171 results about "Pantoprazole Sodium" patented technology

The invention aims at providing a pantoprazole sodium freeze-dried powder injection and comprises pantoprazole sodium and mannitol with the weight ratio of 1: 2 to 5. The invention is simple in formula and little in side effect; products prepared by the method are plump in appearance, good in complex solubility and excellent in quality with the adoption of an advanced freezing and drying process.

A freeze-dried powder injection of pantorazole sodium is proportionally prepared from pantorazole sodium, excipient, weak-acdic strong-alkaline salt, edathamil disodiumk, and inorganic alkali.

The invention relates to a pantoprazole sodium enteric-coated tablet and a preparation method thereof. The enteric-coated tablet is prepared by a pantoprazole sodium plain tablet which is coated with an insulating layer and an enteric coating layer, and the pantoprazole sodium plain tablet contains 0.5 to 5 percent of silicon dioxide and 0.5 to 5 percent of talcum powder. The method solves the tablet pressing problem of extremely easy sticking during the pressing of the pantoprazole sodium plain tablet.

The invention relates to a pantoprazole sodium freeze-dried powder injection and a preparation method thereof. The powder injection is prepared from pantoprazole sodium and mannitol, wherein the consumption ratio of the pantoprazole sodium to the mannitol is (1:0.8)-(1:1.6), and the PH value is 10.5-11.0. In the invention, by lowering the pre-freezing temperature, properly lowering the freezing temperature, maintaining the lowered freezing temperature for a proper time, properly shortening two-stage drying time and carrying out other adjustment processes, good appearance and quality of the product can be kept under the condition that the content of the mannitol is low, the processes are reliable and feasible, and the effect is obvious. The prepared product has low content of related substances and has controllable quality, and the freeze-dried product has good clarity and formability after being redissolved.

The invention provides a method for preparing (L)-pantoprazole sodium, which comprises the following steps of: oxidizing 5-difluoromethoxy-2-{[(3,4-dimethoxy-2-pyridinyl)methyl]thio}-1H-benzimidazole by using 3,5-diisopropylbenzene hydroperoxide under the catalysis of a tetraisopropyl titanate, D-(-)-diethyl tartrate and N,N-diisopropylethylamine system to obtain S-(-)-5-difluoromethoxy-2-{[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl}-1H-benzimidazole, namely (L)-pantoprazole, refining the (L)-pantoprazole, and preparing a salt to obtain the (L)-pantoprazole sodium.

The invention relates to a pantoprazole sodium freeze-drying medicinal composition for injection and a preparation method thereof. The pantoprazole sodium freeze-drying medicinal composition for injection comprises the following components in part by weight: 1 part of pantoprazole sodium, 0.01 to 0.1 part of mannitol, 0.02 to 0.03 part of natrium adetate, 0.07 to 0.10 part of sodium sulfite and 0 to 0.1 part of sodium citrate. In the method, the stability of the solution of the pantoprazole sodium is improved, related matters of the solution of the pantoprazole sodium in the process of preparation, packaging or freeze-drying during preparation are not increased obviously, the content of the related matters is not reduced obviously; the prepared pantoprazole sodium freeze-drying powder injection is good in stability in the process of transportation and storage; solution mixed with the injection during clinical use can be placed for a long time, so that the clinical use is more convenient; and simultaneously, hidden troubles of the medication safety of patients due to the increase of impurities (related matters) and the problem of the curative effect on the patients due to content reduction are reduced greatly.

The invention belongs to the technical field of pharmaceutical compounds, and relates to a pantoprazole sodium compound entity, especially a pantoprazole sodium crystal form, preparation methods and pharmaceutical preparations thereof. The pantoprazole sodium compound is crystal, and measured by X-diffraction powder diffraction, and the diffraction pattern has the following diffraction angles (2Theta) in turn: 9.5 degrees, 10.4 degrees, 11.6 degrees, 13.1 degrees, 13.8 degrees, 14.2 degrees, 15.0 degrees, 15.3 degrees, 15.9 degrees, 16.5 degrees, 17.5 degrees, 18.0 degrees and 18.2 degrees. The pantoprazole sodium compound entity may be associated with a variety of lyophilization supporting agents and the prepared lyophilized powder for injection has good solubility, good clarity and low content of related substances, etc. simultaneously the use level of the used lyophilization supporting agent is relatively less, the cost of the products is reduced, and the stability and quality of the products are improved.

The invention provides a pantoprazole sodium enteric-coated tablet, which consists of the following components in parts by weight: 1 part of a pantoprazole sodium plain film, 0.1-0.5 part of an isolating layer and 0.5-1 part of an enteric-coated layer, wherein the isolating layer consists of hydroxypropyl methylcellulose and an alkali in the weight part ratio of 1:5-5:1; and the enteric-coated layer is prepared from 0.5-1 part of acrylic resin. The invention provides a preparation method of the pantoprazole sodium enteric-coated tablet. Parameters such as spray speed, spray pressure, the rotating speed of a coating pan and the like are improved through process parameters of the isolating layer, an enteric liquid and a coating, so that the prepared pantoprazole sodium enteric-coated tablet has high acid tolerance and dissolution rate, the acid tolerance of a finished product is over 90 percent, the dissolution rate is over 75 percent, and the pantoprazole sodium enteric-coated tablet is accordant with and superior to the requirements of the Chinese Pharmacopoeia on the enteric tablet. The product has the advantages of stable quality, convenience for storing and transporting and contribution to clinical application. The method is simple, is suitable for industrial production, and has high application value.

The invention relates to a pantoprazole sodium freeze-dried preparation for injection and a preparation method thereof. The freeze-dried preparation is formed by preparing components containing the following parts by weight into liquor for freeze drying after dissolving into water for injection: 60 to 80 parts of pantoprazole sodium, 100 to 300 parts of glycocoll, 50 to 100 parts of glucose and aright amount of sodium hydroxide. According to the pantoprazole sodium freeze-dried preparation for the injection, which is disclosed by the invention, the problem of stability of a preparation is solved; and moreover, an adverse reaction existing in a traditional product is lowered.

The invention discloses a freeze-dried preparation of pantoprazole sodium liposomes, wherein pantoprazole sodium is encapsulated in antioxidant-containing liposomes made of soybean lecithin and cholesterol. The freeze-dried preparation is administered intravenously with stable quality, less toxicity and high effectiveness.

The invention provides a pantoprazole sodium enteric-coated tablet and a preparation method thereof. The pantoprazole sodium enteric-coated tablet comprises a pantoprazole sodium tablet, an isolated layer and an enteric-coated layer, wherein the pantoprazole sodium tablet comprises main drug pantoprazole sodium and auxiliaries; and the auxiliaries include a filler, a disintegrant, a lubricating agent, an adhesive, a pH regulating agent, and the like. The pantoprazole sodium enteric-coated tablet accelerates the disintegration time of the pantoprazole sodium enteric-coated tablet and solves the problem of drug instability during a storage period.

The invention relates to a high performance liquid chromatography (HPLC) method for analyzing and separating an optical isomer of pantoprazole sodium. Cellulose 3,5-dimethyl phenyl carbamate chiral column OD-RH (Chiralcel, 150mm*4.6mm, 5 microns) is used, and a mixed solvent of water-acetonitrile in certain proportion is used as a mobile phase for separating and analyzing the optical isomer of the pantoprazole sodium.

The invention discloses pantoprazole sodium enteric pellets which comprise cores containing pantoprazole sodium and enteric coating containing cellulose substances. The invention also discloses the process for preparing the cores. The invention realize higher preparation stability and facilitated mass production.

The invention relates to a pantoprazole sodium medicinal composition which is prepared by dissolving 40g of pantoprazole sodium, 160g of mannitol, 120-300g of polysorbate and 200-600g of 2-hydroxypropyl-beta-cyclodextrin in 2,000ml of injection water and then freeze-drying. The pantoprazole sodium medicinal composition provided by the invention has the advantages of good stability and low hygroscopicity; and after prepared into injection, the pantoprazole sodium medicinal composition has the advantages that the relatively long-time stability can be maintained, and the medicine safety is improved.

The invention discloses a pantoprazole sodium-containing enteric-coated tablet and a preparation method thereof. The enteric-coated tablet is obtained by sequentially coating a tablet core with an isolating coating and an enteric coating, wherein the tablet core is formed by evenly mixing medicine-containing granules with a filler and a lubricant and then directly tabletting, and a preparation method of the medicine-containing granules comprises the following steps of: dissolving pantoprazole sodium into absolute ethyl alcohol, adding polacrilin potassium, drying and volatilizing to remove ethanol, and sieving dried materials. The varieties of auxiliary materials are fewer, the drug release is fast, the stability of the preparation is high, the production technology is simple, no sticking phenomenon exists in tabletting, and the industrial production is easy.

The invention relates to a preparation process (preparation method) for pantoprazole sodium for injection, overcomes the defect of the traditional preparation process for the pantoprazole sodium for injection, and provides a preparation process with low cost, high yield and more stable finished product quality. The process comprises the following steps of: (1) feeding materials according to 100 percent of formula quantity, adding mannitol into injection water in an amount which is about 15 percent of preparation quantity, dissolving the materials with stirring, adding medicinal carbon in an amount which is 0.2 percent (weight/volume) of preparation quantity into the solution, boiling the solution for 30 minutes, removing carbon and filtering the solution, cooling the filtered solution to between 10 and 20 DEG C, and introducing nitrogen (the pressure of the nitrogen is 0.3 to 0.5MPa) into the solution for later use; (2) introducing the nitrogen (the pressure of the nitrogen is 0.3 to 0.5MPa) into the 10-20 DEG C injection water in an amount which is about 60 percent of preparation quantity, adding the medicinal carbon in an amount which is 0.1 percent (weight/volume) of preparation quantity into the solution, stirring the solution uniformly, standing the solution for 20 minutes, removing carbon and filtering the solution; and (3) mixing the filtered solution, introducing the nitrogen (the pressure of the nitrogen is 0.3 to 0.5MPa) into the solution for protecting, adjusting the pH value of the solution to between 10.0 and 10.8 by using 10 percent sodium hydroxide solution, adding 10-20 DEG C injection water to the preparation quantity, stirring the solution uniformly, retesting the pH value which should be between 10.0 and 10.8, filtering the solution by using filters with a 0.45mum filter element and a 0.22mum filter element respectively, and filling the product after the submitted semi-finished products are qualified.

The invention belongs to the technical field of medicines and particularly relates to a preparation method of pantoprazole sodium. Aiming at operation of condensation, oxidization and salification by adopting a one-pot process in the prior art, a phase transfer catalyst is added into the condensation process, so that the reaction speed and yield are increased. By virtue of catalytic oxidation of hydrogen peroxide in the presence of tungstate, the selectivity of the reaction is improved and the impurities are reduced. The method provided by the invention is simple to operate, the yield and the purity of the product are improved, and the method is suitable for industrial production.

The invention relates to a compound of pantoprazole sodium and a preparation method thereof, belonging to the technical field of medicines. By the inventive method, the refined product of pantoprazole with high yield above 90% and high purity above 99.8% is obtained, thus improving the stability and clinical application effect of the pantoprazole sodium preparation. The method of the method is simple, easy to operate, and suitable for large industrial production.

The invention belongs to the field of medicament analysis and particularly relates to a detection method and a content determining method for sodium calcium edetate as an accessory in pantoprazole sodium for injecting. The invention aims at solving the technical problem of providing a method with the advantages of simpleness in and convenience for operation, quickness and accuracy for detecting the sodium calcium edetate as the accessory in the pantoprazole sodium for injecting. HPLC (High Performance Liquid Chromatography) detection conditions are as follows: a stationary phase: octadecylsilane bonded silica gel is used as a filling agent; a mobile phase: in terms of volume, an ion pair buffer solution is 85-95 percent, acetonitrile is 5-15 percent and the pH value is adjusted to 2.2-2.6 with phosphoric acid; the flowing speed is 0.8-1.2 ml/min; the column temperature is 30-40DEG C; the detection wavelength is 250-260 nm; and the theoretical plate number is required not to be lower than 2000 calculated in terms of a sodium calcium edetate peak. The detection method has the advantages of simple and convenient operation, accurate and reliable determination result, stronger specificity and shorter detection time; and the retention time of a main peak is about 6 minutes.

The invention relates to a pantoprazole sodium compound monohydrate sphaerocrystal and a preparation method thereof. The average particle size of the crystal is greater than 150 mu m, the coefficient of variation (C.V.) value is less than 0.32, and the bulk density is greater than 0.45 g/ml. The preparation method comprises the following steps: adding a pantoprazole sodium solid into a solvent to prepare a 0.2-0.3 g/ml solution at 40-50 DEG C; cooling the solution under stirring actions, keeping the temperature constant when the temperature drops to 10-25 DEG C, adding a bridging agent, and growing the crystal at constant temperature for 30-60 minutes; continuing cooling to 0-5 DEG C at the same stirring rate, and continuing stirring at the same stirring rate for 30-90 minutes; and carrying out vacuum filtration on the formed crystal slurry, and drying the filter cake at 50-60 DEG C to constant weight, thereby obtaining the pantoprazole sodium monohydrate sphaerocrystal. The method can directly perform tabletting, and is simple and controllable in operating conditions. The single-pass mole yield of the crystallization process is 90% or above, and the product purity is 99% or above.