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A kind of technology of clevidipine butyrate and crystal form, applied in the field of medicine, can solve problems such as research report of clevidipine butyrate crystal form
Inactive Publication Date: 2010-07-07
WUHAN WUYAO SCI & TECH
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But so far there is no report on the crystal form of clevidipine butyrate
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Embodiment 1
[0103] The preparation of clevidipine butyrate I crystal form:
[0104] To 10 g of clevidipine butyrate solid, add 40 ml of isopropanol, heat to dissolve, add 0.5 g of activated carbon for decolorization, and filter while hot to obtain a filtrate. Add 60ml of water to the filtrate, keep the temperature at 20-25°C, stir for 6h, a white solid is precipitated, filtered, and dried to obtain crystal form I of clevidipine butyrate.
Embodiment 2
[0106] The preparation of clevidipine butyrate I crystal form:
[0107] To 10 g of clevidipine butyrate solid, add 45 ml of isopropanol, heat to dissolve, add 0.5 g of activated carbon for decolorization, and filter while hot to obtain a filtrate. Add 70ml of water to the filtrate, keep the temperature at 25-30°C, stir for 12h, a white solid is precipitated, filtered, and dried to obtain crystals of clevidipine butyrate in I crystal form.
Embodiment 3
[0109] The preparation of clevidipine butyrate I crystal form:
[0110] 10kg of clevidipine butyrate solid, add 32kg of isopropanol, heat to dissolve, add 500g of activated carbon for decolorization, filter while it is hot, add 60kg of water to the filtrate, add a small amount of clevidipine butyrate crystal seed of I crystal form, keep the temperature at 21- After stirring for 9 hours at 25°C, a white solid was precipitated, centrifuged, and dried to obtain Form I crystals of clevidipine butyrate.
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Abstract
The invention belongs to the technical field of medicines, relating to a chemical drug and a preparation method thereof, in particular to a crystal form of butyric acid clevidipine and a preparation method thereof. The position of powder X-ray diffraction pattern peak of the crystal is at 7.5 degrees, 8.5degrees, 10.1 degrees, 16.3 degrees, 20.3 degrees, and 24.8 Ddegrees+ / -0.2degrees 2 theta, the absorption peak of a differential scanning calorimetry pattern is at 140.5 DEG C, and the position of the characteristic peak of an infrared pattern is at 3332, 1732 and 1707 cm<1>. The crystal form of butyric acid clevidipine is prepared by adding a solvent which can dissolve the solid to the butyric acid clevidipine, heating and dissolving, then adding activated carbon for decoloration, filtering during heating, cooling the filtered liquid so as to crystallize butyric acid clevidipine crystal, and then filtering and drying. The physical and chemical properties of the invention are stable, and the invention is convenient for being made to stable pharmaceutical preparations in large scale.
Description
Technical field: [0001] The invention belongs to the technical field of medicine, and in particular relates to a chemical drug and a preparation method thereof, in particular to a crystal form of clevidipine butyrate and a preparation method thereof. Background technique: [0002] Clevidipine butyrate, the chemical name is 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate Base (1-oxobutoxy) methyl ester is a short-acting dihydropyridine calcium channel blocker, and its chemical structure is as follows: [0003] [0004] The U.S. FDA approved The Medicines Company's clevidipine butyrate emulsion for intravenous injection (trade name Cleviprex) in August 2008, for the treatment of hypertensive patients who are not suitable for oral medication or oral medication is ineffective, and can also be used for the treatment of surgical Acute elevation of blood pressure after surgery. Clevidipine butyrate can selectively inhibit the influx of calcium ions ou...
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Application Information
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