14 results about "Valproate Sodium" patented technology

The invention belongs to the technical field of separation of drug intermediates, and particularly relates to a control method for a process impurity 2-ethyl valeric acid (EP-B) in preparation of valproic acid or sodium valproate by a diethyl malonate method. According to the method disclosed by the invention, the content of 2-ethyl-2-propylmalonic acid process impurities in dipropylmalonic acid is controlled, so that the content of 2-ethylvaleric acid (EP-B) which is a process impurity in valproic acid or sodium valproate is accurately controlled; adding a polar solvent into the dipropylmalonic acid crude product, heating, pulping for a certain time, cooling, filtering and drying to obtain a high-purity dipropylmalonic acid refined product; high-purity valproic acid (RRT is equal to 1.00) is prepared through decarboxylation of the dipropyl malonic acid fine product, and the purity is 99.779%; 0.020% of 2-ethyl valeric acid (RRT is equal to 0.90); and valeric acid (RRT = 0.77), 0.039%. The valproic acid product quality meets the requirements of European Pharmacopoeia. According to the method, the problems of quality control and process evaluation of valproic acid or sodium valproate prepared by a diethyl malonate method are solved.

The invention discloses an ingredient mixing device and method for sodium valproate sustained release tablet production, and relates to the field of pharmaceutical equipment.The ingredient mixing device comprises a mixing main body, the top of the mixing main body is connected with a top cover through a plurality of bolts, the bottom of the top cover penetrates through the bottom and is fixedly connected with a feeding cylinder, and a main shaft is arranged in the center of the interior of the mixing main body; four outer plates are fixedly connected to the outer surface of the main shaft at equal intervals, and a mixed discharging switching structure is arranged in the mixing main body. By arranging the mixing and discharging switching structure, rapid switching between a mixing mode and a discharging mode is achieved, and the structure allows a channel to be opened in the mixing stage so that materials can be subjected to sufficient convection, and allows the channel to be closed in the discharging stage so that the materials can be guided to an outlet; due to the integrated design, the tedious step that materials need to be transferred to another device for discharging after mixing in a traditional technology is avoided, the risks of procedure interruption, material loss and cross contamination are remarkably reduced, and the continuity and the overall efficiency of the production process are greatly improved.

The invention belongs to the technical field of medicine detection, and particularly relates to a high performance liquid chromatography detection method for dipropylmalonic acid and impurities thereof. The method comprises the following steps: preparing a to-be-detected sample into a test solution; the to-be-detected sample is dipropyl malonic acid prepared by adopting a diethyl malonate method and impurities of the dipropyl malonic acid; and detecting the test solution by adopting a high performance liquid chromatography method to obtain a detection result of dipropylmalonic acid and impurities thereof in the sample to be detected. According to the detection method provided by the invention, the detection of dipropylmalonic acid prepared by adopting a diethyl malonate method and impurities thereof is realized through high performance liquid chromatography (HPLC) for the first time, and the problems of quality control and process evaluation of the dipropylmalonic acid prepared by adopting the diethyl malonate method, which is an intermediate of a sodium valproate raw material medicine, are solved; therefore, detection and control of impurities (including 2-ethyl valeric acid) in the sodium valproate raw material medicine are realized.

This invention, entitled "A Method and Product for Pretreatment of Mesenchymal Stem Cells and Its Application in Stroke Drugs," belongs to the field of biotechnology. The technical problem to be solved is to improve the function and therapeutic effect of mesenchymal stem cells. The key technical solution is a method for pretreatment of mesenchymal stem cells, including: culturing cells using an activation medium, culturing cells using a directional medium, and culturing cells under hypoxic conditions using an adaptation medium; the activation medium contains complete medium, IFN-γ, TNF-α, and IL-1β; the directional medium contains complete medium, sodium valproate, 5-azacytidine, and all-trans retinoic acid; the adaptation medium is a complete medium containing basal medium and free of animal serum. The pretreatment method of this invention enhances the anti-inflammatory, neuroprotective, and angiogenic capabilities of mesenchymal stem cells, showing significant therapeutic effects on stroke, and since it does not use animal serum, it meets clinical requirements.

The present application relates to a method for detecting impurities in valproic acid or sodium valproate prepared by methyl cyanoacetate method by gas chromatography, characterized in that the impurities in valproic acid or sodium valproate prepared by methyl cyanoacetate method are detected by gas chromatography; the impurities are selected from valeric acid (A), 2-methyl valeric acid (L), 2-isopropyl valeric acid (C), valproic amide (F) or 2-propyl hexanoic acid (X):

The invention relates to a pharmaceutical composition for oral administration. The pharmaceutical composition comprises: a) immediate release particles comprising i. An active ingredient selected from the group consisting of valproic acid, semi-sodium valproate, sodium valproate and magnesium valproate, and ii. A filler, b) sustained release pellets comprising: i. A pellet core comprising (1) an active ingredient selected from the group consisting of valproic acid, semi-sodium valproate, sodium valproate and magnesium valproate, and (2) a filler, ii. A sub-coating disposed on the pellet core, the content of the sub-coating layer is 10-20 wt% based on the weight of the pellet core and the sub-coating layer comprises a film-forming agent, and iii. A slow-release coating layer disposed on the sub-coating layer, the content of the slow-release coating layer is 25-100 wt% based on the weight of the pellet core coated with the sub-coating layer and the slow-release coating layer comprises a film-forming agent, and the content of the slow-release coating layer is 25-100 wt% based on the weight of the pellet core coated with the sub-coating layer. Wherein the amount of the active ingredients in the quick-release particles accounts for 70-80 wt% of the total weight of the active ingredients in the pharmaceutical composition, and the amount of the active ingredients in the slow-release pellets accounts for 20-30 wt% of the total weight of the active ingredients in the pharmaceutical composition. In further aspects, the present invention relates to methods of preparing pharmaceutical compositions and pharmaceutical compositions for use in methods of pre-treating cancer.

The invention provides a sodium valproate oral solution and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The sodium valproate oral solution provided by the invention comprises sodium valproate, sorbitol, sucralose, a preservative, a thickening agent, a pH regulator, essence and water, and a coloring agent is not added. According to the sodium valproate oral solution provided by the invention, sucralose is used for replacing saccharin sodium in an original prescription, and carmine is removed, so that the safety of the sodium valproate oral solution to children can be effectively ensured, and the sodium valproate oral solution is good in taste and suitable for being taken by the children; the preparation method is simple, the preparation efficiency is high, and the oral solution is stable in quality and suitable for industrial production through stability tests.

A stable pharmaceutical composition in the form of orally administrable prolonged release tablet comprising sodium valproate and valprioic acid with no granulating solvent is disclosed, further comprising low viscosity polymer, high viscosity polymer, binder, adsorbent and glidant. A process for the preparation of said orally administrable prolonged release tablet is also disclosed.

The present invention provides a method for administering a γ-hydroxybutyrate composition together with divalproex sodium. [Solution] An oral pharmaceutically acceptable composition of gamma-hydroxybutyrate (GHB) is provided that is suitable for concomitant administration with divalproex sodium (DVP) without substantially altering the dosage of any of the drugs. The therapeutic use of the composition for the treatment of one or more symptoms of narcolepsy is also provided. One of the main treatments for narcolepsy is sodium oxibate, a neuroactive agent with various central nervous system (CNS) pharmacological properties.

The invention relates to a method for detecting impurities in a process for preparing valproic acid, sodium valproate or magnesium valproate by atom economy reaction, which comprises the following steps of: selecting a gas chromatograph with the model of Agilent 8890, and detecting valproic acid prepared by atom economy reaction and process impurities thereof by gas chromatography; the detection conditions of the gas chromatography are as follows: a chromatographic column is DB-FFAP, and the specification is 0.32 mm * 60 m, 0.5 [mu] m; the carrier gas is nitrogen; the detector is an FID (Flame Ionization Detector); the flow rate is 2ml / min; the sample injection volume is 2 microliters; the temperature of a sample inlet is 220 DEG C; the column temperature is 100 DEG C; in the heating procedure, the initial temperature is 100 DEG C and kept for 5 min, then the temperature is increased to 140 DEG C at the speed of 4 DEG C / min and kept for 5 min, and then the temperature is increased to 200 DEG C at the speed of 4 DEG C / min and kept for 15 min; the operation time is 50 min; the temperature of a detector is 220 DEG C; the method comprises the following steps of: injecting 2 microliters of diluent dichloromethane, 2 microliters of reference solution and 2 microliters of test solution into a gas chromatograph, and recording a chromatogram; a test article is selected from a valproic acid crude product prepared by atom economy reaction; the impurities are selected from 2-propyl-4-pentenoic acid, valeric acid, 2-methyl valeric acid, 2-ethyl valeric acid, methyl valproate, ethyl valproate or propyl valproate; the solvent is a solvent; according to the detection result of the gas chromatography, the variety and the content of the process impurities in the valproic acid, the sodium valproate or the magnesium valproate are judged through a control sample.

The present application relates to a kind of sodium valproate nasal mucosa administration preparation and its preparation and application, belong to medical technical field.A kind of sodium valproate nasal mucosa administration preparation, the preparation includes gastrodin and as medicinal component sodium valproate.The weight ratio of sodium valproate and gastrodin is 1:0.0025~2.The administration preparation of the present application is a kind of sodium valproate nasal mucosa administration preparation, can be delivered to brain by bypassing blood-brain barrier through nasal administration, improve brain bioavailability, prolong the effective action time of drug in brain, avoid first pass effect, reduce the risk of peripheral toxic side effect.The present application uses gastrodin as absorption promoter, by optimizing the ratio of gastrodin and sodium valproate, can reach the effect of increasing the absorption of sodium valproate in whole body and brain, further improve its brain bioavailability, enhance its therapeutic potential.

The present application relates to the technical field of crystal preparation, and particularly relates to sodium valproate crystal and a preparation method and application thereof. The sodium valproate crystal provided by the present application has diffraction peaks at least at the following diffraction angles 2theta in the X-ray powder diffraction pattern: 5.67°+ / -0.2°, 6.73°+ / -0.2°, 16.94°+ / -0.2°, 18.18°+ / -0.2°, 18.67°+ / -0.2°, 20.16°+ / -0.2°, 20.92°+ / -0.2°, 21.13°+ / -0.2°, 22.55°+ / -0.2° and 24.45°+ / -0.2°. The sodium valproate crystal provided by the present application has good stability, good water solubility, significantly reduced hygroscopicity, ensures the quality stability within the effective period of the medicine, and significantly shortens the dissolution time of the product, and the product has good redissolution.

The invention discloses a kit for predicting sodium valproate treatment response based on TPH2 gene polymorphism and a method and application thereof, and belongs to the technical field of individualized medication for children epilepsy treatment. The method comprises the following steps: S01, collecting a biological sample of a child epilepsy patient, and extracting genome DNA; s02, detecting the genotype of the rs4570625 site of the TPH2 gene in the genome DNA (Deoxyribose Nucleic Acid); s03, people suitable for sodium valproate treatment are selected according to the genotypes, and the GG genotype patients are suitable for sodium valproate standard dosage maintenance treatment; a non-GG genotype patient adopts an adjusted sodium valproate scheme or a sodium valproate substitute medicine. The invention further provides a corresponding kit and application. According to the invention, the TPH2 gene polymorphism is introduced into the prediction of the VPA treatment response of the child epilepsy, and the individualized medication of the VPA treatment of the child epilepsy is accurately guided.

Oral pharmaceutical compositions of gamma-hydroxybutyrate (GHB) suitable for concomitant administration with a dose of divalproex sodium (DVP) without materially altering the dosage amount of either drug are provided. Also provided are therapeutic uses of the compositions for the treatment of one or more symptoms of narcolepsy.