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818 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.

Real-time monitoring method and system for drug raw material generation process

The invention relates to the technical field of drug analysis, and particularly discloses a real-time monitoring method and system for a drug raw material generation process, and the method comprises the steps: collecting reactant use data, equipment state data and production process data; processing the reactant use data to obtain a reaction process evaluation index, and matching according to the reaction process evaluation index to obtain a current reaction stage; processing the equipment state data to obtain an equipment state abnormity evaluation value, processing to obtain a production process stability evaluation value, and comprehensively analyzing to obtain a drug raw material generation quality evaluation value; and evaluating the drug raw material generation process according to the drug raw material generation quality evaluation value. According to the real-time monitoring method and system for the drug raw material generation process, the quality consistency of the drug raw materials can be ensured, potential quality problems in the raw materials can be found in time, corresponding measures are taken for correction, the quality risk of drug production is reduced, and the curative effect of drugs is improved.
Owner:HUNAN FURUI BIOPHARMA TECH CO LTD

Method for detecting impurities in moxifloxacin hydrochloride bulk drug

The invention relates to the technical field of drug analysis and detection, and provides a detection method of moxifloxacin hydrochloride related substances. The related substances of moxifloxacin hydrochloride are detected by adopting a high performance liquid chromatography method, and the detection conditions are as follows: octadecylsilane chemically bonded silica is taken as a filling agent of a chromatographic column; the wavelength of a UV detector is 296 nm; the column temperature is 35-45 DEG C; the flow velocity of the mobile phase is 1.6-1.8 ml / min; the sample injection volume is 10-50 [mu] l; the mobile phase A is phosphate buffer solution-acetonitrile-methanol; the mobile phase B is phosphate buffer solution-acetonitrile-methanol; the elution mode is gradient elution; the diluent is a mobile phase A; according to the method provided by the invention, effective separation between moxifloxacin hydrochloride and various impurities can be realized, the sensitivity is high, the accuracy is good, the reproducibility is relatively good, a good linear relation is shown in a certain range, and qualitative and quantitative determination can be carried out on various impurities in moxifloxacin hydrochloride bulk drugs.
Owner:NANJING CHIA TAI TIANQING PHARMA

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

Determination method of UPLC fingerprint spectrum of children heat-clearing and cough-relieving granules

ActiveCN119335087AComponent separationAgainst vector-borne diseasesBiotechnologyPseudoephedrine Hydrochloride
The invention discloses a determination method of a UPLC fingerprint spectrum of children heat-clearing and cough-relieving granules, and belongs to the technical field of pharmaceutical analysis. According to the invention, the children's heat-clearing and cough-relieving granules are subjected to UPLC chromatographic analysis, and a UPLC fingerprint spectrum containing 16 common characteristic peaks including ephedrine hydrochloride, pseudoephedrine hydrochloride, amygdalin, liquiritin, baicalin and baicalein is established, so that the overall quality of the children's heat-clearing and cough-relieving granules can be evaluated more comprehensively; a new technical thought is provided for quality control and quality evaluation of the heat-clearing and cough-relieving granules for children.
Owner:ZHUHAI TIANDA RES & DEV CO LTD +1

Small molecule drug dynamic analysis system based on spiking neural network

The invention discloses a small molecule drug dynamic analysis system based on a spiking neural network, and relates to the field of drug analysis, and the system comprises a management module which is used for controlling the editing and sending of control instructions of all function modules and units; the data collection module is used for collecting known drug compound structure data and corresponding in-vivo performance data; the model construction module is used for constructing a pulse graph neural network model architecture, and taking the drug compound structure data collected by the data collection module and the corresponding in-vivo performance data as training samples for training; the pulse calculation of the biological neural network can better simulate the characteristics of a biological system and the dynamic process of the biological system, so that the prediction precision of complex drug molecule behaviors is improved, training is performed on input data distribution through dynamic adjustment, the pulse graph neural network has higher generalization ability, error sources are captured, and the prediction precision is improved. Model structures and parameters are continuously adjusted from model identification output, and dynamic optimization is achieved.
Owner:KUNMING SHUIYAN PHARMACEUTICAL CO LTD

Analysis method of oligosaccharide composition in American ginseng polysaccharide

The invention discloses a method for analyzing oligosaccharide composition in American ginseng polysaccharide, and belongs to the technical field of pharmaceutical analytical chemistry, and the method comprises the following steps: 1) carrying out primary extraction on American ginseng through a methanol / methyl tert-butyl ether solution, and removing supernate to obtain American ginseng subjected to primary extraction; (2) adding pure water into the American ginseng subjected to primary extraction, extracting again, taking supernate, adding absolute ethyl alcohol into the supernate, standing, and centrifuging to obtain precipitate; 3) dissolving the precipitate with water, adding an n-butyl alcohol / chloroform solution, mixing and oscillating, and drying the aqueous solution to obtain crude polysaccharide; 4) adding water into the crude polysaccharide for redissolving, adding trifluoroacetic acid for reaction, and centrifugally concentrating to obtain oligosaccharide; and 5) dissolving the oligosaccharides in an acetonitrile aqueous solution, taking a sample to be detected, and detecting by using liquid chromatography-mass spectrometry to obtain the variety and proportion of the oligosaccharides in the sample to be detected. The problem that the structure of American ginseng polysaccharide is difficult to identify and analyze in the prior art is solved.
Owner:SHANDONG ANALYSIS AND TEST CENTER

Method for detecting related substances in landiolol hydrochloride for injection

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for detecting related substances in landiolol hydrochloride for injection. According to the method, an HPLC (High Performance Liquid Chromatography) method is adopted, octadecylsilane chemically bonded silica is taken as a filler, and a mobile phase A (the volume ratio of a monopotassium phosphate solution containing pentafluoropropionic acid to methanol is 58: 42-62: 38) and a mobile phase B (the volume ratio of the monopotassium phosphate solution containing pentafluoropropionic acid to methanol is 28: 72-32: 68) are used for gradient elution to detect the related substances in landiolol hydrochloride for injection. The detection method is high in specificity, high in sensitivity, good in accuracy and convenient to operate, the medicine quality can be effectively controlled, the technical blank of detection of the landiolol hydrochloride related substances for injection is filled, a reference standard is provided for quality control of landiolol hydrochloride for injection, and therefore the safety and reliability of clinical medication are guaranteed.
Owner:ZHEJIANG HEMUKANG PHARM TECH 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

Characteristic chromatogram of herba epimedii, characteristic chromatogram construction method and identification method

The invention relates to the technical field of pharmaceutical analysis, and particularly provides a characteristic chromatogram of epimedium villosum, a characteristic chromatogram construction method and an identification method. According to the method, an epimedium villosum medicinal material is pretreated, and the characteristic chromatogram of the epimedium villosum is identified by means of a chromatographic analysis technology; the epimedium villosum and the planted epimedium villosum are distinguished through the relative peak area and the characteristic peak of the chromatographic peak, so that the technical problem that the wild epimedium villosum and the planted epimedium villosum cannot be distinguished by the existing methods such as appearance identification, thin-layer identification and DNA identification is solved, and the correct source of the wild epimedium villosum is effectively ensured; the method has the advantages of simple identification method and accurate result.
Owner:JING BRAND +1

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

Method for detecting bacterial endotoxin in melphalan hydrochloride bulk drug

The invention relates to a method for detecting bacterial endotoxin in a melphalan hydrochloride bulk drug, and belongs to the technical field of drug analysis. The invention provides a test solution for detecting bacterial endotoxin in a melphalan hydrochloride raw material medicine, which comprises a test product melphalan hydrochloride raw material medicine, a 2-8 DEG C sulfobutyl beta-cyclodextrin sodium water solution and calcium and / or magnesium ions. The detection method disclosed by the invention is simple to operate, the sample can be dissolved in BET water without reanalysis, and the detection result is accurate; no organic solvent is used for preparing a test solution, so that the safety to operators is good, and bacterial endotoxin interference experiments prove that no interference effect exists; and the detection limit of the bacterial endotoxin in the melphalan hydrochloride bulk drug can reach 0.2 EU / mg.
Owner:SICHUAN HUIYU PHARMA

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

Construction method and application of HPLC (High Performance Liquid Chromatography) specific chromatogram of sunshine prevention and treatment cream

The invention discloses a construction method and application of an HPLC (High Performance Liquid Chromatography) specific chromatogram of sunburn prevention and treatment cream, and relates to the technical field of pharmaceutical analysis. The sunshine prevention and treatment cream is composed of honeysuckle, perfoliote knotweed herb, sedum sarmentosum, dayflower, radix polygonati officinalis, lithospermum erythrorhizon, aloe, asparagus fern, lucid ganoderma, coix seed and bee pollen, and is one of representative products of Guizhou Miao medicine brands. The specific chromatogram of the sunshine prevention and treatment cream is established by adopting a high performance liquid chromatography, and the five medicinal materials including honeysuckle, lithospermum erythrorhizon, aloe, sedum sarmentosum and perfoliote knotweed herb can be identified at the same time. The HPLC characteristic chromatogram of the sunshine prevention and treatment cream established by the method can effectively characterize the quality of the sunshine prevention and treatment cream, and is beneficial to comprehensively monitoring the quality of medicinal materials. Meanwhile, the method has the advantages of being simple, convenient, stable, high in precision, good in reproducibility and the like, and the authenticity of the product can be rapidly and accurately identified.
Owner:GUIZHOU GREEN SUN PHARM CO LTD

Analysis method for measuring content of dihydroergoline mesylate bulk drug

The invention relates to the technical field of drug analysis, and particularly discloses an analysis method for measuring the content of a dihydroergoline mesylate bulk drug, which comprises the following steps: step S1, adding the dihydroergoline mesylate bulk drug into anhydrous acetonitrile to obtain a stock solution to be measured, precisely measuring 1mL of the stock solution, adding a cosolvent, uniformly shaking, and fixing the volume to obtain a solution to be measured; s2, taking a dihydroergoline mesylate raw material medicine, adding the dihydroergoline mesylate raw material medicine into anhydrous acetonitrile to obtain a control stock solution, precisely measuring 1mL of the control stock solution, adding a cosolvent, uniformly shaking, and fixing the volume to obtain a control solution; s3, measuring the content of the dihydroergoline mesylate raw material medicine by using a high performance liquid chromatography; according to the present invention, the cosolvent contains the 1-butyl-3-methylimidazole tosilate, the mobile phase of the high performance liquid chromatography contains the elution reinforcing agent, and through the reasonable ratio of the components, the solubility of the dihydroergoline mesylate can be improved, and the accuracy of the high performance liquid chromatography analysis can be improved.
Owner:宝利化(南京)制药有限公司

Application of nano CDs as fluorescent probe in fluorescence detection of sugammadex sodium and fluorescence detection method of sugammadex sodium

The invention provides application of nano CDs as a fluorescent probe in fluorescence detection of sugammadex sodium and a fluorescence detection method of sugammadex sodium, and relates to the technical field of drug analysis and detection. According to the invention, carboxyl in sugammadex sodium and nitrogen atoms in nano CDs interact with each other, the fluorescence intensity of nano CDs is enhanced through intramolecular charge transfer, sugammadex sodium and nano CDs can be effectively combined through a static combination effect, and nano CDs have high sensitivity and selectivity to sugammadex sodium; the method is suitable for detecting sugammadex sodium. By adopting a fluorescence analysis method, the high-sensitivity, high-selectivity, simple, rapid and accurate quantitative detection of the sugammadex can be realized according to the fluorescence enhancement efficiency of the sugammadex relative to the nano CDs after the sugammadex is added and a standard curve of the concentration of the sugammadex and the fluorescence enhancement efficiency. The fluorescence detection method provided by the invention is low in detection cost.
Owner:TAIYUAN INST OF TECH

Quality detection method of infantile pharyngeal flat granules

The invention belongs to the technical field of pharmaceutical analysis. The invention provides a quality detection method of infantile pharyngeal flat granules, which comprises the following steps: sequentially extracting and filtering an infantile pharyngeal flat granule sample and an organic solvent, evaporating the filtrate to dryness, dissolving residues by using the organic solvent, and filtering to obtain an infantile pharyngeal flat granule sample solution to be detected; and measuring by adopting a high performance liquid chromatography, and calculating according to a standard curve model to obtain the contents of the nine active components in a sample solution of the child pharyngeal flat granules to be measured. According to the quality detection method of the infantile pharyngeal flat granules, the overall quality of the infantile pharyngeal flat granules can be more comprehensively evaluated and controlled, and the curative effect of the product is ensured; the content of nine active ingredients in the infantile pharyngeal flat granules can be rapidly determined, and the durability is good. Moreover, methodology verifies that the detection method is strong in specificity, has good precision, repeatability, stability, linear relation and accuracy, is simple and convenient to operate, and saves cost.
Owner:CHENGDE FOOD & DRUG INSPECTION & TESTING CENT

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 simultaneously detecting three isomer impurities in macloxvir raw material and preparation of macloxvir raw material and application of macloxvir raw material

The invention belongs to the technical field of drug analysis and detection, and particularly relates to a method for simultaneously detecting three isomer impurities in a macloxvir raw material and a preparation thereof and application. The method can be used for simultaneously detecting three isomer impurities in the macarovir raw material and the preparation thereof under one chromatographic condition, the separation degree of each chromatographic peak is relatively good, the detection limit and the quantitation limit also meet the qualitative and quantitative analysis requirements of medicines, the sensitivity is high, the precision and the stability are relatively high, the reproducibility is good, the accuracy is high, and the method is suitable for industrial production. The method can be used for monitoring the impurities in the production process of the macloxvir, and is beneficial to control and improvement of the quality of the macloxvir; meanwhile, operation is easy, detection time is short, and the method is very suitable for quality monitoring of raw material medicines in large-scale industrial production.
Owner:ZHUZHOU QIANJIN PHARMA

A quality control method for pazufloxacin mesylate injection

The present invention relates to the technical field of drug analysis, and is used to solve the problem that the existing quality method of pazufloxacin mesylate cannot separate photodegradable impurities, and provides a quality control method for pazufloxacin mesylate injection, comprising the following steps: (1) preparing a test solution; preparing a control solution; preparing a reference solution; (2) recording a chromatogram of the reference solution and the reference solution; (3) recording the chromatograms of the test solution and the reference solution; (4) calculating the content of pazufloxacin mesylate by peak area according to the external standard method. The present invention adjusts the ratio of two mobile phases in the gradient according to the polarity of each impurity, and changes isocratic elution to gradient elution, so that each impurity with different polarities can be well separated.
Owner:SICHUAN MEDCALO PHARM CO LTD

Method for establishing traditional Chinese medicine fingerprint spectrum of gastrodia elata and uncaria decoction

The invention belongs to the field of pharmaceutical analysis, and particularly relates to a method for establishing a traditional Chinese medicine fingerprint spectrum of a gastrodia elata and uncaria decoction. The method is realized by the following steps: firstly, preparing a reference substance solution and a test solution, then detecting by adopting a high performance liquid chromatography, and establishing a fingerprint spectrum. According to the method provided by the invention, by reasonably selecting the components of the reference substance and adopting a multi-wavelength method according to the maximum absorption wavelength of the components, the change of the component amount between the samples can be effectively represented, so that the quality of the samples is more accurately judged; the invention further provides a screening and optimizing method for the preparation method of the gastrodia elata and uncaria decoction, the prepared method is good in repeatability and stability, the quality of the gastrodia elata and uncaria decoction can be monitored more comprehensively, and the method provides valuable reference for quality evaluation and standardization of traditional Chinese medicine decoction.
Owner:JIANGSU PROVINCIAL HOSPITAL OF TCM

Chiral synthesis method of key impurity-epigalanthamine hydrobromide of galanthamine hydrobromide

The invention relates to the field of novel medical compounds, in particular to a chiral synthesis method of epigalanthamine hydrobromide which is a key impurity of galanthamine hydrobromide. An intermediate easy for industrial production is used as a raw material, and epigalanthamine hydrobromide is synthesized in one step through a chiral reducing agent. The synthesis method utilizes intermediates in the existing industrial production process, has the advantages of simple steps, low reagent cost, high yield, high optical purity of the product and the like, and greatly facilitates preparation of impurities of galanthamine and further development of a pharmaceutical analysis method of galanthamine.
Owner:TAIAN HAVAY CHEM

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

Method for detecting glucose residue in irinotecan hydrochloride liposome injection

PendingCN119619346ARealize accurate quantitative detectionefficient separationComponent separationSucroseUltrafiltration
The invention relates to the technical field of drug analysis and detection, and particularly discloses a method for detecting the residual quantity of glucose in an irinotecan hydrochloride liposome injection. According to the method, irinotecan hydrochloride in the liposome is fully separated from small molecular substances such as glucose and sodium chloride by adopting an ultrafiltration method, then, a Waters XBridge BEH HILIC chromatographic column is adopted, a mixed solution of an acetate buffer solution with the pH value of 3.8-4.2 and acetonitrile is used as a mobile phase, and the content of irinotecan hydrochloride in the liposome is detected in an isocratic elution mode by adopting a high performance liquid chromatography method. The effective separation of glucose, sodium chloride, 4-hydroxyethylpiperazine, sucrose octasulfate potassium and other substances is realized, and the condition of the glucose residue in the irinotecan hydrochloride liposome is accurately detected. The invention provides a reliable guarantee for improving and better controlling the quality of the irinotecan hydrochloride liposome injection product, and has very important significance for improving the medication safety.
Owner:HEBEI DAOEN PHARM CO LTD

Peptide diagram detection and analysis method of thrombopoietin peptidomimetic

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a thrombopoietin peptidomimetic peptide diagram detection and analysis method which comprises the following steps: (1) performing buffer system replacement on thrombopoietin peptidomimetic through ultrafiltration centrifugation; (2) carrying out enzymolysis on the thrombopoietin peptidomimetic by adopting trypsin; and (3) detecting and analyzing the enzymolysis peptide fragment by using a reversed-phase high-performance liquid chromatography. The method disclosed by the invention has the beneficial effects that sample concentration and buffer solution replacement are performed through the ultrafiltration tube, and the sample subjected to enzymolysis is high in purity and can be directly detected by using reversed-phase high-performance liquid chromatography, so that the method for detecting and analyzing the peptide diagram of the thrombopoietin peptidomimetic is simple and convenient to operate, and the detection efficiency of thrombopoietin peptidomimetic drugs is improved; by controlling the chromatographic conditions, the accuracy and precision of high performance liquid chromatography detection are improved, and the quality analysis and control of thrombopoietin peptidomimetic drugs can be realized.
Owner:SHANDONG QUANGANG PHARM CO LTD