is set The temperature is 140°C-175°C, and the rotation speed of the screw is set at 60-90rpm, thereby obtaining a molded body of solid dispersion. The obtained molded body is pulverized in a ball mill, and then the pulverized product is sieved, and the sieved product is collected, thereby obtaining a solid dispersion powder.
[0042] The components and dosage of the lamotrigine solid dispersion granules provided by the present invention are shown in Table 2.
[0043] Table 2 Granule formulation composition
[0044]
Embodiment 7～9
[0045] Above-mentioned embodiment 7~9 are prepared according to the following method:
[0046]The preparation method of the lamotrigine solid dispersion granule provided by the present invention comprises the following steps: adding internally added raw and auxiliary materials into a wet mixing granulator, starting stirring for 3r / s, shearing at 15r / s at the same time, and mixing for five minutes , and then turn on stirring 3r / s and shearing 20r / s at the same time, add water-based soft material, time for 4 minutes, discharge, pass through a 24-mesh sieve to granulate, dry in an oven until the moisture content is below 5%, and then pass through a 24-mesh sieve for granulation , and then moved into the hopper mixer, adding the amount of lubricant, 15r / s speed mixing for 10 minutes, thus obtaining the lamotrigine solid dispersion granules.
[0047] The formula composition of lamotrigine solid dispersion granule embodiment 7 and comparative example 1, comparative example 2, compar...
Embodiment 10
[0055] Example 10: Analysis and comparison Method: Solubility study.
[0056] Preparation of reference solution: Accurately weigh about 20 mg of lamotrigine raw material, place it in a 10 mL volumetric flask, add 6 mL of purified water, dissolve by ultrasonication for 15 minutes, cool to room temperature, add purified water to make up to 10 mL, and shake well. Filter through a 0.45μm filter membrane, take 1mL of the filtrate and place it in a 100mL volumetric flask, add purified water to dilute and make to volume, and shake well.
[0057] Preparation of test solution: Accurately weigh about 200 mg of granules (Example 7) (approximately equivalent to 20 mg of lamotrigine-containing raw material), place in a 10 mL volumetric flask, add 6 mL of purified water, dissolve by ultrasonication for 15 minutes, and cool to room temperature , add purified water to make up to 10mL, and shake well. Filter through a 0.45μm filter membrane, take 1mL of the filtrate and place it in a 100mL vo...
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