A kind of crystalline substance, its preparation method, its pharmaceutical composition and application
A composition and drug technology, applied in the direction of drug combination, pharmaceutical formula, anti-tumor drugs, etc., can solve the problem of little anti-tumor activity
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Embodiment 1
[0040] Preparation method 1 of 990207-22-1 crystal type II sample:
[0041] After 500 mg of the 990207-22-1 sample was completely dissolved at room temperature using 60 mL of tetrahydrofuran solvent, 60 mL of ethyl acetate was added, and recrystallized at room temperature to obtain the 990207-22-1 crystal type II sample, and its powder X-ray diffraction Atlas and figure 1 unanimous.
[0042] Preparation method 2 of 990207-22-1 crystal type II sample:
[0043]After completely dissolving 500 mg of the 990207-22-1 sample at 40°C using a mixed solvent of tetrahydrofuran:ethyl acetate at a ratio of 2:1, recrystallize at 40°C to obtain a 990207-22-1 crystal type II sample, Its powder X-ray diffraction pattern and figure 1 unanimous.
Embodiment 2
[0045] The preparation method 1 (tablet) of combination pharmaceutical preparation:
[0046] A method for preparing a combined drug preparation, which is characterized in that several excipients are used to prepare 990207-22-1 crystal type II pure product or a mixed crystal solid substance containing crystal type II in any proportion as the raw material drug of the combined drug. Form into tablets with a drug content of 10-300 mg per tablet, and Table 2 provides the tablet formulation:
[0047] Table 2 The preparation formula of 990207-22-1 combination medicine tablet
[0048]
[0049]
[0050] The method for preparing 990207-22-1 crystal type II pure product or mixed crystal bulk drug containing crystal type II in any proportion into tablet preparations is as follows: mix several excipients with the bulk drug evenly, and add 1% hydroxymethyl Appropriate amount of sodium cellulose solution is made into a soft material, granulated by sieving, wet granules are dried, siev...
Embodiment 3
[0052] The preparation method 2 (capsule) of combined pharmaceutical preparation:
[0053] A method for preparing a combined drug preparation, which is characterized in that several excipients are used to prepare 990207-22-1 crystal type II pure product or a mixed crystal solid substance containing crystal type II in any proportion as the raw material drug of the combined drug. Form into capsules with a drug content of 10-300 mg per grain, and the capsule formula is given in Table 3:
[0054] Table 3 Preparation formula of 990207-22-1 combination drug capsule
[0055]
[0056] The method of preparing 990207-22-1 crystal type II pure product or mixed crystal bulk drug containing crystal type II in any proportion into capsule preparations is as follows: mix several excipients with the bulk drug evenly, and add 1% hydroxymethyl Appropriate amount of sodium cellulose solution is made into wet granules, dried, sieved and granulated, added with magnesium stearate, mixed evenly, ...
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