591 results about "Drug analysis" patented technology

The invention discloses an application of nano-gold directly bonded with luminol in an immunoassay. The invention is characterized in that the immunoassay probe of a nano-gold directly bonded with luminol comprises antibodies which are labeled by the nano-golds directly bonded with luminol, wherein the nano-gold directly bonded with luminol are prepared through reducing chloroauric acid by the luminol at a single step; a chemiluminescence immunoassay method is based on the immunoassay probe of the nano-gold directly bonded with luminol; and a kit is used for carrying out the immunoassay method. The chemiluminescence immunoassay method of the invention has the advantages of high sensitivity (for instance, the detection limit can reach 1.0pg/mL for detecting human IgG), wide range of linearity, good repeatability, simple operation, low cost and the like, can be applied to detect multi-analyte in various samples and has key application prospect in fields, such as clinical diagnosis and cure, drug analysis, food security detection, environmental monitoring and the like.

A hand-held portable drug monitoring system to detect and quantitate cocaine and other organic drugs in saliva, sweat, and surface wipes by using an ion selective electrode or an array of ion selective electrodes. The ion selective electrode has a cast membrane reference electrode and a sensing electrode with a hydrophobic polymer, a plasticizer, and an ionophore selective for the organic drug to be tested. The ion selective electrode can be connected to a converter that coverts a voltage reading from the ion selective electrode to a quantitative drug concentration level. Also disclosed is the related method of using an ion selective electrode to detect an organic drug in saliva, sweat, and surface wipes, the method of testing electrical contact in an ion selective electrode, and the method of making a cast membrane reference electrode.

The invention belongs to the technical field of the preparation methods of the nanomaterials and specifically discloses a method for preparing water-soluble fluorescent silicon quantum dots by using a hydrothermal process. The method comprises the steps of firstly introducing an amino silane and a reducing agent into a solvent in which nitrogen is introduced and mixing, continuing introducing the nitrogen for protection for a while, next, transferring to a hydrothermal reaction kettle, and heating for reacting for a while, thereby obtaining the fluorescent silicon quantum dots having excellent chemical properties. The method has the advantages of low raw material cost due to the adoption of the amino silane as a silicon source, simple operation steps, direction synthesis in water phase, easy large-scale production, and being green and environment; the obtained quantum dots have high quantum yield and excellent chemical characteristics, and are small in particle size, evenly in distribution, non-toxic, good in biocompatibility and acid resistance; besides, the quantum dots have pH sensitive characteristic in a certain range, and can be widely applied to the biochemical and biomedical sensing fields such as biochemical detection, drug analysis, cell and living imaging and targeting tracing and also can be used as photovoltaic conversion and light-emitting display materials.

The invention relates to a method for determining fingerprint of a Shuanghuanglian oral preparation and belongs to the technical field of drug analysis. The method comprises: preparing a reference solution and a test solution and carrying out analysis detection through high performance liquid chromatography-mass spectrometry. The HPLC detection is carried out under different elution conditions sothat good separation effects are obtained. Through an external internal standard method, the test solution containing the internal standard substance is detected in the fingerprint. The relative peakarea ratio of the common peak and the internal standard peak is used as the mathematical expression of the fingerprint so that the method can reflect the absolute and relative changes of common peak contents better than the method for calculating the relative peak area of each common peak through traditional Chinese medicine ingredients.

The invention belongs to the field of medicament analysis and particularly relates to a detection method and a content determining method for sodium calcium edetate as an accessory in pantoprazole sodium for injecting. The invention aims at solving the technical problem of providing a method with the advantages of simpleness in and convenience for operation, quickness and accuracy for detecting the sodium calcium edetate as the accessory in the pantoprazole sodium for injecting. HPLC (High Performance Liquid Chromatography) detection conditions are as follows: a stationary phase: octadecylsilane bonded silica gel is used as a filling agent; a mobile phase: in terms of volume, an ion pair buffer solution is 85-95 percent, acetonitrile is 5-15 percent and the pH value is adjusted to 2.2-2.6 with phosphoric acid; the flowing speed is 0.8-1.2 ml/min; the column temperature is 30-40DEG C; the detection wavelength is 250-260 nm; and the theoretical plate number is required not to be lower than 2000 calculated in terms of a sodium calcium edetate peak. The detection method has the advantages of simple and convenient operation, accurate and reliable determination result, stronger specificity and shorter detection time; and the retention time of a main peak is about 6 minutes.

The invention belongs to the technical field of medicament analysis, and particularly relates to a qualitative and quantitative method of 3-aminopiperidine as well as a detection method of chiral purity of 3-aminopiperidine. According to the invention, excessive benzoyl chloride is adopted as a derivatization reagent to be subjected to rapid bi-derivatization reaction with 3-aminopiperidine so as to generate diphenyl 3-aminopiperidine, and then common phase reversal HPLC-UV(high performance liquid chromatography-ultraviolet) is used for analyzing diphenyl 3-aminopiperidine qualitatively and quantitatively; Chiral HPLC Columns taking glycoprotein as a filling are adopted for determining the enantiomeric excess rate of diphenyl 3-aminopiperidine. The method is simple and rapid to operate, is good in reproducibility, is high in flexibility, and is easy for standardized operation.

The invention relates to an experiment device for pretreatment on samples, and in particular to a functional pipetting head with double purification functions of ultra-filtration and solid extraction, and application of the functional pipetting head in pretreatment and quantitative analysis on a biological sample in the medicine analysis process. The functional pipetting head comprises a pipetting head body, a solid-phase extraction material and a hollow fiber membrane, wherein the hollow fiber membrane is arranged at the sharp end of the pipetting head body; an adhesive is uniformly applied at the cross part of the sharp end of the pipetting head and the hollow fiber membrane; an upper end opening and a lower end opening are formed in the hollow fiber membrane; the upper end opening is sealed; the lower end opening is kept in an opened state; the solid-phase extraction material is arranged inside the pipetting head body. The functional pipetting head is simple, convenient and controllable in manufacturing process, flexible in extraction condition adjustment, scientific and reasonable in method, convenient in obtaining materials, and good in application prospect.

The invention discloses a signal amplification immunodetection method. According to the method, signal amplification immunity quantitative detection is conducted through a filter, and the method comprises the step of adopting the filter for sequentially filtering a to-be-detected sample solution A containing objects to be detected, a detected object solution B labeled through avidin and an indicator solution C labeled through biotin, wherein a filter element of a filter layer of the filter is a solid phase material coupled to a specific binder of the objects to be detected, detected objects labeled through the avidin can be specifically bound to the objects to be detected, and thereby the quantity of the objects to be detected in the solution A is calculated according to the color or light quantity variation of an indicator. It is proved through experiments that compared with a conventional biotin-avidin amplification reaction sequence, the avidin-biotin amplification reaction sequence has a greater biological signal amplification effect. The method can be used for detecting samples which are from human bodies and animal bodies and can be subjected to disease diagnosis and health detection and applied to development of products for sample quantitative immunodetection in the fields of environment, pharmaceutical analysis, food and industrial analysis.

The invention belongs to the technical field of medicine analysis and particularly relates to a quantitative method for 3-aminopiperidine and a detection method for the chiral purity of 3-aminopiperidine. According to the method, benzoyl chloride which is used as a derivatization reagent and 3-aminopiperidine are rapidly derived at a low temperature in a large quantity of organic solvents to generate benzoyl-3-aminopiperidine; then a detection analysis of benzoyl-3-aminopiperidine is carried out by using HPLC-UV (High Performance Liquid Chromatography-Ultraviolet). The method carries out qualitative analysis and quantitative analysis by adopting a common C18 column, and carries out enantiomeric excess rate determination by adopting a chiral chromatographic column. The method is simple to operate, high in sensitivity and high in accuracy, is easy for standardized operation.

The invention belongs to the field of drug analysis, relates a quality control method of fermented cordyceps taishanensis powder, and particularly relates to fermented cordyceps taishanensis powder, preparation sterols HPLC fingerprint spectrum and a building method thereof. The building method includes the steps of firstly, preparing a control solution; secondly, preparing a test solution; thirdly, using HPLC to determine the fingerprint spectrum, and performing similarity evaluation, to be more specific, separately precisely sucking the control solution and the test solution, performing HPLCseparation detection with the flow phase being a methanol-water elution system to obtain the sterol fingerprint spectrum of the fermented cordyceps taishanensis powder, and importing the fingerprintspectrum into similarity software to perform similarity evaluation.

The invention discloses a method for determining an impurity F in captopril tablets through high performance liquid chromatography and belongs to the technical field of pharmaceutical analysis. Detection is performed under the conditions as follows: an amylase-tris(5-chloro-2-methyl phenyl carbamate) coated chromatographic column is used, normal hexane-absolute ethyl alcohol-trifluoroacetic acid serves as a mobile phase, a volume ratio of the normal hexane to absolute ethyl alcohol to trifluoroacetic acid is 80:20:0.1, a detection wavelength is 215nm, flow velocity is 1ml/min, a column temperature is 35 DEG C and a sample amount is 20[mu]l. A structural formula of the impurity F is as shown in the description. According to the method disclosed by the invention, the content of the impurityF in the captopril tablets can be quantitatively determined, so that the quality of the captopril tablets is effectively controlled. According to the method provided by the invention, the captopril and the impurity F can be proved to be effectively separated in a system suitability solution, and the method has high precision and high separation degree. A signal to noise ratio of a self-contrast solution is more than 10, and if the sample contains the impurity F, the impurity F can be detected.

The invention belongs to the field of pharmaceutical analysis and particularly relates to a HPLC (high-performance liquid chromatography) detection method for escitalopram oxalate related substances. The escitalopram oxalate related substances are determined with HPLC, a C18 column is taken as a chromatographic column, a phosphate buffer solution is taken as a mobile phase A, the mobile phase A and an acetonitrile solution are mixed in a certain ratio to form a mobile phase B, the mobile phase A and the acetonitrile solution are mixed in a certain ratio to form a mobile phase C, and the escitalopram oxalate related substances are detected with a gradient elution method. The method can separate impurities, is high in specificity and sensitivity and good in repeatability and durability, can well control known impurities and unknown impurities of escitalopram oxalate and guarantees safety of escitalopram oxalate.

The invention discloses a detection kit for antiepileptic drugs in serum and application thereof, and belongs to the technical field of drug analysis. The kit disclosed by the invention adopts an LC-MS/MS method; ten common antiepileptic drugs can be detected at one time; the kit is simple in pretreatment process, low in cost, high in sensitivity and high in specificity; separation and detection of the antiepileptic drugs are completed within 6 min, the accuracy and precision basically meet the requirements, the kit can be used for quantitative analysis of the clinical antiepileptic drugs, anda reliable detection method is provided for monitoring the treatment concentration of the clinical antiepileptic drugs.

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to an HPLC analytic method for Nicorandil-related substances. The HPLC analytic method is characterized in that a stationary phase is a reversed-phase column of carbon octadecyl silane, and a moving phase is a mixed solution of a buffer solution, methyl alcohol and tetrahydrofuran. The HPLC analytic method is quick, simple and accurate, is good in repeatability and suitable for control and stability study of the related substances, lays a foundation for formulating quality standards of the related substances, and makes drug quality control and medication safety possible. Through scaling down organic solvents and volatile salt, which have high toxicity, the acquisition time is shortened, the economic cost is lowered, the HPLC analytic method is suitable for large-scale production, and meanwhile, harms to experimenters and environments are reduced.

A web-based tool (as a server) for integrated pharmaceutical analysis and report generation service is provided in the present invention. The server can be used for numerical analysis and report generation for pharmaceutical manufacturing, research and development, and has advantages such as simple operation, complicated but fast calculation and professional report generation, and high accuracy. The server includes at least one pharmaceutical manufacturing and research and development numerical analysis system configured to perform different pharmaceutical manufacturing and research and development numerical analyses and generate different reports. Each of the at least one pharmaceutical manufacturing and research and development numerical analysis system includes an input module configured to receive, via a user interface, at least one of a template file and a backup file previously output by the server as at least one input file, wherein the at least one input file includes a plurality of data fields to provide corresponding data; at least one calculation module, each configured to execute a built-in pharmaceutical manufacturing and research and development numerical analysis calculation program, thereby automatically performing a pharmaceutical manufacturing and research and development numerical analysis calculation on at least one of the data of the at least one input file and on-line filled data; and an output module configured to generate at least one of a backup file and a report file as at least one output file based on the result of the pharmaceutical manufacturing and research and development numerical analysis calculation performed by the at least one calculation module and provide the at least one file via the user interface.

The invention discloses a separation method of effective components of a sharpleaf galangal fruit aqueous extract, belonging to the field of pharmaceutical analysis. The separation method comprises the following steps: (A) fetching dried sharpleaf galangal fruit, grinding, carrying out reflux extraction with water, combining filtrate, carrying out reduced pressure distillation to obtain extractum, dissolving the extractum into distilled water, respectively extracting by virtue of petroleum ether, ethyl acetate and normal butanol, and recycling solvents, so as to obtain ethyl acetate extract dry powder; (B) dissolving the dry powder obtain in the step (A), filtering, and processing by virtue of a sephadex LH20 gel column, so as to obtain six components from F1 to F6; and (C) carrying out HPLC separation and purification on the components from F2 to F6, so as to obtain compounds including protocatechualdehyde, protocatechuic acid, p-coumaric acid, (-)-epicatechin and (+)-catechinic acid. According to the separation method, the effective active components are separated and extracted from the sharpleaf galangal fruit, the structures of the effective components are further defined, the basis is provided for later medication, and required components can be extracted according to different requirements.

The invention belongs to the technical field of pharmaceutical analysis and relates to a fingerprint spectrum of an immature bitter orange medicinal material and a construction method and application of the fingerprint spectrum. Specifically, the invention relates to a high performance liquid chromatography (HPLC) fingerprint spectrum of the immature bitter orange medicinal material and a construction method of the fingerprint spectrum, as well as application of the HPLC fingerprint spectrum and/or a standard fingerprint spectrum of the immature bitter orange medicinal material in identification of the immature bitter orange medicinal material. The method for constructing the HPLC fingerprint spectrum of the immature bitter orange medicinal material specifically comprises the following steps: (1) preparing an immature bitter orange test sample; and (2) performing HPLC analysis. The invention also relates to a method for identifying the immature bitter orange medicinal material. The method is applied to identifying the authenticity and quality of the immature bitter orange medicinal material.

The invention particularly relates to a method for measuring the content of faropenem polymers in faropenem sodium raw materials and preparations by high-efficiency liquid chromatography, which belongs to the field of medicine analysis. The measuring method of the invention is gel chromatography. The high-efficiency liquid chromatogram is used for detection, and the chromatogram conditions are as follows: (1) the gel permeation chromatography has the exclusion molecular weight between 600 and 800 Daltons; (2) the mobile phases as two mobile phases, wherein the mobile phase A is a water phase solution with the pH value between 5.0 and 8.5 and the concentration between 0.01 and 0.2 mol/L, and the mobile phase B is water or a sodium dodecyl sulfate water solution or a glycin solution between 0.005 and 0.02 percent; (3) the column temperature is the room temperature; (4) the flowing rate is between 0.5 and 1.0 ml/min; and (5) the detection wavelength is between 210 and 300 nm. The method of the invention has the advantages of strong specificity, good repetitiveness and high automation degree, and the polymers in the faropenem sodium raw materials and the preparations can be accurately qualified.

The present disclosure provides methods and systems for providing a validated drug to an end-user or distributing business. Also provided herein are methods and systems for providing a certificate of analysis for a drug to provide more information to a user.

The invention provides a method for detecting related substances in sodium ibandronate injection, and belongs to the technical field of drug analysis. According to the method for detecting the relatedsubstances in the sodium ibandronate injection, a high performance liquid chromatograph-charged aerosol detector (CAD) is adopted, a chromatographic column with octadecyl silane chemically bonded silica embedded in a strong anion exchange group as a filler is adopted, acetonitrile-water-trifluoroacetic acid serves as a flowing phase for gradient elution, the injection is subjected to Ag/H type pretreatment small column treatment, and thus the related substances in the sodium ibandronate injection can be effectively separated and determined.

The invention belongs to the field of drug analysis and discloses a method for analysis of a hydroxychloroquine sulfate raw material and preparation by high performance liquid chromatography. The method can realize effective separation of related substances in hydroxychloroquine sulfate so that hydroxychloroquine sulfate quality is controlled, hydroxychloroquine sulfate raw material and preparation content is accurately determined, and hydroxychloroquine sulfate stability is indicated. The method has the advantages of strong specificity, high accuracy and simple operation.

The invention discloses a drug crushing device for drug analysis and a crushing method. The drug crushing device comprises a guiding mechanism, a primary crushing mechanism, a secondary crushing mechanism and a screening mechanism which are sequentially mounted from top to bottom; and the guiding mechanism comprises a guiding cover and two arc-shaped guiding plates symmetrically mounted inside theguiding cover. Through scientific and reasonable structural design, drugs can be continuously crushed, through arrangement of the primary crushing mechanism and the secondary crushing mechanism, thedrug crushing effect is fully ensured, the drugs not meeting the crushing standard can be crushed in a circulating mode, the drug crushing quality is greatly improved, meanwhile, classification collection and storage can be conducted according to the requirements of different particle sizes after crushing, the work efficiency is greatly improved, and the drug crushing device has good practical andpromotional value.

The invention belongs to the field of pharmaceutical analysis, and particularly relates to a high performance liquid chromatography detection method for the content of enantiomer in L-alanine isopropyl ester hydrochloride. According to the method, high performance liquid chromatography is used for determination, a crown ether chiral chromatographic column is used, and a perchloric acid aqueous solution with the pH value of 1.0 serves as the mobile phase. Thus, the L-alanine isopropyl ester hydrochloride can be effectively separated from the corresponding enantiomer, and the content of enantiomer can be detected more accurately. According to the method, a reversed-phase method and isocratic elution are used, operation is simple, peak shape is better, the separation degree is qualified, andvia methodological verification, the method is high in specificity, sensitivity, accuracy and durability.