阿莫西林克拉维酸钾分散片.doc（Amoxicillin and clavulanate potassium dispersible tablets.Doc）.doc

阿莫西林克拉维酸钾分散片.doc（Amoxicillin and clavulanate potassium dispersible tablets.Doc） New varieties Amoxicillin and Clavulanate Potassium Dispersible Tablets Amoxilin Kelaweisuanjia Fensanpian Amoxicillin, and, Clavulanate, Potassium, Dispersible, Tablets This product is a mixture of amoxicillin and amoxicillin / clavulanate potassium (C16H19N3O5S) and clavulanic acid (C8H9NO5) labeled amount ratio of 4: 1 or 7: 1] (C16H19N3O5S), containing amoxicillin and clavulanic acid (C8H9NO5) as all of the labeled amount from 90% to 120%. [features] this product is white or weak yellow or film, and after coating, it is white or yellowish. [identification] the retention time of the two main peaks of the sample solution should be the same as that of the two main peaks corresponding to the corresponding solution, respectively, in the chromatogram recorded under the content determination of [1]. [2] (1) take this product 1, porphyrized, plus pH7.0 phosphate buffer solution (if necessary, the ice bath ETUS 10 minutes) to produce a solution, each 1ml contains about 5mg of amoxicillin static, filtration, the successive filtrate as the test solution; taking amoxicillin and clavulanic acid for reference according to the amount of goods, add pH7.0 phosphate buffer solution (when necessary ETUS 10 minutes, the clavulanic acid to be added after ultrasound) to produce a solution per 1ml respectively containing amoxicillin clavulanic acid and 5mg 2mg, as the reference solution; another control, amoxicillin clavulanate reference substance and cefaclor g control the amount, add pH7.0 phosphate buffer solution (when necessary ETUS 10 minutes, the clavulanic acid to be added after ultrasound) to produce a solution of clavulanic acid and amoxicillin and cefaclor by about 5mg each containing 1ml, as Test solution for system suitability. Thin-layer chromatography (Appendix V B) test, draw the 3 solution (2 L, respectively in the same thin layer plate of silica gel GF254, acetic ether dichloromethane - f