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A rifabutin and crystallization technology, which is applied in the field of drug synthesis, can solve the problems of high production cost of rifabutin, patients with low economic strength, and unsatisfactory product quality, and achieve low price, less solvent residue, and easy recycling Effect
Active Publication Date: 2009-12-16
四川明欣药业有限责任公司
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Problems solved by technology
[0004] The existing rifabutin production process has the defects that the product quality does not meet the quality standards of the United States Pharmacopoeia, the crystallization yield is low, and the production cost is high. Most patients with low economic strength cannot accept it.
The main reason is that the solvent used in the crystallization process of rifabutin leads to low crystallization yield, and the high cost of the solvent itself leads to high production cost of rifabutin
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[0018] Example Recrystallization of Rifabutin
[0019] Under normal pressure, slowly add 25kg of crude rifabutin into a tank with 250kg of crystallization solvent under stirring, heat to reflux for 2 hours, turn off the steam, stir at 50°C for 2 hours, concentrate to 1 / 3 under normal pressure, turn on the cooling Water, control the water temperature at 50-60°C, concentrate under reduced pressure to about 20L, discharge the tank, cool to room temperature overnight, filter, soak and wash with 1 times the solvent, dry under reduced pressure at about 60°C for 8 hours, and obtain the fine product of Rifabutin.
[0020] Using different crystallization solvents, the yield, purity, and solvent residues are shown in Table 1.
[0021] Table 1
[0022] solvent
[0023] The above tests show that the crystallization method of the present invention uses petroleum ether and refined solvent oil alone or mixed within a certain proportion, and the product obtained by crystallization ...
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Abstract
The invention relates to a nifabutin crystallization method, which comprises at 0-0.1MPa, using crystallization dissolvent at 3-30w / w power amounts to crystallize crude nifabutin via first heating and later cooling, while the crystallization temperature is -10-65DEG C, immerges via dissolvent and washes, drying in vacuum at 50-60DEG C, to obtain nifabutin crystal, wherein the crystallization dissolvent is the low-molecular ether, low-molecular mixture ether or low-molecular mixture alkane of C2-C7, particularly the ligroin or the mixture of ligroin and 6# solvent, the dissolvent is cheap as 50-55% of cyclohexane and easily to be recovered, which can be removed completely via general drying method in production, therefore, the final product has little dissolvent leavings, to improve product quality and reduce production cost.
Description
technical field [0001] The invention relates to a rifabutin crystallization process, which belongs to the field of drug synthesis. Background technique [0002] Rifabutin, C 46 h 62 N 4 o 11 , molecular weight: 847.02, chemical name: [0003] [9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S, 21S, 22E, 24Z]-6, 16, 18, 20-tetrahydroxy-1'-isobutyl-14methoxy-7 , 9,15,17,19,21,25-heptamethylspiro[9,4-(epoxypentadecane[1,11,131 trienimine)-2H-furan[2′,3′7 ,8] Naphthalene[1,2-d]imidazole-2,4′-piperidine]-5,10,26,(3H,9H)-trione-16-acetate, is a semi-synthetic rif Mycin drugs have good fat solubility and can be widely distributed in tissues and cells, effectively inhibiting bacterial DNA-dependent RNA polymerase to inhibit and kill bacteria. At present, this product has obtained patent registration in more than 20 countries, has been sold in Europe, the United States and other regions and countries, and has been included in the pharmacopoeia of the United States, Germany and other ...
Claims
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