12 results about "Ilaprazole" patented technology

The invention discloses a method for detecting the dissolution rate of ilaprazole. The invention provides a method for detecting the dissolution rate of ilaprazole. The dissolution rate of ilaprazole is detected by adopting an ultraviolet-visible spectrophotometric method. The detection method disclosed by the invention has the advantages of simplicity and convenience in operation, good repeatability, more stable dissolution rate data, better dissolution amount, convenience and rapidness, easiness in automation, more accurate and stable detection result and more suitability for industrial production.

The present application provides a method for quantitatively analyzing acid-suppressing drugs by a high-performance liquid chromatography-tandem mass spectrometry device, comprising: preparing a sample solution containing the acid-suppressing drug; injecting the sample solution into the high-performance liquid chromatography-tandem mass spectrometry device to obtain a mass chromatogram; and quantitatively analyzing the acid-suppressing drug using an internal standard method according to the mass chromatogram, wherein the acid-suppressing drug is selected from: esomeprazole, rabeprazole, ilaprazole, lansoprazole, pantoprazole and vonoprazan fumarate; using a mixed mobile phase consisting of mobile phase A and mobile phase B for gradient elution in the high-performance liquid chromatography, wherein mobile phase A is an acetonitrile solution containing formic acid or a water-acetonitrile mixture containing ammonia and ammonium acetate (water: acetonitrile volume ratio: 1:99-10:90); and mobile phase B is selected from an aqueous solution containing ammonium acetate, an aqueous solution containing formic acid and ammonium acetate, an aqueous solution containing ammonia and ammonium acetate, and an aqueous solution containing ammonia and ammonium formate.

The invention relates to a preparation method of a high-purity ilaprazole sodium anhydride crystal form (C crystal). The ilaprazole sodium anhydride crystal form (C crystal) prepared by the invention is high in purity, low in impurity content and low in solvent residue, and meets the requirements of medicinal bulk drugs. The preparation method disclosed by the invention is simple, simple and convenient to operate, small in solvent dosage, mild in reaction condition, easy to control and low in preparation cost; and the target product crystal form can be obtained very definitely with good reproducibility.

The invention discloses a method for detecting related substances in ilaprazole, which comprises the following steps: high performance liquid chromatography is adopted, the test conditions are as follows: an octadecylsilane chemically bonded silica chromatographic column is adopted, eluents are a mobile phase A and a mobile phase B for online mixed gradient elution, the mobile phase A is a solution of a phosphate solution and an organic solvent, the mobile phase B is a solution of a phosphate solution and an organic solvent, and the mobile phase C is an octadecylsilane chemically bonded silica chromatographic column. The organic solvent is an alcohol solvent; the mobile phase A is an organic solvent, the mobile phase B is an alcohol solvent, and the related substances are IM-A, IM-C, IM-E and IM-O. According to the method, the ilaprazole raw material medicine and the four impurities can be rapidly and effectively separated under the same chromatographic condition, baseline separation can be achieved between a main peak and adjacent impurity peaks and between the impurity peaks, and the minimum separation degree reaches 5.6. The analysis method disclosed by the invention is strong in specificity, high in sensitivity, good in precision, high in accuracy and good in separation degree, the quality of an ilaprazole product can be effectively controlled, and the effectiveness and the safety of a medicine are finally ensured.

The invention belongs to the technical field of tumor treatment medicines, and particularly discloses a novel combined therapy for treating drug-resistant breast cancer by using abelsilib and ilaprazole. The new application of the ilaprazole in enhancing the drug-resistant breast cancer treatment effect of the abelsiril is found for the first time by applying the abelsiril and the ilaprazole in combination or synergistically in preparing the drug for treating the drug-resistant breast cancer. Compared with the single use of the abesilib, the combined application of the ilaprazole can significantly inhibit the growth and proliferation of the abesilib drug-resistant breast cancer cells, and shows a better anti-tumor effect. Therefore, the invention not only provides a theoretical basis for the application of ilaprazole in breast cancer treatment, but also provides a new treatment strategy and means for clinically overcoming the abelsiril drug-resistant breast cancer.

The present invention relates to a pharmaceutical composition containing ilaprazole or a salt thereof, and a preparation method therefor. The pharmaceutical composition contains or consists of ilaprazole or a salt thereof, and a ilaprazole derivative, wherein the amount of the ilaprazole derivative in the pharmaceutical composition is not higher than 1.3 wt % (less than or equal to 1.3 wt %). The composition can be used for treating peptic ulcer bleeding and stress ulcer and preventing upper gastrointestinal hemorrhage caused by severe diseases.

The present invention relates to an oral immediate-release formulation comprising ilaprazole with improved stability as an active ingredient and a method for preparing same, wherein the present invention relates to an oral immediate-release formulation and a method for preparing same, the oral immediate-release formulation comprising ilaprazole and a stabilizer in an inner core portion thereof and an antacid in an outer layer portion thereof, in which the oral immediate-release formulation has improved compounding stability by suppressing contact between the inner core portion and the outer layer portion through coating on the inner core portion, has excellent stability by minimizing the amount of related substances generated, and has a fast drug effect (the time to reach maximum blood concentration (Tmax) ranges from 0.3 hours to 0.8 hours) and excellent stability, through the rapid antacid effect of the antacid.

The invention discloses an ilaprazole sodium freeze-dried preparation as well as a preparation method and application thereof. The invention provides an ilaprazole sodium freeze-dried preparation which comprises the following components: ilaprazole sodium, an excipient, cycleanine tetraacetic acid and a pH (Potential of Hydrogen) regulator, and does not contain ethylenediamine tetraacetic acid. The ilaprazole sodium freeze-dried preparation is good in stability, lower in impurity content, good in solubility, safer, simple to prepare and suitable for industrial production.

The application provides a preparation method of crystalline form B of ilaprazole. The application provides a preparation method of crystalline form B of ilaprazole, which comprises the following steps: mixing a solution or slurry of ilaprazole raw materials and a good solvent with an anti-solvent, and crystallizing to obtain the crystalline form B of ilaprazole. The preparation method of the application has the advantages of good stability, high yield, good purity, low solvent residue, compliance with the standard of raw materials, and suitability for industrial production.

The present disclosure provides a kind of ilaprazole freeze-dried enteric-coated tablets and its preparation method.The above-mentioned ilaprazole freeze-dried enteric-coated tablets include tablet core and coating layer, tablet core includes ilaprazole, tablet core also includes disintegrating agent, freeze-drying protective agent and pharmaceutical excipient, the tablet core after freeze-drying treatment is formed with loose porous structure, and the moisture content of tablet core is <5%.The above-mentioned ilaprazole freeze-dried enteric-coated tablets, since the tablet core after freeze-drying treatment is formed with loose porous structure, and the moisture content of tablet core is <5%, both can improve the long-term storage stability of tablet core, effectively avoid the increase of related substances in long-term storage process, to improve the efficacy of ilaprazole and the safety of drug;It can also speed up the rapid release of tablet core in the intestine, improve the absorption efficiency of ilaprazole in the intestine, to enhance the curative effect of drug.

The application discloses a preparation method of ilaprazole, and belongs to the field of drug synthesis. The ilaprazole is synthesized from 5-(1H-pyrrol-1-yl)-2-mercaptobenzimidazole and 3-methyl-4-methoxy-2-chloromethylpyridine hydrochloride through two-step reaction. The preparation method is mild in process condition, good in quality, high in yield, and suitable for large-scale production.

The present invention relates to a pharmaceutical combination preparation comprising ilaprazole, an antacid, and an alkalizing agent and, more specifically, to a pharmaceutical combination preparation and a method for preparing same, wherein decomposition of ilaprazole in the stomach is prevented without enteric coating to improve stability, thereby increasing bioavailability, and the quality and productivity of pharmaceutical products are improved due to uncomplicated manufacturing processes and excellent storage stability of the preparation.