120results about How to "Clinical drug safety" patented technology

The invention discloses a compound omeprazole capsule, and a preparation method and a detection method thereof. The capsule is prepared by: in parts by weight, 20 parts of omeprazole, 1100 parts of sodium bicarbonate, 30 parts of cross linked sodium carboxymethyl cellulose and proper amount of magnesium stearate; or the capsule is prepared by 40 parts of omeprazole, 1100 parts of sodium bicarbonate, 30 parts of cross linked sodium carboxymethyl cellulose and proper amount of magnesium stearate. Aiming at the deficiency of the prior art The formulation, the preparation technology and the detection method of the conventional compound omeprazole capsule are optimized, the compound omeprazole capsule of the invention exhibits more substantial curative effect for diseases comprising peptic ulcer, gastroesophageal reflux disease and the like caused by gastric hyperacidity; a systematic, integrated and effective component discrimination and content determination method is established, thereby the medicine quality is effectively controlled, and thus the clinic curative effect is guaranteed.

The invention provides roflumilaste tablets as well as a preparation method and a detection method thereof. The roflumilaste tables are prepared by adopting 0.5mg roflumilast as crude drugs, adding 100mg to 150mg of lactose, 80mg to 120mg of pregelatinized starch, 10mg to 30mg of povidone K30 and 0.5 to 2.6mg of magnesium stearate and adopting acetone, ethanol and pure water as solvent. Aiming at the weaknesses of the prior art, the formula and the preparation process of the roflumilast tablets are optimized, so that a remarkable effect for treating diseases such as chronic obstructive pulmonary disease (COPD) is obtained, a systematic, complete and valid component discrimination and content determination method is established, the quality of the medicine can be effectively controlled, and the clinical effect of the roflumilast tablets can be guaranteed.

A Chinese medicine for treating the apoplexy sequelae is prepared from 9 Chinese-medicinal materials including astragalus root, Chinese angelica root, Chuan-xiong rhizome, red peony root, etc. Its preparing process is also disclosed.

The invention provides a compound omeprazole capsule, a preparation method and a detection method thereof. The capsule is prepared from the following components in accordance with parts by weight: 200 parts of omeprazole, 1100 parts of sodium bicarbonate and a right amount of magnesium stearate and talcum powder or 40 parts of omeprazole, 1100 parts of sodium bicarbonate and a right amount of magnesium stearate and talcum powder. According to the compound omeprazole capsule, the preparation method and the detection method aiming at the defects of the prior art, the preparation process of the compound omeprazole capsule is optimized, so that the compound omeprazole capsule has obvious curative effects on treating diseases such as peptic ulcers, gastroesophageal reflux diseases and the like which are caused by hyperchlorhydria, and a systemic, integral and effective component identification and content determination method is established, so that the quality of the compound omeprazole capsule can be effectively controlled, thereby guaranteeing the clinic curative effects of the compound omeprazole capsule.

Disclosed is a Chinese medicinal suppository for treating chronic prostatitis and its preparing process, wherein the raw materials include corktree bark, dandelion, Herba Corydalis bungeanae, creat, root of red rooted saliva, radix paeoniae rubrathe, dragon's blood resin, boneol, plantain herb, and mixed fatty acid glycerol ester.

The invention relates to a tigecycline freeze dried for injection and a process for preparation, which comprises taking some tigecycline, charging injection water in proper temperature to dissolve the tigecycline, regulating the pH level of the solution to acidity with pH modifier, charging 0.1%(g / 100ml) cubage of activated charcoal for pin, churning up for 15-30 minutes, preliterating and decarbonizing, then filtrating by filter membrane with micropores of 0.45mum, 0.22mum split charging, pre freezing, cryodesiccating, stressing the top, and putting aluminium cover. The pH modifier is one or multiple kind of inorganic acid or organic acid. The tigecycline freeze dried for injection has the advantages of more steady, safe clinical application, and simple operational process.

The invention relates to an Edaravone fat emulsion injection and a preparation method thereof. The method comprises the following steps of: preparing Edaravone into a fat emulsion injection; and preparing a fat emulsion injection capable of being used for intravenous injection through homogenizing under high pressure by utilizing injection oil as a solvent and high-purity yolk lecithin with good biocompatibility as an emulsifier. Compared with the preparations clinically applied at present, the preparation is prepared without using organic solvents such as alcohol, propylene glycol, and the like and adding cosolvents such as poloxamer, and the like, thereby improving the medication safety, meanwhile, proved by animal experiments, the preparation has stronger antioxidative cerebral protection effect, and shown as relevant safety test results, the new preparation does not have the phenomena of hemolysis and blood vessel stimulation.

The invention provides a method for detecting capsules for treating cough with asthma, which comprises properties, identification, detection and content measuring, wherein for the identification, the thin-layer chromatography of baical skullcap root, thunberg fritillary bulb, gerbera and ephedra is identified; and for the content measuring, the ephedrine content and baicalin content in a preparation are measured. Compared with the prior art, aiming at the newly-developed Chinese medicinal preparation for treating the cough with asthma, the systematic, complete and effective detection method is established, and the method has advantages of strong specificity, high precision, good repeatability, high recovery rate and accurate measuring results, and fulfills the aim of controlling the quality of the medicament effectively, so the stability of the quality of products and the safety and effectiveness of clinical administration are ensured.

The invention belongs to the field of Chinese patent medicine preparations and relates to pediatric compound chicken's gizzard-membrane chewable tablets and a preparation method thereof. The pediatric compound chicken's gizzard-membrane chewable tablets comprise the following components in parts by weight: 80-90 parts of chicken's gizzard-membrane, 160-170 parts of medicated leaven, 240-320 parts of first filler, 600-680 parts of second filler, 10-14 parts of flavoring agent, 3-5 parts of fragrance, 6-6.5 parts of pigments, 10-14 parts of lubricant and an appropriate amount of binding agent. The pediatric compound chicken's gizzard-membrane chewable tablets have the advantages of significantly improving the bioavailability and the efficacy, being easily absorbed, having rapid onset of action and being easy to be accepted by children.

The invention is concerned with a kind of new Chinese traditional medicine combination stuff and its preparation method for mildly reinforcing the kidney-yang, relating to epimedium, Curculigo orchioides, broomrape, medlar, dogwood fruit, morinda root, ginseng, cassia and eagle ood. Grind ginseng into powder for using, break cassia and eagle ood and get clear paste and thick paste by distill with ethanol and water. Mix the powder of ginseng with the said clear paste and thick paste, dry and grind into powder in decompression and get the purpose preparation of this Chinese traditional medicine combination stuff. This combination stuff has reliable effect to cure the illness of insufficiency of kidney-yang, and it is a steady and credible method.

The invention discloses a method for determining specnuezhenide content in a Zhenqifuzheng preparation. Taking specnuezhenide standard as contrast, the method can determine the specnuezhenide content in the Zhenqifuzheng preparation by high-performance liquid chromatography by selecting a solution containing methanol and a mixed solution with a ratio of (20-50):(80-50) or a mixed solution containing acetonitrile and the mixed solution with a ratio of (5 to 35):(95-65), wherein the mixed solution consists of water, 0.01% to 5% of phosphoric acid water solution, 0.01% to 5% of glacial acetic acid, 0.01% to 0.5% of methanoic acid water solution. Compared with the prior art, the method provided by the invention has the advantages of high specificity, high precision, high repeatability, high yield, high stability, and accurate result by adopting high-performance liquid chromatography, and can effectively control the preparation quality, thereby ensuring the stability of product quality as well as clinical safety and effectiveness.

The present invention relates to preparation process of freeze dried tigecycline powder for injection. The preparation process includes the following steps: introducing clean treated air into water for injection at 5-30deg.c to replace its oxygen, adding tigecycline through stirring for dissolving, adding active carbon for injection in 0.1 g / 100ml while further introducing clean air and stirring for 15-30 min, coarse filtering to eliminate active carbon, filtering with 0.45 micron microporous membrane, introducing clean air into the filtrate, filtering with 0.22 micron microporous membrane, packing in 5-15 ml size antibiotic ampoule, pre-freezing for 3-6 hr, freeze drying for 24-48 hr, covering, and rolling aluminum cap. The present invention has raised clinical safety.

The invention discloses a Chinese medicinal composition having functions of resolving phlegm, relieving cough, promoting blood flow, dispelling stasis and preparing method, wherein the Chinese medicinal composition is prepared from astragalus root, earthworm, leeches, root of red rooted saliva, kudzu vine root, musk, boneol and buffalo horn concentrated powder through steps of disintegrating, water extracting, concentrating, drying and disintegrating into fines, mixing the fines with concentrated buffalo horn powder and borneol homogenously.

The invention discloses a hydroxypropyl-beta-cyclodextrin inclusion of strychnine and a preparation method thereof. The inclusion is prepared from the strychnine and hydroxypropyl-beta-cyclodextrin in weight ratio of 1: (1-100) by using the preferential inclusion process. Experimental results show that the hydroxypropyl-beta-cyclodextrin inclusion of the strychnine has the advantages of high inclusion rate, great drug loading and good stability, and can significantly improve the water solubility of the strychnine, lead the solubility in water to be more than 20 times that of the strychnine, significantly improve the bioavailability after administration of the strychnine, play a role in reducing the toxicity of the strychnine and lead the clinical application to be safer.

The invention discloses a film coating agent for treating onychomycosis and a preparation method thereof, which relate to a film coating agent and a preparation method thereof. The film coating agent is prepared from a main medicament, a plasticizer, a penetration enhancer, a film forming agent and a medicament solvent. The method comprises the following steps of: weighing raw materials; mixing the film forming agent with water to obtain a substance A, and adding the plasticizer to obtain a colloid B; adding the main medicament into the medicament solvent for performing ultrasonic dissolving, and adding the permeation enhancer to obtain a substance C; and adding the substance C into the colloid B, mixing uniformly, and adjusting a pH value to 5.0 to obtain the film coating agent. The film coating agent for treating onychomycosis disclosed by the invention has the advantages of capability of directly penetrating nail sheets to the deep of connective tissues of nail bed parts for killing fungi and treating onychomycosis, high effective medicament concentration, high transdermal capability, remarkable curative effect, no irritation, no toxic or side effect, capability of completely curing onychomycosis, clinical administration safety, freeness from untoward reactions and reliable curative effect. The preparation method of the film coating agent for treating onychomycosis has the advantages of simple process, simple and convenient content measuring method, stable quality and suitability for medicinal industrial production.

The invention discloses a method for measuring content of formononetin in a Zhenqifuzheng preparation. The method is a high-performance liquid chromatography with a formononetin reference substance used as a contrast and the ratio of methyl alcohol to water / a 0.01%-5% phosphoric acid aqueous solution / a 0.01%-5% glacial acetic acid / a 0.01%-0.5% formic acid aqueous solution of (50-70):(50-30) or the ratio of acetonitrile to the water / the 0.01%-5% phosphoric acid aqueous solution / the 0.01%-5% glacial acetic acid / the 0.01%-0.5% formic acid aqueous solution of (20-50):(80-50) used as a mobile phase. The method is high in specificity, high in accuracy, good in repeatability, high in recovery rate, high in stability, accurate in measurement result and capable of achieving the purpose of effective control of the drug quality and ensuring the stability of the product quality and the safety and the effectiveness of clinical medication.

The invention relates to a crystal form of a quinazoline compound and a preparation method thereof, and belongs to the technical field of biological medicines. The compound can be used as a multi-target-point kinase inhibitor. The invention provides a crystal form of a quinazoline compound with higher stability. The structural formula of the quinazoline compound is shown as a formula (I), and theX-ray powder diffraction pattern 2[theta] diffraction angles of the quinazoline compound crystal forms A, Form1, Form2, Form3, Form4, Form5, Form6, Form7 and Form8 have characteristic diffraction peaks at 3-40 degrees; the preparation method of the crystal form of the quinazoline compound provided by the invention has an important value for optimization and development of the medicine, the preparation method is simple and easy to operate, the process purification effect is remarkable, the used solvent has small harm to the environment and is suitable for industrial production; and the crystalform A of the quinazoline compound provided by the invention has good stability and reproducibility, is convenient to transfer, store and operate in a production process in the future, and is safer inclinical medication.

The invention discloses an antibacterial and antiviral effective part extract of medicated leaven and medicinal use of the extract as an antibacterial agent or an antiviral agent. The extract is prepared by the following steps of: (1) refluxing and extracting coarse powder of the medicated leaven by using low molecular alcohol to obtain an alcohol extract; and (2) extracting the alcohol extract by using ethyl acetate and n-butyl alcohol, and decompressing the extraction liquid to recover a solvent so as to obtain the extract. The antibacterial and antiviral effective part extract of the medicated leaven mainly comprises fermentation products fermented by the medicated leaven; and the effective part extract has higher antibacterial and antiviral activities, particularly has prominent effect on the common enteropathogenic bacteria and influenza virus, and has safe medication and no toxic or side effect.

The invention belongs to the technical field of medicaments, and in particular relates to 7-phenyl quinolone compounds shown as a general formula (I), and pharmaceutically acceptable salt, solvate and stereoisomers thereof, wherein R<1>, R<2>, R<3>, R<4>, R<5> and n are defined in the specifications. The invention also relates to a method for preparing the compounds, medicinal preparations containing the compounds, and application of the compounds to the preparation of medicaments for treating and / or preventing infectious diseases.

The invention discloses a total bufogenin nano cubic liquid crystal and a preparation method thereof. The total bufogenin nano cubic liquid crystal is composed of a lipid material, an emulsifying agent and purified water. The total bufogenin nano cubic liquid crystal provided by the invention is characterized in that amphipathic lipid with certain concentration spontaneously forms double layers of the lipid in water, and the double layers are assembled into a cubic liquid crystal form with thermodynamic stability. The total bufogenin nano cubic liquid crystal disclosed by the invention increases the medicine solubility, realizes the oral administration of lipid-soluble medicine total bufogenin, adjusts and controls the medicine release, improves the medicine bioavailability, effectively improves the tumor cell targeting property of total bufogenin, and reduces toxic or side effects.

The invention discloses a method for measuring content of calycosin-7-glucoside in a Zhenqifuzheng preparation. The method is a high-performance liquid chromatography with a calycosin-7-glucoside reference substance used as a contrast and the ratio of methyl alcohol to water / a 0.01%-5% phosphoric acid aqueous solution / a 0.01%-5% glacial acetic acid / a 0.01%-0.5% formic acid aqueous solution of (30-70):(70-30) or the ratio of acetonitrile to the water / the 0.01%-5% phosphoric acid aqueous solution / the 0.01%-5% glacial acetic acid / the 0.01%-0.5% formic acid aqueous solution of (20-50):(80-50) used as a mobile phase. The method is high in specificity, high in accuracy, good in repeatability, high in recovery rate, high in stability, accurate in measurement result and capable of achieving the purpose of effective control of the drug quality and ensuring the stability of the product quality and the safety and the effectiveness of clinical medication.

The invention relates to a traditional Chinese medicine for treating migraine and can effectively solve a drug administration problem of the migraine. A technical scheme for solving the problem is as follows: the traditional Chinese medicine is prepared from the following raw materials by weight: 220-260 g of trogopterus dung, 220-260 g of ligusticum wallichii, 220-260 g of radix angelicae, 220-260 g of gastrodia elata, 220-260 g of monkshood, 220-260 g of gypsum, 220-260 g of licorice root, 110-130 g of asarum, 110-130 g of schizonepeta spike, 110-130 g of saposhnikovia divaricata, 110-130 g of notopterygium root, 110-130 g of rhizoma atractylodis, 110-130 g of frankincense, 110-130 g of myrrh, 110-130 g of scorpio, 110-130 g of centipedes, 110-130 g of stiff silkworm, 110-130 g of earthworms, 110-130 g of rhizoma arisaematis and 110-130 g of rhizoma typhonii. The raw materials are mixed, dried, ground and prepared into water pills; the traditional Chinese medicine is a pure natural medicine, does not have side effects, is safe, reliable, safe to clinically use, remarkable in curative effect and high in healing rate, and is an innovation of drugs for treating the migraine.

The present invention relates to a compound 1,3-oleic acid-2-linoleic acid glyceride having a structure represented by a formula (I). The present invention further provides a method for preparing the compound by using coix seed powder as a raw material and carrying out coix seed oil preparation, primary 1,3-oleic acid-2-linoleic acid glyceride separation and secondary separation. The present invention further relates to a pharmaceutical preparation containing the 1,3-oleic acid-2-linoleic acid glyceride, and a preparation method thereof, and applications of the compound and the preparation as the antitumor drugs. The formula (I) is defined in the specification.

The invention provides a new preparation of a traditional Chinese medicinal composition for treating breast diseases and a preparation method thereof. The preparation method comprises the following steps of: (1) weighing tangerine leaves, salvia miltiorrhiza, spina gleditsiae, seed of cowherb, toosendan fruit and earthworm; (2) decocting the tangerine leaves, salvia miltiorrhiza, spina gleditsiaeand toosendan fruit in water, mixing decoction, filtering the decoction and concentrating filtrate; (3) carrying out reflux extracting on the earthworm and the seed of cowherb with ethanol, filteringand mixing the filtrate; (4) adding the filtrate obtained in the step (3) to the concentrated filtrate obtained in the step (2), adjusting the ethanol amount to be 70 percent, standing the filtrate, recovering ethanol from the filtrate, concentrating to thick paste with the relative concentration of 1.25 (at 50 DEG C); and (5) reducing the pressure of thick paste obtained in the step (4), drying and crushing, mixing with a suitable amount of dispersed media and pressing into soft capsules. Proved by clinical tests, the curative effect of the mammary block dispelling soft capsules prepared by applying the preparation method is remarkably different from that of mammary block dispelling tablets and granules.

The invention is calf dehemoglobinize extract transfusion and its manufacturing method. The amino acid and small peptide in the extract of the calf dehemoglobinize can be polymerized into high molecular peptide and large molecular weight peptide, thus the medicine has antigenicity and reduces the biology activity of the medicine, and causes the increase of clinic hypersusceptibility. The ingredients of the calf dehemoglobinize are: the calf dehemoglobinize extract and osmotic pressure regulator, the calf dehemoglobinize extract is extracted from the calf blood or blood serum, the extract solid contains nitrogen and amino acid, its weight shares are: amino acid is 20.0-30.0, the nitrogen 12.5-18.75, the osmotic pressure regulator 50-100, pH value is 5.5-8.0, the product is a little yellow or yellow transparent liquid. The product can be applied to cure cerebral ischemia, cerebral dementia, brain trauma and incompetence of brain fucntiosn, and so on, they are all brain cell metabolism handicap diseases; it also can be applied to cure the twig artery, vein circulation obstruction, and artery angiopathy.

The invention discloses a Chinese herbal compound composition with a blood fat reduction effect. The composition is prepared from the following active ingredients in parts by weight: 0.5-2 parts of ginkgo biloba extract, 45-180 parts of lotus leaves, 3-12 parts of eucommia ulmoides leaves, 3-12 parts of purslane, 45-180 parts of gynostemma pentaphyllum, 50-200 parts of hawthorn, 45-180 parts of radix curcuma, and 15-60 parts of semen ziziphi spinosae. Under the guidance of the theory of Chinese medicine, the formula is screened by adopting diagnosis and treatment based on an overall analysis through combining the pathogenesis and the symptoms of hyperlipemia, and the overall composition is scientific and reasonable in proportion. Experimental results show that the Chinese herbal compound composition has a good blood fat reduction effect and can prevent atherosclerosis and cardiovascular diseases; moreover, all herbal medicines in the composition are both medical and edible, thus being good in curative effect, low in toxic and side effects, and safer for clinical medication.

The present invention discloses a diabetes treating traditional Chinese medicine preparation identification method. According to the present invention, the traditional Chinese medicine preparation is prepared from Keyaoluoqu, plantago depressa willd, agrimonia pilosa ledeb, and lonicera confusa dc; the identification is carrying out thin-layer chromatography on Keyaoluoqu, plantago depressa willd, agrimonia pilosa ledeb, and lonicera confusa dc, wherein the Keyaoluoqu identification method is the thin-layer chromatography method adopting a luteoloside reference substance as a control and adopting a mixed solution comprising ethyl acetate, acetone, formic acid and water according to a ratio of 7:3:1:1.2 as a developing solvent, the plantago depressa willd identification method is the thin-layer chromatography method adopting a plantamajoside reference substance as a control and adopting a mixed solution comprising ethyl acetate, acetone, formic acid and water according to a ratio of 7:3:1:1.2 as a developing solvent, the lonicera confusa dc identification method is the thin-layer chromatography method adopting an isochlorogenic acid A reference substance as a control and adopting a mixed solution comprising ethyl acetate, acetone, formic acid and water according to a ratio of 7:3:1:1.2 as a developing solvent; and the identification method of the present invention has characteristics of high sensitivity, good reproducibility, convenience, feasibility, and no negative control interference.

The invention discloses a Chinese herbal preparation resistant to hyperlipidemia and atherosclerosis and a preparation process of the Chinese herbal preparation. The Chinese herbal preparation is prepared from, by weight, 0.5-3 parts of seabuckthorn fruit, 0.5-3 parts of cattail pollen and 0.3-3 parts of kelp. The Chinese herbal preparation is scientific and reasonable, conforms to the traditional Chinese medicine theory and is exact in hyperlipidemia and atherosclerosis treating efficacy as proved by modern pharmacology and toxicology test, is free of obvious toxic and side effects and safe in clinical treatment. Alcohol extraction and water extraction processes are adopted respectively in the preparation process according to physicochemical properties of active ingredients of each medical material, and accordingly the content of the active ingredients is guaranteed, impurities are reduced, taking dosage is decreased, and the preparation process is low in production cost and easy for batch production.

The invention provides a traditional Chinese medicinal composition for tonifying kidney and arresting spontaneous emission, and a preparation method thereof, and belongs to the field of traditional Chinese medicines. The traditional Chinese medicinal composition comprises epimeddium, Radix Morindae officinalis, Herba Cynomorii, wolfberry fruits, semen cuscutae, Coridius chinensis, Corn Cervi Pantotrichum, geckos, Cistanche deserticola, prepared rehmannia root, Rhizoma Anemarrhenae and Chinese angelica root. The traditional Chinese medicinal composition adopts kidney tonifying, spontaneous emission arresting and yang invigorating medicines as main raw materials, is clinically safe to use, and has a substantial treatment effect on the kidney vacuity. The preparation method comprises the following steps: drying and crushing all medicinal materials in the raw materials, mixing the crushed medicinal materials to obtain medicine powder, and processing the medicine powder to prepare a medicament. The preparation method allows the medicament to be directly prepared through powdering the medicinal materials to make all components in the medicinal materials enter the medicament, and the medicinal material utilization rate reaches up to 99% or above.