140 results about "Drug standards" patented technology

The invention discloses an enzyme immune agent box for detecting lake drugs of animal foodstuff; it also provides a method for using the agent to detect the lake drugs residue. The agent box comprises: enzyme mark plate which coats lake drugs antigen or antibody, lake drugs mouse monoclonal antibody or polyclonal antibody working solution, enzyme mark antibody or enzyme mark lake drugs antigen, lake drugs standard solution, base material color developing solution, compression cleaning liquid, ending solution and compression twin solution. The invention also discloses a method for applying the detecting method, which comprises: first doing sample front process, then using the agent box to detect, at last analyzing the detected result.

The invention belongs to the technical field of traditional Chinese medicine, relating to a Xinjiang chamomile planting technique. The planting technique provided by the invention solves the technical problems in chamomile seeding, staged fertilization, field management, harvesting, processing and the like, and realizes standardized planting of chamomile. Chamomile products planted by the technique provided by the invention meet the drug standard of ministry of public health of China, part of Uygur medicine, 1998, and the yield per mu of chamomile dried flowers can reach 60-100 kilograms.

The invention relates to a quality test method of Dianxianning tablets (WS3-B-2823-97) in volume 4 of health ministry drug standard of People's Republic of China (traditional Chinese medicine set prescription preparation). The quality test method of the Dianxianning tablets improves the quality control standard of the Dianxianning tablets, establishes a test method of volatile ether extract in the preparation, cancels a physical-chemical reaction identification method with poor specificity, improves a thin-layer chromatography identification method of valeriana jatamansi jones, enables the method to be more accurate, increases the thin-layer chromatography identification methods of uncaria and acorus gramineus and ensures that the compound preparation has higher quality standard level.

The invention provides a preparation method of naringenin. The preparation method comprises the following steps: (1) preparing solution of naringin in lower alcohol or lower ketone solvent, leading the naringin in the prepared solution to be subjected to acid hydrolysis in an acidic condition to obtain naringenin, distilling under reduced pressure to remove solvent to obtain a naringenin crude product; (2) dissolving the naringenin crude product in absolute ethanol or absolute methanol, adding active carbon, stirring to decolor; and (3) filtering the active carbon, separating and purifying the prepared solution to obtain the naringenin. The preparation method has the advantages of few reaction steps, less used solvent, less emission of the 'three wastes', mild reaction condition and complete reaction and easy operation, is suitable for industrial production, and has higher practical value; and the prepared product has more stable quality, the purity is higher than 99 percent, which is higher than the drug standard.

The invention provides an enzyme immune agent box for detecting chloromycetin drugs of animal foodstuff which comprises: enzyme mark plate which coats chloromycetin drugs antigen or antibody, chloromycetin drugs mouse monoclonal antibody compression solution, chloromycetin drugs standard solution, enzyme mark material, base material color developing solution, compression cleaning liquid, ending solution and compression twin solution. The invention also discloses a method for applying the detecting method, which comprises: first doing sample front process, then using the agent box to detect, at last analyzing the detected result.

The invention provides an enzyme immune agent box for detecting sulpha drugs of animal organization, which uses enzyme immune method to detect the preprocessed animal organization, honey, urine, milk. The enzyme immune agent box comprises: enzyme mark plate which coats sulpha drugs antigen or antibody, sulpha drugs mouse monoclonal antibody working solution, enzyme mark antibody or sulpha drugs antigen solution, sulpha drugs standard solution, base material color developing solution, compression cleaning liquid, ending solution and compression extracting solution. The invention also discloses a method for applying the detecting method, which comprises: first doing sample front process, then using the agent box to detect, at last analyzing the detected result.

The invention provides a kit for detecting anti-depressant drugs in serum and plasma by liquid chromatography tandem mass spectrometry. The kit comprises drug standard substances, drug internal standardization compounds, drug extraction compositions, negative plasma and a diluent. The drug standard substances comprise amfebutamone, oxybupropion, citalopram, Escitalopram, venlafaxine, O-desmethylvenlafaxine, duloxetine, fluoxetine, norfloxetine, fluvoxamine, mirtazapine, paroxetine, sertraline and trazodone. The drug internal standardization compounds comprise amfebutamone-d9, oxybupropion-d6,citalopram-d6, venlafaxine-d6, O-desmethylvenlafaxine-d6, duloxetine-d3, fluoxetine-d6, norfloxetine-d6, fluvoxamine-d4, mirtazapine-d3, paroxetine-d6, sertraline-d3 and trazodone-d6. The drug extraction compositions comprise, by volume, 60% of methanol solution, 20% of acetonitrile solution, 10% of isopropyl alcohol solution and 10% of purified water. The diluent comprises 50 % of methanol waterfluid. The kit can be used for simultaneous detection of the anti-depressant drugs and active metabolites, the detection time is short, and flux is high.

The invention provides a synthesis method of middle-molecular-weight hydroxyethyl starch. The synthesis method comprises the following steps: carrying out hydroxyethyl substitution reaction on waxy corn starch hydrolyzate and a hydroxyethyl substituting agent under the conditions that water is used as a solvent and sodium hydroxide is taken as a catalyst; and carrying out ultrafiltration interception membrane separation and activated carbon decoloration, filtering, and carrying out spray drying on filtrate so as to obtain the white powdery middle-molecular-weight hydroxyethyl starch product. According to the invention, an adopted aqueous phase synthesis method has the advantages that an ideal molar degree of substitution (MS) of hydroxyethyl and an ideal substitution position ratio (C2:C6) are conveniently controlled in the reaction, and the byproducts of the reaction are easy to separate; and under the condition of the aqueous phase synthesis method, the reaction is a room temperature reaction, reactants and the catalyst are completely dissolved in the reaction system, the substitution positions are uniformly distributed in the product, the reaction byproducts such as sodium chloride, chlorohydrin, cyclochloroethane, glycol and the like can be easily removed once through a membrane separation technology, the obtained product has proper MS and a ratio of C2:C6, and the obtained product quality can reach or be superior to the existing national drug standard.

The invention discloses an ascites pill and a quality control method for the preparation of the ascites pill, wherein the preparation is provided with a plurality of formulations by adding conventional accessories according to the ascites pill preparation formula in the second volume of traditional Chinese medicine set prescriptions preparations of Drug Standards of Ministry of Health of the People's Republic of China. The quality control method which comprises a content determination or content identification or one of the content determination and the content identification increases the thin layer identification of euphorbia Gansui Root, jujube oleanolic acid and elecampane based on the original quality standards, revises the thin layer identification of melanterite and builds the content determination for the green copperas (FeSO4 7H2O) and improves the controllability of the product quality.

The invention relates to portable drug field identification equipment and method. The equipment comprises a control module, a rectangular ion trap mass spectrome analysis module, a data collection andprocessing module, a spectrogram recognition and warning module and a result output module, wherein a drug test specimen or a practical sample generates current signals after passing through identification equipment; the current signals are converted into voltage signals; an inside clock outputs time signals; voltage signals are converted into digital signals; time signals and digital signals areextracted; normalization and base line correction processing are performed; if a sample is a drug standard sample, a standard spectrum base is generated; if the sample is a practical sample, a samplespectrogram is generated; the sample spectrogram and the standard spectrum base are subjected to feature comparison. The equipment and the method have the advantages that the size is small; the weight is light; complicated pre-treatment is not needed; liquid samples or solid samples are directly subjected to feeding sample detection; the automatic recognition, warning and printing on the detection result can be realized; the single sample detection and warning time is shorter than 2s; the equipment and the method are suitable for drug field investigation and seizing and identification; wide application prospects are realized.

The invention discloses a method for producing L-tyrosine through an enzyme method. The method comprises the following steps of adopting a fermentation method to produce pyruvic acid, adding beta-tyrosinase, phenol and NH4Cl at the fermentation anaphase of the pyruvic acid, converting the generated pyruvic acid into the L-tyrosine, and obtaining fermentation liquor containing the L-tyrosine; heating the fermentation liquor containing the L-tyrosine to be 70 DEG C to 90 DEG C, and acidifying until L-tyrosine crystals are completely dissolved; adding activated carbon to decolor, after decoloring, filtering by utilizing a ceramic membrane, removing bacteria, albumen and the activated carton, carrying out secondary filtering on obtained clear liquid through an acid-resisting liquid cartridge filter; adjusting the pH of the secondary filtered clear liquid to be 5.0 to 7.0, cooling to crystallize, centrifuging, and obtaining the L-tyrosine. According to the method for producing the L-tyrosine through the enzyme method provided by the invention, the process is simplified, the production efficiency is improved, the obtained L-tyrosine is high in purity and yield, the purity of the obtained tyrosine is remarkably improved and reaches to 98.0 percent or above compared with a traditional extraction method, and various tyrosine drug standards are met.

The invention relates to a quality detection method for Jinhuaxiaocuo pills (WS3-B-2169-96) in the eleventh volume of Drug Standard of Ministry of Public Health of the Peoples Republic of China (Chinese patent medicaments). Through the quality detection method for the Jinhuaxiaocuo pills, the quality control standard for the Jinhuaxiaocuo pills is improved, a method for detecting the content of a main ingredient in a preparation is established, physical and chemical reaction identification with poor specificity is eliminated, and thin layer chromatography identification methods for geniposide and berberine hydrochloride are improved to have the advantages of simplness and clear characteristic spots, thin layer chromatography identification methods for rhubarb, golden thread, amur corktree bark and baical skullcap root in the Jinhuaxiaocuo pills are increased, and the high quality standard level of the compound preparation is guaranteed.

The invention discloses a preparation method of a propofol fat emulsion injection. The preparation method comprises the following steps: uniformly mixing soybean oil, lecithin and oleic acid and adding propofol; spraying an oil phase into a water phase under the protection of nitrogen gas to prepare emulsion; shearing the emulsion to obtain primary emulsion; homogenizing the primary emulsion under the pressure of 10000psi-20000psi to prepare an emulsion semi-finished product; and filtering, inflating nitrogen and sterilizing to prepare the propofol fat emulsion injection. According to the preparation method, the grain diameter uniformity is enhanced and the disadvantage that the grain diameter deviation of the primary emulsion is too great is improved; the stability of finished-product emulsion is improved; the average grain diameter of the detected emulsion is 210nm-230nm and the grain diameter deviation is 0.20-0.30; the requirements on the grain diameters by the fat emulsion injection are met; the emulsion grains with the size being more than 1 micron are not detected, and the grain diameters are obviously better than the standards that the content of the emulsion grains with the size being 1 micron in emulsion large grains of national drug standards is not more than 3%; the physicochemical properties are stable, the toxic side effect is low, the pains caused by injection are reduced, and the compliance of using drugs by patients is increased, so that the application prospect is very good.

The invention provides a kit for determining antianxiety/hypnotic type drugs in serum and plasma through liquid chromatography tandem mass spectrometry. The kit comprises the following constituents: drug standards comprising bromazepam, clonazepam, diazepam, lorazepam, midazolam, nitrazepam, oxazepam and Temazepam; drug internal standard compounds comprising alprazolam-d5, clonazepam-d4, diazepam-d5, lorazepam-d4, midazolam-d4, nitrazepam-d5, oxazepam-d5 and Temazepam-d5; drug extraction compositions comprising, by volume, 60% of methanol solution, 20% of acetonitrile solution, 10% of isopropanol solution and 10% of purified water; negative plasma; and diluent: 50% of carbinol water solution. The kit can be used for simultaneously determining antianxiety/hypnotic type drugs and active metabolites thereof, and has the advantages of short determination time and high flux.

The present invention discloses a quinolone drug chemiluminescence enzyme-linked immunodetection kit, which comprises a kit body, an enzyme label plate placed inside the kit body, and reagents placed inside the kit body, and is characterized in that every hole of the enzyme label plate is coated with coating antigen, the coating antigen is a norfloxacin derivative and carrier protein conjugate, and the reagents comprise quinolone drug monoclonal antibody, horseradish peroxidase-labeled goat anti-mouse antibody, a series of quinolone drug standard solutions, a concentrated phosphate buffer, a concentrated washing solution and a chemiluminescence solution. The quinolone drug chemiluminescence enzyme-linked immunodetection kit has characteristics of high sensitivity, simple and rapid detection, high accuracy, and more drug detection types, provides a substantially reduced operation time compared to the conventional colorimetric ELISA method, and can be used for detection of residues of the 12 quinolone drugs in animal tissues (pork, chicken, pork liver and chicken liver), aquatic products (fish and shrimp) and honey.

The invention discloses a traditional Chinese medicine preparation, in particular a traditional Chinese medicine preparation for treating ophthalmic diseases and a preparation method thereof. The prepared preparation is powder, ointment or gelata and belongs to the field of traditional Chinese medicine. The preparation has the advantages that the prescription originates from a classic and famous transcription of the Drug Standard of Ministry of Public Health of the People's Republic of China, the preparation method induces an ultrafine grinding technology for the first time, the raw materials (especially minerals and animal medicines) have thorough grinding, small granularity and large specific area, active ingredients can be better exposed to be in a release condition, so the dissolution rate of the active ingredients is greatly enhanced, the biological availability is enhanced multiply and the general reaction of clinic curative effect is good; at the same time, the foreign body sensation is obviously relieved and granular sensation almost disappears when the preparation is used by a suffer, thereby the preparation is an ideal medicine for treating ophthalmic diseases, is deeply popularized with suffers and has wide market prospect.

The invention discloses an enzyme linked immunosorbent assay kit for detecting drugs in urine, saliva, blood and hairs in the technical field of the prohibited goods detection and analysis as well as a detection method of the drug testing enzyme linked immunosorbent assay kit. The kit comprises a drug standard substance solution, a drug specificity antibody, an elisa plate which is coated with the drug specificity antibody, a drug antigen enzyme marker, a color developing agent, concentrated washing liquor, a termination solution and a sample dilute solution. The enzyme linked immunosorbent assay kit has characteristics of high specificity, high sensitivity, high accuracy and the like and plays an important role in drug testing.

The embodiment of the invention relates to a marketed drug information standardization method and device, a server and a computer readable storage medium. The method comprises the following steps: collecting drug standard data from drug standards; carrying out structured processing on the collected drug standard data to form structured drug standard data; collecting drug data, wherein the drug data comprises a drug name and an approval document number; matching the acquired drug data in the structured drug standard data; and in the case of successful matching, automatically retrieving a drug specification corresponding to the drug data on a network, and storing the acquired drug data and the acquired drug specification in association in corresponding entries in a structured drug information database. Therefore, the invention provides the method for collecting and providing standardized marketed drug information more quickly and comprehensively.

A method for detecting a generic drug pretended to be an reference listed drug comprises the following steps: step 1, obtaining reference listed drug standard spectral data and to-be-measured sample spectral data; step 2, choosing reference listed drug characteristic peaks and to-be-measured sample characteristic peaks; step three, screening matched characteristic peaks in the to-be-measured sample characteristic peaks conforming to matching conditions, and calculating the number of the matched characteristic peaks; and step four, comparing a difference value between the number of the reference listed drug characteristic peaks and the number of the matched characteristic peaks with a predetermined standard threshold t, when the difference value is less than or equal to t, judging a to-be-measured sample to be a real drug, and when the difference value is greater than t, judging the to-be-measured sample to be a fake drug, wherein t is an arbitrary integer value of 1-10. According to the method provided by the invention, the difference between the generic drug and the reference listed drug can be intuitively and comprehensively displayed, and a drug system with relatively low API content and with the other components in the drug and with relatively large interference on API characteristic peaks also can be effectively detected.

The invention provides a method for detecting drugs in human bodies. The method comprises the following steps of: preparing a series of mixed drug standard solutions with gradient concentrations by using 14 drug standards; respectively performing mass spectrum detection on a sample and the mixed drug standard solutions by adopting a liquid chromatography-tandem mass spectrometry (LC-MS/MS), and determining one or more than one drugs in the mixed drug standard solutions in the sample on the basis of a mass spectrum detection result so as to achieve qualitative analysis; drawing a standard curve, detecting the peak area of a parent ion/child ion pair corresponding to at least one of the 14 drugs in the sample, and obtaining the concentration of the sample according to the standard curve for quantitative analysis, wherein the sample is optionally derived from human saliva, and optionally, the sample is pretreated. The method for detecting drugs in human bodies has the advantages of convenient material obtaining, the small dosage, the low detection limit and quantitative limit, the high accuracy, the high efficiency and the like.

The invention discloses an Orthosiphon n-butanol fraction medicine for treating chronic nephritis and a preparation method thereof, belonging to the technical field of medicine. The content of phenolic acid in the Orthosiphon n-butanol fraction is 50-60 wt%. The preparation method comprises the following steps: boiling Orthosiphon extraction liquid and carrying out condensation, extracting with chloroform, and then extracting with n-butanol. According to the invention, the active site of treating chronic nephritis by Orthosiphon is the n-butanol fraction, the composition and content of the ingredients are clear; by extraction and purification, ineffective substances for treating chronic nephritis are removed, the dosage is reduced, and patients compliance with medication is increased. Simultaneously, the invention is good for the establishment of drug standard and quality control, and is convenient for development and application of various preparations.

The invention discloses a method for optimizing a freeze-drying curve of a urokinase freeze-drying preparation for injection. According to the technical scheme, reasonable pre-freezing and sublimationtemperatures and reasonable vacuum degrees during drying are selected to improve the properties of freeze-dried products. The quality standards of the freeze-dried products conform to various indexesspecified by the national drug standard. The method has the advantages of stable characters, attractive appearance and the like for freeze-dried products.

The invention relates to a method for detecting quality of a lung clearing and phlegm eliminating pill in Volume 12 of Drug Standard of Ministry of Public Health of Peoples Republic of China (traditional medicine prescribed preparation). The method for detecting quality of a lung clearing and phlegm eliminating pill comprises microscopic identification, a thin layer chromatography identification method for orange peel and bitter orange, a thin layer chromatography identification method for ephedrine hydrochloride in herba ephedrae, a thin layer chromatography qualitative identification method for balloon flower, and scutelloside content measurement. The invention enhances the quality control standard of the lung clearing and phlegm eliminating pill, establishes content measuring and detecting indexes in main medicines of preparation and a detecting method thereof, increases the thin layer chromatography qualitative identification methods for orange peel, bitter orange, ephedrine hydrochloride and balloon flower, and ensures the higher quality standard levels of the compound preparation.

The invention discloses a detection method of traditional Chinese medicine preparations. The detection method is used for detecting active ingredient content of f traditional Chinese medicine preparations, ensuring that medicine quality accords with drug standards, and ensuring stability of curative effect of the traditional Chinese medicine preparations. The detection method comprises following steps: TLC is adopted for qualitative identification of radix achyranthis bidentatae, radix salviae miltiorrhizae, fructus gardenia, herba epimedii, and semen cassia in the traditional Chinese medicine preparations, and HPLC is adopted for detection of contents of salvianolic acid B and gastrodin in the traditional Chinese medicine preparations.

The invention provides a traditional Chinese medicine granule for treating postpartum lochiorrhea and lesser-abdominal pain and a preparation method thereof, and belongs to the field of medicine. The granule and the preparation method overcome the defects that according to an existing preparation method, the volatile oil extraction rate is low, the utilization rate is low, losses of effective components of medicine materials are large, particle appearance is not good, and dissolubility is poor. The preparation method includes the steps that seven decoction pieces of angelica sinensis, rhizome chuanxiong, peach kernels, honey-fried licorice roots, ginger charcoal, dried leonurus and safflower are obtained according to the formula of new granule for postpartm troubles (the fifth volume of drug standard traditional Chinese medicine prescription preparation of Ministry of Health of the People's Republic of China), the materials are smashed into coarse powder to extract volatile oil through a microwave method, a mixed volatile oil cyclodextrin clathrate compound is prepared through a colloid milling method, residues are decocted twice with water, decocted liquid of the first time and decocted liquid of the second time are combined and filtered, filter liquid is refrigerated, supernate is sucked to be subjected to centrifugation twice through a tubular centrifugal machine, then supernate is decompressed and concentrated to be clear ointment with the relative density being 1.05-1.30 (60 DEG C), the clear ointment is added into the cyclodextrin clathrate compound and evenly mixed into suspension, the suspension is sprayed, granulated, screened and subpackaged, and the granule is obtained. The invention further discloses application of novel particles for postpartm troubles in the aspect of treatment of climacteric syndromes.

The invention belongs to the technical field of medical analysis and particularly relates to a method for determining the contents of ginsenosides Rg1 and Re in a Xinnaoning tablet. According to the method, the technical difficult problems that active pharmaceutical ingredients of the Xinnaoning tablet are difficult to separate, and the contents of the ginsenosides Rg1 and Re in the Xinnaoning tablet cannot be simultaneously determined by adopting a high performance liquid chromatography method, which are always expected to be solved by people but still are not solved, are solved. By using the provided gradient elution high performance liquid chromatography method, the ginsenosides Rg1 and Re are successfully separated from other peaks. The method disclosed by the invention has the advantages of simplicity and convenience in operation, lower cost and shorter detection time, and can be used as a standard quantitative determination method in the drug standard of the Xinnaoning tablets.