748 results about "CMC chromatography" patented technology

The present invention provides a process for the production of erythropoietin (EPO) with high purity and with a desired profile of EPO glycol-isoforms by using a combination of specific chromatographic steps in such a manner that the starting EPO glycol-isoform profile is changed or modified. The applied chromatographic steps includes at least (a) dye affinity chromatography, and (b) hydrophobic chromatography and/or (c) anion-exchange chromatography. In a preferred embodiment, the process further includes (d) gel filtration chromatography. The present invention also provides a process for the determination of erythropoietin (EPO) glycol-isoform profile in an EPO containing composition.

The present invention is directed to methods for purifying a protein of interest, e.g., an antibody, from a sample comprising the protein of interest and at least one impurity, e.g., an aggregate, by employing a hydrophobic interaction chromatography (HIC) method that allows for binding of both the protein of interest and the at least one impurity under strong binding conditions. The present invention is based, at least in part, on the finding that both flow through and bind-elute techniques can be combined to achieve greater purification and recovery of a protein of interest, e.g., an antibody, under isocratic wash conditions and strong binding conditions.

The invention relates to a liquid chromatography for detecting anabolic hormone drug residue in animal-derived food, which is characterized by first sampling: animal musculature is taken off the fat and connective tissue, then minced and evenly ground, and the sample is weighed; extracting: anabolic hormone extract is extracted from the weighed sample by methanol ultrasonic extraction, the extract is evaporated to dryness in water bath through a rotary evaporator, and the residue is dissolved by methanol aqueous solution; purifying: C18 Solidoid extraction column on the extract is carried out solid phase extraction; and testing by devices: the filtrate is tested by opposite phase high efficiency liquid chromatography, quantified by external reference method-peak area, and then carried out with binary gradient elution. In the invention, the detected sample is complex biological sample; the established method can complete one detection in about one hour and is simple and fast, with reliable sensitivity and low cost; the method can analyze more veterinary hormone drug species than the synchronous usage of the existing GC or HPLC methods with easier operation, and has lower cost than the existing GC/MS and LC/MS or LC/MS/MS methods with low solvent toxicity.

The present invention relates to methods for purifying fibrinogen. In one aspect, the present invention relates to a method of separating fibrinogen from plasma fraction I precipitate. In another aspect, the invention relates to the purification of fibrinogen using ion exchange chromatography.

The present invention generally provides systems and methods for the detection, identification, or characterization of differences between properties or behavior of corresponding species in two or more mixtures comprised of molecules, including biomolecules and/or molecules able to interact with biomolecules, using techniques such as partitioning. The experimental conditions established as distinguishing between the mixtures of the molecules using the systems and methods of the invention can also be used, in some cases, for further fractionation and/or characterization of the biomolecules and/or other molecules, using techniques such as single-step or multiple-step extraction, and/or by liquid-liquid partition chromatography. The methods could also be used for discovering and identifying markers associated with specific diagnostics, and can be used for screening for such markers once discovered and identified during diagnostics screening.

The invention is in the field of electrokinetic chromatography. In particular, the invention is directed to reagents and methods of performing electrokinetic chromatography. The reagents and methods afford fast, high resolution separations with increased detectability.

The invention provides a quality detection method for Taurolidine. The method uses thin-layer chromatography, gas phase chromatography and titering process to detect the quality of the Taurolidiene. The quality detection method for Taurolidine has the advantages of rapidness, accuracy, convenient operation and excellent reproduction quality, and ensures the product quality of the Taurolidine.

The invention is about a method to purify the recombined human urokinase by the chromatography. The invention relates to recovery the gene engineering production from the mammal cell culture using the Streamline-SP, Sephacryl S-200, Sepharose Fast Flow and DEAE-Sepharose Fast Flow method. The recombined human urokinase can meet the SFDA standard and the percent recovery is above 70%, the purity is above 99% by using the method.

The invention discloses coumarin compounds. The preparation method comprises the following steps: extracting from rattan of Derris eriocarpa How by the inventor; according to the detection introduction of thin-layer chromatography, carrying out reversed-phase silica gel column chromatography, carrying out gradient elution by a petroleum ether-ethyl acetate system for further systematic separation, and recrystallizing. The antioxidation activity experiment proves that the compounds 1 have favorable antioxidation actions, the IC50 value for superoxide anion removal activity is less than that of the positive drug control ascorbic acid, the IC50 value DPPH.free radical removal activity has no great difference from the positive drug, and the compounds 1 have excellent antioxidation activity as compared with the coumarin compounds 6,7-dihydroxycoumarin, daphnetin and daphnoretin which are reported in documents. Therefore, the coumarin compounds disclosed by the invention can be used as a pharmaceutical or non-pharmaceutical antioxidant and the like.

A Chinese medicine for treating anorexia of baby is prepared from 12 Chinese-medicinal materials including tuckahoe, tangerine peel, haw, rhubarb, etc through decocting, filtering, concentrating, mixing, etc. Its quality control method including thin-layer chromatography and high-effect liquid-phase chromatography is also disclosed.

The invention relates to the technical field of biological product and blood product production, and mainly relates to a separation and purification method of human serum albumin in the blood product production, in particular to a preparing method of human serum albumin. According to the method, healthy plasma supernatant is used as raw materials; a Kistler-Nitchmann low-temperature ethanol method is adopted for precipitating and separating ingredients FI+II+III and ingredients FIV; supernatant after the ingredient FIV separation is subjected to dealcoholization treatment; then, one-step ion exchange chromatography and ultrafiltration are further performed; a proper amount of sodium caprylate is added as a stabilizer; after the Pasteur virus inactivation treatment is performed, the human serum albumin finished product is obtained. Through efficient liquid chromatography detection, the purity of the human serum albumin prepared by the process is higher than 99 percent; the polymer content is lower than or equal to 1 percent; the yield of the plasma reaches 28 to 30g/L. The purity of the product is higher; the impurity protein content is lower, so that the clinical medication is safer.

The invention discloses a quality detection method for a houtou jianweiling Chinese medicament, which comprises the following steps: performing thin layer chromatography identification on rhizoma corydalis; and measuring that the content of paeoniflorin in radix paeoniae alba is not less than 0.40 mg by a high performance liquid chromatography. The method also relates to the following detection steps: a, identifying the thin layer chromatography of rhizoma cyperi; b, identifying the thin layer chromatography of the radix paeoniae alba and liquorice; and c, measuring that the content of adenosine C10H13N5O4 is not less than 0.070 mg by the high performance liquid chromatography. The method can effectively improve the quality standard of the houtou jianweiling Chinese medicament; and the detection method can come up with new related detection indexes, adds detection indexes, strictly controls the product quality, and ensures the efficacies.

The invention provides an establishment method of a traditional Chinese medicine composite fingerprint, and particularly relates to an establishment method of a Weilikang granule fingerprint. Pure water is added to Weilikang granules, so as to dissolve, and paeoniflorin, naringin, rutin, salvianolic acid B, rosmarinic acid, emodin-8-O-beta-D glucopyranoside and glycyrrhizic acid are used as reference substances, so as to establish the fingerprint by referring to high-performance liquid chromatography. The method is more comprehensive and objective than the current quality standard, and the current quality standard is increased and improved, and more information is provided for the internal quality control of the Weilikang granules.

A method for purifying abamectin medicines by the special immunoaffinity chromatographic column carrying immunoaffinity adsorbent is disclosed. Said adsorbent is composed of solid carrier and its coupled abamectin polyclonal or monoclonal antibody. It features that the chromatography is used to measure the contents of abamectin, having high correctness.

The invention discloses a quality control method of a loins-strengthening and kidney-invigorating medicine. In the method, beautiful millettia root, rhizoma cibotii, kadsura coccinea, caulis spatholobi, parasitic loranthus and glossy privet fruit in the medicine are respectively identified by a thin layer chromatography; and the content of protocatechuic acid and the content of protocatechuic aldehyde in the medicine are measured via a liquid chromatography. In the quality control method established by the invention, the medicine material identifying method is mature and feasible, strong in specificity, negative and interference-free; the content measurement method is easy in operation, high in precision and good in reproducibility; and by adopting the quality control method disclosed by the invention, the quality of the medicine can be precisely and stably controlled to adapt to the industrial and stable production of the medicine.

Method and apparatus for characterizing drug-modified polymers, macromolecules, proteins, antigens, antibodies or nanoparticles and quantitative determination of their impurity profile by two-dimensional liquid chromatography analysis. The first dimension is preferably size exclusion chromatography (SEC)—which is also known as gel permeation chromatography in case of non-aqueous samples (GPC)—for complete molecular weight analysis of nanoscale particles. It is not just included the application of separating small molecules from big molecules, but it is also the separation of different sorts of oligomers (e.g. monomers, dimers, trimers, tetramers). The second dimension is adapted for separating and characterizing small molecules which can be impurities or non-reacted modifiers with high-performance liquid chromatography (HPLC). Between the dimensions it is feasible to use solid phase extraction column(s) to collect small molecules, wash off or change solvent, or minimize broadening of their peaks.

The present invention provides a measurement method utilizing immunochromatography, an immunochromatographic test strip, and a reagent kit of immunochromatography capable of accurate short-time measurement of an analyte in blood with simple operations as compared to the conventional methods. The present invention provides a method of measurement by immunochromatography in which concentrations of an analyte and hemoglobin in the same sample are measured by immunochromatography to perform hematocrit correction of a measurement value of the analyte by using a measurement value of hemoglobin, as well as a test strip and a reagent kit for immunochromatography.

The invention relates to the method for detecting the quality of senile cough and cough tablets. The method comprises the following steps: qualitatively distinguishing the active ingredients including radix astragaliseuhedysari, bighead atractylodes rhizome, radix saposhnikoviae, licoriceroot,herbaepimedii andfructuspsoralea in asenile cough and cough tabletpreparation by using a thin layer chromatography, and determining the contents of icariin, psoralen and isopsoralenin the preparation by a UPLC method. The detection method provided by the invention has the advantages of simplifying the sampling steps, having simple operation and high specificity, shortening the content determination time, simultaneously detecting multi-index components, having stabledetection baseline, good resolution, high detection accuracy and good stability, improving efficiency, and being relatively economic and environmentally friendly.

The invention discloses a method for detecting 3-amino-2-azepanone through a high performance liquid chromatography. According to the method, the following chromatographic conditions are adopted: a chromatographic column is an ODS column; a mobile phase A is a 0.01-0.09 mol/L monopotassium phosphate solution; a mobile phase B is a mixed water solution of methanol and acetonitrile in which the volume ratio of methanol, acetonitrile and water is (1-5):(1-5):1; the flow velocity is 0.4-1.2 ml/min; the detection wavelength is 100-300 nm; the column temperature is 20-60 DEG C; the sample size is 5-20 [mu]l. Through adoption of the method, the content of the impurity of 3-amino-2-azepanone degraded by lysine can be accurately measured, and the specificity is good; the quantification limit repeatability is good, the recovery rate is high, and a solution is high in stability; when the column temperature, the detection wavelength and the flow velocity change slightly, the difference between a detected recovery rate of 3-amino-2-azepanone and a result detected at a basic condition is very small, so that the durability of the method is high.