2009年国产注射用阿奇霉素评价性抽验结果与质量评价.pdf

1804 C in J P arm Anal 2010, 30( 9) * 2009 ** 张斗胜, 王晨, 刘文, 王立新, 王悦雯, 王明娟, 张力, 杨亚莉, 胡昌勤 (, 100050) : : 2009, , : 217 190 ( 876% ) , 27( 124% ), ; H PLC , : , , ; , , H PLC : ; ; : R917 : A : 0254- 1793( 2010) 09- 1804- 05 Sampling resultsand assessmentthe quality ofdomestic * azithromycin for injection in2009 ZHANG Dou- s eng, WANG C en, LIU W en, WANG Li- xin, WANG Yue- w en, * * WANG M ing- juan, ZHANG Li, YANG Ya- li, HU C ang- qin ( National Institute for t e Control of P arm aceutical and B iological Products, Beijing 100050, C ina) AbstractObjective:To evaluate t e quality status of domestic azit romycin for injection and exsisting problem s. ethods:Accord ing to t e general requ irements of national assessment program s in 2009, use statutory testing met ods and combine w it t e exploratory researc to exam ine samp le, evaluate t e quality status of dom estic az it romycin for injection by statistical analysis of t e resu lts. Rseults: In 217 batc s of samp les, 190 batc of qualified ( 876% ), 27 groups ( 124% ) failed, clarity of solution as t e m ain causes of failure, exp loratory stud ies ave s own t at if usingHPLC met od to replace t e originalm et od of c eck ing content and related substances, t en t e samp le failure rate increased sign ificantly. Conclusions:A t present t emost products quality of domestic azit romy cin for injection can meet t e current standards, t ere are still in som e problems in few enterprises, suc as clarity and visible foreign matter exceeded, w e