1、,Amoxicillin Injection 阿莫西林,-cillin 西林（词干）,什么是词干？,为了表明同类药品的关系，WHO采用了一系列的“词干”，药理作用相同的属于同一类的物质采用统一的词干。 Sulfa- 磺胺类药物的词干，译作磺胺； Cef- 头孢菌素类抗生素的词干，译作头孢-cycline 环素 -mycin 霉素 - caine 卡因,General NoticesDefinition Amoxicillin Injection is a sterile solution of Amoxicillin Sodium in Water for Injections. It is
2、prepared by dissolving Amoxicillin Sodium for Injection in the requisite amount of Water for Injections immediately before use. sterile solution 灭菌溶液 requisite amount 需要量,规定量,The injection complies with the requirements stated under Parenteral Preparations.Parenteral = par + enter + al 相反 肠 的,肠溶片 En
3、teric-coated Tablets全胃肠外营养(全静脉营养 )total parenteral nutrition 肠内营养 enteral nutrition,Storage Amoxicillin Injection should be used immediately after preparation,FOR INJECTION INJECTION,AMOXICILLIN SODIUM FOR INJECTION 注射用阿莫西林钠 (粉剂）Amino Acids Injection 氨基酸注射液（液体）,Definition Amoxicillin Sodium for Inje
4、ction is a sterile material consisting of Amoxicillin Sodium with or without excipients. It is supplied in a sealed container sterile 无菌的excipients 辅料sealed container 密封容器,The contents of the sealed container comply with the requirements for Powders for Injections stated under Parenteral Preparation
5、s and with the following requirements.,Content of amoxicillin, C16H19N3O5 S 90.0 to 105.0% of the prescribed or stated amount.（标示量）本品含阿莫西林(C16H19N3O5 S ) 应为标示量的90.0105.0 。,Identification 鉴别 A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of amoxicillin s
6、odium (RS 010).,B. Carry out the method for thin-layer chromatography, Appendix III A, using a TLC silica gel silanised plate (Merck silanised silica gel 60 plates are suitable) and 90 volumes of a 15.4% w/v solution of ammonium acetate adjusted to pH 5.0 with glacial acetic acid as the mobile phase
7、. TLC = thin-layer chromatographySilanised 使硅烷化,Apply separately to the plate 1 l of each of three solutions in a 4.2% w/v solution of sodium hydrogen carbonate containing,(1) sufficient of the contents of the sealed container to give a solution containing the equivalent of 0.25% w/v of amoxicillin,
8、(2) 0.25% w/v of amoxicillin trihydrate BPCRS and (3) 0.25% w/v of amoxicillin trihydrate BPCRS and 0.25% w/v of ampicillin trihydrate BPCRS. BPCRS ？,After removal of the plate, allow it to dry in air, expose it to iodine vapour until spots appear and examine in daylight.,The principal spot in the c
9、hromatogram obtained with solution (1) is similar in position, colour and size to that in the chromatogram obtained with solution,(2). The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.,C. Yield the reactions characteristic of sodium salts, Ap
10、pendix VI.,Alkalinity pH of a solution containing the equivalent of 10% w/v of amoxicillin, 8.0 to 10.0, Appendix V L.,Degradation products Not more than 9.0% with respect to the content of Amoxicillin Sodium when determined by the following method. To a quantity of the contents of the sealed contai
11、ner containing the equivalent of 0.24 g of amoxicillin,add 25 ml of boric buffer pH 9.0 and 0.5 ml of acetic anhydride, stir for 3 minutes, add 10 ml of acetate buffer pH 4.6 and titrate immediately with 0.02M mercury(II) nitrate VS,Determine the end point potentiometrically using a platinum or merc
12、ury indicator electrode and a mercury-mercury(I) sulphate reference electrode. Disregard any preliminary inflection on the titration curve.,Each ml of 0.02M mercury(II) nitrate VS is equivalent to 7.748 mg of degradation products, calculated as C16H18N3NaO5 S,WaterNot more than 4.0% w/w, Appendix IX
13、 C. Use 0.3 g,Pyrogens Comply with the test for pyrogens, Appendix XIV D. Use per kg of the rabbits weight 1 ml of a solution in water for injections containing the equivalent of 18.7 mg of amoxicillin per ml.,Assay Determine the weight of the contents of 10 containers as described in the test for U
14、niformity of weight under Parenteral Preparations, Powders for Injections,Dissolve a quantity of the mixed contents of the 10 containers containing the equivalent of 0.15 g of amoxicillin in sufficient water to produce 500 ml.,Transfer 10 ml of the resulting solution to a 100-ml graduated flask, add
15、 10 ml of boric buffer pH 9.0 followed by 1 ml of acetic anhydride-dioxan solution, allow to stand for 5 minutes and add sufficient water to produce 100 ml. resulting solution 所得的溶液 graduated 有刻度的 graduated flask 量筒,量杯 boric buffer 硼酸缓冲溶液,Place two 2-ml quantities of the solution in separate stopper
16、ed tubes. To one tube add 10 ml of imidazole-mercury reagent, stopper the tube and place in a water bath at 60for exactly 25 minutes, swirling occasionallystoppered tubes 具塞的试管swirling 回荡,shake 指“震摇”，作往复运动。例如萃取 时分液漏斗的动作。agitate 为“搅动”，指用玻棒将物料搅动、混匀或帮助结晶溶解。swirl 是“旋摇”，如滴定时锥形瓶的摇动。stir 译成“搅拌”，多指恒速长时间的搅拌，
17、如机械搅拌。,Remove the tube from the water bath and cool rapidly to 20 (solution A),To the second tube add 10 ml of water and mix (solution B). Without delay measure the absorbances of solutions A and B at the maximum at 325 nm, Appendix II B,using in the reference cell a mixture of 2 ml of water and 10
18、ml of imidazole-mercury reagent for solution A and water for solution B. reference cell 参比电池imidazole-mercury 咪唑-汞,Calculate the content of C16H19N3O5 S in a container of average content weight from the difference between the absorbances of solutions A and B, from the difference obtained by repeatin
19、g the operation using 0.17 g of amoxicillin trihydrate BPCRS in place of the preparation being examined and from the declared content of C16H19N3 O5S in amoxicillin trihydrate BPCRS.,Storage The sealed container should be stored at a temperature not exceeding 25,Labelling The label of the sealed con
20、tainer states the quantity of Amoxicillin Sodium contained in it in terms of the equivalent amount of amoxicillin.（按阿莫西林计算）,When amoxycillin injection or amoxycillin sodium for injection is prescribed or demanded , Amoxicillin Injection or Amoxicillin Sodium for Injection shall be dispensed or supplied. prescribed 开处方,
