13 results about "Levamlodipine" patented technology

The invention belongs to the technical field of pharmaceutical preparations, and relates to an oral solid pharmaceutical composition containing irbesartan and a preparation method thereof. Irbesartan particles are prepared by adopting a wet granulation process, levamlodipine besylate particles are prepared by adopting a dry granulation process, the irbesartan particles and the levamlodipine besylate particles are mixed, a filling agent adopted in the dry granulation process is microcrystalline cellulose, and the mass ratio of irbesartan to levamlodipine besylate is (150-300): (2-4). The content uniformity of the levamlodipine besylate can meet the standard, and the stability of the composition can be improved.

The invention discloses a method for detecting N-nitroso benazepril impurities in levamlodipine benazepril, which comprises the following steps: grinding a benazepril hydrochloride tablet to be detected, mixing and dissolving the benazepril hydrochloride tablet with 1-methyl-2-pyrrolidone and a solvent according to the mass ratio of the effective amount of benazepril hydrochloride to the mass of 1-methyl-2-pyrrolidone of (10-50): 1, filtering, and concentrating to obtain the N-nitroso benazepril impurities in levamlodipine benazepril. Obtaining a test solution; and detecting the impurities of the N-nitroso benazepril in the test solution by adopting liquid chromatography-tandem mass spectrometry. The detection method provided by the invention is a liquid chromatography-mass spectrometry method, has the characteristics of strong specificity, high sensitivity, high accuracy and the like, and is suitable for trace detection of N-nitroso benazepril in the levamlodipine benazepril capsule preparation.

The utility model discloses a levamlodipine besylate tablet crusher, and particularly relates to the technical field of tablet processing, the levamlodipine besylate tablet crusher comprises a crushing cavity, the top of the crushing cavity is provided with a sealing cover in a threaded manner, the bottom of the crushing cavity is provided with a charging box in a threaded manner, the sealing cover is fixedly provided with a crushing motor, and the output end of the crushing motor is fixedly provided with a rotating shaft; a first smashing cutter and a second smashing cutter are arranged at the bottom of the rotating shaft, the second smashing cutter is located at the bottom of the first smashing cutter, a dust absorption structure is arranged on the surface of the sealing cover and located on one side of the smashing motor, the dust absorption structure comprises a treatment box, and the treatment box is located on one side of the smashing cavity. According to the levamlodipine besylate tablet crushing device, levamlodipine besylate tablets can be well crushed, generated dust can be absorbed and filtered in the crushing process, the situation that dust escapes in the environment and affects operators is avoided, and the whole levamlodipine besylate tablet crushing device is convenient to disassemble, assemble and maintain.

The invention belongs to the technical field of pharmaceutical preparations, and relates to a levoamlodipine folic acid compound tablet and a preparation process thereof, and the preparation process comprises the following steps: mixing microcrystalline cellulose with vitamin C, and enabling nitrite in the microcrystalline cellulose to be in full contact with the vitamin C to obtain a first mixture; mixing folic acid with part of the first mixture to obtain a second mixture; mixing levamlodipine besylate with the remaining first mixture to obtain a third mixture; and uniformly mixing the second mixture, the third mixture and other auxiliary materials, and tabletting to obtain the tablet. The method comprises the following steps: reacting microcrystalline cellulose with vitamin C to consume nitrite in the microcrystalline cellulose so as to prevent the nitrite from reacting with secondary amino in levamlodipine to generate nitrosamine impurities with genetic toxicity;

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to bisoprolol amlodipine tablets and a preparation method thereof. The bisoprolol amlodipine tablet is composed of a bisoprolol fumarate solid dispersion, amlodipine besylate / levamlodipine besylate, a filler, a disintegrating agent and a lubricant, the bisoprolol fumarate solid dispersion takes HPMCP as a carrier material, and triethyl citrate is added. The obtained bisoprolol and amlodipine tablet blocks the contact opportunity of bisoprolol fumarate and amlodipine, the problem of compatibility of bisoprolol fumarate and amlodipine is fundamentally solved, the storage requirement can be met without special packaging, the preparation process is simple, and the industrialization requirement is met.

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for determining related substances of irbesartan and levoamlodipine compound tablets. According to the method, high performance liquid chromatography is adopted for detection, a chromatographic column is YMC-Triart C18, a 0.55% phosphoric acid aqueous solution with the pH value of 3.0-3.5 is used as a mobile phase A, methanol is used as a mobile phase B, and gradient elution is performed. According to the method, known impurities and various unknown impurities including amlodipine impurities A, B, D, E, F, G and H, irbesartan impurities I and the like can be measured under the same chromatographic condition, the separation degree of each chromatographic peak and a main peak or other impurity peaks meets the requirements, the peak shape is good, the method is high in specificity, good in reproducibility and high in accuracy, the sensitivity meets the analysis and detection requirements, and the method is suitable for industrial production. And a reliable detection method is provided for related substances of the irbesartan-levoamlodipine compound.

According to the tablet containing the arginine perindopril and the levamlodipine besylate and the preparation method of the tablet, the pregelatinized starch and microcrystalline cellulose colloidal silicon dioxide co-treated substance is used as a filling agent, and the proportion of the pregelatinized starch and the microcrystalline cellulose colloidal silicon dioxide co-treated substance is controlled, so that the tablet containing the arginine perindopril and the levamlodipine besylate is prepared. The problem that the fluidity of the tablet is poor in preparation is solved, the stability is remarkably improved, the tablet has the advantages of being simple in preparation method, low in cost, good in fluidity, good in compressibility and the like, meanwhile, the tablet shows rapid disintegration, dissolution and stability, and the tablet is suitable for large-scale industrial production.

The present invention relates to a composition comprising levamlodipine besylate hydrate and its production, pharmaceutical preparations and use, especially the composition of (S)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro-3,5-pyridinedicarboxylic acid-3-ethyl ester, 5-methyl ester benzenesulfonic acid hydrate and its production method and use. The composition of levamlodipine besylate crystallized in pure water and dried is easy for industrial production, has no organic solvent residue, good thermal stability and good dissolution amount in solid-form preparations.

The invention provides a method for measuring levamlodipine in human plasma through LC-MS / MS (liquid chromatography-mass spectrometry / mass spectrometry) chiral separation, which comprises the following steps: A, sample pretreatment: adding an internal standard working solution into to-be-measured plasma, then adding an extracting agent, carrying out vortex and centrifugation, then taking supernate, concentrating until the supernate is dry, and finally redissolving; b, preparing a standard curve and a quality control sample, namely preparing a levamlodipine standard curve sample and a quality control sample working solution, adding the working solution into blank plasma, uniformly mixing, and preparing the levamlodipine standard curve sample and the quality control sample with a series of concentration gradients. C, LC-MS / MS (liquid chromatography-tandem mass spectrometry) determination. According to the present invention, the chiral chromatographic column is adopted to perform the chromatographic separation of the enantiomer, and the LC-MS / MS detection method with characteristics of high specificity, strong specificity, rapid pretreatment, high efficiency, high reproducibility, strong operability, rapid analysis speed, low cost investment and wide application range is established.

The invention relates to a pharmaceutical composition for treating cardiovascular diseases and a preparation method thereof, in particular to a pharmaceutical composition containing levamlodipine besylate and atorvastatin calcium, and the pharmaceutical composition is used for treating mixed hypertension and hyperlipidemia, has a synergistic effect and can effectively reduce blood pressure and blood fat levels. By controlling the granularity and crystal form of levamlodipine besylate and atorvastatin calcium, the dissolution rate and stability of the medicine are optimized. The preparation method adopts a direct powder tabletting process, so that the production process is simplified, the production efficiency is improved, and meanwhile, the uniformity and the stability of the medicine are ensured. In-vitro dissolution experiments show that the dissolution rate of the composition reaches 90% or above within 15 minutes, and the composition has good bioavailability.

The invention belongs to the technical field of raw material crystal forms, and particularly relates to a L-amlodipine maleate crystal form and a preparation method thereof. Cu-K alpha radiation is used, and X-ray diffraction represented by a 2 theta angle (degree) has peaks at the following positions: 4.5 + / -0.2 degrees, 8.8 + / -0.2 degrees, 11.8 + / -0.2 degrees, 13.2 + / -0.2 degrees, 13.5 + / -0.2 degrees, 15.7 + / -0.2 degrees, 17.6 + / -0.2 degrees, 18.4 + / -0.2 degrees, 22.2 + / -0.2 degrees, 22.6 + / -0.2 degrees, 23.2 + / -0.2 degrees, 24.8 + / -0.2 degrees, 26.4 + / -0.2 degrees, 29.1 + / -0.2 degrees, 30.3 + / -0.2 degrees, 35.4 + / -0.2 degrees and The purity and the stability of the novel crystal form are better than those of an original product, the operation is simpler, the salt is directly formed, refining is not needed, the yield is higher, and the batch is not limited any more.

The invention relates to a pharmaceutical composition for treating hypertension and a preparation method thereof, in particular to a pharmaceutical composition containing valsartan and levamlodipine besylate. The valsartan and the levamlodipine besylate are combined for use, so that the valsartan and the levamlodipine besylate not only can play a synergistic effect and enhance a treatment effect, but also have relatively high safety and relatively low adverse reaction occurrence rate, and are worthy of wide popularization and application. By controlling the crystal form of levamlodipine besylate and the particle sizes of valsartan, levamlodipine besylate, filler, disintegrating agent, lubricant and glidant and packaging with medicinal aluminum foil, polyvinyl chloride solid medicinal hard tablets and polyamide / aluminum cold-formed solid medicinal composite hard tablets, the dissolution rate and stability of the medicine are optimized. According to the method, direct powder tabletting is adopted, the powder fluidity is good, tabletting is easy, the production time is shortened, the production efficiency is improved, and the product stability is also improved. In-vitro dissolution experiments show that the dissolution curve of the composition is consistent with that of a control preparation, and the composition has good bioavailability.

The invention relates to the technical field of pharmaceutical preparation preparation processes, in particular to a compound bisoprolol and levamlodipine tablet and a preparation method thereof. According to the bisoprolol and bisoprolol fumarate bisoprolol double-layer tablet provided by the invention, the bisoprolol raw material is prepared into core particles by adopting wet granulation, and then the bisoprolol fumarate raw material is wrapped, so that the bisoprolol fumarate raw material is prevented from being in contact with the levamlodipine besylate raw material, and the growth speed of impurities formed by adding the bisoprolol and the bisoprolol fumarate into the impurities is obviously reduced. The levoamlodipine layer adopts a mode of dry granulation after mixing, the content of main drugs in the prepared granules is uniform, the layering risk in the tabletting process is reduced, and finally, the two layers of granules are pressed into double-layer tablets by adopting a double-layer tablet press, so that the contact of the two main drugs is avoided. The bisoprolol and levoamlodipine double-layer tablet provided by the invention has better stability, the levoamlodipine content uniformity is better, and the dissolution curve is closer to that of contrast drugs such as a bisoprolol fumarate tablet (Kinapi) and an amlodipine besylate tablet (Heishi).