19 results about "Polymyxin B Sulfate" 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 provides a polymyxin B sulfate microbial limit counting inspection method, which comprises the following steps: filtering a 1: 100 test solution and less than or equal to 100cfu test bacteria in a sterile sodium chloride aqueous solution by adopting a membrane filtration method, flushing with the sterile sodium chloride aqueous solution, and pasting a filter membrane on a culture medium plate to serve as a test group; referring to the method of the test group, taking the polymyxin B sulfate control group without adding the test bacteria; by referring to a method of a test group, respectively replacing the test solution with a 1mol / L magnesium chloride aqueous solution to serve as a bacteria solution control group; by referring to a method of a test group, replacing a test solution with a 1mol / L sterile magnesium chloride aqueous solution, and taking the test solution as a negative control group without adding test bacteria; the experimental group and the control group are cultured and counted, and the recovery ratio of the experimental bacteria is within the range of 0.5-2 and meets the requirements. The problem of applicability of the microbial limit counting inspection method is solved.

The invention provides polymyxin B sulfate and a preparation method thereof. According to the method, paenibacillus polymyxa is fermented in a liquid culture medium with wheat flour as a main carbon source and cottonseed cake powder and high-temperature soybean cake powder as main nitrogen sources to generate polymyxin B, and aluminum oxide is used as a chromatography medium to purify polymyxin B sulfate through a column chromatography process. Wheat peptone is added into the seed tank, so that growth of hyphae is facilitated, and the hyphae are full; the inoculation amount is reduced, and the seed expanding period is shortened. In the middle stage of fermentation, the amino acid mixed liquid is supplemented, so that the yield of the polymyxin B is increased, and specific impurities after the component B2 can be reduced. The quality of the product prepared by the method is obviously improved, the preparation method does not use an organic solvent and is green and environment-friendly, aluminum oxide can be regenerated and reused, and industrial production is facilitated.

The application discloses a preparation method of polymyxin B sulfate impurity Z3 control product, and comprises the following steps: preparing a mobile phase, dissolving a sample containing polymyxin B sulfate, and then loading the sample into a chromatographic column, eluting the sample with the mobile phase, intercepting a fraction between a peak valley position of impurity B1-I and B1, and then re-loading and eluting the fraction to obtain a B1-I, Z3 and B1 triple peak after concentration, collecting a fraction corresponding to a peak part of Z3, repeatedly loading and eluting the fraction after concentration, and finally crystallizing to obtain a product Z3. The application has the advantages of simple operation, good separation effect and high-purity Z3 control product.

The application discloses a preparation method of a polymyxin B sulfate dry powder and belongs to the technical field of medicine preparation. The preparation of the polymyxin B sulfate dry powder is that the polymyxin B sulfate fermentation liquor is subjected to adsorption filtration by using a ZIF-8@polyurea / polyether sulfone composite membrane, and the filter cake is subjected to elution by using a sulfuric acid aqueous solution. The eluate is post-treated to obtain the polymyxin B sulfate dry powder. The application has the advantages of mild preparation condition, simple process, low reaction energy consumption and industrial application prospect.

The invention discloses an external antibacterial medicine composition as well as a preparation method and application thereof, and belongs to the technical field of antibacterial medicines. The external antibacterial pharmaceutical composition provided by the invention comprises a medicinal active component and a pharmaceutically acceptable carrier, wherein the medicinal active component comprises polymyxin B sulfate, trimethoprim sulfate and lidocaine; every 10 g of the antibacterial pharmaceutical composition for external use is prepared from the following components in parts by weight: 40000 to 60000 U of polymyxin B sulfate, 0.08 to 0.16 g of trimethoprim sulfate and 0.30 to 0.35 g of lidocaine. The pharmaceutical composition disclosed by the invention has broad-spectrum inhibition on multiple drug-resistant bacteria such as common gram-negative drug-resistant bacteria and acinetobacter baumannii on a wound surface, synchronously plays a synergistic role in relieving inflammatory response of the wound surface and relieving local pain, and remarkably improves the medication safety and the comprehensive treatment effect while ensuring excellent antibacterial activity.

The invention provides an analysis method of polymyxin B sulfate related substances, which comprises the following steps: dissolving polymyxin B sulfate for injection in water-acetonitrile (80: 20) to obtain a test solution; the method comprises the following steps: dissolving a polymyxin B standard substance in water-acetonitrile (80: 20), and uniformly shaking to obtain a standard substance solution; detecting the test solution and the standard solution by adopting a high performance liquid chromatography, wherein the detection adopts linear gradient elution; wherein the mobile phase A is a sodium sulfate solution; and the mobile phase B is acetonitrile. According to the technical scheme, a high performance liquid chromatography method is adopted, automatic operation can be achieved, repeatability is good, accuracy is high, sensitivity is high, component content and related substance inspection are combined into one method, the component content in a sample can be effectively detected, related substance inspection can also be considered, the detection time needed during quality control is shortened, and the analysis efficiency is improved.

The invention belongs to the technical field of analysis and detection of polymyxin B sulfate, and provides an analysis and detection method of polymyxin B. In a historical detection period, historical column efficiency values of a chromatographic column when the polymyxin B sulfate is analyzed and detected for multiple times are recorded, trend change analysis is carried out, whether the column efficiency is reduced or not is judged, and whether the column efficiency is reduced or not is judged. If the overall column efficiency in the historical detection period is in a descending trend, identifying the change trend type of a plurality of column efficiency values, and according to the identified change trend type, obtaining the predicted column life loss degree and the current column efficiency value of the current chromatographic column for analyzing and detecting the polymyxin B sulfate; and calculating the ratio of the current column efficiency value to the predicted column life loss degree to obtain a predicted residual column life value, thereby solving the problem that the service life of the chromatographic column cannot be accurately known in analysis and detection of polymyxin B sulfate.

The invention relates to a polymyxin B sulfate dry powder inhalation and application thereof, which can effectively solve the problem of medication for treating pneumonia and pulmonary infection caused by multi-drug-resistant gram-negative bacteria, the polymyxin B sulfate dry powder inhalation is prepared from polymyxin B sulfate, leucine and mannitol, and the preparation method comprises the following steps: dissolving polymyxin B sulfate, leucine and mannitol in ultrapure water according to a mass ratio, carrying out ultrasonic treatment to obtain a uniformly mixed medicine solution, and carrying out freeze drying to obtain the polymyxin B sulfate dry powder inhalation. The composition is simple, scientific and reasonable, the raw materials are rich, the preparation method is easy to operate, the product quality is good, the composition is administrated through aerosol inhalation, the composition is effectively used for treating pneumonia and pulmonary infection caused by multi-drug-resistant gram-negative bacteria, the composition is fast to absorb, the pulmonary drug concentration is high, the stability is good, and the composition is suitable for clinical application. The medicine is a great innovation in treatment of pneumonia and pulmonary infection caused by the multi-drug-resistant gram-negative bacteria, and has remarkable economic and social benefits.

The invention relates to a method for simultaneously determining contents of four B components and related substances in a polymyxin B sulfate raw material and a preparation thereof, which adopts ultra-high performance liquid chromatography combined with an ultraviolet detector, and uses octadecylsilane chemically bonded silica as a chromatographic column. A trifluoroacetic acid aqueous solution with the volume fraction of 0.07% is used as a mobile phase A, and a trifluoroacetic acid acetonitrile solution with the volume fraction of 0.05% is used as a mobile phase B; compared with a traditional method, the method has the advantages that the mobile phase is simple to prepare, the compound retention time is stable, the analysis time is shortened by one time, the analysis cost is reduced, the sensitivity is high, the reproducibility is good, and four B components and related substances thereof can be completely separated; the contents of the four B components and related substances in the polymyxin B sulfate can be rapidly and accurately measured at the same time.

The invention belongs to the technical field of biological fermentation, and particularly relates to a fermentation medium, a fermentation method and application of polymyxin B sulfate. According to the method, carbon and nitrogen sources for fermentation are optimized, special amino acid is added, fed-batch components are optimized, the fermentation process is controlled, the adjusted fermentation culture medium and fermentation method meet the standards of EP8.0 and CP2015, the fermentation titer is high, the ratio of a fermentation product B1 / B2 is high, the purity of a target product is high, loss caused by follow-up refining or purification is reduced, and industrial popularization is facilitated.

The invention discloses a method for determining related substances and components of polymyxin B sulfate by adopting HPLC (High Performance Liquid Chromatography), and belongs to the field of medicine detection. The components are polymyxin sulfate B1, B2, B3 and B1-I, the related substances are impurities E, F, G and M. The method is a high performance liquid chromatography method, Thermo Hypersil GOLDTM is used as a chromatographic column, a sodium sulfate solution is used as a mobile phase A, acetonitrile is used as a mobile phase B, the detection wavelength is 215 nm, the flow velocity of the chromatographic column is 0.8 ml per minute, the column temperature of the chromatographic column is 20 DEG C, the sample injection volume is 20 microliters, the detection time is 30 minutes, and the detection time is 30 minutes. According to the present invention, the components of the polymyxin B sulfate are separated from the related substances by using the gradient elution, such that the effective separation of the four main component peaks and the adjacent peak impurities of the polymyxin B sulfate on the chromatographic column is achieved, and the contents of the related substances and the components of the polymyxin B sulfate can be rapidly, conveniently and accurately determined.

A topical cream composition is provided which comprises a mixture of a moisture barrier component, a steroid component, an antifungal component, and an antibiotic component. The combination of a moisture barrier, a steroid, an antifungal component, and an antibiotic component works together to optimally provide quick treatment and resolution for diaper dermatitis, also known as diaper rash, or other skin condition(s). The moisture barrier component provides a barrier between affected skin and diaper wetness; the steroid reduces swelling, itching, and / or other discomfort; the antifungal component treats any present fungal skin infection(s); and / or the antibiotic component treats any present bacterial skin infection(s). In one aspect, the topical cream comprises a composition of petroleum jelly, hydrocortisone cream, clotrimazole antifungal cream, and triple antibiotic ointment including bacitracin zinc, neomycin sulfate, and polymyxin B sulfate.

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 application relates to a kind of polymyxin B sulfate dry powder, inhalation powder aerosol and preparation method thereof.The polymyxin B sulfate dry powder is prepared by spray drying from the aqueous solution of polymyxin B sulfate and carrier;The carrier is composed of guar gum and L-leucine with a mass ratio of 1-2.5:1;The mass percentage of polymyxin B sulfate and carrier is 45%-65%:35%-55%, and the total amount of polymyxin B sulfate and carrier is 100%;The total concentration of polymyxin B sulfate and carrier in the aqueous solution is 3mg / mL-18mg / mL.The polymyxin B sulfate inhalation powder aerosol prepared from the polymyxin B sulfate dry powder can directly deliver the drug to the lung lesions by local administration, with high lung effective deposition rate, greatly reducing the dosage, and can effectively inhibit the formation of bacterial biofilm.

To provide: methods and compositions for detecting, identifying and treating glaucoma diseases; and compositions and methods for affecting intraocular pressure and increasing ocular outflows in glaucoma.SOLUTION: The invention provides an aqueous pharmaceutical composition for treating a glaucoma disease, reducing intraocular pressure, and / or reducing ocular extracellular vesicle complexes, the composition comprising an active agent selected from cetylpyridinium chloride, polymyxin B sulfate, a mycin, and heparin sodium.SELECTED DRAWING: None

The invention relates to the technical field of culture media, in particular to a streptococcus suis enrichment culture medium for high-density fermentation and a preparation method of the streptococcus suis enrichment culture medium. Tryptone; a soluble starch; glucose; sodium azide; a polymyxin B sulfate; l-cysteine hydrochloride is added; a buffer salt; an ion supplement; a cell wall relaxant; thiamine hydrochloride; an antioxidant; a composite nutrient source; an osmotic pressure regulator; growth factors. According to the culture medium, quick-acting glucose and slow-release starch are used for synergistically supplying energy, quick start and continuous metabolism are both considered, and the enrichment period is greatly shortened; polymyxin B is introduced to be combined with a sodium azide targeted inhibitor, so that gram-negative bacteria and part of positive infectious microbes are accurately inhibited, and the selectivity is remarkably improved; meanwhile, the activity of thalli is maintained by an anti-oxidation and buffer system, high-sensitivity detection of low-concentration samples is ensured, and the application scenario of efficient detection and industrial fermentation of streptococcus suis is conformed.

The invention relates to polymyxin B sulfate dry powder, a dry powder inhalation and a preparation method of the polymyxin B sulfate dry powder and the dry powder inhalation. The polymyxin B sulfate dry powder is prepared from polymyxin B sulfate and an aqueous solution of a carrier through spray drying, the carrier is composed of guar gum and L-leucine in a mass ratio of (1-2.5): 1; the mass percentage ratio of the polymyxin B sulfate to the carrier is (45%-65%): (35%-55%), and the total amount of the polymyxin B sulfate and the carrier is 100%; in the aqueous solution, the total concentration of the polymyxin B sulfate and the carrier is 3 mg / mL to 18 mg / mL. The polymyxin B sulfate inhalation powder inhalation prepared from the polymyxin B sulfate dry powder can directly deliver the medicine to a lung focus through local administration, the effective deposition rate of the lung is high, the administration dosage is greatly reduced, and the formation of a bacterial biofilm can be effectively inhibited.

The present invention belongs to the technical field of analysis and detection of polymyxin B sulfate. The present invention provides an analysis and detection method for polymyxin B sulfate. During the historical detection period, the historical column efficiency values are recorded when the chromatographic column analyzes and detects polymyxin B sulfate multiple times, and trend change analysis is carried out to judge whether the column efficiency decreases. If the overall column efficiency shows a downward trend during the historical detection period, the change trend types of multiple column efficiency values are identified, and according to the identified change trend types, the predicted column life loss degree is obtained, as well as the current column efficiency value of the current chromatographic column for analyzing and detecting polymyxin B sulfate. The current column efficiency value is divided by the predicted column life loss degree to obtain the predicted remaining column life value, which solves the problem that the service life of the chromatographic column cannot be accurately known in the analysis and detection of polymyxin B sulfate.