Single crystal of 14-dehydroxyl-13-dehydroandrographolidume-12-calcium sulfonate acetone solvate, and preparation method thereof
A technology of andrographolide and acetone solvent is applied in the field of drug crystal form research, which can solve the problems of difficult crystallization and purification, complex substances, difficult product quality control, etc., and achieves the effects of good crystallinity and stable solvate properties.
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experiment example 1
[0044] Add 41.5g (0.1mol) of 14-dehydroxyl-13-dehydroandrographolide-12-sulfonic acid (97.1% content) and 3.7g (0.05mol) of calcium hydroxide (analytically pure) to 500mL of water, 60 Heat at ℃ for 10 minutes to obtain a clear solution. Then, keep at 60℃, add 500mL of acetone, stop heating, naturally cool to 50℃, keep at 50℃ for 2 hours, naturally cool to 20℃, crystallize for 30 hours, filter, filter The cake was vacuum-dried overnight at room temperature to obtain 36.9 g of a single crystal of uniform and stable 14-dehydroxy-13-dehydroandrographolide-12-sulfonate calcium acetone solvate. Yield 70.2%, content 99.95% (HPLC, Figure 7 ,Table 2).
[0045] Table 2 HPLC test results of single crystal of 14-dehydroxy-13-dehydroandrographolide-12-sulfonate calcium acetone solvate
[0046] Peak Results
[0047] name RT area Height USP Resolution USP Plate Count %Area 1 7.674 2491 342 2.532020e+004 0.03 2 8.504 734 96 4.298152e+000 3.0...
experiment example 2
[0069] Add 83.0 g (0.2 mol) of 14-dehydroxyl-13-dehydroandrographolide-12-sulfonic acid (content 97.1%) and 7.4 g (0.1 mol) of calcium hydroxide (analytical pure) to 900 mL of water, 60 Heated at ℃ for 12 minutes to obtain a clear solution, then, kept at 60℃, added 900mL of acetone, stopped heating, naturally cooled to 50℃, kept at 50℃ for 2 hours, naturally cooled to 20℃, crystallized for 36 hours, filtered, filtered The cake was vacuum dried overnight at room temperature to obtain 75.6 g of a single crystal of 14-dehydroxy-13-dehydroandrographolide-12-sulfonate calcium acetone solvate which was uniform and stable. Yield 71.9%, content 99.95% (HPLC, Figure 7 ).
[0070] The single crystal of 14-dehydroxy-13-dehydroandrographolide-12-sulfonate calcium acetone solvate prepared according to the method of above-mentioned experimental example 2, its crystal structure and characteristics are as follows figure 1 , as shown in 3 and 5, the content is as Figure 7 shown.
experiment example 3
[0072] 14-dehydroxy-13-dehydroandrographolide-12-sulfonic acid (content 97.1%) 207.5g (0.5mol) and calcium hydroxide (analytical pure) 18.5g (0.25mol) were added to 2300mL water, 60 Heated at ℃ for 18 minutes to obtain a clear solution, then kept at 60℃, added 2300mL of acetone, stopped heating, naturally cooled to 50℃, kept at 50℃ for 2 hours, naturally cooled to 20℃, crystallized for 48 hours, filtered, filtered The cake was vacuum dried overnight at room temperature to obtain 187.9 g of a single crystal of 14-dehydroxy-13-dehydroandrographolide-12-sulfonate calcium acetone solvate which was uniform and stable. Yield 71.5%, content 99.95% (HPLC, Figure 7 ).
[0073] The single crystal of 14-dehydroxy-13-dehydroandrographolide-12-sulfonate calcium acetone solvate prepared according to the method of above-mentioned experimental example 3, its crystal structure and characteristics are as follows figure 1 , as shown in 3 and 5, the content is as Figure 7 shown.
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