39 results about "Japanese Pharmacopoeia" patented technology

[Problem] As compared with the current oral sustained-release preparation containing tamsulosin hydrochloride which have been supplied to the medical setting, there is a problem to provide a sustained-release pharmaceutical composition in which efficacy is equivalent or even better, adverse events such as adverse reactions (e.g., postural hypotension) are reduced, dose can be increased and, if desired, ingestion of food is not limited. [Means for Resolution] 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 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 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.

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.

The invention relates to a purification method for obtaining high-purity recombinant human serum albumin. The method comprises the following steps: centrifugal ultrafiltration and secondary ultrafiltration are carried out after centrifuging and heating the fermentation liquid, the impurities encapsulated in the recombinant human serum albumin are then removed using 30% of alcohol and 6 of mol/L urea, the protein is renatured, eluted, and dialyzed to obtain the decontamination liquid, finally, the obtained decontamination liquid is sequentially subjected to cation exchange chromatography, anionexchange chromatography, and hydrophobic chromatography to obtain the high-purity recombinant human serum albumin. The recombinant human serum albumin obtained by the method has the advantages of high purity, less impurities, low degradation, high stability, and the like, and has the good application prospect. The final obtained recombinant human serum albumin reaches the level of pharmaceuticalgrade (the purity is greater than 99.999999%), which fully meets the requirements of the US Pharmacopoeia and the Japanese Pharmacopoeia for the injection-level recombinant human serum albumin.

The present invention pertains to a resin formed article obtained by forming a resin composition that comprises a cycloolefin resin and a styrene-based thermoplastic elastomer, the styrene-based thermoplastic elastomer having a weight average molecular weight of 20,000 to 150,000, and having a difference in refractive index (ΔnD) of more than −0.002 to less than +0.002 with respect to the cycloolefin resin, the resin composition having a residual ratio of 0.10 wt % or less when analyzed based on the residue on ignition test method specified in the Japanese Pharmacopeia, the resin composition having a light transmittance (optical path length: 3 mm) of 55% or more with respect to light having a wavelength of 450 nm when the resin composition is formed in a shape of a sheet having a thickness of 3.0 mm, and subjected to light transmittance measurement, and the resin composition having a Charpy impact strength of 5 to 40 kJ/m² when the resin composition is formed to have a thickness of 4.0 mm, a length of 80.0 mm, and a width of 10.0 mm, and subjected to the notched Charpy impact test specified in JIS K 7111-1 at 23° C.

The invention discloses a production method of a medicinal rubber plug. The production method includes: thermally treating a rubber plug under a vacuum condition; using water to rinse the rubber plug which is subjected to vacuum thermal treatment; subjecting the rubber plug which is rinsed to siliconization and drying to obtain the medicinal rubber plug. The production method is simple in process, pollution-free, easy for industrialization, energy saving and environment friendly. Extractable matter and extract in the medicinal butyl rubber plug which is treated by the production method are reduced to great extent, sealability of an original butyl rubber plug is unaffected, and the medicinal rubber plug can meet requirements of Standards YBB00042005 and/or YBB00052005 issued by the State Food and Drug Administration, can meet requirements on compatibility of special drug and can reach requirements of the Japanese Pharmacopoeia.

Disclosed is an oral liquid preparation which contains 2-(4-ethyl-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10- hexahydrocycloocta[b] pyridine (an active ingredient) stably and can exhibit good elution behavior of the active ingredient in a wide pH range. The oral liquid preparation comprises the active ingredient and a dissolution aid for the active ingredient, and has an elution rate of 50% or more in an elution test in accordance with the Japanese pharmacopoeia 15th edition 15 minutes after the start of the test in a second elution test solution.

Soft capsules being easily disintegratable in the stomach and avoiding any ready leakage of contents at mastication, which soft capsules encapsulate (2R)-2-propyloctanoic acid or its salt and are characterized in that there is realized at least one property, preferably all thereof, selected from among (A) strength of 150 to 400 N as measured by a cracking load test; (B) disintegration time of 3 to 10 min as measured by a disintegration testing method stipulated in Japanese Pharmacopoeia; (C) thickness of 0.05 to 0.50 mm with respect to the central part of capsule shell; (D) thickness of 0.10 to 0.55 mm with respect to the first joint part of capsule shell; (E) thickness of 0.05 to 0.50 mm with respect to the second joint part of capsule shell; and (F) capsule shell water content of 5.0 to 9.0%.

The invention discloses a gefarnate key intermediate (E-farnesyl acid) refining or reaction solution post-processing method, and belongs to medicines. The method is as follows: according to the fact that E-farnesyl acid is water-soluble in alkaline conditions and insoluble in water in acidic conditions, through washing and filtering, fat soluble impurities can be removed in alkaline conditions, and water soluble impurities can be removed in acidic conditions; and the step is as follows: dissolving the E-farnesyl acid with an alkali solution, washing and filtering with an organic solvent, then adjusting filtrate to acidic, adding an organic solvent for extraction, and concentrating to obtain high purity E-farnesyl acid. Finally, gefarnate is prepared from the E-farnesyl acid and geraniol by the method well-known by technical personnel in the field. The gefarnate key intermediate (E-farnesyl acid) refining method can well improve the E-farnesyl acid purity, and especially removes the fat soluble impurities to enable finished product gefarnate after esterification reaction to fully meet and be higher than Japanese Pharmacopoeia standards, the purity can reach 99.5%, and the method is simple in operation, and is more suitable for industrial production.

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 hydrogel-forming composition capable of forming a sterilized hydrogel having a high mechanical strength. Also provided are a hydrogel using the hydrogel-forming composition, and a method for producing the hydrogel-forming composition. The hydrogel-forming composition contains a vinyl alcohol polymer having an ethylenically unsaturated group and having a polymerization degree of 450 or more, in which the ethylenically unsaturated group introduction ratio is 0.01 to 10 mol % in all the structural units constituting the vinyl alcohol polymer, and in which no microorganisms detectable by the sterility test method (direct method) specified in the general test methods of the Japanese Pharmacopoeia are present.

The invention relates to a polystyrene sulfonic acid sodium cation exchange resin which is copolymerization prepared by the styrene-two ethylene benzene, through the compound which contains calcium ion transform, it purifies to the polystyrene sulfonic acid calcium resin, the compound which contains calcium ion is composed of calcium ion and its balance ion, the complexing agent, the acid alkalinity regulator and water. The balance ion is the chlorine ion; the complexing agent is: one kinds, two kinds or more than two kinds of the ethylene diamine four ethanoic acid, the second two support three amine five ethanoic acid, the ammonia three acetic acid, the citric acid and the calcium salt or sodium salt; the acid alkalinity regulator is hydrochloric acid and sodium hydroxide or hydrogen calcium oxide and so on abio-acid and alkali. The invention technical index has achieved to the standard of outward appearance,the calcium content, the potassium exchange quantity and the impurity (ammonium, heavy metal, arsenic, styrene and sodium) in the Japanese pharmacopoeia (JP14 e), the residual 1,2- dichloroethane content conforms to the standard about the organic solvent in the Chinese pharmacopoeia (2005 editions).