406 results about "CMC chromatography" patented technology

The invention discloses hawthorn leaf pectic polysaccharide with lipid-lowering activity and a preparation method and application thereof, and belongs to a preparation method of plant polysaccharide, the preparation method comprises the following steps: refluxing hawthorn leaves with ethanol, discarding monosaccharide and small molecule compounds, refluxing with hot water to extract medicinal materials, removing protein through an enzymolysis method and a Sevage reagent method, decolorizing with polyamide resin, and drying to obtain the hawthorn leaf pectic polysaccharide with lipid-lowering activity. The crude polysaccharide is separated through DEAE-52 column chromatography, and finally, the crude polysaccharide is further purified through Sephadex G-100, so that the uniform purified polysaccharide is obtained. Tests on pancreatic lipase inhibition, taurocholate binding capacity and glycocholate binding rate show that the compound has remarkable lipid-lowering activity and is expected to become a potential natural lipid-lowering preparation.

The present disclosure provides systems and methods for separating and characterizing oligonucleotides. Fixed dose combinations of small interfering RNAs can be subjected to denaturing ion pairing reverse phase liquid chromatography using optimal conditions to separate single RNA strands for purity analysis.

The invention provides a construction method and application of a fingerprint spectrum of a liver-warming decoction, and belongs to the technical field of medicine detection.The construction method includes the steps that a test solution is prepared through the liver-warming decoction, acetonitrile (A)-0.08-0.12 wt% formic acid aqueous solution (B) serves as a mobile phase, and the fingerprint spectrum of the liver-warming decoction is obtained through high performance liquid chromatography detection; and a standard fingerprint spectrum is established and is used for quality evaluation or control in the whole process of research / development / production / clinical application of the liver-warming decoction. According to the construction method of the fingerprint spectrum of the liver-warming decoction, main medicinal material components in the liver-warming decoction can be detected through high performance liquid chromatography, so that the quality condition of the liver-warming decoction can be reflected more comprehensively.

The invention relates to a method for detecting six second-line antituberculous drugs by high performance liquid chromatography. The method comprises the following steps: providing an internal standard stock solution and a standard stock solution of six second-line antituberculosis drugs; preparing an internal standard working solution and a standard curve working solution by utilizing the diluent; preparing a solution of a product to be detected by using the Tianlongitudinal sample extraction liquid TZ-002; a liquid chromatograph is used for detection, and the conditions are as follows: a mobile phase A is a Tianlongitudinal sample releasing agent TZ-D004; a mobile phase B is acetonitrile; a mobile phase C is water; and gradient elution. According to the method, the plasma concentration of the second-line antituberculous drug taken by a tuberculosis patient is measured by applying the reversed-phase high-performance liquid chromatography, the cost is relatively low, the analysis time is short, the sensitivity is high, and the accuracy is high. The kit can be used for simultaneously detecting the blood concentration of six second-line antituberculosis drugs such as isopropylthioamide, levofloxacin, linezolid, moxifloxacin, deramanib and bedaquiline in human serum, and is expected to provide a more reliable basis for clinicians to adjust the dosage of the antituberculosis drugs.

Provided is a method for large-scale preparation of a purified preparation of a recombinant lentiviral vector at the GMP grade. The method comprises: (a) providing raw material feed liquid to be purified that comprises recombinant viral vectors; (b) carrying out a microfiltration treatment on the feed liquid to obtain a microfiltered filtrate comprising the recombinant viral vectors; (c) optionally concentrating the filtrate to obtain a concentrated filtrate; (d) purifying the filtrate obtained in the previous step by means of chromatography to obtain a crude pure product comprising the recombinant viral vectors; and (e) subjecting the crude pure product obtained in the previous step to liquid exchange and elaborate purification to obtain the purified recombinant viral vectors.

The invention provides a method for detecting the contents of collagen and regenerated silk fibroin in a composite material, which comprises the following steps: (1) hydrolyzing the composite material for a certain time, and neutralizing to obtain a solution to be detected; (2) preparing a tyrosine reference solution; and (3) detecting the peak areas of the solution to be detected and the tyrosine reference substance solution by adopting high performance liquid chromatography, and calculating to obtain the content of regenerated silk fibroin in the composite material, and (4) detecting the total nitrogen content of the composite material by using a Kjeldahl method, and calculating to obtain the collagen content in the composite material. According to the method, the high performance liquid chromatography is combined with the Kjeldahl determination method, accurate determination of two components can be realized without derivatization treatment, the operation is simple and convenient, and the detection cost is low; the limit of quantitation of the method reaches 10.35 mu g / mL (S / N is greater than or equal to 16.59), the precision RSD is less than 1%, and the method has high sensitivity and accuracy.

Provided herein are methods for purifying polypeptides (e.g., antibodies) comprising an Fc region by Protein A chromatography; methods for using wash solutions comprising benzoate and / or benzyl alcohol during Protein A chromatography; and methods for conditioning the harvest using sodium benzoate prior to Protein A chromatography. [Selected Figure] Figure 1

The invention discloses a method for determining related substances in a fluralamoxidectin drop, the related substances comprise an impurity A, an impurity B, an impurity C, an impurity D, an impurity G and an impurity J. The method is carried out by adopting a high performance liquid chromatography method, and the chromatographic conditions are as follows: an ammonium dihydrogen phosphate buffer solution with the pH value of 4.5-5.2 is taken as a mobile phase A, the mobile phase B is taken as a mobile phase C, and the mobile phase C is taken as a mobile phase D; acetonitrile is used as a mobile phase B for gradient elution, and the concentration of the ammonium dihydrogen phosphate buffer solution is 0.02 mol / L-0. 1 mol / L; the flow velocity is 0.7 mL / min to 1.3 mL / min; the column temperature is 40-50 DEG C; and the detection wavelength is 242 nm. According to the method, related substances in the fluralamoxidectin drops can be simultaneously determined under the same chromatographic condition, simultaneous detection and separation of various impurities are realized, the detection time is shortened, the method can be used for quality research and quality control of fluralamoxidectin drop products, and the drug safety risk is reduced.

The invention discloses a method for detecting the content of nicotinamide mononucleotide, ergothioneine and nicotinamide. According to the method, the content of nicotinamide mononucleotide, ergothioneine and nicotinamide in a sample is analyzed by adopting a high performance liquid chromatography; according to the method, a CAPCELL PAK ADME chromatographic column is used, and the molecular weight of the CAPCELL PAK ADME chromatographic column is 100 And an acetonitrile-buffer solution is used as a mobile phase. Chromatographic peaks obtained by the method are sharp and symmetrical in shape, good in area reproducibility, good in separation degree, simple, rapid, high in specificity, short in detection period and high in sensitivity; the contents of nicotinamide mononucleotide, ergothioneine and nicotinamide in a sample can be rapidly, efficiently, accurately and simultaneously detected.

The current invention reports a method for purifying an antibody by reducing the content of a host cell protein. The method employs a wash step with a low conductivity aqueous solution in an affinity chromatography.

The invention belongs to the technical field of medicine detection, and particularly relates to a method for determining the content of impurities in OAB-14 by using high performance liquid chromatography. The method comprises the following steps: preparing a test sample labeling solution, a test sample solution and a contrast solution of OAB-14, respectively injecting the test sample labeling solution, the blank solution, the contrast solution and the test sample solution into a liquid chromatograph, recording chromatograms, and calculating according to a main component self-contrast method to obtain the content of impurities in the test sample solution; wherein the impurities are one or more of an impurity A, an impurity B, an impurity C, an impurity D, an impurity E or an impurity F. According to the method, the impurities in the OAB-14 can be qualitatively and quantitatively measured at the same time, the stability and the reproducibility are good, the separation degree between a main peak and each impurity peak is good, the precision is high, and an analysis means is provided for quality control of the OAB-14.

The invention discloses a method for detecting the contents of main components of proteins and composite adjuvants in a recombinant varicella-herpes zoster vaccine and application of the recombinant varicella-herpes zoster vaccine. Comprising the following steps: preparing a protein calibration standard solution sample; preparing a QS-21 calibration standard solution sample; preparing a dioleoyl phosphatidylcholine and cholesterol calibration standard solution sample; preparing a detection sample; loading the sample into a liquid chromatograph, and operating an analysis method; and calculating the contents of main components of proteins and adjuvants in the vaccine. The method is a high performance liquid chromatography method capable of simultaneously detecting the contents of protein, dioleoyl phosphatidylcholine, cholesterol and saponin QS-21 in the vaccine. According to the method, the contents of protein, dioleoyl phosphatidylcholine, cholesterol and saponin QS-21 in the vaccine can be accurately detected only through one-time detection, and the vaccine verification efficiency is greatly improved.

The invention belongs to the technical field of medical analysis, and particularly relates to a method for separating chemical components in hemsley rockvine root. According to the present invention, various chromatography methods are adopted to carry out separation and purification, such that sitroside (I), vanillyl glycolII (II), 5-hydroxymaltol (III), vanillic acid (IV), afzelin (V), 2, 3-dihydroxypyrazole (9E, 11E)-13-hydroxypyrazole (9, 11-dienoate), and 2, 3-dihydroxypyrazole (10E, 12E)-9-hydroxypyrazole (10, 12-dienoate) are obtained from hemsley rockvine root. Wherein the compounds II, III, VI and VII are separated from the hemsley rockvine root for the first time, and development and quality control of the hemsley rockvine root medicinal material are facilitated.

The disclosed methods are directed to preparing and detecting polypeptides using neutrophil elastase, such as human neutrophil elastase. The polypeptides are optionally denatured, reduced, and / or alkylated before being subjected to a first digestion. A second digestion comprises the use of neutrophil elastase, such as human neutrophil elastase. The prepared fragments are then analyzed chromatographically, electrophoretically, or spectrometrically, or a combination of these methods. The methods are especially useful for the preparation of therapeutic polypeptides for analysis, especially those that are not easily cleaved, such as some bi-specific T-cell engager (BiTE®) molecules.

The invention belongs to the technical field of pharmaceutical analysis, and discloses a method for determining two potential genotoxic impurities in carbon [13C]-urea by gas chromatography. Comprising the following steps: (1) preparing a sample solution; (2) preparing a reference solution; (3) taking nitrogen as carrier gas, and detecting by adopting a medium-polarity or weak-polarity chromatographic column separation system; and (4) calculating by a peak area through an external standard method to obtain the accurate contents of methyl carbamate and ethyl carbamate in the carbon [13C]-urea. The method disclosed by the invention is simple to operate, good in specificity, linearity, precision and accuracy and high in sensitivity, and can realize accurate detection of residual potential genotoxic impurities, namely methyl carbamate and ethyl carbamate, in the carbon [13C]-urea.

Provided herein are fusion proteins and methods for purifying nucleic acids from a composition. The disclosed compositions and methods allow for faster, more efficient purification of nucleic acids compared to traditional affinity chromatography.

The invention discloses an establishment method of an HPLC (high performance liquid chromatography) characteristic chromatogram of granules for treating common cold and clearing heat and a component content test thereof, and belongs to the technical field of pharmaceutical analys.According to the research, the HPLC characteristic chromatogram of the granules for treating common cold and clearing heat is established under the same chromatographic condition by adopting a high performance liquid chromatography, and the overall internal quality in a preparation is comprehensively reflected; the method for simultaneously determining the content of amygdalin, puerarin, cimicifugin and corydalis bungeana is established, methodology verifies that the method is simple, convenient and feasible, has good stability and repeatability, and can be used for detection in production process monitoring and quality evaluation of the cold and heat clearing granules to ensure that the quality of the cold and heat clearing granules meets the standard. The scheme not only scientifically restores the overall pharmacodynamic material basis of the compound preparation, but also provides a new generalizable normal form for quality control of traditional Chinese medicines with the advantages of low cost and high efficiency, and has milestone significance for promoting industry standardization and internationalization.

The invention discloses a method for qualitatively and quantitatively detecting protein in a recombinant varicella-herpes zoster vaccine and application. The method comprises the following steps: preparing a protein calibration standard solution sample; preparing a detection sample; loading the sample into a liquid chromatograph, and operating an analysis method; calculating the relative deviation of the protein retention time in the vaccine; and calculating the protein content in the vaccine. The technical problem that in the prior art, two different methods are needed for twice detection in qualitative and quantitative detection of the protein in the vaccine is solved, and the technical problem that in an existing protein content detection technology, the protein in the vaccine can only be quantitatively detected and cannot be qualitatively detected is also solved. According to the high performance liquid chromatography disclosed by the invention, the protein in the vaccine can be qualitatively and quantitatively detected only by one-time sample loading detection, so that the vaccine verification efficiency is greatly improved.

This invention generally relates to methods for enriching antibodies of interest. Specifically, this invention relates to enriching therapeutic antibodies from upstream cell culture processes using protein A chromatography in the form of a centrifugal column for product quality property profiling analysis.

The present disclosure is directed to methods of performing affinity chromatography. The injection elution methods disclosed herein afford rapid and robust elution of a target analyte from an affinity chromatography column, therefore improving workflow efficiency. Further, the single injection elution methods result in highly concentrated samples, mitigating the need for sample concentration or manipulation.

Disclosed herein are methods for characterizing lipid nanoparticles (LNPs) using size-exclusion chromatography. The disclosed methods utilize a denaturing mobile phase (i.e., denaturing SEC) to afford robust disruption of LNPs and to permit the direct injection of LNPs onto a size-exclusion chromatography column. Accordingly, said methods allow for the characterization of formulated LNPs without pre-treatment or other modifications.

To provide a method for increasing an antibody yield during antibody purification.SOLUTION: A method for increasing an antibody yield in a flow-through of ion exchange chromatography during antibody purification includes: a. a step of providing a sample including an antibody; b. a step of adjusting the electric conductivity of the sample; c. a step of processing the adjusted sample by ion exchange chromatography of a flow-through mode; and d. a step of collecting the flow-through including the antibody, where the electric conductivity of the sample on step b) is adjusted to at least 10 mS / cm by using tris, and pH after adjusting electric conductivity is within the range of pH6.5 to 7.5.SELECTED DRAWING: None

This invention discloses the XO-inhibiting peptide GDEY and its applications, belonging to the field of bioactive peptide technology. The amino acid sequence of the XO-inhibiting peptide GDEY is shown in SEQ ID NO.2. The invention also discloses the application of the XO-inhibiting peptide GDEY in the preparation of xanthine oxidase inhibitors and in the preparation of drugs with the effect of inhibiting uric acid levels. This invention used molecular docking and BLAST+ software to virtually screen 15 potential XO-inhibiting peptides from the complete protein sequence of Litopenaeus vannamei. High-performance liquid chromatography (HPLC) was used to determine the XO-inhibiting activity, and the results showed that 7 small molecule peptides exhibited significant XO-inhibiting activity, possessing potential value in preventing hyperuricemia.

The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.

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.

A method for purifying a protein comprising an antibody, antibody fragment, or immunoglobulin single variable domain, from a solution containing at least one contaminant by superantigen chromatography comprising: a) adsorbing the protein to the superantigen immobilized on a solid support; b) removing the at least one contaminant by contacting the immobilized superantigen containing the adsorbed protein with a first wash buffer comprising an aliphatic carboxylate; and c) eluting the protein from the superantigen immobilized on the solid support.

The invention relates to the technical field of thin-layer chromatography detection, and discloses a thin-layer chromatography separation method for amino polyether and a matrix in a fluorine-18 labeled radiopharmaceutical, and the adopted developing solvent is acetonitrile and ammonia water, and the volume ratio of the acetonitrile to the ammonia water is 90: 10-85: 15. According to the method, amino polyether and matrix components are separated by adopting a developing solvent with a specific volume ratio, and particularly, sodium ascorbate in the amino polyether and the matrix is separated.

To provide methods and systems for improving the efficiency and / or productivity of polypeptide preparation.SOLUTION: The embodiment of the disclosure is directed to a method for preparing a target polypeptide from a mixture containing the target polypeptide. The method comprises contacting the mixture to a hydrophobic interaction chromatography (HIC) apparatus consisting of multiple chromatography zones. The method may further comprise passing the target polypeptide through the outlets of at least first and second zones. The residence time for the mixture including the target polypeptide in the first zone may be substantially the same as a residence time of one or more mobile phases in the second zone.SELECTED DRAWING: Figure 2

The present disclosure relates to a method for separating and obtaining a target protein-enriched solution, such as immunoglobulin G (IgG), and a plurality of target protein-depleted fractions from a protein mixture, such as plasma or fractions thereof, using continuous chromatography. The present disclosure also relates to a continuous chromatography system for separating a target protein from a protein mixture, a formulation of its purified product and uses.

The invention relates to the technical field of pharmaceutical analysis, in particular to a chromatographic method for determining optical isomers in a carbidopa raw material medicine and a preparation thereof by using an HPLC (High Performance Liquid Chromatography) method. The detection method is simple, convenient, rapid and accurate to operate, and specifically comprises the following steps: dissolving a proper amount of a sample with a solvent, diluting to a certain concentration, taking a certain volume of the sample, carrying out isocratic elution at a certain column temperature by adopting a high performance liquid chromatography, using a hand-type chromatographic column, a mobile phase A and a mobile phase B, and carrying out quantitative analysis by adopting a self-control method with correction factors. And calculating the isomer in the test solution. The method is good in specificity, solution stability, linearity, repeatability, intermediate precision and durability, and the detection result is accurate and reliable through verification.