47 results about "Inhalation Solution" patented technology

The invention relates to a polymyxin inhalation liquid preparation and a preparation method thereof. The polymyxin inhalation liquid preparation comprises 0.1-5% (W / V) of polymyxin B sulfate, 0.05-1% (W / V) of a stabilizer, 0.1-0.9% (W / V) of an osmotic pressure regulator, a pH value regulator and a solvent, the pH (Potential of Hydrogen) of the liquid preparation is 3.0 to 6.0; the solvent is selected from purified water and water for injection; the polymyxin inhalation solution provided by the invention is simple in composition, the pH value of the polymyxin inhalation solution is 3.0-6.0, osmotic pressure and isotonic pressure are simultaneously realized, bronchus spasm and cough caused by the polymyxin inhalation solution can be reduced, safety evaluation verifies that the polymyxin inhalation solution has better safety, and a new choice is provided for clinical application.

The invention relates to the technical field of ultra-high performance liquid chromatography, in particular to an ultra-high performance liquid chromatography (UPLC) analysis method of a levosalbutamol hydrochloride inhalation solution. The detection method comprises the following steps: detecting levosalbutamol and related substances in a levosalbutamol hydrochloride inhalation solution; the related substances comprise an impurity A, an impurity B, an impurity C, an impurity D, an impurity E, an impurity F, an impurity G and an impurity H; the detection method adopts ultra-high performance liquid chromatography, and the chromatographic conditions are as follows: octadecylsilane chemically bonded silica is used as a filler; a phosphoric acid aqueous solution with the mass percent of 0.05-0.1% is used as a mobile phase A, and methanol-acetonitrile-water-phosphoric acid is used as a mobile phase B; the detection wavelength is 215 to 225 nm; the column temperature is 40-50 DEG C; the flow velocity is 0.5 to 0.7 mL / min; according to the method, eight impurities can be simultaneously detected and can be effectively separated; the method has the advantages of sensitivity, exclusiveness, accuracy, high efficiency, convenience, low cost and the like, the detection process is completed within 15 minutes, and the efficiency is high. According to the method disclosed by the invention, the contents of the levosalbutamol and the related substances can be effectively controlled, and a basis is provided for quality control of the levosalbutamol hydrochloride inhalation solution, so that the clinical curative effect of the levosalbutamol hydrochloride inhalation solution is ensured.

The application discloses a modified bromhexine hydrochloride inhalation solution with enhanced stability and a preparation method thereof, and belongs to the technical field of medical preparations. The inhalation solution is mainly prepared from a targeting impurity control modified bromhexine hydrochloride inclusion compound, a special composite buffer mother liquor for inhibiting impurity B, inhalation grade sodium chloride, pharmaceutical grade sodium hydroxide and water for injection, and the pH value of the finished product is 4.5-5.5. The application constructs a three-stage progressive modification system, covalently grafts a mercapto-activated L-cysteine derivative onto hydroxypropyl-gamma-cyclodextrin to prepare a functional carrier, and realizes molecular-level isolation of bromhexine hydrochloride through host-guest inclusion, thereby blocking the generation of impurity B of bromhexine hydrochloride from the whole path, and solving the core pain points of easy impurity exceeding, short effective period and airway irritation of the existing product. The application can realize long-acting stable storage for 36 months, is suitable for the existing industrial production line, and has high clinical application and industrialization values.

The invention relates to a detection method of a revivacin inhalation solution, and belongs to the technical field of medicine detection. According to the detection method provided by the invention, a revivin inhalation solution sample is analyzed by adopting high performance liquid chromatography to obtain the content of impurities in the revivin inhalation solution; the high performance liquid chromatography uses a phosphate buffer as a mobile phase A and acetonitrile as a mobile phase B, and the elution conditions are as follows: 0-5 min, the volume ratio of the mobile phase A to the mobile phase B is gradually changed from 95: 5 to 80: 20; the volume ratio of the mobile phase A to the mobile phase B is gradually changed from 80: 20 to 20: 80 in 5-30 min; the volume ratio of the mobile phase A to the mobile phase B is 95: 5. The method provided by the invention can realize accurate detection of five different impurities in the revienacin inhalation solution, and is beneficial to actual production quality control and improvement of drug safety.

The application relates to the field of traditional Chinese medicine quality control, and particularly discloses a quality control method for Shuanghuanglian inhalation solution. The method can simultaneously determine the fingerprint spectrum and ingredient content of the Shuanghuanglian inhalation solution. The fingerprint spectrum detection method disclosed by the application adopts UPLC determination, has 17 characteristic peaks, and attributes 8 characteristic peaks. The contents of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, isochlorogenic acid B, isochlorogenic acid A, isochlorogenic acid C and forsythoside are simultaneously determined. Compared with the prior art, the method for determining the fingerprint spectrum and content of the Shuanghuanglian inhalation solution is improved, and the quality of the Shuanghuanglian inhalation solution can be comprehensively monitored conveniently, quickly and accurately.

The invention relates to an application of genipin-1-beta-D gentiobioside in preparation of a medicine for treating chronic obstructive pulmonary disease. The genipin-1-beta-D gentiobioside is prepared into an aerosol inhalation solution, and the aerosol inhalation administration mode is adopted, so that the lung function in the chronic obstructive pulmonary disease can be improved, the content of inflammatory factors in lung tissues can be reduced, and the lung tissue injury can be relieved.

The invention belongs to the technical field of biological medicines, and particularly relates to a honeysuckle total extract inhalation solution as well as a preparation method and application thereof. According to the invention, the honeysuckle total extract with poor water solubility, phospholipid and chitosan are innovatively and directionally assembled into the chitosan-phospholipid nanoparticles with uniform structure, and the nanoparticles are prepared by adopting a microfluidic technology. The strategy significantly improves the water solubility and stability of the honeysuckle total extract, and successfully prepares an inhalation solution suitable for pulmonary administration based on the nanoparticle dispersion system. The obtained preparation has the characteristics of high physical stability and good bioavailability potential. The honeysuckle total extract inhalation solution provided by the invention can effectively relieve the pathological process of the pyotoxic pneumonia through multiple mechanisms of remarkably inhibiting lung inflammatory response, relieving pulmonary edema, protecting the structural integrity of pulmonary alveoli and the like. Especially, a high-dose group shows a curative effect superior to that of a positive control drug, and a good dose-effect relationship is combined, so that the preparation has remarkable development potential and clinical transformation prospect in treatment of the septic pneumonia.

The present application provides a kind of nintedanib solution for inhalation and preparation method and application, the inhalation solution includes active substance, solvent and auxiliary material, the single dose specification of the inhalation solution is 1-5ml, and the active substance in single dose specification is 2.41-12.04mg / ml nintedanib ethanesulfonic acid;The solvent is sterile injection solution water;The auxiliary material includes isotonicity regulator and pH regulator and can also include antioxidant;The addition amount of the isotonicity regulator is to make the inhalation solution have the weight molal osmotic concentration of 240-400mOsmol / kg;The addition of the pH regulator is to make the pH value of the inhalation solution preparation 3.0-4.0.The inhalation nintedanib solution of the present application can provide a kind of nintedanib for inhalation with convenient, safe and effective, and good stability of drug dosage form and drug delivery system in combination with liquid atomization device.

The application discloses a pirfenidone nanosuspension inhalation solution for treating interstitial pneumonia and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The pirfenidone nanosuspension inhalation solution is composed of the following components in 1000ml: 8-12g of pirfenidone hydrochloride, 4-6g of polyethylene glycol-poly-L-histidine block copolymer, 45-55g of mannitol, 0.4-0.6g of antioxidant, 0.05mol / L of citric acid-sodium citrate buffer, and water for injection, wherein the amount of the citric acid-sodium citrate buffer is appropriate, and the water for injection is added to 1000ml. The application adopts a pulmonary targeted inhalation administration path of non-gastrointestinal absorption, so that the drug directly acts on the lung interstitial lesion part by bypassing the intestinal absorption link.

The invention belongs to the technical field of analysis and detection, and relates to a method for detecting nitrosamine impurities in a terbutaline sulfate aerosol inhalation solution. The method comprises the following steps: diluting a terbutaline sulfate aerosol inhalation solution to obtain a test solution; detecting the test solution by adopting an ultra-high performance liquid chromatography-tandem mass spectrometry method; wherein the chromatographic conditions are as follows: a filling agent of a chromatographic column is octadecylsilane chemically bonded silica; the mobile phase A is an ammonium acetate aqueous solution; the mobile phase B is acetonitrile; the nitrosamine impurity is N-nitroso-terbutaline, and the nitrosamine impurity is N-nitroso-terbutaline. The method for detecting the N-nitroso-terbutaline impurities in the terbutaline sulfate aerosol inhalation solution by adopting the ultra-high performance liquid chromatography-tandem mass spectrometry technology is proposed for the first time, the method is high in selectivity, the quantitation limit is as low as 1.5% of the limit, the detection limit is as low as 0.5% of the limit, detection can be completed only in 10 minutes, and the method is suitable for large-scale popularization and application. Powerful guarantee is provided for effectively controlling the medicine quality and guaranteeing the medicine safety.

The application discloses an inhaled solution medicine production line wastewater environment-friendly treatment device, which comprises a treatment tank, a storage tank for storing high-efficiency activated carbon powder, an agitating device for agitating liquid in the treatment tank and a stirring plate rotationally connected with the agitating device, and further comprises a material scattering device for scattering the high-efficiency activated carbon powder into the liquid for catalysis when the liquid enters the treatment tank. When the wastewater is added and enters a catalytic oxidation stage, hydrogen peroxide needs to be separately injected. If the linkage is not cut off, the liquid flow at the water inlet will trigger the blocking plate again, so that the excessive high-efficiency activated carbon enters the treatment tank. The sliding block drives the connecting rod to be displaced, so that the connecting rod is separated from the blocking plate, and mechanical limiting is realized through the key, so that the solid-liquid ratio in the tank is kept constant, and the influence of the excessive high-efficiency activated carbon on the subsequent catalysis is avoided.

The present invention belongs to the field of drug therapy, and specifically relates to the use of methyl parahydroxybenzoate and its sodium salt in the preparation of drugs for treating viral infectious diseases. The present invention discloses the use of methyl parahydroxybenzoate, its sodium salt and its inhalation preparation in the treatment of coronavirus infectious diseases. By verifying the new use of methyl parahydroxybenzoate and its sodium salt inhalation solution in a mouse test infected with human coronavirus HCoV-229E, the technical solution has novelty, and an efficacy test of meta-cresol inhalation solution in treating pneumonia caused by HCoV-229E virus infection was conducted. The results showed that methyl parahydroxybenzoate and its sodium salt inhalation solution showed good efficacy in the lung index and inhibition rate of pneumonia mice infected with HCoV-229E virus, and could significantly reduce the mouse lung index.

The invention relates to the technical field of substance impurity detection methods, in particular to a procaterol hydrochloride inhalation solution related substance detection method which adopts high performance liquid chromatography for detection, and chromatographic conditions are as follows: mobile phases include a mobile phase A and a mobile phase B; the mobile phase A is a phosphate buffer solution, and the mobile phase B is methanol. The method can effectively detect the related substances in the procaterol hydrochloride inhalation solution, has the advantages of strong specificity, high sensitivity and comprehensive impurity control, and can better control the quality of a preparation.

The invention relates to a dihydromyricetin inhalation liquid preparation and a preparation method thereof. The dihydromyricetin inhalation liquid preparation comprises dihydromyricetin, a stabilizer, an osmotic pressure regulator, a pH value regulator, a cosolvent and a solvent, the content of the dihydromyricetin is 0.1-2 mg / mL, the content of the stabilizer is 0.4-3 mg / mL, the content of the osmotic pressure regulator is 1-10 mg / mL, and the content of the cosolvent is 20-25% V / V; the pH (Potential of Hydrogen) of the liquid preparation is 3.0 to 6.0; according to the dihydromyricetin inhalation solution preparation provided by the invention, the bioavailability of the medicine is effectively improved, the dihydromyricetin inhalation solution preparation has the characteristics of definite medicine effect, reliable quality, high safety and the like, and the preparation method is few in steps, easy to operate and beneficial to industrial production.

The invention relates to a revienacin inhalation solution and a preparation method thereof. The revienacin inhalation solution comprises revienacin, a stabilizing agent, a buffering agent and water for injection, wherein the stabilizer is disodium edetate and propylene glycol, and the mass volume ratio of the disodium edetate to the propylene glycol is (0.05-0.1) g: (50-300) ml. The revivin inhalation solution can effectively delay degradation of revivin under the high-temperature condition, the long-term stability of a preparation under the high-temperature condition is guaranteed, the preparation prescription and the preparation process are simple and easy to operate, and the revivin inhalation solution is suitable for large-scale industrial production.

1. Name of the designed product: package box (formoterol fumarate). 2. Use of the designed product: the designed product is used for packing formoterol fumarate inhalation solution. 3. Design points of the designed product: combination of shape and pattern. 4. Picture or photo best indicating the design points: perspective view.

The invention provides an inhalation solution for bronchial constriction maintenance treatment of a chronic obstructive pulmonary disease patient and a preparation method of the inhalation solution, and relates to the technical field of pharmaceutical preparations. The preparation method comprises the following steps: adding 50-95% of water for injection into a liquid preparation tank, cooling the water for injection to 50 DEG C, starting stirring, synchronously and sequentially adding sodium chloride, citric acid and sodium citrate according to the prescription dosage, stirring to dissolve the sodium chloride, the citric acid and the sodium citrate, continuously cooling to 40 DEG C, adding formoterol fumarate according to the prescription dosage, stirring to dissolve for 60 minutes, fixing the volume, and stirring again for 10 minutes for later use. According to the preparation method of the formoterol fumarate inhalation solution provided by the invention, process parameters are accurately controlled, so that the sterility guarantee level of the formoterol fumarate inhalation solution can be improved, the increase of the impurity content can be effectively controlled, and good stability of the formoterol fumarate inhalation solution is ensured.

SOLUTION: Provided herein is a liquid formulation comprising recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF) for inhalation by nebulization.SELECTED DRAWING: None

There is provided a budesonide nebulization inhalation solution composition and its application. The composition, which is a budesonide nebulization inhalation solution composed of budesonide, a pH adjuster, and water, has, as the particle size of the spray droplets, D 90 The particle size is 7.0 to 10.0 μm, D 50 The particle size is 2.8 to 4.5 μm, D 10 The particle size is 0.5 to 1.5 μm, and the deposition percentage of particles with an aerodynamic diameter of 1.4 to 5.4 μm in the budesonide inhalation solution is 50% or more. Further provided is a medicinal assembly for use in combination with a nebulization inhalation solution, comprising an inhalation composition, a nebulizer with specific parameters, and a nebulizer cup. The budesonide nebulization inhalation solution composition and its medicinal assembly have the advantages of a small effective amount, rapid onset of effect, and high drug delivery efficiency, and are particularly effective in the treatment of tracheal and main bronchial diseases.

A fudosteine nebulization inhalation solution composition and use thereof. The fudosteine nebulization inhalation solution consists of fudosteine, a pH-adjusting agent and water. The droplet particle size of the composition is as follows: the D90 particle size is 7.0-10.0 µm, the D50 particle size is 2.8-4.5 µm, and the D10 particle size is 0.5-1.5 µm; and the percent deposition of the particles with the aerodynamic particle size of 1.4-5.4 µm in the fudosteine inhalation solution is not less than 50%. In addition, further provided is a drug assembly for use in conjunction with the nebulization inhalation solution, comprising the inhalation composition, and a nebulizer and a nebulizing cup with specific parameters. The fudosteine nebulization inhalation solution composition and the assembly thereof have the advantages of a small effective dose, acting fast, high drug delivery efficiency, and the like, and are particularly effective in treating tracheal and main bronchial diseases.

The invention provides a penehyclidine hydrochloride liquid preparation quality stability control method and a penehyclidine hydrochloride inhalation solution thereof. The preparation is packaged by adopting a plastic package or adding sodium chloride into a glass package. The packaging method can control the pH value of the preparation. The weight ratio of the water for injection to the penehyclidine hydrochloride to the sodium chloride of the inhalation preparation is 2000: 0.5-1: 18. The preparation can be used for treating chronic obstructive pulmonary disease.

The invention relates to a medicinal preparation for treating pulmonary arterial hypertension as well as a preparation method and application of the medicinal preparation. Every 1000mL of liquid preparation comprises 0.3-18mg of beraprost or pharmaceutically acceptable salt thereof, 0-15g of an osmotic pressure regulator, 0.05-15g of a buffering agent, 0-0.5 g of a metal chelating agent, 0-15g of a pH regulator and water for injection. The beraprost inhalation solution is more stable in physicochemical property, higher in bioavailability, higher in safety, smaller in toxicity, smaller in irritation and higher in patient use compliance, and meets clinical medication requirements.

The present invention provides a solution of vilanterol triphenylacetate for inhalation, a preparation method and an application thereof, wherein the inhalation solution comprises an active substance, a solvent and an excipient. The single-dose specification of the inhalation solution is 1 ml, and the single-dose specification comprises 15 to 50 μg / mL of vilanterol triphenylacetate and / or its hydrate as an active substance; the solvent is water for sterile injection, and the excipients comprise an osmotic pressure regulator and a pH regulator, the osmotic pressure regulator has a concentration of 5 to 9 mg / ml, and the pH regulator is added to make the pH value of the inhalation solution preparation be 5.0 to 7.0. The solution of the present invention is packaged in a single dose, does not contain a preservative, is safe and convenient to use, and is used in combination with a liquid nebulizer to provide a safe, effective and stable pharmaceutical dosage form and drug delivery system for inhalation of vilanterol triphenylacetate.

This invention relates to a polymyxin inhalation liquid formulation and its preparation method, comprising 0.1-5% (w / v) polymyxin B sulfate, 0.05-1% (w / v) stabilizer, 0.1-0.9% (w / v) osmolarity regulator, pH adjuster, and solvent; the pH of the liquid formulation is 3.0-6.0; the solvent is selected from purified water and water for injection; the polymyxin inhalation solution provided by this invention has a simple composition, a pH of 3.0-6.0, and is osmotonic, which can reduce bronchospasm and cough caused by polymyxin inhalation solution. Safety evaluation has verified that it has good safety, providing a new option for clinical application.

The present invention provides a refenacin inhalation solution and a preparation method thereof, wherein the refenacin inhalation solution comprises refenacin at a concentration of 130-180 μg / ml, a buffer stabilizer at a concentration of 5-18 mM, a stabilizer at a concentration of 1.8-3.2 g / L, and a solvent, and the solution pH is 4.9-5.2, and the stabilizer is at least one of sodium gluconate, L-fucose, and acetylcysteine. The present invention can significantly improve the stability of the refenacin inhalation solution under ultrasonic atomization, has good storage stability, and has a better lung deposition rate effect; the preparation process is simple to operate and has low production cost, and is easy to industrialize.

The invention provides a rafenasin inhalation solution composition and a preparation method thereof. The rafenasin inhalation solution composition is prepared from the following components: rafenasin, a buffer pair, sodium chloride, hydrochloric acid or sodium hydroxide and water, wherein the acidic compound of the buffer pair is one or more of phosphoric acid, acetic acid, boric acid, gallic acid, cysteine, glycolic acid, malonic acid, succinic acid, glutaric acid, fumaric acid, malic acid, tartaric acid and benzoic acid. In the technical scheme, the refenasin inhalation solution composition uses a buffer pair except citric acid, so that the stability of the solution is improved, the composition can tolerate excessive killing and sterilization, the safety is higher, and the production cost is lower.

The invention discloses a medicine assembly containing an etimicin sulfate solution and application of the medicine assembly. The medicine assembly comprises (a) the etimicin sulfate solution; the vibrating screen atomizer is used in cooperation with the etimicin sulfate solution; 1500-2200 micropores are formed in the central area of an atomizing sheet of the vibrating screen atomizer; the diameter of each micropore is 2.2 microns to 3.8 microns; wherein the vibration frequency of the vibrating screen atomizer is 90-120KHZ; the sections of the micropores in the vibrating screen atomizer are distributed in a step shape, and the taper is 18 degrees. The nebulizer is matched with the etimicin sulfate inhalation solution for use, so that the administration efficiency of the etimicin sulfate inhalation solution is improved, and the medicine can safely reach an effective treatment concentration in the lung. In addition, the form can improve the amount of delivered medicine, can deposit a large amount of medicine in terminal bronchus and pulmonary alveoli, increases the proportion of fine fog drops reaching the lung, shortens the atomization time, and reduces the volume of medicine liquid residues.

The present application provides a kind of nintedanib solution for inhalation and preparation method and application, the inhalation solution includes active substance, solvent and auxiliary material, the single dose specification of the inhalation solution is 1-5ml, and the active substance in single dose specification is 2.41-12.04mg / ml nintedanib ethanesulfonic acid;The solvent is sterile injection solution water;The auxiliary material includes isotonicity regulator and pH regulator and can also include antioxidant;The addition amount of the isotonicity regulator is to make the inhalation solution have the weight molal osmotic concentration of 240-400mOsmol / kg;The addition of the pH regulator is to make the pH value of the inhalation solution preparation 3.0-4.0.The inhalation nintedanib solution of the present application can provide a kind of nintedanib for inhalation with convenient, safe and effective, and good stability of drug dosage form and drug delivery system in combination with liquid atomization device.

The invention relates to the technical field of pharmaceutical preparations, and discloses a formoterol fumarate inhalation solution and a preparation method thereof. The formoterol fumarate inhalation solution provided by the invention is prepared from the following components in mass concentration: 0.05 percent to 0.2 percent of sodium hydroxide, 0.6 percent to 1.0 percent of tartaric acid, 0.1 percent to 0.3 percent of aminocaproic acid, 0.001 percent to 0.1 percent of polysorbate 20, 0.0009 percent to 0.0011 percent of formoterol fumarate, 0.7 percent to 0.9 percent of sodium chloride and the balance of water for injection. By adjusting the pH value of the solution, adding the polysorbate 20 and the aminocaproic acid, controlling the raw materials and the dissolving temperature thereof, filling nitrogen in the dissolving process and the filling process, and combining filtration and sterilization, the invention provides a method for improving the stability of the product under the condition of controlling the impurity level of the product. And the preparation method can be used for industrially producing the formoterol fumarate inhalation solution.

The invention discloses a method for detecting related substances in a rafenasin aerosol inhalation solution, and belongs to the technical field of medicine detection. Carrying out analysis and detection on the rafenasin aerosol inhalation solution by adopting an ultra-high performance liquid chromatography; chromatographic conditions of the ultra-high performance liquid chromatography are as follows: a chromatographic column takes octadecylsilane chemically bonded silica as a filler; the mobile phase A is a mixed solution of trifluoroacetic acid and water, and the mobile phase B is a mixed solution of acetonitrile, water and trifluoroacetic acid; and gradient elution. The method provided by the invention can be used for separating and detecting four impurities in the rafenasin aerosol inhalation solution, analysis can be completed in 19 minutes, the separation effect is good, the analysis time and the analysis cost are remarkably shortened, the requirement of drug detection accuracy can be met, and a basis is provided for quality control of the rafenasin aerosol inhalation solution.