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594 results about "Drug analysis" patented technology

Drug analysis is the testing of a suspected controlled substance to determine its composition. For information about forensic toxicology, or the testing of bodily fluids for controlled substances, click here.

Traditional Chinese medicine raw material quality monitoring and analyzing method

The invention relates to the technical field of medicine analysis, in particular to a traditional Chinese medicine raw material quality monitoring and analyzing method which comprises the following steps: merging a fluctuation direction consistent interval based on storage environment data, extracting a component extraction rate identification trend value, screening a concentration and impurity change overlapping section to generate an abnormal batch index; tracking a humidity and drug effect deviation section clustering early warning interval, and analyzing grade label fluctuation to judge a quality stability list. According to the method, temperature and humidity light data sampled at equal intervals are merged into a direction consistent interval, the environmental influence stability is dynamically defined, the accuracy of a quality analysis starting point is enhanced, the concentration difference and duration are quantified in combination with the extraction rate fluctuation trend, the component change recognizability is improved, the concentration and impurity fluctuation are overlapped, a pointer list is constructed, and sampling distribution is fused; and batch abnormity positioning is enhanced, a quality label change path and a mutation point are analyzed, a multi-source data stability logic chain is reconstructed, and the efficiency and accuracy of traditional Chinese medicine raw material quality screening are remarkably improved.
Owner:ZHONGKE STEM CELL REGENERATIVE MEDICINE (LIAONING) CO LTD

Intelligent drug stability analysis and monitoring system

The invention relates to the technical field of drug analysis, and discloses an intelligent drug stability analysis and monitoring system, which comprises a drug information acquisition module, a drug stability analysis module, a drug prediction module, a dynamic regulation and control module and an early warning display module, through the arrangement of the drug stability analysis module and the drug prediction module, the drug storage environment is analyzed to obtain the stability condition of the drug, then the remaining validity period of the drug is obtained, and the stability change of the drug is monitored in real time to prolong the remaining validity period of the drug; meanwhile, liquid medicine and solid medicine are subjected to special analysis, the degradation rate constant of the medicine is obtained on the basis of a second improved Arrhenius formula for the solid medicine, and a physical property cross-border line is set, so that the stability of the medicine is improved by analyzing the stability of the medicine and regulating and controlling environmental parameters, and the stability of the medicine is improved. The medicine validity period and storage time are prolonged, and the storage strategy is dynamically adjusted in combination with medicine chemical characteristics.
Owner:BORUIWEI (SHENZHEN) BIOINNOVATIVE DRUG TECHNOLOGY SERVICE CO LTD

Method for simultaneously determining contents of tolperidone hydrochloride, methyl hesperidin and vitamin B6 in Naoluotong capsule

PendingCN120121747AComponent separationVitamin b6Tolperisone Hydrochloride
The invention belongs to the field of pharmaceutical analysis, and discloses a method for simultaneously determining the contents of tolperidone hydrochloride, methyl hesperidin and vitamin B6 in Naoluotong capsules, the method comprises three steps of preparation of a mixed reference solution, preparation of a test solution and content determination, and the chromatographic conditions of the content determination are as follows: a C18 chromatographic column, a C18 chromatographic column, a C18 chromatographic column, a C18 chromatographic column, a C18 chromatographic column, a C18 chromatographic column, a C18 chromatographic column, a C18 chromatographic column and a C18 chromatographic column; a mobile phase is methanol (A)-0.1% glacial acetic acid solution (B), gradient elution is carried out for 0-5 min, and 96% of B is obtained; 5-6 min, 96%-60% of B is selected; 6-20 min, the content of B is 60%-50%; the volume flow rate is 1.0 ml / min; the column temperature is 30 DEG C; the detection wavelength is 291 nm; the sample size is 1 microliter. According to the method, synchronous detection of three components (tolperidone hydrochloride, methyl hesperidin and vitamin B6) with remarkable physicochemical property difference can be realized, the chromatographic condition is simple, and the detection speed is high.
Owner:ZHEJIANG INST FOR FOOD & DRUG CONTROL

Method for detecting content of povidone K30

The invention belongs to the technical field of pharmaceutical analysis, and relates to a method for detecting the content of povidone K30. According to the method, the content of povidone K30 in the medicinal preparation is detected by adopting a high performance liquid chromatography; detection conditions of the high performance liquid chromatography are as follows: a chromatographic column is a C18-AQ column; a mobile phase is a phosphate solution. The method has the characteristics of high accuracy, strong specificity and the like for detecting the content of povidone K30 in the pharmaceutical preparation, can overcome the interference of other auxiliary materials in the pharmaceutical preparation, and has important application value in development and consistency evaluation of the pharmaceutical preparation.
Owner:GUANGZHOU BAIMEI MEDICAL TECH CO LTD

Determination method of tandospirone and salt intermediate thereof

The invention relates to the field of pharmaceutical analytical chemistry, in particular to a method for determining tandospirone and salt intermediates thereof, high performance liquid chromatography is adopted, and chromatographic conditions include that a chromatographic column with octadecylsilane chemically bonded silica as a filler is adopted, and gradient elution is performed by a mobile phase A and a mobile phase B; wherein the mobile phase A consists of a first water phase and acetonitrile; the mobile phase B is composed of a second water phase and acetonitrile; the first water phase is a water solution containing monopotassium phosphate and sodium hexanesulfonate, and the pH value of the first water phase is 3.0-3.8; the second water phase is an aqueous solution containing monopotassium phosphate and sodium hexanesulfonate, and the pH value of the second water phase is 1.8-2.6. The testing method disclosed by the invention has good specificity, accuracy and repeatability, and can be used for monitoring the quality of the tandospirone raw material medicine.
Owner:SHENYANG HUATAI MEDICATION RES CO LTD

Construction method, detection method and application of specific chromatogram of szechuan lovage rhizome perfume extract

The invention relates to the technical field of medicine analysis and traditional Chinese medicine detection, in particular to a construction method, a detection method and application of a specific chromatogram of a szechuan lovage rhizome perfume extract. Wherein the conditions of the liquid chromatographic analysis are as follows: gradient elution is carried out by adopting an aqueous solution of a mobile phase A acetonitrile and a mobile phase B phosphoric acid for 0-5 minutes, the volume percent of the mobile phase A is maintained to be 4% and 5-12 minutes, the volume percent of the mobile phase A is increased to 16% from 4% and 12-19 minutes, the volume percent of the mobile phase A is maintained to be 16% and 19-29 minutes, the volume percent of the mobile phase A is increased to 40% from 16% and 29-31 minutes, and the volume percent of the mobile phase A is maintained to be 4% and 12-19 minutes. The volume percentage of the mobile phase A is increased to 55% from 40%, 31-37 min, and the volume percentage of the mobile phase A is maintained to be 55%. The method can be used for quantitatively determining the water-soluble components of the szechuan lovage rhizome perfume extract, and can also be used for identifying the true and false.
Owner:GUANGDONG YIFANG PHARMA

Method for determining residual solvent in LXH-2103 by headspace gas chromatography

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for determining a residual solvent in LXH-2103 by headspace gas chromatography. The determination method comprises the following steps: preparing a blank solution, a reference substance solution and a sample solution, respectively injecting the blank solution, the reference substance solution and the sample solution into a headspace for balancing, injecting the solutions into a gas chromatograph in a headspace sample injection manner, recording a chromatogram, and calculating the content according to a peak area by an external standard method; the residual solvent is absolute methanol, absolute ethyl alcohol, isopropanol, dichloromethane and methylbenzene. The method for determining the residual solvents in the LXH-2103 by using the headspace gas chromatography, provided by the invention, is high in sensitivity, good in repeatability and high in accuracy, and can be used for simultaneously detecting various residual solvents in the LXH-2103, so that the quality of the LXH-2103 is ensured, and the safety of clinical medication is improved.
Owner:SHANDONG XINHUA PHARMA CO LTD

Analysis method of mutagenic impurities in small molecule fungal inositol acyltransferase 1 inhibitor bulk drug

The invention relates to the technical field of medicine analysis, in particular to a method for analyzing mutagenic impurities in a small molecule fungal inositol acyltransferase 1 inhibitor raw material medicine, the analysis method can be used for trace detection of potential mutagenic impurities I and II in the raw material medicine, the limit of quantitation concentration of the impurity I is not higher than 0.53 ng / ml, and the limit of quantitation concentration of the impurity II is not higher than 0.53 ng / ml. The detection limit concentration of the impurity I is not higher than 0.27 ng / ml; the quantitation limit concentration of the impurity II is not higher than 0.52 ng / ml, and the detection limit concentration of the impurity II is not higher than 0.26 ng / ml. The analysis method suitable for the mutagenic impurities in the small-molecule fungal inositol acyltransferase 1 inhibitor bulk drug is high in sensitivity and high in specificity, and the blank solvent does not interfere with detection of the impurities.
Owner:TIANJIN CHENXIN PHARM RES CO LTD +1

Method for qualitatively analyzing small molecule compounds in Xinnaoning capsules by using UPLC-MS (Ultra Performance Liquid Chromatography-Mass Spectrometry) technology

The invention relates to the technical field of medicine analysis and detection, in particular to a method for qualitatively analyzing small molecule compounds in Xinnaoning capsules by using a UPLC-MS (Ultra Performance Liquid Chromatography-Mass Spectrometry) technology. The small molecule compounds comprise polar small molecule compounds and weak polar small molecule compounds. The method comprises the following steps: preparing a test solution; carrying out UPLC / Q-TOF MS detection; and performing qualitative analysis. Through qualitative analysis of polar and weak polar small molecule compounds in the Xinnaoning capsule, a material basic component library is established, and a theoretical basis and technical support are provided for more comprehensive and effective control of product quality.
Owner:GUIZHOU JINGCHENG PHARMA

Method for detecting related substances of 4-chlorobenzoyl chloride

The invention relates to the technical field of pharmaceutical analysis, and particularly discloses a method for detecting related substances of 4-chlorobenzoyl chloride. According to the method, a chromatographic column with 50% of phenyl and 50% of methylpolysiloxane as a stationary liquid is adopted to perform gas chromatographic analysis on a 4-chlorobenzoyl chloride sample, and accurate detection of four related substances, namely methyl parachlorobenzoate, ethyl parachlorobenzoate, o-chlorobenzoyl chloride and m-chlorobenzoyl chloride, in the 4-chlorobenzoyl chloride and the content of the four related substances is realized at the same time. The detection method is high in specificity, low in detection limit and quantitation limit, good in linear relation, high in recovery rate, good in repeatability, good in stability, good in durability, easy and rapid to operate, low in detection cost and accurate and reliable in detection result, and guarantees are provided for monitoring the quality stability and clinical medication safety of rebamipide.
Owner:河北广祥制药有限公司

Method for detecting content of carbomer in eye drops

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for detecting the content of carbomer in eye drops. The method comprises the following steps: by adopting a two-time washing and centrifugal separation mode, controlling the washing and centrifugal times, centrifugal conditions and washing volume, separating carbomer and brinzolamide from other auxiliary materials in the brinzolamide eye drops, obtaining the weights of carbomer and brinzolamide by adopting a drying and weighing mode, subtracting the weight of brinzolamide, and calculating the content of the auxiliary materials in the brinzolamide eye drops. And calculating to obtain the carbomer content in the sample. The method is suitable for detecting the carbomer content in the carbomer-containing brinzolamide eye drops, and is simple and convenient to operate, efficient, accurate and low in cost.
Owner:HUNAN PEGLAN PHARMACEUTICAL CO LTD

Multi-technology combined medication analysis platform for oligonucleotide drugs

The invention discloses a multi-technology combined medication analysis platform of an oligonucleotide drug, which relates to the technical field of drug analysis and is technically characterized by comprising an oligonucleotide drug delivery technology module, a liposome, a polymer nanoparticle or an exosome is selected as a delivery carrier, the surface of the delivery carrier is modified with hydrophilic polyethylene glycol or a targeting ligand, and the oligonucleotide drug delivery technology module is connected with the oligonucleotide drug delivery module. The performance of the material is represented by dynamic light scattering and a transmission electron microscope; the multi-technology platform analysis module integrates RT-qPCR, LC-FL, LC-MS / MS and LC-HRMS technologies, is respectively used for target gene expression quantification, drug distribution tracking, drug principal component quantification and metabolite structure analysis, establishes a cross validation rule, and requires a correlation coefficient R2gt of an LC-MS / MS quantitative result and RT-qPCR expression data; 0.95%, 0.95%; the pharmacokinetic evaluation module constructs a PBPK model to predict human pharmacokinetic parameters, and draws a drug metabolism network diagram in combination with an LC-HRMS metabolite identification result; by integrating various advanced analysis technologies, the problems of low sensitivity, poor specificity and difficult metabolite analysis in the prior art are solved.
Owner:SUZHOU FANGDA NEW DRUG DEV CO LTD

Method for detecting dichromate based on surface enhanced Raman spectroscopy

The invention provides a method for detecting dichromate radicals based on surface enhanced Raman spectroscopy, and belongs to the technical field of analytical chemistry. Comprising the following steps: mixing a to-be-detected sample with a sulfydryl-containing compound solution, and adjusting to an acidic condition, so that dichromate Cr (VI) and the sulfydryl-containing compound are subjected to an oxidation-reduction reaction; constructing an SERS substrate, namely preparing a ZnO / Ag heterostructure substrate; mixing the suspension of the ZnO / Ag heterostructure substrate with a reaction system to obtain a mixed solution, so that the ZnO / Ag heterostructure substrate adsorbs a sulfydryl-containing compound and enhances a Raman signal; dropwise adding the mixed solution to the surface of a solid carrier, acquiring a Raman spectrum signal by using a Raman spectrometer, and quantifying the Cr (VI) concentration through the change of signal intensity. The method realizes rapid and high-sensitivity detection of Cr (VI), has strong selectivity and anti-interference capability, and is suitable for detection in the fields of environmental monitoring, food safety, pharmaceutical analysis and the like.
Owner:GANNAN MEDICAL UNIV

Cerebral disease drug curative effect analysis and prediction system and method

The invention provides a brain disease drug curative effect analysis and prediction system and method, and relates to the technical field of drug analysis. Multi-source heterogeneous data such as genetic variation spectrum, neural image topological characteristics, metabolic trajectory vectors and microbiome dynamic distribution matrix are integrated, and cross-modal dynamic fusion is realized through decomposition. The system constructs a drug prediction coupling network based on dynamic causal inference, analyzes overlapped potential intervention nodes of multiple disease mechanisms, and generates a disease-drug-phenotype multi-dimensional mapping library. A short-term drug response toxicity threshold is predicted through a metabolic entropy change model, a long-term neurological function degeneration trajectory is evaluated in combination with epigenetic drift, and an anti-fact strategy gradient is utilized to dynamically optimize a drug administration scheme. According to the invention, accurate fusion and dynamic analysis of multi-modal data are realized, a balance mechanism of curative effect and risk is established, and accurate drug combination sequence and administration strategy support can be provided for individualized treatment of complex brain diseases.
Owner:SHENZHEN RUIYU BIOTECHNOLOGY CO LTD

Method for determining extinction coefficient of toxin connexon in antibody-coupled drug and method for detecting drug-antibody coupling ratio in antibody-coupled drug

The invention provides a method for determining an extinction coefficient of a toxin connexon in an antibody-coupled drug and a method for detecting a drug-antibody coupling ratio in the antibody-coupled drug. The method for measuring the extinction coefficient comprises the following steps: a) dissolving a toxin connexon in a solvent to obtain a toxin connexon solution; b) respectively mixing the concentration toxin connexon solution and the solvent with the excessive antibody solution to obtain a toxin connexon reaction solution and an antibody negative control solution; c) completely reacting the toxin connexon with the antibody; d) carrying out baseline calibration by using the antibody negative control solution as a reference solution and scanning a toxin linker reaction solution absorption spectrum; and e) drawing a linear curve of the absorbance of the toxin connexon and the concentration of the toxin connexon, fitting to obtain a linear equation, and the slope of the linear equation being the extinction coefficient of the coupled toxin connexon. The method can solve the problem that the extinction coefficient of the toxin connexon in the antibody-coupled drug is difficult to accurately determine in the prior art, and is suitable for the field of antibody-coupled drug analysis.
Owner:ASYMCHEM LIFE SCI TIANJIN +2

Thin-layer chromatography identification method for vigor-preserving decoction and preparation of vigor-preserving decoction

The invention relates to the technical field of pharmaceutical analysis, in particular to a thin-layer chromatography identification method of vitality-preserving decoction and a preparation thereof. Comprising the following steps: S1, extracting a sample to be detected by using diethyl ether, and preparing a test solution; s2, preparing a cinnamaldehyde reference substance solution and a 6-gingerol reference substance solution; the method further comprises at least one of the steps S3 and S4; s3, dripping the test solution and the cinnamaldehyde reference solution on the same thin-layer plate, developing with a first developing solvent, and identifying the cinnamon; the first developing solvent comprises petroleum ether and ethyl acetate in a volume ratio of (15-20): 3; s4, dripping the test solution and the 6-gingerol reference substance solution on the same thin-layer plate, developing with a second developing solvent, and identifying the ginger; the second developing solvent is prepared from petroleum ether, trichloromethane and ethyl acetate according to the volume ratio of (2-4): (1-2): (1-3). The method is good in overall separation effect, clear in spots, good in specificity and durability, and capable of identifying the medicine flavors of cinnamon and ginger in the vitality-preserving decoction and the preparation thereof.
Owner:SHENZHEN TRADITIONAL CHINESE MEDICINE MFG INNOVATION CENT CO LTD +1

Method for analyzing propylene glycol content by diazepam solution chromatograph and verification method thereof

The invention discloses a method for analyzing propylene glycol content by a diazepam solution chromatograph and a verification method thereof, and relates to the field of medicine analysis, the key points of the technical scheme are as follows: a diazepam oral solution is analyzed by the chromatograph, and the conditions of the gas chromatograph are as follows: an SH-WAX polar capillary chromatographic column is used, the temperature of a sample inlet is 230 DEG C, and the temperature of a detector is 250 DEG C; the carrier gas is nitrogen, the flow velocity is 1.0 ml / min, and the split ratio is 10: 1; temperature programming is carried out, the initial temperature is kept at 130 DEG C for 1 minute, and the temperature is raised to 240 DEG C at the speed of 10 DEG C / min and kept for 3 minutes; determining the content of propylene glycol by using an internal standard method; the purposes of low analysis cost and high sensitivity are achieved.
Owner:MIANYANG YIKANG PHARMACY CO LTD

Thin-layer chromatography identification method for cinnamon and ginger in vitality-preserving granules

The invention discloses a thin-layer chromatography identification method for cinnamon and ginger in vitality-preserving granules, and belongs to the technical field of pharmaceutical analysis. Aiming at the problems of step-by-step detection, serious cinnamic acid tailing and dependence on toxic solvents in the existing method, the method comprises the following steps: dissolving vitality-preserving particles in water, carrying out ultrasonic treatment, extracting filtrate by using absolute ether, merging extract liquor, evaporating to dryness, and dissolving by adding ethyl acetate to obtain a test solution; preparing a cinnamon reference medicinal material solution and a cinnamic acid and 6-gingerol reference substance solution; a silica gel GF254 thin-layer plate is adopted, petroleum ether-normal hexane-ethyl formate-formic acid is used as a developing solvent for developing, and inspection is conducted under the ultraviolet light of 254 nm and the ultraviolet light of 365 nm respectively. Cinnamon and ginger can be synchronously identified, spots are clear and free of trailing, no toxic solvent exists, durability is high, cost is low, and an accurate and reliable basis can be provided for quality control of the vitality-preserving granules.
Owner:JING BRAND

HPLC (High Performance Liquid Chromatography)-based heart-protecting granule fingerprint spectrum construction and component quantitative detection method

The invention discloses a heart-protecting granule fingerprint spectrum construction and component quantitative detection method based on HPLC (High Performance Liquid Chromatography), and belongs to the technical field of pharmaceutical analysis. The method comprises the following steps: preparing heart-protecting granules into a test solution by adopting a high performance liquid chromatography (HPLC) technology, affiliating and identifying chromatographic peaks in the test solution by taking chromatograms of a single medicinal material decoction piece solution and a standard solution as a contrast, and constructing an HPLC fingerprint spectrum containing 12 common characteristic peaks. And a foundation is laid for the establishment of a comprehensive quality control and quality evaluation method of the heart-protecting granules. The method disclosed by the invention can also be used for quantitatively detecting important components, namely naringin and salvianolic acid B, in the heart-protecting granules, has the advantages of high precision, good reproducibility, good stability, high recovery rate, good durability and accurate determination result, and provides technical support for high-precision quality monitoring and evaluation of the heart-protecting granules.
Owner:ZHUHAI TIANDA RES & DEV CO LTD

Method for monitoring baicalein-betaine eutectic process based on terahertz spectrum

The invention relates to the technical field of pharmaceutical analysis, and discloses a method for monitoring a baicalein-betaine eutectic process based on terahertz spectroscopy, and the method comprises the following steps: mixing and ball-milling baicalein and betaine to obtain powder samples, collecting the powder samples with different ball-milling times, drying, mixing with a dispersing agent, tabletting, and drying to obtain the baicalein-betaine eutectic crystal. The method comprises the following steps: measuring spectral data by using terahertz time-domain spectroscopy equipment, selecting a characteristic peak and tracking intensity change to obtain a curve, carrying out nonlinear fitting on the curve, obtaining a molecular vibration mode through a density functional theory, and analyzing the eutectic process by combining the two modes. The terahertz spectrum technology is combined with theoretical calculation, complete analysis of the baicalein-betaine eutectic process from macrodynamics monitoring to microcosmic molecular action mechanism analysis is achieved, and an effective means is provided for eutectic formation research and process optimization.
Owner:ZHENGZHOU UNIV

Detection method of Evocamide enantiomer

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a detection method of an evocamide enantiomer, which comprises the following steps: S1, preparing a test solution; s2, preparing a contrast solution; s3, preparing a system applicable solution; s4, carrying out a system applicability test; s5, testing a test sample and a contrast solution; a chromatographic column is a chiral chromatographic column taking a polysaccharide derivative or a cellulose derivative as a filler, and a mixed solution of n-hexane, isopropanol, trifluoroacetic acid and diethylamine is taken as a mobile phase to detect the Evocadum enantiomer. The method has the characteristics of simplicity in operation, high sensitivity and high accuracy, the chromatographic peaks are high in separation degree, do not interfere with one another, the peak shape is good, the result accuracy is guaranteed, the method can be used for detecting enantiomers in the Evocamide and the Evocamide preparation, the level of the enantiomers of the Evocamide is effectively controlled, and the medication safety is guaranteed.
Owner:HEBEI CHUANGJIAN PHARMA +2

Method for detecting two potential genotoxic impurities in carbon [13C]-urea based on gas chromatography

PendingCN121762706AComponent separationMethyl carbamateVapor phase chromatography
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.
Owner:VERIZON BIOTECHNOLOGY (KUNSHAN) CO LTD

Method for separating and determining nafamostat mesylate SM2 and related impurities thereof

PendingCN121703284AComponent separationPotassium hexafluorophosphateSilanes
The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for separating and determining nafamostat mesylate SM2 and related impurities thereof. The method is a high performance liquid chromatography, and comprises the following steps: by taking octadecylsilane chemically bonded silica as a chromatographic column filler, a potassium hexafluorophosphate solution as a mobile phase A and acetonitrile as a mobile phase B, separating nafamostat mesylate SM2 and related impurities thereof through linear gradient elution; and detecting by using detection wavelengths of 200 nm to 240 nm and 250 nm to 280 nm to obtain a chromatogram, so that effective determination of the nafamostat mesylate SM2 and the related impurities thereof is realized. The method provided by the invention adopts common buffer salt as a mobile phase, and has the characteristics of short analysis time, strong specificity, high sensitivity and good reproducibility.
Owner:CHONGQING HUAPONT PHARMA

Method for detecting related substances of moxifloxacin hydrochloride bulk drug

The invention relates to the technical field of drug analysis and detection, in particular to a method for detecting related substances in moxifloxacin hydrochloride bulk drugs. According to the detection method provided by the invention, the separation efficiency of the known impurity (impurity F) can be improved, and the separation degree between the main component and the adjacent impurity can reach 1.5 or above; in addition, a solvent formula is optimized, so that a test sample is more stable, and the detection method is more accurate; the detection accuracy is improved, and the recovery rate is controlled within the range of 93-102%.
Owner:TIANJIN CHASE SUN PHARM CO LTD

Detection method of L-alanine isopropyl ester in emtricitabine, propiophenol and tenofovir tablet

PendingCN121453970AComponent separationEmtricitabineGradient elution
The invention relates to the technical field of pharmaceutical analysis, and particularly discloses a high performance liquid chromatography-mass spectrometry tandem method (HPLC-MS / MS) for detecting a genotoxic impurity L-alanine isopropyl ester in an emtricitabine-propofol tenofovir tablet. By optimizing chromatographic column selection, a mobile phase gradient elution procedure and mass spectrometric detection parameters, the method realizes exclusive, sensitive and accurate detection of the L-isopropyl alanine. The methodological verification result shows that the detection limit is 1.00 ng / mL, the quantification limit is 2.00 ng / mL, the linear range is 2.00-100.00 ng / mL (the correlation coefficient r is equal to 0.9994), the recovery rate is stabilized between 92% and 98%, and the precision and repeatability are good. The detection method has the advantages of high sensitivity and strong selectivity, is suitable for quality control of emtricitabine propofol tenofovir tablets, meets the control requirements of ICH M7 guide on genotoxic impurities, and has good practicability and popularization value.
Owner:SHANDONG BOJI MEDICAL TECH CO LTD

Method for detecting content of guanidine nitrate by precolumn derivatization-high performance liquid chromatography

The invention relates to the technical field of pharmaceutical analysis, in particular to a method for detecting the content of guanidine nitrate by precolumn derivatization-high performance liquid chromatography, which comprises the following steps: oscillating and uniformly mixing a guanidine nitrate reference substance or sample and pure water at room temperature, adding sulfuric acid concentrated liquor in cold water bath to perform derivatization reaction, after the reaction is finished, placing at room temperature, and performing column chromatography to obtain the guanidine nitrate content. Adding liquid caustic soda for neutralization, carrying out gradient constant volume by using a mobile phase, and filtering by using a microporous filter membrane to respectively obtain a derivatization reference solution and a derivatization sample solution; and respectively injecting the derivatization reference substance solution and the derivatization sample solution into HPLC, recording peak areas, and calculating the content of guanidine nitrate in the sample by adopting an external standard method. The guanidine nitrate sample is pretreated through the precolumn derivatization reaction, the guanidine nitrate derivative generated through the reaction has the advantages of being high in stability and easy to separate, ammonium nitrate and nitric acid impurities can be effectively prevented from interfering the detection result, the explosive picric acid is not adopted in the detection method, and the detection method is simple, safe and easy to implement.
Owner:NANTONG TENDENCI CHEM

Method for separating active components in tobacco based on liquid-phase subsection separation, SPR (Surface Plasmon Resonance) and affinity chromatography enrichment, product and application

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for separating active components in tobacco based on liquid-phase segmented separation, SPR, affinity chromatography enrichment and mass spectrometry detection, a product and application. According to the method, liquid chromatography separation, SPR detection screening, affinity chromatography enrichment and mass spectrum identification technologies are fused, and active small molecules are screened and enriched from a complex system by virtue of high sensitivity of SPR and accuracy of mass spectrum. The method comprises the following steps: firstly, carrying out liquid chromatography segmented separation on extract components to improve SPR detection precision and affinity enrichment efficiency; by means of specific binding of Ni Sepharose FF (NTA) resin and a His tag, more target proteins are fixed, and the micromolecule enrichment effect is further enhanced; and finally, identifying the molecular structure by using mass spectrum, and locking the bioactive small molecule combined with the target protein. According to the strategy, efficient enrichment of small molecule ligands is achieved, and a new way is provided for early-stage development of small molecules in drug discovery. 6.
Owner:BEIJING LIFE SCIENCE ACADEMY CO LTD

Method for detecting dissolution rate of drug nanocrystal based on aggregation-induced fluorescence probe

The invention provides a method for detecting the dissolution rate of drug nanocrystals based on an aggregation-induced fluorescence probe, and belongs to the field of drug analysis. Comprising the steps of construction of an AIE probe-nanocrystal hybrid system, establishment of a fluorescence intensity-drug solid content standard curve, determination of the dissolution rate of the nanosuspension and the like. The amount of undissolved medicine is directly reflected through a solid-state fluorescence signal, and the adsorption error of a filter membrane is thoroughly eliminated; the microplate reader can online monitor the change of the fluorescence intensity of a plurality of samples along with time at one time; meanwhile, the detection method can be compatible with standard dissolution devices such as a paddle method; complex test conditions such as pH gradient dissolution are supported; compared with the prior art, the detection efficiency of the final implementation effect is improved by 5-30 times, the manual intervention of operation is reduced by 80%, the equipment and solvent cost is reduced by 80%, and the HPLC is only used for the establishment process of the fluorescence intensity-drug solid content standard curve; and the problem of too long time consumption of HPLC detection is substantially solved.
Owner:LIAOCHENG UNIV