8 results about "Vardenafil" patented technology

The invention discloses an androdenafil citrate crystal form and a preparation method thereof, and particularly provides a crystal form A to a crystal form H of androdenafil citrate, and X-ray powder diffraction analysis spectrums respectively correspond to a figure 1 to a figure 8. Compared with amorphous androdenafil citrate, the androdenafil citrate with the crystal structure obtained by the invention has higher purity, better stability and dissolution performance while ensuring the effect of inhibiting the activity of PDE5 enzyme, so that higher bioavailability can be obtained, the safety of clinical application is improved, and the androdenafil citrate is more suitable for medicine application.

A phosphodiesterase type 5 inhibitor is used in the preparation of a medicament for resisting fibrotic diseases. Experiments in animal models of ischemia-reperfusion (UIRI)-induced renal fibrosis, unilateral ureteral obstruction (UUO)-caused kidney fibrosis and idiopathic pulmonary fibrosis show that a PDE5 inhibitor such as tadalafil, sildenafil and vardenafil can significantly inhibit the expression of multiple fibrosis iconic proteins such as fibronectin, collagen I, renal injury molecule-1, and α-skeletal muscle actin in UIRI and UUO renal fibrosis lesions, improves glomerulopathy, degree of renal tubular distension, renal interstitial collagen fiber deposition and inflammatory cell infiltration, reduces the fibrotic area within the lesion, and significantly inhibits the progression of renal fibrosis; and the PDE5 inhibitor can significantly improve smooth muscle proliferation and inflammatory cell infiltration in bronchioles and pulmonary arterioles of idiopathic pulmonary fibrosis lesion, improve damage condition of alveolar tissue, and significantly inhibit the progression of pulmonary fibrosis.

The invention belongs to the technical field of drug quality analysis, and particularly relates to a separation method and a detection method of impurities in Vonoprasone fumarate. The separation method comprises the following steps: dissolving a to-be-detected Vonoprazan fumarate sample with a diluent to obtain a test solution; and carrying out high performance liquid chromatography separation on the test solution to realize the separation of impurities in the Vonoprasone fumarate. According to the method, a phosphate buffer solution-methanol-acetonitrile (mobile phase A) and a phosphate buffer solution-acetonitrile (mobile phase B) are taken as a mobile phase system, and specific mobile phases and gradient elution procedures are adopted, so that the Vonoprazan and 12 impurities can be highly separated at one time, and the method is short in time consumption, high in separation efficiency, simple to operate and low in separation cost. According to the method, the content of the impurities can be obtained by detecting the separation result through a liquid chromatographic detector, and the detection method is efficient, convenient, good in reproducibility, high in specificity, high in accuracy and high in sensitivity.

The invention discloses a detection method and application of vardenafil impurity 30, and relates to the technical field of pharmaceutical analysis. Comprising the following steps: ultrasonically extracting a sample by methanol, filtering, determining filtrate by an ultra-high performance liquid chromatography-triple quadrupole tandem mass spectrometer (electrospray ionization source, MRM mode), and quantifying by an external standard method by taking 503.3-326.2 and 503.3-299.1 as qualitative ion pairs and 503.3-151.1 as quantitative ion pairs. The method is suitable for determining the vardenafil impurity 30 in foods such as drinks, jellies, protein powder, biscuits, candies, wines, coffee and the like (including health-care foods, tablets, capsules, soft capsules and other dosage forms which are the same as the matrix).

The invention provides a detection method for determining an impurity pyridine-3-sulfonic acid in a Vonoprazan fumarate tablet, and relates to the technical field of drug analysis and detection. High performance liquid chromatography is adopted for determination, and chromatographic conditions are as follows: octadecylsilane chemically bonded silica serves as a filler, a mobile phase A is ammonium acetate solution-sodium octanesulfonate-methanol, a mobile phase B is a methanol aqueous solution, and a gradient elution procedure is adopted for elution. The detection method is stable and feasible, the quality of the product can be effectively controlled, and research results of methodology such as linear relation, precision, repeatability, recovery rate and durability show that the method is reasonable in design, high in operability, precise and reliable. The method is high in specificity and high in detection sensitivity, impurity peaks and main peaks can be completely separated, matrix interference can be effectively eliminated, accurate quantification of target impurities is achieved, the method has the advantages of being high in sensitivity, good in repeatability and easy and convenient to operate, and the product quality control level is greatly improved.

This invention belongs to the field of pharmaceutical content detection, specifically relating to a method for determining the content of vonoprazan fumarate tablets. The vonoprazan fumarate tablets of this invention are prepared using mannitol, fumaric acid, croscarmellose sodium, hydroxypropyl cellulose, microcrystalline cellulose, and magnesium stearate as excipients. The preparation method described in this invention simplifies the preparation process and reduces production costs. This invention also provides the above-mentioned method for determining the content of vonoprazan fumarate tablets. High-performance liquid chromatography (HPLC) is used to accurately determine the content of the active ingredient vonoprazan in the prepared vonoprazan fumarate tablets. This method effectively eliminates the influence of added excipients and impurities on the determination of the active ingredient vonoprazan content, providing important assurance for clinical medication safety and offering a new method for the quality control of vonoprazan fumarate tablets.

In accordance with embodiments of the invention, a method of treating pulmonary arterial hypertension comprises administering to a subject in need thereof a therapeutically effective amount of vardenafil or a pharmaceutically acceptable salt or hydrate thereof. According to the method, a portable inhaler is used for on-demand inhalation administration, and the vasodilator needs to be applied 2-30 minutes before physical activity.

This invention discloses a method for determining impurities in vonoprazan fumarate tablets, belonging to the field of pharmaceutical testing technology. This invention, through a specific chromatographic column, mobile phase, and gradient elution scheme, can effectively determine the content of impurities A, B, C, and E in vonoprazan fumarate tablets. This method has advantages such as excellent separation effect, good peak shape, strong stability, high sensitivity, and short detection time, enabling accurate and efficient determination of the content of key impurities in vonoprazan fumarate tablets, meeting the requirements of pharmaceutical quality control.