8 results about "Rupatadine" patented technology

The invention relates to a method for detecting genotoxic impurities of rupatadine fumarate, which is characterized in that a phosphate buffer solution is matched with acetonitrile, a high performance liquid chromatography method is adopted, a chromatographic column is a silica gel bonded octadecylsilane column, a gradient program is adopted for elution, and the content of the rupatadine fumarate genotoxic impurities in the rupatadine fumarate genotoxic impurities in the rupatadine fumarate genotoxic impurities is detected. Effective separation between rupatadine fumarate and genotoxic impurities and between genotoxic impurities can be achieved, accurate quantitative analysis can be achieved, and the quality of drugs can be effectively controlled.

The present application relates to a kind of HPLC-MS / MS detection method of detecting in human plasma, desloratadine and 3-hydroxydesloratadine in human plasma, it includes the following steps: (1) human plasma sample pretreatment;(2) liquid chromatography-mass spectrometry detection, using mobile phase A and mobile phase B as mixed mobile phase is carried out gradient elution, wherein: mobile phase A is methanol-acetonitrile mixed solution, in mixed solution methanol and acetonitrile volume ratio is 4-6:6-4;Mobile phase B is 2-20mM ammonium formate aqueous solution;(3) the determination of the concentration of human plasma in lopatadine, desloratadine and 3-hydroxydesloratadine.The present application uses lopatadine-d4, desloratadine-d5, 3-hydroxydesloratadine-d4 as deuterium internal standard, using Agilent, ZORBAX Eclipse XDB-Phenyl is carried out gradient elution, deuterium internal standard and the measured substance has the same retention time, chemical property and matrix effect, the reproducibility, accuracy of determining the concentration of lopatadine, desloratadine and 3-hydroxydesloratadine in plasma are good.The method of the present application can be used to evaluate the bioequivalence of lopatadine.

The application provides fumarate lopanfene hemihydrate and a preparation method thereof, and relates to the technical field of drug synthesis. The fumarate lopanfene hemihydrate is a crystalline compound in orthorhombic system, has high purity, low moisture content, low content of related substances, good fluidity and high stability, and the fumarate lopanfene hemihydrate can be obtained by controlling the water activity of an alcohol solvent during recrystallization, and the preparation method is simple.

To provide an orally disintegrating tablet that exhibits good dissolution behavior even when a coating layer is applied to mask the bitter taste, and is of a size that is easy to pick up with your fingers. [Solution] The problem is solved by an orally disintegrating tablet containing granules in which a coating layer is provided on a core particle comprising rupatadine or a salt thereof and at least one additive selected from the group consisting of excipients, disintegrants, and binders, characterized in that the mass is 180 to 300 mg.

The invention belongs to the technical field of chemical analysis, and particularly relates to a method for separating and determining related substances in a rupatadine fumarate intermediate Z2. The related substances comprise any one or more of an impurity SM1, an impurity Z1, an impurity Z2a and an enantiomer thereof, an impurity Z2b and an enantiomer thereof, and an impurity Z2e and an enantiomer thereof. According to the self-built high performance liquid chromatography, octadecyl silane bonded silica gel is adopted as a chromatographic column filler, a phosphate solution is adopted as a mobile phase A, acetonitrile is adopted as a mobile phase B, and related substances in the rupatadine fumarate intermediate Z2 are separated through linear gradient elution; then detecting in a detector to obtain a chromatogram; and calculating the content of each impurity by adopting a correction factor-added principal component self-contrast method. The analysis method has the characteristics of short separation time, high sensitivity, strong specificity, good reproducibility, strong durability and simplicity and feasibility in operation.

The invention relates to the field of compounds, in particular to application of a small molecule compound in preparation of a CXCR7 agonist. The invention provides an application of a small molecule compound or a pharmaceutically acceptable salt thereof in preparation of a CXCR7 agonist, and is characterized in that the small molecule compound comprises one or more of JMS-17-2, rupatadine, ibutamolam mesylate, asenapine, alverine and vilanterol. The small molecule compound can specifically activate an intracellular beta-arrest signal channel instead of being coupled with a G protein signal channel, so that the small molecule compound can be used as a novel CXCR7 agonist.

The invention belongs to the technical field of analytical chemistry, and particularly relates to an HPLC (High Performance Liquid Chromatography) method for separating and determining rupatadine fumarate SM2 and impurities thereof. The method comprises the following steps: by taking octadecylsilane chemically bonded silica as a chromatographic column filler, a phosphate solution as a mobile phase A and methanol as a mobile phase B, separating rupatadine fumarate SM2 and related impurities thereof through linear gradient elution, and detecting by adopting a detector to obtain a chromatogram; and each impurity is quantified according to a correction factor-added principal component self-contrast method and a limit method. The method realizes effective detection of 15 impurities, namely SM2f, SM2j, SM2k, SM2a, SM2b / SM2d, SM2c, SM2e, SM2g, SM2h, SM2i, SM2l, SM2m, SM2n and SM2o, in rupatadine fumarate SM2, and has the characteristics of short separation time, strong specificity, high sensitivity, good reproducibility and strong durability.

Provided is a technique for suppressing discoloration that occurs when at least one selected from the group consisting of rupatadine, a salt thereof and a solvate thereof is enclosed in an airtight package.SOLUTION: A pharmaceutical product comprising a pharmaceutical composition packaged in an airtight package, the pharmaceutical composition comprising the following components (A) and (B-2): (A) one or more selected from the group consisting of rupatadine, a salt thereof and a solvate thereof; and (B-2) one or more selected from glycyrrhetinic acids.SELECTED DRAWING: None