Composition of L-5-methyltetrahydrofolate or pharmaceutically acceptable salt thereof and pharmaceutical adjuvants and preparing method thereof
A technology of methyltetrahydrofolate and pharmaceutical excipients, which is applied in the fields of drug combination, food science, cardiovascular system diseases, etc., can solve the problems of affecting the bioavailability of drugs, difficult to achieve medicinal and edible, poor chemical stability, etc. Achieve fast dispersion and dissolution rate, improve bioavailability, and good dispersion.
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Embodiment 1
[0040] Dissolve L-5-methyltetrahydrofolate calcium salt (50 mg) and povidone K30 (500 mg) in water (10 ml), heat to 60°C and stir to dissolve. The above solution is freeze-dried to obtain the composition of amorphous L-5-methyltetrahydrofolate calcium salt and povidone K30, and the X-ray powder diffraction pattern of the composition is as follows: figure 1 As shown, there is no characteristic peak of the crystal form of L-5-methyltetrahydrofolate calcium salt in the X-ray powder diffraction pattern after deducting the background peak of the pharmaceutical excipient.
Embodiment 2
[0042] Dissolve L-5-methyltetrahydrofolate (50 mg) and povidone K30 (500 mg) in water (2 ml), heat to 60°C and stir to dissolve. The above solution was lyophilized to obtain a composition of amorphous L-5-methyltetrahydrofolate and povidone K30, and no L-5 -Characteristic peaks of the crystalline form of methyltetrahydrofolate.
Embodiment 3
[0044] Add L-5-methyltetrahydrofolate glucosamine salt (0.1 g) and polyethylene glycol 8000 (10 g) into water (300 ml), heat to 60° C. and stir to dissolve. Dry the above solution with JISL micro spray dryer LSD-48, maintain the inlet temperature at 60°C and the outlet temperature at 50°C, collect the outlet material to obtain a white solid, and further vacuum dry to obtain amorphous L-5-methyltetrahydrofolate glucosamine The composition of the salt and polyethylene glycol 8000, in the X-ray powder diffraction diagram of the composition, there is no characteristic peak of the crystal form of L-5-methyltetrahydrofolate glucosamine salt after deducting the background peaks of pharmaceutical excipients.
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