121 results about "Drug quality" patented technology

The invention discloses a liquid medicine foreign matter detection method and system based on machine vision, and the method comprises the steps: obtaining multiband spectral data of a liquid medicine sample, and carrying out the normalization processing to generate a liquid medicine background standard spectral feature template; comparing the refractive index spectral characteristics of the template and the foreign matter-containing liquid medicine, and recording the surface roughness scattering mode and polarized light reflection angle change data of a foreign matter area; calculating a spectrum peak displacement quantized value according to the polarized light data, and extracting foreign matter edge spectrum gradient information in combination with a threshold value; calculating a transparency spectral attenuation coefficient based on the edge gradient information, and obtaining spectral contrast enhancement factors of different foreign matters in combination with the spectral response characteristic data; and if the enhancement factor does not reach the standard, adjusting the spectrum correction parameter and recalculating, fusing the scattering mode and the multi-angle incident spectrum response result to carry out consistency verification, and obtaining a final identification result containing the foreign matter material type and the danger level. The method can improve the drug detection accuracy and guarantee the drug quality safety.

The invention relates to the technical field of medicine management, and discloses a medicine informatization whole-process management system based on big data analysis. According to the system, a drug full-life-cycle multi-dimensional data stream is captured through a distributed sensing node network, and a drug state tensor is generated after noise filtering and missing value compensation are carried out through a real-time stream processing engine. The risk identification module scans and locates an abnormal data cluster through a multi-scale mode and constructs a drug quality hypersurface model; and the data aggregation module establishes a mapping relation between a state tensor and a quality model by using a space-time diagram attention network and calculates a global consistency metric value. The intelligent decision-making module generates an optimal drug management action sequence based on the measurement value under multiple constraint conditions, the closed-loop control module executes the action sequence and monitors system state deviation in real time, data acquisition parameters are dynamically calibrated, and autonomous optimization and closed-loop management of the whole process of drugs are achieved.

The invention provides a fingerprint spectrum and multi-component content determination method of a calamus-far nerve calming mixture, and relates to the field of quality control of traditional Chinese medicines. 31 common peaks are calibrated by establishing a fingerprint spectrum, and 24 common peaks can clearly belong to polygala tenuifolia. Meanwhile, synchronous content determination of seven components including chlorogenic acid, caffeic acid, ferulic acid, liquiritin, 2, 3, 5, 4 '-tetrahydroxy stilbene-2-O-beta-D-glucoside, 3, 6'-dimustard acyl sucrose and rosmarinic acid is realized. The method is good in precision, high in repeatability and stable and reliable in result, the medicine quality can be comprehensively and accurately reflected and controlled, and powerful support is provided for guaranteeing the safety and effectiveness of the calamus-far Ningmind mixture.

The invention discloses a method for determining nitrosamine impurity N-nitrosociprofloxacin in ciprofloxacin lactate, and relates to the field of substance detection methods, the method adopts a liquid chromatography-mass spectrometry technology, and the liquid chromatography condition comprises that a mobile phase is a mixture of a formic acid solution with the concentration of 0.08%-0.12% and acetonitrile, and the volume ratio of the formic acid solution to the acetonitrile is (45-55): (45-55). According to the present invention, the liquid chromatography (LC) technology and the mass spectrometry (MS) technology are combined, such that the efficient separation ability of the liquid chromatography and the high sensitivity detection ability of the mass spectrometry are combined, the detection sensitivity and the detection accuracy are significantly improved, and the strict requirements of drug quality control and safety are met.

The invention relates to a heparin drug consistency evaluation method, system and device, and belongs to the technical field of drug quality control. Comprising the following steps: carrying out disaccharide analysis, oligosaccharide analysis and two-dimensional liquid phase analysis on a selected standard preparation to respectively obtain corresponding peak parameters, and constructing a qualitative database and a quantitative database according to the peak parameters; acquiring the chromatographic data of the reference preparation treated under the same condition as the sample to be detected, and performing consistency evaluation on the chromatographic data and the two databases; wherein the consistency evaluation comprises the following steps: acquiring chromatographic data of a reference preparation, performing automatic integration on the chromatographic data, and performing automatic attribution on components by utilizing a qualitative database to respectively obtain two peak contents; obtaining samples in a quantitative database; according to the sample, carrying out consistency evaluation on the two peak contents; and if yes, acquiring the chromatographic data of a large batch of samples to be detected and carrying out consistency evaluation on the chromatographic data. According to the method, the chromatographic data processing process is simplified, and the efficiency, accuracy and reliability of quality evaluation of the heparin drugs are improved.

The invention discloses a method for preparing an isavuconazole sulfate RS isomer impurity and a quaternary ammonium salt impurity, which comprises the following steps: taking SM1 and SM2 as starting materials, reacting in an ethyl acetate solvent, and preparing and separating after the reaction to obtain the RS isomer impurity and the quaternary ammonium salt impurity. The method for preparing the isavuconazole sulfate impurity is mild in reaction condition, simple to operate and high in product purity, does not need other harsh reaction conditions and high-pressure liquid phase preparation and other complex separation and purification means, and provides powerful support for quality research of isavuconazole sulfate. By controlling the two specific impurities, namely the RS isomer impurity and the quaternary ammonium salt impurity, in the production process, the product quality of isavuconazole sulfate and the stability of the medicine quality can be improved.

This invention relates to the field of pharmaceutical injection technology, specifically to a neostigmine methylsulfate injection and its preparation method. The preparation method of the neostigmine methylsulfate injection of this invention includes the following steps: S1 pretreatment of water for injection, S2 preparation, S3 filtration, S4 filling and sealing, and S5 sterilization. This invention features a simple process, high yield, and low cost. It effectively reduces the generation of impurity I in the neostigmine methylsulfate injection, improves the storage stability of the product, reduces potential medication safety hazards caused by impurities, and ensures drug quality and medication safety.

The invention discloses an improved loading method of a nano-drug carrier, which comprises the following steps: adding a carrier of recombinant human heavy-chain ferritin or a derivative thereof into a high-concentration urea solution, mixing and reacting to depolymerize a shell of the recombinant human heavy-chain ferritin; adding a medicine, mixing and incubating; and diluting a reaction solution obtained by incubation into a low-concentration urea solution by using a Tris buffer solution, reacting for 8-15 hours to re-polymerize the recombinant human heavy chain ferritin shell, and finally changing the solution by using a membrane bag with the molecular weight cutoff of 50 KD through the Tris buffer solution to obtain the loaded ferritin drug composite particles. According to the preparation method provided by the invention, the effect of obviously improving the protein recovery rate and the drug loading capacity is achieved by providing a preparation method of replacing liquid after dilution and then standing and optimizing the drug-mass ratio, the protein recovery rate can reach 100%, and the drug loading capacity can reach 186 mu g / mL.

The application discloses a method for purifying and removing impurities from ranitidine base, which comprises the following steps: (1) dissolving ranitidine base; (2) removing water under reduced pressure to obtain a water content of less than 0.2 wt%; (3) crystallizing; and (4) filtering, washing and drying to obtain refined ranitidine base after removing impurities. The method for purifying and removing impurities from ranitidine base is characterized in that: first, non-polar solvent is used to dissolve and distill water; then, ranitidine base is extracted by crystallization; and finally, impurity A of ranitidine is retained in the non-polar solvent, so that impurity A in the ranitidine base is effectively removed, and the content of impurity A in the ranitidine base is reduced to below the limited requirement of drug quality control.

The present application relates to the technical field of warehousing logistics, and in particular to a big data-based cold chain logistics warehousing intelligent management system. The system comprises: acquiring and analyzing a loading plan, and determining drug information and warehouse information; analyzing the drug information to determine a suitable storage temperature; analyzing the drug information, the warehouse information, and the suitable storage temperature to determine a non-cold chain environment quality assurance time of a drug; determining vehicle information on the basis of the suitable storage temperature and the drug information; and on the basis of the drug information, the warehouse information, the vehicle information, and the non-cold chain environment quality assurance time, formulating a loading strategy for reference by the cold chain logistics warehousing staff. By comprehensively analyzing the drug information, the warehouse information, the vehicle information, etc., a scientific loading strategy is formulated, so as to improve cold chain logistics efficiency, ensure drug quality, optimize resource configuration, and provide decision support for the staff, thereby improving the customer satisfaction and the overall operational performance.

The invention belongs to the technical field of medicine synthesis, and particularly relates to a synthesis method of a suzertraline impurity, the process route is shown as the following reaction formula: S1, a compound I is subjected to double bond reduction to obtain a compound II; s2, carrying out carbonyl reduction on the compound II to obtain a compound III; s3, esterifying the compound III to obtain a compound IV; s4, performing nucleophilic substitution on the compound IV to obtain a compound V; s5, hydrolyzing the compound V to obtain a compound VI; and S6, carrying out condensation reaction on the compound VI and the compound VII to obtain an isomer impurity VIII. The invention discloses a synthesis route of the suzertraline isomer impurity VIII for the first time, solves the problem that the impurity lacks a standard reference substance in drug quality control, and provides a necessary material basis for quality research and analysis method development and verification of suzertraline bulk drugs and preparations.

The invention belongs to the technical field of biosensing detection, and particularly discloses a label-free ratio fluorescence sensor and application thereof in quinine detection. The label-free ratio fluorescent aptamer sensor takes isothiocyanate as an internal reference signal and a fluorescent dye as a detection signal, and is obtained by mixing and incubating a quinine specific nucleic acid aptamer, a triphenylmethane fluorescent dye and isothiocyanate in a buffer solution. According to the invention, isothiocyanate is introduced as an internal reference signal, triphenylmethane dye is selected as a target response fluorescence signal molecule, and the quinine is detected by using the obvious fluorescence change of the target response fluorescence signal molecule in the binding-dissociation process of the target response fluorescence signal molecule and a quinine specific nucleic acid aptamer. The label-free ratio fluorescence sensor has excellent selectivity and stability, can be widely applied to the fields of food safety supervision, drug quality control, environmental water quality detection and the like, and is particularly suitable for rapid detection and emergency monitoring of quinine under the condition of limited resources.

The utility model belongs to the technical field of pharmaceutical preparation production equipment, especially is with metering feeder for choline bitartrate tablet preparation, including sealed storage unit, sealed gas control unit, anti -blocking unit and metering conveying unit, sealed storage unit includes sealed storage tank, sealed gas control unit includes gas injection port, suction port and pressure gauge, anti -blocking unit includes the electromagnetic vibrator and linkage stirring subassembly that are established, metering conveying unit includes the feed pipe and screw conveying mechanism, the top surface one end of feed pipe is equipped with the material inlet nozzle, bottom surface other end is equipped with the material outlet nozzle, is equipped with solenoid valve and microwave solid flowmeter on the material inlet nozzle, replaces manual weighing feeding, has improved production efficiency, adapts to scale production, adopts inert atmosphere closed loop control, avoids raw material oxidation, guarantees raw material active ingredient and drug quality, whole sealed conveying path, no dust flying, avoids the risk of professional exposure of operating personnel simultaneously.

The present application relates to the technical field of data transmission, and discloses a radioactive drug synthesis data transmission method and system, which comprises the following steps: collecting drug synthesis data and data generation time, and obtaining a drug synthesis data sequence; determining the adjustment distance of two different kinds of drug synthesis data, and determining the data fluctuation influence of the target data generation time; determining a single difference kind and a single difference sequence, determining the synthesis drug quality influence degree of the single difference kind, determining the data outlier evaluation value of the current radioactive drug, dividing the drug synthesis data sequence of the current radioactive drug into sequence segments according to the data outlier evaluation value of the current radioactive drug; and encrypting the sequence segments to realize the transmission of the radioactive drug synthesis data. The present application can adjust the encryption security and transmission speed according to the storage requirements of the drug synthesis data.

The invention provides a medicine quality detection data processing analysis system and method, and the method comprises the steps: carrying out the time sequence alignment processing of original multi-source detection data, extracting a detection data fragment reflecting the quality attribute of a target medicine, and generating a characteristic evolution sequence of the quality of the target medicine between different batches according to the detection data fragment; screening out a plurality of difference sensitive features representing the batch stability of the target drug according to the feature evolution sequence, and converting all the difference sensitive features into inter-batch difference quantities of the target drug in the batch quality inspection process; generating a uniformity index of the quality in the target drug batch according to the dispersion of the quality data of different sample points in the same batch in the aligned multi-source detection data; and carrying out quality grade analysis on the target drugs of the current batch based on the inter-batch difference quantity and the uniformity index to obtain an analysis result. By adopting the scheme, the comprehensive analysis of the batch difference of the medicine quality can be realized in a batch quality inspection scene, so that the analysis error in the medicine quality monitoring process is reduced.

The invention provides an electron beam sterilization method of an implant, which is characterized in that the implant is irradiated by using a high-energy electron beam, the irradiation mode is at least twice, the irradiation dose of each time is not more than 20kGy, and the absorbed dose of the implant after irradiation is not less than 16kGy and not more than 50kGy. The method provided by the invention can ensure that the sterility level SAL is less than 10 <-6 >, can ensure that the drug quality of the implant is not affected, and can ensure that no new impurities are generated in the sterilization process.

The invention discloses an LMTIA primer group for detecting a subprostrate sophora component, a detection method, a kit and application of the LMTIA primer group, and belongs to the technical field of molecular biology nucleic acid detection. The invention designs an LMTIA primer group for identifying the components of the subprostrate sophora, the LMTIA primer group comprises primers SdouG-1F1, SdouG-1B1, SdouG-1LF and SdouG-1LB, and a detection method for identifying the components of the subprostrate sophora is constructed on the basis of an LMTIA technology. The method is simple to operate, short in reaction time, high in sensitivity and strong in specificity. The minimum detection concentration of the vietnamese sophora root can reach 1pg / mu L, and the minimum detection limit content of the vietnamese sophora root is 0.1% for a mixed system containing other sample gene DNA (Deoxyribose Nucleic Acid). The detection method not only can specifically identify the true and false characteristics of the subprostrate sophora product, but also can effectively detect the subprostrate sophora component in the medicine matrix. The method is suitable for the fields of food and drug quality control, Chinese herbal medicine identification and market supervision.

The utility model discloses a weighing device for a powder charging machine, which relates to the technical field of weighing devices, is mounted at the bottom end of a conveying mechanism and comprises a workbench arranged at the bottom end of the conveying mechanism, and a weighing body is arranged at the top end of the workbench. A sealing mechanism matched with the conveying mechanism is arranged above the weighing body, and a clamping mechanism is arranged on the outer side of the sealing mechanism. Through cooperative arrangement of the weighing body, the sealing mechanism and the clamping mechanism, powder can be weighed, and meanwhile, the contact amount of powder particles and the weighing body can be reduced, so that the adhesion rate of part of fine particles in the powder on the surface or in gaps of the weighing device is reduced, cross contamination of the powder is reduced, and the quality of the powder is improved. The medicine quality is improved.

The invention discloses a method for detecting the content of methanol in histidine, which adopts headspace sampling-gas chromatography and comprises the following steps: preparing a reference solution; preparing a test solution; performing chromatographic analysis; and measuring and calculating. According to the gas chromatography determination method for the methanol content in the histidine, high-sensitivity and high-accuracy detection of methanol residues in the histidine is realized by adopting a headspace sampling mode and combining with optimized chromatographic conditions. The method is high in specificity, wide in linear range, good in repeatability, excellent in durability and suitable for conventional detection of methanol residues in drug quality control.

The application discloses a method for rapidly and quantitatively determining biological activity of anti-PCSK9 monoclonal antibody drugs, and is based on HepG2 liver cancer cells, and utilizes the principle that specific binding of a series of concentration gradient PCSK9 monoclonal antibodies to a certain concentration of PCSK9 protein indirectly causes a dose response of DiI-LDL absorption to LDL receptors on the surface of liver cells, so that a biological activity detection method of the PCSK9 monoclonal antibody drugs is preliminarily established, and methodological verification proves that the method has strong specificity, good accuracy and high precision, and can be used for release detection of products, and has important significance for process control in a production process and drug quality control.

The utility model discloses a multi-functional sampler for medicine quality detection, which comprises a cylinder body, the outer wall of one side of the cylinder body is fixedly connected with a handle, the top of the cylinder body is in threaded connection with a top cover, the top of the top cover is fixedly connected with a feeding channel, the inner wall of the cylinder body is provided with a material collecting box, and the inner wall of the material collecting box is provided with a crushing treatment mechanism. And a ventilation treatment mechanism is arranged on the inner wall of the material collecting box. Solid medicine entering from the feeding channel can be loaded by arranging the material collecting box, the medicine can be crushed by arranging the crushing treatment mechanism in the material collecting box, the medicine can be blown away by arranging the ventilation treatment mechanism in the material collecting box, the medicine crushing uniformity is guaranteed, and the medicine crushing efficiency is improved. The medicine can be filtered by arranging the filter plate, and further grinding and refining treatment can be performed on the medicine by arranging the grinding and refining mechanism in the material guide channel, so that the refining degree of the medicine sample finally collected in the bottom cover is ensured.

The invention discloses an HPLC (High Performance Liquid Chromatography) detection method for ipragmine hydrochloride enantiomers, and belongs to the technical field of pharmaceutical analysis. The HPLC detection method provided by the invention comprises the following steps: dissolving ipragmine hydrochloride to be detected in a diluent to prepare a test solution; detecting the test solution by adopting normal-phase high performance liquid chromatography; the stationary phase of the normal-phase high performance liquid chromatography is silica gel of which the surface is covalently bonded with cellulose-tri (3-chloro-4-methyl phenyl carbamate); a mobile phase of the normal-phase high performance liquid chromatography is a mixed solution of normal hexane, isopropanol, trifluoroacetic acid and diethylamine. According to the detection method established by the invention, the ipragmine hydrochloride main peak and the S-configuration enantiomer impurity peak can be subjected to baseline separation, the separation degree can reach 4.5 or above, the method is high in specificity and sensitivity, and various methodology verification parameters all meet the drug quality control requirements.

The utility model discloses a tool for preventing dust from being generated by friction of a rubber plug, which relates to the technical field of rubber plug tools and comprises a vibration material channel, a flexible pad is detachably fixed on the vibration material channel through a mounting angle plate, the flexible pad is a flexible body which is made of flexible materials and has a smooth surface, and the flexible pad comprises a U-shaped pad. The U-shaped pad is embedded in the vibration material channel and attached to the inner wall of the vibration material channel. Due to the fact that the flexible pad is installed on the vibration material channel, the rubber plug is in flexible contact with the outer surface of the U-shaped pad in the moving process, the probability that the rubber plug is damaged due to friction is reduced, the probability of generating dust is reduced, and meanwhile the dust falling hole is formed, so that the rubber plug is prevented from being damaged. The dust falling holes are formed in the rubber plugs, so that dust possibly generated can be sucked away through the dust falling holes under the action of air flow, and therefore it is further guaranteed that no dust adheres to the rubber plugs after feeding, the sealing performance of packaging and the good medicine quality are guaranteed, and the qualified rate of packaged medicines is increased.

The invention belongs to the technical field of medicine quality detection, and particularly relates to a method for detecting bacterial endotoxin of a raw material medicine in bromhexine hydrochloride injection. According to the method, a mode of heating and dissolving the hydrochloric acid solution with the pH value of 4.0 is adopted, and the 001 * 7 type cation exchange resin microcolumn purification is combined, so that the inhibition effect of cation impurities in the raw material medicine on agglutination reaction of the tachypleus amebocyte lysate can be effectively eliminated, and a stable and uniform test solution is prepared. According to the process, the minimum non-interference dilution multiple is obviously reduced to 160 times, and the operation error and the detection sensitivity loss caused by high-multiple dilution are reduced. As the dilution ratio is greatly reduced, a tachypleus amebocyte lysate with the sensitivity of 0.25 EU.mL <-1 > can be selected in the method. Compared with a high-sensitivity reagent needed in the prior art, the reagent of the specification is easier to purchase and lower in cost, solves the problems that the high-sensitivity reagent is large in daily purchase difficulty and high in price, and is more suitable for conventional application in industrial quality control.

The utility model discloses a kind of donepezil hydrochloride tablets equivalent progressive addition mixing devices, it is related to pharmaceutical technical field, including fixed cylinder, the side of fixed cylinder is provided with the feeding mechanism for feeding, the top of fixed cylinder is fixedly connected with feeding pipe and is penetrated, the inside of fixed cylinder is provided with the stirring mechanism for mixing, the inner wall of fixed cylinder is slidably connected with mixing bucket one and mixing bucket two, the inner wall of fixed cylinder bottom end is fixedly connected with mixing bucket three, the bottom of mixing bucket one, mixing bucket two and mixing bucket three is all provided with the unloading mechanism for opening and closing, the side of mixing bucket one and mixing bucket two is all fixedly connected with fixed block, the bottom of fixed block is fixedly connected with spring and telescopic rod, solved if it is through the method of adding batch quantity to mix, not only time-consuming and laborious, while opening and closing feeding pipe every time, it will increase the risk of introducing foreign contamination source in the process of mixing drug, possibly affect the finished drug quality problem.

The invention discloses a pemetrexed-containing sustained-release implant and application thereof. The sustained-release implant is prepared from the following substances in percentage by weight: 5 to 60 percent of pemetrexed or pemetrexed sodium salt and 40 to 95 percent of sustained-release auxiliary materials. The preparation method has the beneficial effects that the degradable polymer auxiliary material is used as a dispersion matrix, the stability of medicine quality is ensured, the release period is prolonged, the release behavior is improved, no obvious sudden release or delayed release exists in in-vitro release, continuous production can be realized by adopting a solid-solid mixed hot-melt extrusion method, the production efficiency of the implant is remarkably improved, the production cost is reduced, and the preparation method is suitable for industrial production. The industrialization is easy; no solvent participates in the preparation process, no solvent residue exists, and the safety is high; the medicine is dispersed uniformly and released controllably; the preparation is safe and reliable in quality and more beneficial to clinical application.

The application provides a Dendrobium officinale powder release control method, relates to the technical field of drug quality control, and comprises the following steps: acquiring hyperspectral images of Dendrobium officinale powder under different temperature gradients and correcting; extracting average spectra and preprocessing by using an SNV algorithm; determining polysaccharide content; dividing a calibration set and a test set; extracting characteristic wavelengths by using a CARS algorithm; establishing a PLSR model under different temperature gradients; taking the characteristic wavelengths under all temperature gradients as input, and establishing a SO-PLS model; and determining whether to release or not by evaluating the probability risk of test set samples exceeding a control limit through bootstrap sampling. The application combines temperature control with hyperspectral technology, significantly improves prediction accuracy, introduces a probability risk evaluation mechanism, guarantees quality control, improves detection efficiency, and effectively solves the problems of long time consumption and low efficiency of traditional detection methods.

The invention relates to the field of medicinal chemistry, in particular to a preparation method of a benzamide compound, which can provide a standard reference substance for quality control and clinical medication safety detection of medicines and guarantee the safety and reliability of clinical medication.

The invention discloses a yak bone polypeptide and cordyceps militaris extract nano-composite and a method for determining the content of cordycepin, cordycepic acid and adenosine in a product of the yak bone polypeptide and cordyceps militaris extract nano-composite, and belongs to the technical field of food and drug quality detection. According to the method, dynamic ultrasonic-assisted extraction is creatively combined with a dual purification technology, and high-sensitivity detection is carried out in combination with a high performance liquid chromatography-triple quadrupole mass spectrometry method. Specifically, efficient release of target components is achieved through 40% methanol aqueous solution with the temperature controlled to be 45 DEG C under the synergistic effect of high-speed homogenization and intermittent ultrasound, and accurate quantification is conducted in an MRM mode after protein precipitation and secondary centrifugal purification are conducted through acetonitrile. According to the method, the extraction efficiency and the detection sensitivity of the trace components in the complex nano-composite are remarkably improved, and the detection limit is as low as ng / mL level. Compared with a traditional method, the method has the advantages of being easy and convenient to operate, high in accuracy, high in matrix interference resistance and the like, and a standardized solution is provided for quality control of related products.

The present application relates to the technical field of drug quality detection, and particularly relates to a rapid detection method for organic solvent residues in drugs. By collecting organic solvent residue parameter information of target drugs in a historical period, a comprehensive score benchmark containing the types and concentration weighted fusion is determined; based on the comprehensive score and statistical determination, the stability risk of a gas chromatography device is determined; if there is a risk, the first and second heating rates of the chromatography effluent are extracted, and the effectiveness of the chromatography effluent of the target drug is determined in combination with the peak shape index output by the hydrogen flame ionization detector; the heating rate direction and value are adjusted respectively for different peak shape abnormalities. The present application realizes active monitoring of device stability and self-adaptive correction of the heating rate, and overcomes the problem of low detection accuracy of organic solvent residues in drugs.