56results about How to "Perfect quality control method" patented technology

The invention discloses a method for simultaneous determination of organic acids and flavone components in polygonum viviparum, wherein the method comprises the following steps: (1) preparing a test sample solution; (2) detecting with LC-MS/MS; and (3) carrying out component qualitative analysis. On the basis of qualitative analysis of the components of the polygonum viviparum, a reference substance solution is prepared, and the contents of chlorogenic acid and gallic acid in the polygonum viviparum are also determined. 10 kinds of substances in the two active components of the organic acids and the flavones in the polygonum viviparum are determined at the same time for the first time, and a quality control method of the polygonum viviparum medicinal material is improved. The LC-MS/MS analysis detection method is adopted to be combined with a multi-wavelength switching procedure, and the method has the advantages of being simple, stable, fast, high in efficiency, high in sensitivity, good in repeatability and low in interference, can complete the detection of 10 kinds of substances within 1 h, and obtains a chromatogram which can contain multiple pieces of wavelength information at the same time.

The invention relates to a preparation method and a quality control method for a compound indigowoad leaf preparation. The preparation method comprises a step of preparing a basic remedy and a step of preparing a corresponding preparation. The basic remedy in the basic remedy preparation comprises the following compositions in part by weight: 360 to 440 parts of indigowoad leaves, 180 to 220 parts of lonicera confusa or honeysuckle flower, 90 to 110 parts of incised notopterygium rhizome, 90 to 110 parts of bistort rhizome, and 90 to 110 parts of rhubarb; the medicinal materials are decocted twice with conventional amount of water for 1 hour each time; the decoctions are mixed and filtered; the filtrate is concentrated to the relative density of between 1.08 and 1.32 at 60 DEG C; ethanol is added into the filtrate to ensure that alcohol content reaches 50 to 60 percent, the mixture is stood and is filtered, the filtrate is subjected to ethanol reclamation and is concentrated to an extract with the relative density of between 1.17 and 1.43 at 60 DEG C for later use; and the corresponding preparation is prepared according to a drug specification. The quality control method comprises the following steps of the identification of contents and the content determination of the contained compositions including the identification of the indigowoad leaves, the identification of the lonicera confusa or honeysuckle flower, the identification of the rhubarb, the identification of the incised notopterygium rhizome, the total content determination of emodin and chrysophanol in the rhubarb, and the content determination of chlorogenic acid. The methods can be applied to preparation of medicinal preparations for treating cold, influenza, parotitis and acute viral hepatitis.

The invention discloses a quality control method of a peach kernel qi activating decoction composition and belongs to the field of traditional Chinese medicine analysis. The method includes the steps that a peach kernel qi activating decoction fingerprint spectrum is established through high performance liquid chromatography, and chromatographic conditions are characterized in that a chromatographic column adopts octadecylsilane chemically bonded silica as filler; an ultraviolet detector is adopted as a detection instrument, and the detection wavelength of the fingerprint spectrum ranges from 210 nm to 250 nm; the flow rate ranges from 0.9 ml/ml to 1.1 ml/ml, the column temperature ranges from 25 DEG C to 35 DEG C, the detection wavelength ranges from 210 nm to 250 nm, the number of theoretical plates should not be smaller than 3,000 according to calculation of catechinic acid peaks, methyl alcohol serves as a moving phase A, a 0.1% phosphoric acid solution serves as a moving phase B, and gradient elution is carried out according to the following sequence: the gradient condition of elution detection of the fingerprint spectrum is defined in the specification. The fingerprint spectrum comprehensively reflects quality information of a peach kernel qi activating decoction, and therefore the quality of the peach kernel qi activating decoction can be more comprehensively and effectively controlled.

The invention provides a construction method of an HPLC (High Performance Liquid Chromatography) fingerprint spectrum of a salvia miltiorrhiza and radix puerariae depression relieving drug. The method comprises the steps of preparing a sample solution, preparing a reference substance solution, preparing efficient liquid chromatogram condition, and detecting to obtain the HPLC fingerprint spectrum of the salvia miltiorrhiza and radix puerariae depression relieving drug; 17 characteristic peaks are detected from the HPLC fingerprint spectrum of the salvia miltiorrhiza and radix puerariae depression relieving drug, including 14 characteristic peaks of salvia miltiorrhiza, and 3 characteristic peaks of radix puerariae. According to the construction method, the HPLC-DAD-TOF/ MS serial connecting technology is carried out to point out each chromatographic peak of the HPLC fingerprint spectrum of the salvia miltiorrhiza and radix puerariae depression relieving drug; meanwhile, the one-testing and multi-evaluation method is carried out to detect the content of main effective ingredients of the salvia miltiorrhiza and radix puerariae depression relieving drug, as well as detecting the content limit standard; therefore, the construction method of the fingerprint spectrum of the salvia miltiorrhiza and radix puerariae depression relieving drug has the advantages that the qualitative perforamnce and quantification performance are combined to construct a multi-information fingerprint spectrum with clear spectrum, clear ingredients and controllable content, thus the quality of the salvia miltiorrhiza and radix puerariae depression relieving drug can be comprehensively reflected, and the quality control method of the salvia miltiorrhiza and radix puerariae depression relieving drug can be effectively improved.

The invention belongs to analysis and detection of drugs, and particularly relates to a method for simultaneously detecting various effective components in compound lonicera granules with high performance liquid chromatography. The method is used for simultaneously detecting neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, forsythiaside A, forsythin, pinoresinol, baicalin and wogonin in the compound lonicera granules with the high performance liquid chromatography and comprises steps as follows: preparation of a reference substance solution, preparation of a solution of a testing product, determination, result calculation and the like. The method effectively solves the problems that quality evaluation of the compound lonicera granules is mainly about single-component content determination and the like in the prior art, and has the advantages of comprehensively characterizing active pharmaceutical ingredients of the compound lonicera granules and being high in repeatability and good in precision and the like.

The invention provides a method for controlling the quality of Resina Draconis drug. The method can be one or more of the following four methods for controlling the quality: (1) determining the content of total phenols; (2) determining the content of 7,4'-dihydroxyflavone; (3) determining the content of loureirin B; and (4) detecting high performance liquid chromatography fingerprint. The invention provides an accurate and precise method for controlling the quality with good stability, which can effectively control the quality of the Resina Draconis drug.

The invention discloses a quality control method of a traditional Chinese medicine compound preparation for treating osteoporosis. The quality control method comprises the following steps: (1) by taking eucommia ulmoides as a contrast medicinal material and taking pinoresinol diglucoside and geniposidic acid as comparison products, carrying out qualitative identification on eucommia ulmoides in the traditional Chinese medicine compound preparation by adopting a thin-layer chromatography; (2) by taking radix achyranthis bidentatae as a contrast medicinal material and taking beta-ecdysterone as a comparison product, carrying out qualitative identification on radix achyranthis bidentatae in the traditional Chinese medicine compound preparation by adopting the thin-layer chromatography; (3) by taking wolfberry fruits as contrast medicinal materials, carrying out qualitative identification on the wolfberry fruits in the traditional Chinese medicine compound preparation by adopting the thin-layer chromatography; and (4) determining the content of three active components (or index components) including epimedium glucoside, gentiopicroside and loganin acid in the traditional Chinese medicine compound preparation by adopting a high performance liquid chromatography. According to the quality control method, the quality of the traditional Chinese medicine compound preparation can be controlled very well, and the stability of a product production process is monitored; and the quality of the traditional Chinese medicine compound preparation is stable, uniform and controllable.

The invention provides a method for detecting a liver-enhancing medicine. The liver-enhancing medicine is composed of oriental wormwood, isatis root, angelica, white paeony root, danshen root, Radix curcumae, Astragalus mongholicus, Codonopsis pilosula, Rhizoma alismatis, sealwort, rehmannia, yam, hawthorn, large-leaved gentian, liquorice and medicated leaven. The detecting method comprises the step of detecting paeoniflorin, gentiamarin and salvianolic acid B in the liver-enhancing medicine by using a high efficiency liquid chromatography method, wherein conditions are as follows: a chromatographic column takes octadecylsilane chemically bonded silica as a filling material; mobile phases comprise a mobile phase A which is acetonitrile and a mobile phase B which is an acidic water solution, and the mobile phases are subjected to gradient elution; the flow velocity is 1.0mL/min; the column temperature is 30 DEG C; the detection wavelength is 210nm to 400nm; and the number of theoretical plates is calculated according to the paeoniflorin peak and should not be less than 6000. According to the detecting method provided by the invention, the content of active ingredients of the paeoniflorin, the gentiamarin and the salvianolic acid B in the liver-enhancing medicine can be detected at the same time, so that the active ingredients of the liver-enhancing medicine can be comprehensively represented, and the method has the characteristics of high precision, high stability and high repeatability.

The invention discloses a quality control method of a danggui sini decoction composition, wherein the method belongs to the field of traditional Chinese medicine analysis. According to the method of the invention, a fingerprint spectrum is established by means of high-efficiency liquid chromatography; a chromatographic column is a octadecylsilane chemically bonded silica chromatographic column; the column temperature is 25-35 DEG C; the flow velocity is 0.9-1.1ml/min; the detecting wavelength is 220nm; acetonitrile (A)-0.1% phosphoric acid solution (B) is used as a mobile phase, and gradient elution is performed according to a sequence which is represented in the description. The fingerprint spectrum according to the invention comprehensively reflects quality information of the danggui sini decoction composition, thereby realizing a purpose of more comprehensively and effectively controlling the quality of the danggui sini decoction composition.

The invention discloses a novel compound and a preparation method thereof, as well as a pharmaceutical composition with the compound as an active ingredient and the effects and the uses thereof. The inventive compound and the pharmaceutical composition with the compound as the active ingredient can be used for treating tumors, relieving tumor pain, and enhancing immunity.

The invention discloses a method for simultaneously determining content of three components for traditional Chinese medicine phyllanthus emblica through whole-time three-wavelength fusion. According to the method, a modern analysis detection method and an information processing method are combined, spectrogram information of marker components of Chinese herbal medicines is effectively fused, determined components are the largest ultraviolet absorption wavelengths, the signal to noise ratio of the determined components is increased, the defect of insufficient information amount of single wavelength and index detection can be overcome, and internal quality of Chinese herbal medicines can be reflected perfectly. The quality control method of the three components is simple in operation, stable and reliable, good in reproducibility, and capable of being applied to quality evaluation and control of Chinese herbal medicines and new drug development, particularly serving as one of indexes of quality control and identification for the traditional Chinese medicine phyllanthus emblica.

The invention relates to a quality control method of children lung clearing pills serving as a Chinese medicinal preparation. The method comprises the steps of: firstly, performing microscopical identification; secondly, identifying whether a prescription of the children lung clearing pills comprises platycodon root, pummelo peel, bitter orange, whiteflower hogfennel root and white mulberry root-bark or not by a thin layer chromatography; and lastly, detecting the baical skullcap root content of the prescription of the children lung clearing pills by taking baicalin as a comparison substance by a liquid chromatography. The quality standard of the children lung clearing pills is enhanced and perfected; based on the original standard, a microscopical identification method is provided for liquoric root, inula flower, baical skullcap root, radish seed and perilla fruit; a thin-layer identification method for whiteflower hogfennel root, white mulberry root-bark, platycodon root, bitter orange and pummelo peel in the prescription is drawn up; and a content test method for the baical skullcap root in the prescription is set up by taking baicalin as a comparison substance. By a modified quality standard, the quality control method of a product is enhanced, and counterfeit medicaments and substandard medicaments can be inspected more correctly; and the standard plays an important role in the modernization and overseas development of traditional Chinese medicines.

The invention provides a quality control method for pharmaceutic preparation containing sanguis draconis extract, which can adopt any one or more of the four quality control methods: (1) adopting an ultraviolet-visible spectrophotometry to measure the content of 7,4'-dyhydroxyl flavone; (2) adopting a high performance liquid chromatography to measure the content of lourerin B; (3) adopting the high performance liquid chromatography to detect finger-print; and (4) adopting the high performance liquid chromatography to detect dissolution by combining with a dissolution measurement method. The quality control method provided by the invention has good accuracy, precision and stability, and can effectively control the quality of pharmaceutic preparation containing the sanguis draconis extract.

The invention provides a method for preparing ligustrum lucidum ait. The method comprises the following steps: weighing the raw medicinal material of ligustrum lucidum ait, and removing impurities and stems; washing, drying, and screening dust; uniformly stirring with black bean juice; braising until the ligustrum lucidum ait is soft; and steaming at high pressure, and drying. The invention further provides a ligustrum lucidum ait preparation prepared by the method. By adopting the method, the time for preparing the medicinal material can be effectively shortened, the economic benefit can be increased, and the production efficiency of enterprises can be improved; and the medicinal material prepared by the method has stable content and excellent quality.

The invention belongs to the field of medicine analysis, and particularly relates to a high performance liquid chromatography method for determining nicergoline related substances. According to the high performance liquid chromatography method, a filler obtained by mixing strong cation exchange resin and a reversed phase C18 according to a volume ratio of 1 to 4 is used as a filling agent, acetonitrile is used as a mobile phase A, a phosphate buffer is used as a mobile phase B, the mobile phase A and the mobile phase B are mixed according to a ratio of 30 to 70 for isocratic elution, the detection wavelength is 288nm, and the column temperature is 30 DEG C. By the high performance liquid chromatography method, the content of an impurity D can be accurately determined and known impurities C, B, A, G, F and H and other unknown impurities in nicergoline can be simultaneously determined.

The invention belongs to the technical field of medicine, and particularly relates to a 2-ethyl-1,3-hexanediol purifying process and a related substance detecting method thereof. The purifying process is a calcium hydride reducing process. The detecting method comprises the following steps that 1, a system suitability solution is prepared, wherein an impurity1, an impurity 2, an impurity 3 and 2-ethyl-1,3-hexanediol are taken to be prepared into the system suitability solution; 2, a test solution is prepared, wherein 2-ethyl-1,3-hexanediol is taken to be prepared into the test solution; 3, a contrast solution is prepared, wherein the test solution is taken to be prepared into the contrast solution; , the system suitability solution, the contrast solution and the test solution are injected into a gaschromatograph, and a chromatogram is obtained; 5, according to the chromatogram of the system suitability solution, the contrast solution and the test solution, the content of know impurities, unknown impurities and total impurities in the test solution is obtained through calculation.

The invention discloses a quality control method for an artemisia rupestris herb extract. The method is characterized in that the content of general flavone in the artemisia rupestris herb extract is determined by taking linarin as a reference substance, and by using ultraviolet spectrophotometry. High performance liquid chromatography is utilized to assaying the content of the linarin. The quality control method provided by the invention is good in accuracy, stability and repeatability, the quality of the artemisia rupestris herb extract can be controlled effectively, and the quality control method can be applied to massive industrial production.

The invention relates to a method for detecting the residual of solvent in idelalisib, and concretely relates to a method for detecting the residual of various organic solvents in idelalisib by gas chromatography. The method comprises the following steps: 1) preparing an N,N-dimethylformamide solution of idelalisib, used as a test solution; 2) mixing all organic solvents to be detected with the N,N-dimethylformamide to form a mixed reference substance solution; 3) respectively carrying out gas chromatography detection on the test solution obtained in step 1) and the mixed reference substance solution obtained in step 2) to obtain chromatograms; and 4) calculating the content of every organic solvent to be detected in idelalisib according to peak areas through an external standard technology. The detection method can achieve easy, fast and accurate detection of the residual amounts of the organic solvents to be detected in the idelalisib. The detection method also has the advantages ofgood applicability, good durability, good precision, good sensitivity, good accuracy, good repeatability, good recovery rate, good stability of the test solution and improvement of the quality controlmethod of the above medicine.