39 results about "Japanese Pharmacopoeia" patented technology

The present invention provides a solid oral dosage form pharmaceutical for the treatment of dysuria, which comprises, as an active ingredient, an indoline compound having an alpha 1 -adrenoceptor blocking activity and represented by the formula: a prodrug thereof, pharmaceutically acceptable salt or pharmaceutically acceptable solvate thereof, wherein said pharmaceutical is prepared to have 85% dissolution time of not more than 60 minutes in a dissolution test according to method 2 (paddle method) of Japanese pharmacopoeia in a condition using water.

The present invention provides a sustained-release pharmaceutical composition, characterized in that, there are contained tamsulosin or a pharmaceutically acceptable salt thereof and a carrier for a sustained-release pharmaceutical composition and, when a dissolution test is carried out according to Japanese Pharmacopoeia Dissolution Test Method 2, the tamsulosin release after 7 hours from the start of the dissolution is about 20 to about 85%.

The present invention provides a solid oral dosage form pharmaceutical for the treatment of dysuria, which comprises, as an active ingredient, an indoline compound having an α1-adrenoceptor blocking activity and represented by the formula:prodrug, pharmaceutically acceptable salt or pharmaceutically acceptable solvate thereof, wherein said pharmaceutical is prepared to have 85% dissolution time of not more than 60 minutes in a dissolution test according to method 2 (paddle method) of Japanese pharmacopoeia in a condition using water.

The invention discloses a preparation method of flomoxef sodium. The preparation method comprises the following steps of dropwise adding a sodium bicarbonate solution into flomoxef acid while stirring at the temperature of 0-10 DEG C until the pH value of a reaction solution is up to 4.2-5.2, and after flomoxef acid is completely dissolved, extracting, decoloring and removing a decolorizing agent to obtain flomoxef sodium. By using the preparation method of flomoxef sodium, provided by the invention, flomoxef sodium can be effectively and uniformly produced in real time, the residues of sodium salt and flomoxef acid in a product are avoided, the purity of obtained flomoxef sodium is larger than or equal to 99%, and the residual quantity of 1-ethoxyl-5-thiol-1H-tetrazole is smaller than or equal to 0.2%, therefore, the standard requirement of Japanese pharmacopoeia JP16 is completely met.

The invention discloses a preparation technology of high-purity flomoxef sodium. The preparation technology includes following steps: on the basis of a flomoxef intermediate, performing an acidifying reaction to obtain a reaction liquid; performing a water washing process, an extraction process, an aseptic filtration process and the like to the reaction liquid; and performing a solventing-out crystallization step through a one-step crystallization process to obtain a flomoxef sodium product with a purity being higher than 99.90%, wherein key points in the solventing-out crystallization step are selection and proportion of a solventing agent and dropwise addition of a salifying agent and the solventing agent at the same time with crystal growing. The preparation technology overcomes problems which are difficult to control during the solventing-out crystallization step of the flomoxef sodium. The flomoxef sodium is prepared in one step with the flomoxef intermediate as a raw material and the purity of the product of the flomoxef sodium reaches higher than 99.90% just through one crystallization step, which is cannot be achieved through a freeze-drying method or a common solventing-out crystallization process in the prior art. Quality of the product is in conformity with or even exceeds a standard in japanese pharmacopoeia JP16. The preparation technology has a more wide application prospect.

Disclosed is a preparation which, in an orally fast-disintegrating tablet having as an active ingredient 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazole carboxylic acid, causes basically no irritation in the mouth or throat, retains good dissolvability and oral disintegration even when stored under high temperature or high humidity conditions. The disclosed orally fast-disintegrating tablet is formed to contain particles comprising nuclear particles which contain 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazole carboxylic acid, which are covered by a layer containing a methacrylic acid copolymer, and which are further coated with an outer layer containing water-soluble sugars, such that after two weeks of storage under conditions with the cap open at 40C / 75% RH, a dissolution test performed according to the Japanese Pharmacopoeia Paddle Method at 50 revolutions per minute (test solution: pH6.0McIlvaine buffer) evaluates the dissolution rate of the 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazole carboxylic acid at 70% or greater after 10 minutes.

To provide: a composition containing a swelling agent which less imposes a burden on the stomach or intestines even when the composition is taken in excess; and a food, obesity preventive, and constipation alleviator each containing the composition. [MEANS FOR SOLVING PROBLEMS] The composition is obtained by mixing the Japanese-Pharmacopoeia first liquid or second liquid, a swelling agent comprising a water-soluble polysaccharide swellable in water, and a swelling inhibitor which controls swelling of the swelling agent, bringing the mixture into a homogeneous solution state, and then drying it.

The invention discloses a vulcanizing system, which consists of the following components in parts by weight: 0.5-5 parts of a vulcanizing agent, 0.1-2 parts of a catalyst and 0.5-6 parts of an activating agent, wherein the vulcanizing agent is a silane coupling agent of which the general formula is shown as Y(CH2)nSiX3; in the formula, Y represents alkyl, vinyl, an epoxy group, amino or sulfydryl, and X represents chloro or alkoxyl; the catalyst is thiolimidazoline or 2-thiolbenzimidazole; and the activating agent is zinc oxide or magnesium oxide. A medical chlorinated butyl rubber plug has the advantages of readily-available raw materials and simple process. The medical chlorinated butyl rubber plug prepared by adopting the vulcanizing system can meet the requirements of standards YBB00042005 and / or YBB00052005 issued by the State Food and Drug Administration, can meet the requirements of the Japanese Pharmacopoeia, can meet the requirement of compatibility of special medicaments simultaneously, and is equivalent to the quality of national and international products of the same type.

An object of the present invention is to provide a method capable of detecting and quantifying endotoxin in a sample in which endotoxin derived from gram-negative bacteria cannot be accurately detected or quantified by the method described in Commentary of the Japanese Pharmacopoeia Fourteenth Edition, Hirokawa Publishing Co. 2001 B-63. It has been found that the above object can be achieved by performing an endotoxin test using a lysate reagent in which the lysate reagent is added into a sample in the presence of albumin and / or globulin.

Provided is a laxative tablet which includes magnesium oxide as a main constituent, wherein (1) the particle size by volume of 50% (D50) of particles which emerge when the tablet is suspended in water is 70 mum or less as determined by laser diffractometry, (2) the particle size by volume of 90% (D90) of the particles which emerge when the tablet is suspended in water is 130 mum or less as determined by laser diffractometry, and (3) the dissolution time of the tablet when the tablet is suspended in water according to the Japanese Pharmacopoeia - general testing methods - dissolution testing methods is 10 seconds or less.

The invention relates to an intermediate for synthesizing latamoxef and a preparation method of the intermediate. The intermediate provided by the invention is a latamoxef aluminium chloride (stannum)-anisole complex which is simple and convenient in preparation method, easy to separate, high in content and yield and stability and low in cost and can be conveniently converted to latamoxef acid (sodium) for current use, so that the difficulty that purity of latamoxef acid (sodium) synthesized by the prior art is inadequate can be overcome. The latamoxef sodium prepared by using the complex as raw material and hydrolyzing has a purity of greater than 99%, and the purity is considerably higher than the standard of the Chinese pharmacopoeia (single impurity is not higher than 2% and total impurities are not higher than 5%) and that of the Japanese pharmacopoeia.