38 results about "Piperacillin Sodium/ Tazobactam Sodium" patented technology

The invention discloses a compound preparation of piperacillin sodium and tazobactam sodium for injection, which comprises piperacillin sodium and tazobactam sodium by the weight ratio of 3-4:0.8-1.2. The preparation can be used for treating respiratory system infection, urological infection, otologia infection and skin infection.

The invention discloses a suspension powder injection of a piperacillin sodium and tazobactam sodium pharmaceutical composition, and further discloses an application thereof to preparing medicines for treating lung abscess.

The invention discloses a production method of a piperacillin sodium tazobactam sodium freeze-drying preparation for injection and belongs to the technical field of medicines. The production method comprises the steps of reacting, prefreezing, sublimation drying, drying again and taking out of a box. According to the production method, in the step of reacting, sodium hydroxide is adopted for substituting sodium bicarbonate, so that no bubble is produced in a reaction process; and a sodium hydroxide solution is dropwise added into a turbid liquid containing piperacillin acid and tazobactam acid, reaction is carried out in a manner of adding nitrogen to the bottom of a reaction tank, and reaction speed of feed liquid can be increased while time that local concentration of sodium hydroxide is overhigh can be shortened, so that degradation effect of a high-concentration sodium hydroxide solution on piperacillin sodium tazobactam sodium is effectively avoided. According to the production method, mutual combination between quick freezing and slow cooling is realized on prefreezing of the piperacillin sodium tazobactam sodium freeze-drying preparation, so that a crystal form of the obtained piperacillin sodium tazobactam sodium freeze-drying preparation product, insoluble particles and related impurities of freeze-drying products are at the best level. The product piperacillin sodium tazobactam sodium freeze-drying preparation for injection prepared by using the production method disclosed by the invention is good in quality and low in impurity content.

The invention discloses a piperacillin sodium and tazobactam sodium pharmaceutical composition and a preparation method thereof. The pharmaceutical composition mainly comprises piperacillin sodium and tazobactam sodium, as well as a disodium hydrogen phosphate-sodium dihydrogen phosphate buffer pair, and the powder injection is prepared by spraying and drying. The disodium hydrogen phosphate-sodium dihydrogen phosphate buffer pair is adopted for playing a role in buffering the pH of a solution, thus ensuring the content stability of piperacillin sodium, and no generation of carbon dioxide; the preparation technology is simple, convenient to control, fast to dry, and applicable to continuous large-scale production. The piperacillin sodium and tazobactam sodium powder injection is fast to dissolve, stable in quality, free from crystallization and degradation products, and the solution clarity meets the specification.

The invention discloses a preparation method of piperacillin sodium and tazobactam sodium for injection. The preparation method comprises the following steps: adding water into a blending tank, cooling to 5-10 DEG C, adding citric acid, then slowly adding sodium bicarbonate, and after reacting, reading the pH value and adjusting the pH value to be 6.3-6.6; adding piperacillin acid into the blending tank, and then dropwise adding the sodium bicarbonate solution, wherein the pH value in the dropwise adding process is controlled to be less than or equal to 7.0; after dropwise adding, adding tazobactam acid, and then dropwise adding the sodium bicarbonate solution, wherein the pH value in the dropwise adding process is controlled to be less than or equal to 7.0; after dropwise adding, carrying out vacuum removal on carbon dioxide gas by suction, and after the feed liquid in the blending tank is stabilized, reading the pH value and adjusting the pH value to be 6.0-6.5; and carrying out aseptic filtration and freeze-drying to obtain raw powder of piperacillin sodium and tazobactam sodium for injection. According to the preparation method, by adding salified citric acid, the acidity stability of the product is increased, the decomposition of piperacillin sodium and tazobactam sodium is inhibited, and the storage stability of the product is increased.

The invention discloses piperacillin sodium-tazobactam sodium medicinal composition microsphere injection. The injection is characterized by consisting of piperacillin sodium, tazobactam sodium, polylactic acid-polyethylene glycol (PLA-PEG), PEG600, polysorbate 80 and mannitol and particularly consisting of 4 to 8 parts of piperacillin sodium, 1 part of tazobactam sodium, 4 to 9 parts of PLA-PEG, 6 to 10 parts of PEG600, 1 to 3 parts of polysorbate 80 and 2 to 4 parts of mannitol. Compared with the prior art, the piperacillin sodium-tazobactam sodium medicinal composition microsphere injection prepared by the invention has the characteristics of good stability, high entrapment rate, high preparation technology repeatability, suitability for industrial production, uniform particle distribution, few solvent residue, good injectability and excellent sustained release property.

The invention discloses a medicine composition of piperacillin sodium tazobactam sodium and a preparation method thereof. The medicine composition is sterile powder injection, wherein the weight ratio of piperacillin sodium tazobactam sodium is (2-4):1. The piperacillin sodium tazobactam sodium sterile powder injection prepared in the invention has high stability and less impurity; by utilizing the sterile powder injection, the safety and effectiveness of clinical medication are improved greatly.

The invention discloses a prescription of piperacillin sodium and tazobactam sodium for injection, which comprises the following raw materials: 1000 parts of piperacillin sodium, 250 parts of tazobactam sodium, 25 parts of activated carbon, an appropriate amount of sodium hydrogen carbonate, and an appropriate amount of water for injection up to 6000 ml. The invention further discloses a technology of the piperacillin sodium and tazobactam sodium for injection, which comprises the following steps: selecting stainless steel utensils and performing dry heat sterilization treatment for later useafter washing clean; calculating the amount of the raw materials charged according to the ratio in the prescription, and preparing 1000 pieces of the piperacillin sodium and tazobactam sodium for injection, which comprise 1000 g of piperacillin sodium, 250 g of tazobactam sodium and 25 g of activated carbon respectively, according to the specification of 1.25g/piece; and preparing 1000 pieces of the piperacillin sodium and tazobactam sodium for injection, which comprise 2000 g of piperacillin sodium, 500 g of tazobactam sodium and 50 g of activated carbon respectively, according to the specification of 2.5g/piece. The prescription disclosed by the invention and the preparation technology using the prescription are simple in steps, and a higher quality piperacillin sodium tazobactam and sodium product for injection can be produced.

The invention discloses a compound pharmaceutical composition containing piperacillin sodium and tazobactam sodium. The compound pharmaceutical composition contains piperacillin sodium, tazobactam sodium, an excipient and a pH regulator, wherein the ratio of piperacillin sodium to tazobactam sodium is 4:1. Moreover, the invention also discloses a preparation method of the pharmaceutical composition. Compared with the prior art, the pharmaceutical composition disclosed by the invention not only is good in stability, low in impurity content and high in safety, but also is improved in dissolution rate and is more suitable for industrialization.

The invention relates to a method for controlling the acidity of piperacillin sodium and tazobactam sodium for injection. The method is characterized by comprising the following steps of: (1) determining the weight ratio of piperacillin sodium to tazobactam sodium at 2:1; (2) determining the weight ratio of ion exchange resin to water at 1:25, mixing with one or two of piperacillin sodium and tazobactam sodium, and adding alkali in a salifying process while stirring, wherein the alkali is prepared into an alkali solution with certain concentration; (3) controlling the acidity of liquid medicine subjected to filter pressing at 5.8-6.2, filtering, and preparing filtrate into a liquid injection, an infusion solution, a powder injection and a freeze-dried powder injection according to a pharmaceutic conventional requirement. According to the method, the pH value is 6.13, the moisture is 0.7%, and the bacterial endotoxin content of every 1 mg of a product is less than 0.060 EU; the acidity of a finished product is 5.8-6.5, so that the stability of the product is enhanced, and the compliance of the medication of a patient is changed.

The invention relates to a piperacillin sodium, tazobactam sodium and probenecid sodium tripartite freeze-dried preparation for injection, which is characterized by comprising the following steps: adding piperacillin sodium, tazobactam sodium and probenecid sodium in a ratio of 8: (1-0.5): (1-2) raw material into water for injection for complete dissolution, regulating the pH value to 6.5-7.5, adding the water for injection to full dose, sterilizing, filtering and freeze-drying; wherein the plate layer of the freeze dryer is cooled to-40 DEG C from the room temperature at the speed of about 2DEG C/min, and heat preservation is conducted for 60-90 min; after sublimation drying, performing desorption drying, fully volatilizing moisture, performing judgment according to the pressure change condition in the freeze-drying box body, taking out the freeze-drying box body after being qualified, and the total freeze-drying time is 22 hours; and taking out the sample, capping and inspecting. The three components are completely mixed in the solution, the uniformity is high, the defects of the traditional sterile powder mixing process are overcome, the qualification rate of the finished product is greatly improved, and meanwhile, the activity of the three components is not damaged.

The invention provides a preparation method of a piperacillin sodium and tazobactam sodium freeze-drying agent for injection. The preparation method comprises the following steps: preparing a citric acid solution and a buffer solution, adding tazobactam acid to form a sodium salt, and adding piperacillin acid to prepare piperacillin sodium to obtain a composite salt solution;adding sodium bicarbonate powder into a composite salt solution for multiple times in a stirring state to adjust a reaction state, and performing one-time constant volume treatment: cleaning a solution preparation container with 10%-20% ultrapure water and diluting the solution until raw materials and auxiliary materials are completely dissolved in a vacuumizing and stirring state; chelating the composite salt solution with EDTA-2Na to remove impurities so as to obtain a liquid medicine; and carrying out secondary constant volume: adjusting the pH value to 6.3-6.6, and then, carrying out low-temperature filling and freeze-drying, thereby obtaining the freeze-drying agent. Through an innovative raw material and auxiliary material adding method, stirring rate control and prolonging of raw material and auxiliary material reaction time, complete reaction of raw material medicines can be guaranteed, product content and insoluble particles can easily meet medicine quality requirements, and it is guaranteed that the insoluble particles of the product have no obvious growth trend over time.

The invention relates to a pharmaceutical composition of a piperacillin sodium-tazobactam sodium compound. By adopting sodium caprylate as a stabilizer, polysorbate as an emulsifier and trehalose as afrozen-dried supporting agent, the stability of piperacillin sodium and tazobactam sodium during preparation and storage can be effectively enhanced, and the efficacy and safety of clinical use can be guaranteed.

The present invention discloses a special piperacillin sodium-tazobactam sodium ultra-fine powder preparation and a preparation method thereof. The preparation method comprises: respectively dissolving a piperacillin sodium crude product and a tazobactam sodium crude product in water, respectively carrying out gel column chromatography, and respectively collecting the elution fractions of piperacillin sodium and tazobactam sodium by using an alkyl alcohol aqueous solution as an eluant; carrying out chromatography on the obtained elution fractions through a reverse phase chromatography column, and respectively collecting the elution fractions of piperacillin sodium and tazobactam sodium; respectively drying 99% of the elution fractions of piperacillin sodium and tazobactam sodium by using a vacuum drying method to prepare the raw materials such as the high purity piperacillin sodium and the high purity tazobactam sodium; mixing the obtained high purity piperacillin sodium and the obtained high purity tazobactam sodium according to a weight ratio to obtain the high purity piperacillin sodium-tazobactam sodium mixing powder raw material; and carrying out jet crushing on the obtained piperacillin sodium-tazobactam sodium mixing powder raw material to obtain the ultra-fine powder, and carrying out freeze drying.

The invention discloses a piperacillin sodium and tazobactam sodium co-amorphous substance and a preparation method thereof. The preparation method comprises the steps of dissolving piperacillin and tazobactam into an organic solvent in proportion, dropwise adding dissolved organic sodium salt (or inorganic sodium salt) in an anhydrous state, and separating out piperacillin sodium and tazobactam sodium mixed powder after reaction. The mixed powder is determined as a hydrogen bond bonded co-amorphous substance of piperacillin sodium and tazobactam sodium through powder X diffraction, infrared spectroscopy and DSC analysis. Compared with the traditional generation mode, the piperacillin sodium and tazobactam sodium co-amorphous substance prepared by the method has the advantages of low impurity content and good stability, the medication safety can be better improved, and the generation of adverse reactions is reduced.