Calcium dobesilate tablet and preparation method thereof
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A calcium dobesilate tablet, calcium dobesilate technology, applied in the field of medicine, can solve the problems of low purity, low stability of calcium dobesilate raw materials, poor fluidity, etc.
Inactive Publication Date: 2016-01-06
SHIJIAZHUANG HUAXIN PHARMA
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Problems solved by technology
[0003] However, at present, the calcium dobesilate raw material obtained by the existing method has shortcomings such as low stability, low purity, strong hygroscopicity, poor fluidity, expensive reagents used in the method, difficult solvent recovery, etc., which affects the production of hydroxybenzene Clinical use of calcium sulfonate tablets
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Embodiment 1
[0029] The preparation of calcium dobesilate described in embodiment 1 of the present invention
[0030] Add 200ml of methyl carbamate and 500ml of methyl tert-butyl ether to 100g of crude calcium dobesilate, heat to 60°C to dissolve, cool to room temperature, then add 210mL of water to the solution, stir and mix evenly, and then cool down to 3 ℃, standing for crystallization for 3 hours, filtering, and drying to obtain 97.7 g of calcium dobesilate, with a yield of 97.7% and a purity of 99.82% by HPLC.
Embodiment 2
[0031] The preparation of embodiment 2 calcium dobesilate of the present invention
[0032] Add 83ml of methyl carbamate and 417ml of methyl tert-butyl ether to 100g of crude calcium dobesilate, heat to 55°C to dissolve, cool to room temperature, then add 50mL of water to the solution, stir and mix evenly, and then cool down to 0 ℃, standing for crystallization for 5 hours, filtering, and drying to obtain 95.1 g of calcium dobesilate, with a yield of 95.1% and an HPLC purity of 99.52%.
Embodiment 3
[0033] The preparation of calcium dobesilate described in embodiment 3 of the present invention
[0034] Add 375ml of methyl carbamate and 625ml of methyl tert-butyl ether to 100g of crude calcium dobesilate, heat to 65°C to dissolve, cool to room temperature, then add 500mL of water to the solution, stir and mix evenly, and then cool down to 5 ℃, standing for crystallization for 1 h, filtering, and drying to obtain 98.4 g of calcium dobesilate, with a yield of 98.4% and an HPLC purity of 99.43%.
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Abstract
The invention relates to a calcium dobesilate tablet and a preparation method thereof, and belongs to the technical field of medicine. The calcium dobesilate tablet is prepared from, by weight, 200-300 parts of calcium dobesilate, 5-15 parts of mannitol, 2-4 parts of sodium dihydrogen citrate anhydrous, 6-8 parts of sodium metabisulfite, 0.2-0.5 part of anhydrous citric acid, 30-50 parts of absolute ethyl alcohol and 20-40 parts of magnesium stearate. According to the prepared calcium dobesilate tablet, through 6-month accelerated test inspection, the characters all meet the specification, the dissolution rate is qualified, the dry weight loss change range does not exceed +/-0.5%, related substances have the little rising tendency, the total impurity increasing amplitude does not exceed 0.02%, and the content ranges from 98 percent to 101 percent; all the inspection indexes do not change obviously, the quality is stable, and therefore the calcium dobesilate tablet can be more suitable for clinical application.
Description
technical field [0001] The invention relates to a tablet and a preparation method thereof, in particular to a calcium dobesilate tablet and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Calcium dobesilate was put into clinical use in the prevention and treatment of diabetic retinopathy in the 1970s. It was included in the European Pharmacopoeia in 1997 and the British Pharmacopoeia in 1998. The drug was introduced to the market in June 2001 in China. The drug mainly reduces capillary permeability, inhibits platelet aggregation, and reduces blood viscosity. With the deepening of research on the mechanism of the drug, it is found that the drug can also be used for kidney diseases, chronic venous insufficiency, thrombotic diseases, and certain heart diseases, especially in diabetic nephropathy, which indicates that it has a good application prospect. [0003] However, at present, the calcium dobesilate raw material o...
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