30 results about "ITOPRIDE HYDROCHLORIDE" patented technology

The invention relates to a preparation method of gastrointestinal crude drug itopride hydrochloride, and belongs to the field of medicines. The invention discloses a method for preparing itopride hydrochloride, which comprises the following steps of: taking cheap N,N-dimethylaminoethanol as an initial raw material; implementing an etherification reaction to obtain an intermediate product (VII) and implementing one-step reduction ammoniation to obtain a benzylamine product (IX); and reacting with 3,4-dimethoxy benzoyl chloride to generate hydrochloride. The preparation method of the itopride hydrochloride is cheap in raw material, moderate in reacting condition, and low in preparation cost of the itopride hydrochloride.

The invention discloses a itopride hydrochloride sustained release preparation which is prepared from the following components in parts by weight: 50 to 100 parts of itopride hydrochloride, 40 to 50 parts of hydroxypropyl methylcellulose K100, 20 to 40 parts of hydroxypropyl methylcellulose E5, 20 to 30 parts of microcrystalline cellulose, 20 to 30 parts of lactose and 1 to 2 parts of magnesium stearate. The invention further discloses a preparation method thereof. The preparation method has the beneficial effects that the preparation is convenient, and the effective components of prepared tablets are slowly released.

The invention relates to an itopride hydrochloride sustained-release tablet composition. The technical scheme comprises that the cores of per 1000 tablets of itopride hydrochloride composition comprises 75 g of itopride hydrochloride, 45 g of Hydroxypropyl methyl cellulose, 15 g of sodium alginate, 40 g of microcrystalline cellulose, 8 g of aerosi, 7 g of polyvinylpyrrolidone K30, and 3 g of magnesium stearate. The beneficial effects comprise that the itopride hydrochloride sustained-release tablet according with clinic requirements is obtained through reasonable prescription adjusting, and the problem that the table release degree difference of the itopride hydrochloride sustained-release tablets is large is solved.

The invention relates to the technical field of pharmaceutical preparations, in particular to an orally disintegrating itopride hydrochloride tablet and a preparation method thereof: 50 parts by weight of itopride hydrochloride, 90-110 parts by weight of mannitol, and 10-30 parts by weight of lemon Acid, 30-40 parts by weight of polyvinylpyrrolidone and an appropriate amount of 50% ethanol solution are mixed evenly and added to the above-mentioned mixed material powder, 10-30 parts by weight of citric acid and stevioside are mixed in an appropriate amount to make a uniform soft material, and passed through 30 mesh Wet granules are prepared by nylon sieve, dried at 50-60°C for about 30 minutes, sieved with 30 meshes for granulation, the granules and 2-3 parts by weight of magnesium stearate and 1-2 parts by weight of micro-powdered silica gel are mixed evenly, and pressed into tablets. It can disintegrate quickly in the oral cavity under anhydrous conditions (or only a small amount of water exists), enter the digestive tract with swallowing action, and have no mucosal absorption in the oral cavity. The absorption and metabolism process in the body are consistent with ordinary tablets. Compared with common preparations, it has the advantages of convenient administration, fast absorption, high bioavailability, and less irritation to the mucous membrane of the digestive tract.

The invention relates to a preparation method of gastrointestinal crude drug itopride hydrochloride, and belongs to the field of medicines. The invention discloses a method for preparing itopride hydrochloride, which comprises the following steps of: taking cheap N,N-dimethylaminoethanol as an initial raw material; implementing an etherification reaction to obtain an intermediate product (VII) and implementing one-step reduction ammoniation to obtain a benzylamine product (IX); and reacting with 3,4-dimethoxy benzoyl chloride to generate hydrochloride. The preparation method of the itopride hydrochloride is cheap in raw material, moderate in reacting condition, and low in preparation cost of the itopride hydrochloride.

The invention provides a detection method of an impurity demethylated itopride nitrosamine in itopride hydrochloride, wherein the method comprises the steps: selecting octadecylsilane chemically bonded silica as a filler, and an ammonium acetate aqueous solution and acetonitrile as mobile phases to carry out liquid chromatography separation, and detecting target molecules by using combination of mass spectrometry. According to the method, the system applicability, specificity, precision, quantitation limit, detection limit, linearity and range all meet the requirements, the separation effect is good, operation is easy and convenient, and the method sensitivity is high.

The invention discloses an itopride hydrochloride micro-tablet, a preparation method thereof and application thereof in consistency evaluation of generic drugs. According to the itopride hydrochloridemicro-tablet, the preparation method thereof and the application thereof in the consistency evaluation of the generic drugs, itopride hydrochloride and various ingredients are mixed, pelletized and dried, and then evenly mixed with an extra disintegrant and a lubricant, and the mixture is pressed into the micro-tablet of which the diameter is no more than 3MM. A capsule can be filled with the micro-tablet, multiple dissolution curves of a prepared itopride hydrochloride capsule in vitro are consistent with an original product (product name: itopride hydrochloride tablet; trade name: Weilisu;specification: 0.05g; certificate holding merchant: ABBOTT LABORATORIES (M) SDN. BHD), in the process of accelerated test and long-term test stability investigation, related substances have no significant change, and the micro-tablet has a bioequivalence trend with the original product after the meal.

The invention relates to an itopride hydrochloride controlled-release tablet combination. The technical scheme includes that an itopride hydrochloride controlled-release tablet comprises a tablet core and a coating layer; the itopride hydrochloride controlled-release tablet is characterized in that the tablet core contains itopride hydrochloride, polyethylene glycol 1000, lactose, mannitol, aerosil and povidone K30, and the coating layer contains ethyl cellulose and hydroxypropyl methyl cellulose. By the technical scheme, the problem that release rate of single-chamber itopride controlled-release tablets can reach about 70% only is solved, and a pharmaceutical which is safe, effective and high in utilization rate is provided for clinical medication.

The invention relates to an itopride hydrochloride sustained-release tablet composition. The technical scheme comprises that the cores of per 1000 tablets of itopride hydrochloride composition comprises 75 g of itopride hydrochloride, 45 g of Hydroxypropyl methyl cellulose, 15 g of sodium alginate, 40 g of microcrystalline cellulose, 8 g of aerosi, 7 g of polyvinylpyrrolidone K30, and 3 g of magnesium stearate. The beneficial effects comprise that the itopride hydrochloride sustained-release tablet according with clinic requirements is obtained through reasonable prescription adjusting, and the problem that the table release degree difference of the itopride hydrochloride sustained-release tablets is large is solved.

A kind of preparation method of itopride hydrochloride The present invention relates to the preparation method of itopride hydrochloride, the reaction takes 2-dimethylaminochloroethane hydrochloride and phenol as starting materials, through etherification, chloromethylation , amino substitution, amidation, and salt-forming 5-step reaction to obtain itopride hydrochloride. In the present invention, the chloromethylation promoted by HCl / CHO avoids the imine reduction step, eliminates the solid waste generated by the reducing agent, and improves the safety of the reaction; the raw materials used are cheap, the market supply is sufficient, and they are easy to purchase; The one-step reaction is more classic, safe and easy to control, and suitable for industrial production.

The invention provides a preparation method of itopride hydrochloride. The method comprises a step that N,N-dimethylamino ethoxy aniline and 3,4-dimethoxy benzoyl chloride are subjected to an amidation reaction in dichloromethane. The method provided by the invention also comprises a step that a hydrogen chloride isopropyl alcohol solution and an itopride prototype material are subjected to a reaction, such that a salt is produced. According to the itopride hydrochloride preparation method provided by the invention, dichloromethane is used for replacing toluene, such that the harm brought by toluene is avoided. Also, no water is introduced during the salt formation process, such that loss can be reduced, product yield can be improved, and impurities are further removed. Therefore, the quality of a finished product is improved.

The invention relates to an itopride hydrochloride controlled-release tablet combination. The technical scheme includes that an itopride hydrochloride controlled-release tablet comprises a tablet core and a coating layer; the itopride hydrochloride controlled-release tablet is characterized in that the tablet core contains itopride hydrochloride, polyethylene glycol 1000, lactose, mannitol, aerosil and povidone K30, and the coating layer contains ethyl cellulose and hydroxypropyl methyl cellulose. By the technical scheme, the problem that release rate of single-chamber itopride controlled-release tablets can reach about 70% only is solved, and a pharmaceutical which is safe, effective and high in utilization rate is provided for clinical medication.