179 results about "Reversed-phase chromatography" patented technology

The invention belongs to the field of biological medicines, and discloses an application of a stem cell extract in lysosome and mitochondrial related diseases, a preparation method of the stem cell extract comprises the following steps: S1) culturing mesenchymal stem cells and creating stress conditions to stimulate the mesenchymal stem cells; and S2) separating and purifying the culture supernatant of the mesenchymal stem cells cultured in the step S1) to obtain the stem cell extract, wherein S21) the culture supernatant is filtered to obtain a filtrate; s22) performing 3KD ultrafiltration concentration on the filtrate to obtain a crude sample; s23) purifying the crude sample by using molecular sieve exclusion chromatography or reversed-phase chromatography to prepare a purified sample; in molecular sieve exclusion chromatography, by taking the volume of the eluent as a reference, collecting the 10th to 40th mL of eluent, namely a purified sample; and S24) taking the purified sample to form a preparation. According to the application, the culture supernatant containing stress stem cell secretions is taken through stress culture of stem cells, and a purification method is combined, so that the prepared preparation can be used for treating lysosome and mitochondrial related diseases.

The invention relates to the technical field of pharmaceutical analysis, in particular to a method for detecting related substances of a compound sodium picosulfate oral solution. According to the method, high performance liquid chromatography is adopted for detection, a chromatographic column is a bonded silica gel reversed-phase chromatographic column, a mobile phase A is a dipotassium phosphate buffer solution, a mobile phase B is acetonitrile, and gradient elution is adopted. The method can effectively detect related substances in the compound sodium picosulfate oral solution, has the advantages of strong specificity, high sensitivity and the like, has good detection capability on specific impurities in the compound sodium picosulfate oral solution, and effectively guarantees the quality of the compound sodium picosulfate oral solution.

An exemplary machine learning-based system and method are disclosed for a clinical tool that can provide a comprehensive prediction of ovarian cancer propensity using metabolite and metabolomic profiles acquired from ultra-performance liquid chromatography, high-resolution mass spectrometry (UPLC-MS) analysis. Each serum sample may be independently processed through two different columns (HILIC and C18 reversed phase). Different ionization modes (negative and positive) may be used. The clinical tool can validated to provide successful prediction of ovarian cancer by over 90%. Ultra-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS / MS) and the like can be used.

The invention discloses a method for detecting melogabalin besylate and isomer impurities of melogabalin besylate. According to the method, liquid chromatography is adopted, an FXAA reagent and a sample to be tested are subjected to a reaction under the alkaline condition to obtain a solution to be detected, then the solution to be detected is subjected to liquid chromatography separation, the structural formula of the FXAA reagent is # imgabs0 #, R is selected from-CH (CH3) 2,-CH2CH2SCH3 or-C6H5, and the structural formula of the FXAA reagent is as shown in the specification, the structural formula of the FXAA reagent is as shown in the specification, and the structural formula of the FXAA reagent is as shown in the specification, the structural formula of the FXAA reagent is as shown in the specification, the structural formula of the FXAA reagent is as shown in the specification, and the structural formula of the FXAA reagent is as shown in the specification. The test sample comprises melogabalin besylate and isomer impurities thereof, and the liquid chromatography adopts a reversed-phase chromatographic column. According to the method, melogabalin besylate and three isomer impurities thereof can be safely and effectively separated and respectively detected, the detection sensitivity, repeatability and durability are good, and a powerful guarantee is provided for quality control of the medicine.

The invention discloses a total component and a blood-entering component of a herba artemisiae scopariae dampness-clearing granule and a detection method of the total component and the blood-entering component. The preparation method comprises the following steps: A, decocting the herba artemisiae scopariae dampness-clearing granules, filtering decoction to obtain filtrate, and concentrating the filtrate to obtain concentrated liquid; b, detecting the concentrated solution by adopting liquid chromatography-mass spectrometry; the liquid chromatography conditions are as follows: a reversed-phase C18 chromatographic column is adopted, the column temperature is 40 DEG C, a mobile phase A is formic acid water with the volume fraction of 0.1%, a mobile phase B is acetonitrile, and the flow velocity is 0.3 ml / min. The research investigates all components of the dampness-clearing prescription, i.e., the rhizoma smilacis glabrae dampness-clearing granules, and investigates blood entering components of the dampness-clearing prescription, i.e., the rhizoma smilacis glabrae dampness-clearing granules after long-term intervention in patients with the dampness-syndrome metabolic syndrome in clinical practice. A new modern theoretical system is injected for the research of traditional Chinese medicine dampness syndrome and dampness clearing prescription clinical intervention, and a reference is provided for the research of other syndromes of traditional Chinese medicine.

The invention discloses a rapid mass spectrum determination kit for strychnine and strychnine, and relates to the technical field of biological detection. The rapid mass spectrum determination kit comprises an MCX mixed type cationic adsorbent and a pyrrolidone-styrene polymer adsorbent. The rapid mass spectrum determination kit effectively improves the accuracy and sensitivity of detection, and through a porous plate extraction-liquid chromatography-tandem mass spectrum method, the detection sensitivity is greatly improved on a silica gel matrix C18 reversed-phase chromatographic column under the conditions of specific mobile phase composition and flow velocity. Separation of strychnine and strychnine from interference impurities in blood on a silica gel matrix C18 reversed-phase chromatographic column and multi-reaction monitoring (MRM) mass spectrometry detection under an electrospray ionization source positive ion mode are realized, and finally rapid, accurate and high-sensitivity detection of strychnine and strychnine in blood is realized.

The present invention proposes a method for purifying polypeptides, which uses a high-precision high-performance liquid chromatography system and is also equipped with a control cabinet, an axially pressurized liquid chromatography column (DAC), an eluent delivery system, a sample loading device, an online detection device, and an automatic fraction collection system; the flow error of the pump of the eluent delivery system is within 1.5%; the chromatographic column filler is a spherical mesoporous silica matrix reversed-phase chromatography filler, which is a type of specially constructed silica gel, and has undergone special bonding modification, which effectively improves the effect and yield of polypeptide separation and purification, increases the sample loading amount of the filler, and solves the technical problems existing in the polypeptide purification process such as the large number of micropores, low lifespan, and alkali resistance of traditional silica gel. At the same time, through a closed-loop fully automatic chromatographic purification method that integrates online solvent recovery, online liquid preparation, and UHPLC online detection / automatic fraction collection, the problems of purification, fraction collection, and solvent recovery of large molecular weight polypeptides are solved.

The invention belongs to the field of cosmetics, and particularly relates to a blue-copper peptide related substance detection method which adopts a high performance liquid chromatograph for detection, and the chromatographic conditions are as follows: a chromatographic column is a reversed-phase C18 or C8 reversed-phase chromatographic column; a mobile phase: phosphate; the wavelength of an ultraviolet detector is 220nm; the column temperature is 25-40 DEG C; the flow velocity of the mobile phase is 0.5-1.0 ml / min; the elution procedure is equal-gradient elution. The chromatographic column in the detection method of the blue-copper peptide related substance can realize separation of the ligand compound and the blue-copper peptide, the separation reaches 1.5, and qualitative and quantitative accurate detection of the blue-copper peptide related substance can be realized based on the excellent separation effect of the chromatographic column.

The invention provides a method for determining < 99m > Tc-DOTA-FAPI-46 and metabolites of < 99m > Tc-DOTA-FAPI-46 in a biological sample. The determination method comprises the following steps: after performing intravenous injection on < 99m > Tc-DOTA-FAPI-46, collecting the sample; adding an organic solvent into the collected sample, uniformly mixing, centrifuging, taking supernate, blow-drying the supernate, dissolving the supernate in normal saline, and concentrating by 1-10 times to obtain a sample injection solution, and the volume ratio of the collected sample to the added organic solvent is 1: (1-3); the sample injection solution is taken and put into high performance liquid chromatography for determination, a detector is a radioactive detector, a chromatographic column is a reversed-phase chromatographic column, and the elution mode is gradient elution; and calculating the proportion of the peak areas of < 99m > Tc-DOTA-FAPI-46, radioactive metabolites and radioactive impurities in the sample in the total radioactive components according to the determined peak area containing the radioactive components. By setting proper pretreatment conditions and liquid chromatogram detection conditions, radioactive metabolites can be detected in a biological sample, the detection sensitivity and accuracy are improved, and the in-vivo stability of drugs can be accurately and efficiently evaluated.

The invention discloses a quantitative detection method for tobacco components. The quantitative detection method comprises the following steps: extracting a tobacco sample to obtain extract liquor; performing component analysis on the extracting solution by adopting high-resolution liquid chromatography-mass spectrometry to obtain a spectrogram of the tobacco sample; the high-resolution liquid chromatography mass spectrometry adopts two ion sources of an ESI source and an APCI source for detection, and the two ion sources both adopt reversed-phase chromatographic columns for detection; in detection, under the ESI source condition, positive and negative ion modes are adopted for scanning respectively, and under the APCI source condition, a positive ion mode is adopted for scanning. According to the quantitative detection method, two different ion sources are adopted, and high coverage and detection precision are both considered; corresponding chromatographic columns are adopted for liquid phase separation, separation of tobacco metabolism components with different properties in a complex natural tobacco matrix is facilitated, and the separation efficiency and the coverage degree are improved; by combining the ultrahigh resolution and high precision of the high-resolution liquid chromatography-mass spectrometry, the to-be-detected substance and the interfering substance are effectively distinguished, and the detection accuracy of various samples is improved.

The invention belongs to the field of biological medicines, and discloses an application of a stem cell extract in preparation of a medicine for treating or preventing arthritis by regulating lysosome and / or mitochondrial function, a preparation method of the stem cell extract comprises the following steps: S1) culturing mesenchymal stem cells and producing stress conditions to stimulate the mesenchymal stem cells; s2) separating and purifying the culture supernatant of the mesenchymal stem cells cultured in the step S1) to obtain a stem cell extract; wherein S21) the culture supernatant is filtered to obtain a filtrate; the preparation method comprises the following steps of (S1) extracting a culture supernatant containing stress stem cell secretions through stress culture of stem cells, (S2) carrying out 3KD ultrafiltration concentration on the filtrate to obtain a crude sample, (S23) purifying the crude sample through molecular sieve exclusion chromatography or reversed-phase chromatography to obtain a purified sample, and (S24) taking the purified sample to form the preparation.

The utility model relates to a two-dimensional liquid phase system which comprises a hydrophilic interaction chromatographic column, a reversed-phase chromatographic column, a detector, an automatic sample injector, a first pump assembly, a second pump assembly, a sample temporary storage unit and a switching valve, the first pump assembly is communicated with the hydrophilic interaction chromatographic column and is used for pushing a sample loading solution and carrying out gradient elution on the hydrophilic interaction chromatographic column; the second pump assembly is communicated with the reversed-phase chromatographic column and is used for carrying out gradient elution on the reversed-phase chromatographic column; wherein the switching valve comprises a first double-four-way valve and a second double-four-way valve which are communicated with each other; the switching valve has at least two connection states through position switching: state 1: the switching valve communicates a liquid inlet of the detector with a liquid outlet of the hydrophilic interaction chromatographic column; and state 2: the switching valve communicates the liquid inlet of the detector with the liquid outlet of the reversed-phase chromatographic column, and communicates the first port of the sample temporary storage unit with the liquid inlet of the hydrophilic interaction chromatographic column. The system can realize one-time analysis of a multi-component target object with relatively large polarity difference.

The invention relates to the technical field of biochemical detection, in particular to a method for detecting the purity of defibrase of agkistrodon acutus and application of the method. The method is a reversed-phase HPLC (High Performance Liquid Chromatography) detection method, and elution is performed by adopting a mobile phase A and a mobile phase B; the mobile phase A is a 0.1% trifluoroacetic acid aqueous solution; and the mobile phase B is an acetonitrile solution of 0.1% trifluoroacetic acid. Silica gel bonded with neutral functional groups on the surface is used as a filler in a chromatographic column. According to the detection method provided by the invention, the two active components of the agkistrodon halys defibrase can be accurately separated, a foundation is laid for improving and perfecting the quality standard of the agkistrodon halys defibrase, and data support is provided for improving and optimizing a production process. In addition, the method can also be used for identifying defibrases from different snake venom sources.

The invention discloses a high performance liquid chromatography detection method for the content of cibopadol in cibopadol citrate. Chromatographic conditions are as follows: a reversed-phase chromatographic column is adopted, and a phosphate buffer solution and tetrahydrofuran-acetonitrile are taken as mobile phases. By detecting the content of the cibopadol in the cibopadol citrate, the quality of a cibopadol preparation product is favorably controlled, whether the content of the cibopadol meets the requirement or not is judged, and the stability of the cibopadol product is improved. The detection method disclosed by the invention is high in accuracy, good in separation degree, good in stability, simple and convenient to operate, good in repeatability, strong in pertinence and very good in application value.

The invention discloses a method for simultaneously detecting sodium chloride and 4-hydroxyethylpiperazine ethanesulfonic acid and application thereof.According to the method, reversed-phase chromatography is combined with an electrospray detector, sodium chloride and 4-hydroxyethylpiperazine ethanesulfonic acid in a preparation can be detected under the same chromatographic condition, and the method is easy and rapid to operate, high in sensitivity, high in specificity and good in repeatability; the method is suitable for analyzing other products with similar auxiliary materials.

The invention discloses a separation process of an alpha-glucosidase inhibitor Lycbarbarspermides Q with a new structure in red Chinese wolfberry fruits and application of the alpha-glucosidase inhibitor Lycbarbarspermides Q with the new structure in the red Chinese wolfberry fruits. The specific preparation process comprises the following seven steps: extraction, on-line alpha-glucosidase inhibitor component identification, hydrophilic water pressure preparation column coarse separation, reversed-phase high-pressure preparation column preparation, hydrophilic high-pressure preparation column preparation, gel filtration chromatography and in-vitro alpha-glucosidase inhibition experiment. The method is low in cost, and the product purity is greater than 95%; the technical means adopted by the invention can be used for large-scale production: the raw material requirement is not high, the cost is low, and batch material preparation is easy; in the preparation process, solvents and separation materials used by an extraction solvent, a hydrophilic preparative column, a reversed-phase preparative column, gel chromatography and a reversed-phase chromatographic column can be recycled.

The invention discloses a general secondary amine molecular cage-nanocellulose composite chiral stationary phase for positive and negative phases as well as a preparation method and application of the general secondary amine molecular cage-nanocellulose composite chiral stationary phase. A secondary amine molecular cage (RCC3-R) modified silica gel is used as a substrate, a nano cellulose derivative (NCDMPC) is loaded through a coating method to prepare two chiral stationary phases (CSP-1 and CSP-2), and aminopropyl silica gel is used as a substrate to prepare a control chiral stationary phase (CSP-3). By utilizing the three-dimensional cavity screening effect of RCC3-R and the synergistic effect of an NCDMPC chiral spiral skeleton, the common use of normal phase and reversed phase chromatography modes is realized, and the chiral recognition and separation performance is superior to that of CSP-3. 15 chiral compounds can be split in a normal-phase mode, 12 chiral compounds can be split in a reverse-phase mode, excellent splitting performance on alcohols, amines and chiral drugs is shown, a novel material can be provided for efficient separation of complex systems such as chiral drugs and pesticides, and the application prospect is wide.

The invention discloses a method for improving the detection recovery rate of ascorbyl palmitate in a compound product, which comprises the following steps: taking a sample, adding BHT (butylated hydroxytoluene), then adding an isopropanol-n-hexane mixed solution containing 0.8-1.2% by volume of glacial acetic acid as an extraction solvent, then fully mixing, extracting, freezing, centrifuging, taking supernate, and collecting the supernate to obtain the ascorbyl palmitate. The chromatographic conditions are as follows: a C18 reversed-phase chromatographic column is adopted, a mobile phase A and a mobile phase B are used for gradient elution, the flow velocity of the mobile phase is 0.8-1.2 mL / min, the column temperature is 28-32 DEG C, and the maximum absorption wavelength of ascorbyl palmitate is taken as the detection wavelength. According to the method, the extraction efficiency is improved by optimizing a sample pretreatment process, and the problem that the liquid phase detection error of the substance in the compound product is generally higher than 10% is effectively solved in combination with improved high performance liquid chromatography separation conditions.

The invention relates to the technical field of analysis and detection, in particular to a detection method of L-malic acid. The detection method of L-malic acid provided by the invention comprises the following steps: diluting a sample with a diluent, and then carrying out HPLC (High Performance Liquid Chromatography) detection, the diluent is composed of water; chromatographic conditions of the HPLC detection are as follows: a chromatographic column is a C8 reversed-phase chromatographic column; a mobile phase is composed of phosphoric acid, water and methanol, and isocratic elution is carried out. When the method provided by the invention is used for detection, the dosage of the L-malic acid in the reference preparation can be accurately reversely analyzed. The detection result shows that the method can be used for accurately determining the content, and the detection accuracy, sensitivity, repeatability and precision are good.

The present invention discloses a kit for rapid determination of brucine and strychnine by mass spectrometry, which relates to the technical field of biological detection. The kit for rapid determination of mass spectrometry includes an MCX mixed cationic adsorbent and a pyrrolidone-styrene polymer adsorbent. The kit for rapid determination of mass spectrometry effectively improves the accuracy and sensitivity of detection. Through the method of extraction by multi-well plate - liquid chromatography - tandem mass spectrometry, on a silica-based C18 reversed-phase chromatography column, under specific mobile phase composition and flow rate conditions, the separation of brucine and strychnine from interfering impurities in blood on the silica-based C18 reversed-phase chromatography column and the multi-reaction monitoring (MRM) mass spectrometry detection in the positive ion mode of the electrospray ionization source are realized, and finally the rapid, accurate and highly sensitive detection of brucine and strychnine in blood is achieved.

The invention relates to the technical field of medicines, and discloses an application of a traditional Chinese medicine composition in serum neurotransmitter, which comprises the following steps: selecting 6-8 weeks old mice to establish a normal model, a chronic fatigue syndrome model and a functional dyspepsia model; the method comprises the following steps: sampling blood from mice of a normal model, a chronic fatigue syndrome model and a functional dyspepsia model to respectively obtain a normal blood sample, a CFS blood sample and an FD blood sample, and performing protein precipitation operation to obtain normal deproteinized supernatant, CFS deproteinized supernatant and FD deproteinized supernatant; separating by using a reversed-phase chromatographic column, and then carrying out mass spectrometric detection to respectively obtain a normal serum neurotransmitter mass spectrogram, a CFS serum neurotransmitter mass spectrogram and an FD serum neurotransmitter mass spectrogram; and carrying out concentration value calculation and rhythm fluctuation analysis to respectively obtain a neurotransmitter function index and a rhythm stability quantitative score. Therefore, the action mechanism of the serum neurotransmitter of the traditional Chinese medicine composition can be clearly and quantitatively represented.

The invention provides a method for detecting a lesinurad derivative U01 and / or related substances thereof, and relates to the technical field of pharmaceutical analysis. According to the method, a high performance liquid chromatography is adopted, a C18 reversed-phase chromatographic column is adopted, a formic acid aqueous solution-acetonitrile is used as a mobile phase system, and a specific gradient elution procedure is adopted; high separation and detection of the lesinurad derivative U01 and intermediates (impurity B and impurity C), enantiomers (impurity D) and side reaction products (impurity E and impurity F) generated in a synthesis process route thereof are realized, and the conditions of related substances can be accurately determined and quantified. The detection method provided by the invention has the advantages of high sensitivity, good specificity, high accuracy, high precision and capability of simply, conveniently, quickly and accurately determining related substances and intermediates, provides a more reliable basis for synthesis process route research and quality control of the Lesinurad derivative U01, and ensures the quality of the Lesinurad derivative U01 product.

The application discloses a lipoic acid high-performance liquid chromatography detection method, which comprises the following steps: S1, sample pretreatment: ultrasonic extraction is carried out on the sample by using a composite extraction liquid, then solid-liquid separation is carried out, and a test sample solution is obtained; the composite extraction liquid is an acetonitrile water mixed solution containing cysteine and EDTA salt; S2, HPLC detection: the chromatographic conditions are as follows: a C18 reversed-phase chromatographic column is used, a buffer solution-alcohol mixed system is used as a mobile phase, the pH of the buffer solution is 2.5-3.5, the detection wavelength is 210-220 nm in the first stage and is 275-285 nm in the second stage, the first stage is 0-7-9 min, and the second stage is 7-9 min-14-16 min. By optimizing the pretreatment method, optimizing the chromatographic conditions and adopting a dynamic detection wavelength, the lipoic acid content detection method with high sensitivity and strong anti-interference ability is obtained.

The invention discloses a quantitative method for detecting trace free chelate deferoxamine in ACCs medicine based on reversed phase chromatography. The quantitative method comprises the following steps: preparing a deferoxamine standard substance solution; the method comprises the following steps: respectively detecting a sample to be detected and a deferoxamine standard substance solution by adopting a liquid chromatograph under the detection conditions that a chromatographic column is PLRP-S (2.1 * 100 mm, 5 [mu] m), the column temperature is 25-80 DEG C, and a filler is PS / DVB porous particles; mobile phases: a phase A is an aqueous solution containing organic acid, and a phase B is an organic solvent containing organic acid; establishing a calibration curve according to the concentration of the standard deferoxamine solution and the peak area of the corresponding elution peak, and then substituting the peak area of the elution peak of the sample to be detected into the calibration curve to obtain the concentration of the deferoxamine in the sample to be detected. According to the method, the tedious sample pretreatment step is omitted, the direct sample injection analysis of the sample is realized, the experimental period is greatly shortened, and the detection efficiency is improved.

This invention discloses a purification method for Tirzepatide. The method includes: dissolving crude Tirzepatide peptide in ammonia or sodium bicarbonate solution, filtering, and purifying by reversed-phase chromatography to obtain a purified sample; eluting the purified sample using reversed-phase high-performance liquid chromatography (RP-HPLC) with a sodium or potassium buffer solution as mobile phase A3 and one or a mixture of acetonitrile, methanol, and isopropanol in any proportion as mobile phase B, preparing a sodium or potassium salt fraction; cooling the sodium or potassium salt fraction to -20 to 10°C and maintaining the temperature; then adding an organic solvent to the fraction, controlling the temperature at -20 to 10°C to precipitate the sample; after complete precipitation, solid-liquid separation is performed, the solid is collected, dissolved in water, filtered, and freeze-dried. This invention improves the concentration speed, ensures product purity, and strictly controls impurities.

The invention discloses a method for extracting and purifying Calceolariside E and Paucifloside, and belongs to the technical field of separation and purification of plant extracts. The invention relates to a method for extracting and purifying Calceolarioside E and Paucifloside, which comprises the following steps of: mixing Fujian Jiangxi boea cavaleriei and a solvent, and performing ultrasonic extraction to obtain an extracting solution; separating the extracting solution by adopting a gel chromatographic column, and then separating the extracting solution by adopting a reversed-phase chromatographic column, so as to obtain an enriched solution of Calceolariside E and Paucifloside; the enrichment liquid is dried, then redissolved and dried again, and the Calceolariside E and the Paucifloside are obtained. According to the method disclosed by the invention, Calceolariside E and Paucifloside are separated from Jiangxi boea longissima for the first time, the speed of separating the compound is relatively high, and the purity of the obtained compound is relatively high.

The invention relates to the technical field of polypeptide medicine purification, in particular to a purification method of retaglutide. The method comprises the following steps: mixing a retaglutide crude product aqueous solution with salt to enable the final concentration of the salt to be 0.5-2.0 mol / L, and loading a sample to a chromatographic column filled with a hydrophobic interaction chromatographic filler; eluting by adopting a salt concentration decreasing gradient, and collecting to obtain a first purified solution; adjusting the pH and conductivity of the first purified liquid, and loading the first purified liquid to a chromatographic column filled with an ion exchange chromatographic filler; eluting by adopting a gradient of increasing salt concentration, and collecting to obtain a second purified solution; and loading the second purified solution to a chromatographic column filled with a reversed-phase chromatographic filler, taking an acidic modifier aqueous solution as a mobile phase A and an organic solvent as a mobile phase B, eluting by adopting a gradient of increasing concentration of the organic solvent, and collecting to obtain a final product. Through innovative process combination, the problems that in the prior art, impurities are difficult to deeply remove, and the consumption of an organic solvent is large are effectively solved.

The invention belongs to the technical field of drug detection and analysis, and particularly provides a method for determining the content of impurity 3-DG in icodextrin peritoneal dialysis fluid, which comprises the following steps: selecting a reversed-phase chromatographic column AgilentZORBAX SB-C18 (250mm * 4.60 mm, 5 [mu] m), taking methanol and an acetic acid aqueous solution (50-55: 50-45, v / v) with the pH value of 3 as mobile phases, realizing that the separation degree of a 3, 4-DGE peak and a 3-DG peak is greater than 4.5, the separation degree of a sodium lactate peak and the 3, 4-DGE peak is greater than 3.0, and the separation degree of a sodium lactate peak and the 3, 4-DGE peak is greater than 3.0. The 3-DG can be rapidly, effectively and accurately determined, the quality of the icodextrin peritoneal dialysis solution can be accurately controlled, and the clinical medication safety is guaranteed.

The application provides a method for determining the content of biotin in a complex vitamin preparation. The method comprises detecting the content of biotin by high performance liquid chromatography, wherein a surface porous reversed-phase chromatographic column with modified amide groups is used for gradient elution, and a mobile phase A and a mobile phase B are used, the mobile phase A comprises potassium dihydrogen phosphate buffer and acetonitrile, and the mobile phase B comprises acetonitrile. The method can realize the non-interference separation and detection of the content of biotin in the complex vitamin preparation with a complex matrix, and has the advantages of simplicity, good specificity, rapid analysis, accurate result and sensitive response.

This invention provides a method for purifying high-purity recombinant follicle-stimulating hormone (FSH). Specifically, it includes the following steps: (a) providing a raw material solution containing recombinant FSH; (b) sequentially subjecting the raw material solution to: (b1) ammonium sulfate precipitation; (b2) hydrophobic interaction chromatography (HIC); (b3) low pH incubation to inactivate the virus; and (b4) reversed-phase chromatography (RPC); wherein steps (b1), (b2), (b3), and (b4) cannot be performed in any arbitrary order. Compared with existing preparation methods, the recombinant FSH obtained by the method of this invention is simpler and easier to operate, and the purity of the recombinant FSH obtained by the method of this invention can reach up to 99.5% w / w, with a specific activity as high as 16000 IU / mg.