356results about How to "Guaranteed clinical efficacy" patented technology

The invention discloses a method for controlling the quality of ginkgo leaves and an extract thereof. After the screening of a great quantity of experiments, the method adopts ultra-high performance liquid chromatography for detection; and the method can be used for detecting three types of components including flavone, terpene lactones and phenolic acid, twenty-four active compounds in total, in the ginkgo leaves and the extract of the ginkgo leaves. The results of the experiments prove that the method is high in detection sensitivity and good in stability, and can be used for objectively, comprehensively and accurately evaluating the quality of ginkgo leaf medicines, the extract of the ginkgo leaves and ginkgo leaf preparations, thus having important significance on controlling the quality and guaranteeing the clinical treatment effect.

The invention relates to a colloid bismuth pectin compound and a quality control method of pharmaceutical compositions of the colloid bismuth pectin compound, and specifically provides a colloid bismuth pectin compound, new quality control indexes of pharmaceutical compositions of the colloid bismuth pectin compound and a detection method of the colloid bismuth pectin compound and the pharmaceutical compositions of the colloid bismuth. In the prior art, the quality of products having poor efficacy can not be well controlled because the efficacy-related indexes are not controlled strictly in the existing quality control methods of colloid bismuth pectin and pharmaceuticals thereof. Based on the existing quality control methods of colloid bismuth pectin and pharmaceuticals thereof, the following detection items and indexes are added: intrinsic viscosity, gel property, uniformity and galacturonic acid content. The invention can effectively ensure clinical efficacy of products, make the product quality standards more scientific, reasonable and controllable, and has great significance in quality control of the colloid bismuth pectin and the pharmaceutical preparation of colloid bismuth pectin.

The present invention provides a butyl phthalide raw material drug product with the butyl phthalide content not less than 99.0%; the raw material drug is stable in quality, and can ensure the clinical curative effect and drug safety of a butyl phthalide preparation.

The invention discloses a quality control method of a sunset abelmoschus root medicinal material, as well as an extract and a preparation of a sunset abelmoschus root. With the adoption of a liquid chromatographic separation technique, the contents of seven flavone components in the sunset abelmoschus root are calculated with the aid of a one-detection multi-evaluation method by calculating a correction factor. The method is high in detection sensitivity and good in stability, can evaluate the quality of the sunset abelmoschus root medicinal material, the extract thereof and the preparation of the sunset abelmoschus root objectively, comprehensively and accurately, can solve the problem that the quality of the medicinal material and the preparation thereof cannot be controlled objectively and reasonably due to the lack of a control, and has a great significance in controlling the quality and ensuring the curative effect.

The invention provides a butylphthalide medicine active composition, which comprises the following ingredients: first ingredients: the butylphthalide content is higher than or equal to 98.0 percent; second ingredients: the second ingredients are one kind of materials or several kinds of materials selected from methylene phthalide, ethylene phthalide, propylene phthalide, butane phthalide, amylene phthalide, phthalide, methyl phthalide, ethyl phthalide, propyl phthalide and amyl phthalide, in addition, the content of the second ingredients is higher than 0 but is lower than or equal to 2.0 percent, when the second ingredients comprise any one kind of materials from methylene phthalide, ethylene phthalide, propylene phthalide, butane phthalide and amylene phthalide, the content of any one kind of included ingredients does not exceed 0.5 percent, and when the second ingredients comprise any one kind of materials from phthalide, methyl phthalide, ethyl phthalide, propyl phthalide and amyl phthalide, the content of any one kind of included ingredients does not exceed 1.0 percent. The quality of the medicine active composition is stable, and the clinic curative effect and the medication safety of the butylphthalide preparation can be ensured.

The invention discloses a method for detecting a fingerprint spectrum of Guigui zhugan decoction. The fingerprint spectrum is established by the following steps: S1, preparing a Guigui zhugan decoction test sample solution; S2, preparing a reference solution; S3, absorbing the test sample solution and the reference solution precisely and respectively and injecting the solutions into a liquid chromatograph, and recording a chromatogram map; and S4, outputting a Guigui zhugan decoction fingerprint spectrum obtained in the S3 into a traditional Chinese medicine chromatographic fingerprint similarity evaluation system, selecting chromatographic peaks exiting in all chromatogram maps of Guigui zhugan decoction with different batches as common peaks and generating a contrast fingerprint spectrumof the Guigui zhugan decoction based on an average value calculation method, and calculating relative retention time and relative peak areas of all common peaks. According to the invention, the detecting method having advantages of high stability and precision, and high reproducibility and the like is capable of analyzing the effective components in the Guigui zhugan decoction accurately and hasthe important significance in evaluating the quality of the Guigui zhugan decoction comprehensively and objectively.

The invention belongs to the technical field of preparation of veterinary Chinese medicinal oral liquid, and in particular relates to a method for preparing veterinary heat-clearing and detoxifying oral liquid. The method comprises the steps of crushing of raw medicinal materials, screening, enzymolysis, decocting, micro-filtration, ultra-filtration, reduced pressure concentration, volume setting and the like. Compared with the prior art, the method has the advantages that plant cell walls can be hydrolyzed with an enzyme more effectively, so that the dissolution rate of active ingredients of the medicinal materials is improved; and by combining the micro-filtration and ultra-filtration technologies, impurities are effectively removed from the medicinal liquid, the clarity of the solution is higher, the loss of the active ingredients of the medicinal materials is less, and the clinical treatment effect of the medicaments is well guaranteed. By reasonably matching the bio-enzyme and using the bio-enzyme to assist in extracting the active ingredients in the medicinal materials, the content of key effect ingredients in the medicinal liquid is effectively improved, so that the quality of the product is well improved, and the oral liquid has good popularization and application values.

The invention discloses a preparation method and a detection method of a roflumilast material. The preparation method comprises the following steps: mixing 3-cyclopropyl methoxy group-4-difluoro methoxy group benzoic acid SM-1, thionyl chloride, dimethyl formamide with toluene, and carrying out an acylating chlorination reaction to obtain a midbody 1; mixing 3,5-dichloro-4-aminopyridine SM-2, tetrahydrofuran with potassium tert-butoxide and carrying out a salt forming reaction to obtain tetrahydrofuran solution of a midbody 2; and then mixing the midbody 1 and the midbody 2 with tetrahydrofuran, carrying out amidation to obtain a crude product of roflumilast, and refining the crude product of roflumilast to prepare the roflumilast material. Aiming to overcome the shortage of the prior art, the preparation process of the roflumilast material is optimized, so that the curative effect for treating diseases such as chronic obstructive pulmonary disease (COPD) is more remarkable; and besides, a systematic, complete and effective composition identifying and content measuring method is provided, so that the quality of the medicine can be effectively controlled, and the clinical effect is ensured.

The invention discloses a method for detecting the quality of a medicinal preparation for curing hepatitis. The method comprises the following steps of: detecting characters, identifying, inspecting and determining content, wherein identification means identifying astragalus, red paeony root and root of red-rooted salvia in the preparation by adopting thin layer chromatography; and content determination means determining icraiin content of the preparation through high performance liquid chromatography or simultaneously determining tetrandrine content and fangichinoline content of the preparation through the high performance liquid chromatography under the same chromatographic condition. The method has the advantages of effectively controlling and ensuring stable, controllable, high-efficient and safe quality of Jinma Gantai tablets and Jinma Gantai capsules for curing the hepatitis, ensuring clinical curative effect of the preparation and meeting medical requirements, along with scientificity, reasonability, high accuracy and high reproducibility.

The invention discloses a callicarpa nudiflora medicine, an intermediate and a fingerprint detection method of a preparation. The method comprises the following steps: (a) preparation of a reference solution; (b) preparation of a test solution; (c) chromatographic condition; (d) formulation of a standard fingerprint of isoacteoside as a reference peak; and (e) quality control of the fingerprint. According to the above method, a pretreatment method of each tested object is simple, characteristic constituents are retained completely, stability is good, precision is high, and there is certain specificity. The separation effect of each characteristic peak in the fingerprint is good. The callicarpa nudiflora medicine, the intermediate and the fingerprint of the preparation have good correlation. The method can be used for identifying quality of the callicarpa nudiflora medicine and increasing production process controllability of the callicarpa nudiflora preparation, and is helpful for guaranteeing quality stability and clinical efficacy of the callicarpa nudiflora preparation. The invention also discloses the callicarpa nudiflora medicine obtained according to the above fingerprint detection method, the intermediate and the standard fingerprint of the preparation.

The invention discloses an oily composition which is extracted from Litsea lancilimba and Blumea mollis and contains 1, 8-eudesmin and blumeatin. The oily composition is oily substance extracted from the Litsea lancilimba and the Blumea mollis. The main compositions by weight percentage of the oily composition are: 2.01 to 19.61 percent of the 1, 8-eudesmin, 0.2 to 9.40 percent of sabinene, 0.40 to 4.71 percent of alpha-pinene, 0.40 to 7.84 percent of lemonene, 0.21 to 8.27 percent of the blumeatin, 1.66 to 23.95 percent of L-camphol and 0.64 to 7.98 percent of beta-caryophyllene. The oily composition is definite in main active ingredients, small in content variation, stable in quality which can be effectively controlled, and reliable in healing effect. The invention also discloses use of the oily composition.

The invention discloses a quality control method of a capsule preparation for treating a painful swollen joint. The quality control method of the capsule comprises the following steps of property research, identification, inspection and content determination, wherein the identification refers to identifying Yunnan gaultheria, sargentgloryvine stem and psammosilene tunicoides; and the content determination refers to determining the contents of a fumaric acid in the capsule according to high performance liquid chromatography in an appendix VI D of volume one of Chinese pharmacopoeia 2005. The quality control method of a Jingulian capsule preparation for treating the painful swollen joint is provided. The adopted quality control method has the advantages of scientificity, rationality, high accuracy, good reproducibility, comprehensive and effective quality control of the Jingulian capsule, and guaranteed clinical curative effect of the preparation.

The invention discloses a traditional Chinese medicine preparation for treating gastropathy and a preparation method and a detection method thereof. The preparation is prepared by the following herbs by weight: 40-44 parts of radix hemsleyae, 30-34 parts of wild buckwheat Rhizome, 30-34 parts of sargentgloryvine stem, 20-22 parts of beautyberry, 30-34 parts of gunny, 30-34 parts of rhizoma corydalis, 30-34 parts of herba agrimoniae, 60-66 parts of bletilla rhizome, 40-44 parts of membrana follicularis ovi, 30-34 parts of elecampane, and 38-42 parts of walnut kernels. By using elecampane instead of aristolochia debilis in Shuangjinweiyang capsules, the traditional Chinese medicine preparation prepared by the invention has the same efficacy of smoothing liver and rectifying qi, strengthening stomach and relieving pain, convergence and haemostasis, and the drug efficacy is more significant. In addition, the toxic and side effect of aristolochia debilis is removed in the formula, and the safety of the drug is greatly improved; the medicinal materials are pulverized into fine powder during preparation, which increases the dissolubility and bioavailability of the finished product, and brings the efficacy into full play; the newly-established detection method has high precision, good stability, and accurate measurement results, can effectively control the product quality, and thus can ensure the clinical curative effect.

The invention discloses a detection method for compounded Sichuan fritillary bulb extract tablets. The detection method comprises the steps of carrying out character detection, carrying out microscopic observation, carrying out thin-layer chromatography qualitative identification and carrying out content determination, wherein thin-layer chromatography qualitative identification comprises the steps of identifying ephedrannin and neoephedrine A in a preparation, identifying polygala root and cynanchum atratum and identifying glycyrrhiza uralensis; content determination comprises the step of determining the content of ephedrine hydrochloride in the preparation. The detection method disclosed by the invention has the advantages that the mixing of radix ephedrae and cynanchum atratum is effectively controlled, and meanwhile, the composition and content of the compounded Sichuan fritillary bulb extract tablets are effectively controlled, so that the drug can be safer and more effective.

The invention discloses a sugar-free granule for treating chronic fatigue syndrome and a preparation method and a detecting method thereof, wherein the sugar-free granule is prepared by the following ingredients in parts by weight: 75 parts of ginseng, 250 parts of dwarf lilyturf root, 150 parts of fructus schizandrae, 150 parts of angelica, 250 parts of astragalus root, 200 parts of arillus longan, 50 parts of cinnamon, 150 parts of lucid ganoderma, 150 parts of leatherleaf milletia, 125 parts of tuckahoe, 250 parts of hawthorn, 150 parts of radix salviae miltiorrhizae, 150 parts of jujube kernels, 100 parts of donkey-hide gelatin, 5 parts of steviosin and 767 parts of dextrin. The sugar-free preparation of the invention has the advantages of fast dissolution speed, high bioavailability and good stability so as to solve the drug use limit problem of diabetics and old patients, thereby expanding the adaptable crowds; besides, the detecting method of the invention has the advantages of high precision, good repeatability and accurate measurement result, thereby effectively guaranteeing the clinical treatment effect of the preparation.

The invention provides dimethyl sulfonate of a compound A, a crystal form of the dimethyl sulfonate, application of the dimethyl sulfonate of the compound A in preparation of a medicine for preventing and/or treating mammal diseases, and a medicinal composition containing the dimethyl sulfonate of the compound A, wherein the mammals comprise human beings, and the diseases comprise various cancers, preferably non-small cell lung cancer, particularly mutated non-small cell lung cancer.

The invention discloses a method for measuring the content of polysaccharides in a glossy privet fruit and astragalus membranaceus healthy energy-strengthening preparation. The method takes anhydrous dextrose as a reference substance and can be used for measuring the content of the polysaccharides in the glossy privet fruit and astragalus membranaceus healthy energy-strengthening preparation at the wavelength being 480-490nm by using a phenol-sulfuric acid method or at the wavelength being 600-625nm by using an anthrone-sulfuric acid method. The method is simple and convenient to operate, good in quick reproducibility, high in recovery rate and sensitivity and accurate in measurement result, and can be used for effectively controlling the quality of the glossy privet fruit and astragalus membranaceus healthy energy-strengthening preparation so as to ensure a clinical treatment effect of the glossy privet fruit and astragalus membranaceus healthy energy-strengthening preparation.

The invention discloses a quality control method of a medicinal preparation for treating gynecological inflammation and hysteromyoma. The quality control method of the capsules comprises character, identification, examination and content detection, wherein the identification is to identify bittersweet herb, spreading hedyotis herb, sowthistle tasselflower herb, asiatic pennywort herb and herb of common goldernrod; the content measurement is to measure the chlorogenic acid content and total flavones content of the preparation by using high performance liquid chromatography and UV spectrophotometry respectively. The quality control method of the invention is scientific, reasonable, high in accuracy and high in repeatability, can completely and effectively control the quality of the capsules for treating gynecological inflammation and hysteromyoma to assure the clinic effectiveness of the preparation.

The present invention discloses a method for detecting the vitamin D content in a vitamin D drop. According to the present invention, through a large number of optimizations, the optimal mobile phase composition, the optimal flow rate, the optimal detection wavelength, the optimal chromatography column and other analysis conditions are obtained, and the multiple experiment results show that the method has characteristics of good stability, good repeatability, high analysis efficiency and good separation, and can sensitively and accurately perform qualitative and quantitative detection on the vitamin D3, such that the quality of the vitamin D drop can be objectively, completely and accurately evaluated, and the important significance can be provided for the vitamin D drop quality control and the clinical treatment effect ensuring.

The invention discloses a fingerprint map detecting method of radix astragali drug, intermediate compound and a preparation thereof, the method is as follows: taking onocol as reference substance, obtaining each sample solution through the processes of extracting/ dissolving, determining constant volume and the like, performing HPLC detection under the condition of the same chromatogram, performing gradient elution, recording a chromatogram map, and obtaining the product. In the method, the preliminary treatment method for each sample is simple, the reservation of the characteristic components is complete, the sample solution is stable; the precession is high, reproduction quality is good, and the solution has a certain specificity; the separation effect of each characteristic peak in the obtained fingerprint map is good, the fingerprint map of the radix astragali drug, intermediate compound and the preparation has better correlation; the method can be used for identifying the fake of the radix astragali drug, increases the controllability of the production process of the radix astragali preparation, and is in favour of ensuring the quality stability and the clinical healing efficacy of the radix astragali preparation. The invention also discloses a standard fingerprint map of radix astragali drug, intermediate compound and preparation thereof obtained by the fingerprint map detecting method.