Vitamin B12 solid dispersion and preparation method thereof
A technology of solid dispersion and B12, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., to achieve the effects of improving intestinal absorption rate, easy preparation, and low cost
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Embodiment 1
[0039] Dissolve 4 mg of vitamin B12 in 400 μL of absolute ethanol to obtain mixed solution A; after melting 1.5 g of Gelucire 44 / 14 at 60 °C, add 300 μL of mixed solution A dropwise to the melted Gelucire 44 / 14, fully After mixing evenly, the mixed solution B is obtained;
[0040] Evaporate the mixed solution B at 45°C under reduced pressure, remove absolute ethanol, and dry it. After cooling and solidifying at room temperature, a vitamin B12 solid dispersion with a uniform red appearance is obtained. The prepared vitamin B12 solid dispersion was sealed and packaged, and stored in a refrigerator at 4°C away from light. The formation of the vitamin B12 solid dispersion was verified by differential scanning calorimetry, as follows Figure 2A to Figure 2D shown. Depend on Figure 2A to Figure 2D It can be seen that a solid dispersion of vitamin B12 is produced which is distinct from the physical mixture.
Embodiment 2
[0042] Dissolve 12mg of vitamin B12 in 1.2mL of absolute ethanol to obtain mixture A; weigh 0.1g of Gelucire44 / 14 and melt it at 80°C, then add 1.0mL of mixture A to the melted Gelucire 44 / 14 dropwise , after fully mixing uniformly, the mixed solution B is obtained;
[0043] Evaporate the mixed solution B at 55°C under reduced pressure, remove absolute ethanol, and dry it. After cooling and solidifying at room temperature, a vitamin B12 solid dispersion with a uniform red appearance is obtained. The prepared vitamin B12 solid dispersion was sealed and packaged, and stored in a refrigerator at 5° C. away from light.
Embodiment 3
[0045] Dissolve 140mg of vitamin B12 in 14mL of absolute ethanol to obtain mixed solution A; weigh 2.72g of Gelucire44 / 14 and melt it at 70°C, then add 13.6mL of vitamin B12 solution dropwise to the melted Gelucire 44 / 14, After fully mixing evenly, the mixed solution B is obtained;
[0046] The mixture B was evaporated under reduced pressure at 50°C to remove absolute ethanol to dryness. After cooling and solidifying at room temperature, a vitamin B12 solid dispersion with a uniform red appearance was obtained. The prepared vitamin B12 solid dispersion was sealed and packaged, and stored in a refrigerator at 3° C. in the dark. With the vitamin B12 solid dispersion that makes in embodiment 3, adopt following image 3 The rat everted intestinal sac model shown was used for in vitro animal-level testing to evaluate drug absorption.
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Abstract
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