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Brand new medicinal composition containing levamlodipine and atorvastatin calcium and preparation method thereof
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A technology of atorvastatin calcium and levamlodipine is applied in the field of medicine to achieve the effects of good stability, improved medication safety and reasonable prescription
Active Publication Date: 2012-08-29
HAINAN JINRUI PHARMA CO LTD
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Problems solved by technology
[0013] For overcoming above-mentioned defect, the inventor starts with levamlodipine besylate which is insoluble in water, and has made a kind of levamlodipine besylate crystal through a large amount of refining tests, and this crystal can improve benzene to a certain extent. The solubility of levamlodipine sulfonate, and it is even more surprising to find that the pharmaceutical composition of this crystal and atorvastatin calcium can well overcome the above-mentioned defects, so that the two can better play a synergistic effect, and its curative effect is better. significantly
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Embodiment 1
[0067] [embodiment 1] preparation of levamlodipine besylate crystal
[0068] 1) dissolving levamlodipine besylate in a mixed solvent of dichloromethane and ethanol to obtain a dichloromethane / ethanol solution of levamlodipine besylate;
[0069]2) Add n-heptane dropwise to the dichloromethane / ethanol solution of levamlodipine besylate obtained in step 1) under an ultrasonic field until crystallization occurs;
[0070] 3) Turn off the ultrasonic field, let stand, filter, wash the filter cake with dichloromethane and ethanol respectively, and dry to obtain the levamlodipine besylate crystal.
[0071] Gained levamlodipine besylate crystals use Cu-K α rays to measure characteristic peaks in the X-ray powder diffraction pattern that are 8.0°, 12.1°, 15.4°, 17.0°, 19.8°, 21.6°, 23.0° at 2θ °, 24.3°, 25.7°, 27.4°, 30.7° and 33.5° display, such as figure 1 shown.
[0072] Below is embodiment 2-9, and preparation method is with embodiment 1, and its concrete process parameter is show...
[0083] 1) Pass atorvastatin calcium and auxiliary materials through a 60-mesh sieve respectively, and set aside;
[0084] 2) Take respectively the levamlodipine besylate crystal of the prescription quantity and 50% of the prescription quantity of lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate and micropowder silica gel, according to the method of equal increment After mixing evenly, obtain the mixture powder of levamlodipine besylate which can be directly compressed into tablets;
[0085] 3) Weigh the prescribed amount of atorvastatin calcium and 50% of the prescribed amount of lactose, microcrystalline cellulose and low-substituted hyd...
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Abstract
The invention relates to a brand new medicinal composition containing levamlodipine and atorvastatin calcium and a preparation method thereof. The medicinal composition comprises the levamlodipine and the atorvastatin calcium serving as active ingredients and medicinal auxiliary materials, including a filling agent, a disintegrating agent and a lubricating agent, wherein the levamlodipine refers to a levamlodipine besylate crystal; and the characteristic peaks of the crystal in an X-ray powder diffraction pattern obtained by measuring through Cu-K alpha rays are displayed when 2 theta is 8.0 degrees, 12.1 degrees, 15.4 degrees, 17.0 degrees, 19.8 degrees, 21.6 degrees, 23.0 degrees, 24.3 degrees, 25.7 degrees, 27.4 degrees, 30.7 degrees and 33.5 degrees. The crystal can be used for improving the solubility of levamlodipine besylate, so that the synergy, accumulation and complementation effects of the levamlodipine besylate and the losartan potassium are enhanced, a high in-vitro dissolution rate is achieved, and the medicinal composition has high bioavailability is high and a more remarkable curative effect.
Description
technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a brand-new pharmaceutical composition containing levamlodipine and atorvastatin calcium and a preparation method thereof. Background technique [0002] Levoamlodipine besylate is white or off-white powder, its chemical name is (s)-(-)-3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4- (2-Chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate, molecular formula C 20 h 25 N 2 o 5 Cl·C 6 h 6 o 3 S, molecular weight 567.1, structural formula: [0003] [0004] Levoamlodipine besylate belongs to the long-acting dihydropyridine (DHP) calcium antagonist, which is separated from amlodipine, and its drug effect is twice that of racemic amlodipine. Amlodipine has the effect of protecting renal function in patients with EH, which is not only dependent on the decrease of systemic blood pressure. Also because the drug can permanently expand the affere...
Claims
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