上海医药
上海醫藥
상해의약
SHANGHAI MEDICAL & PHARMACEUTICAL JOURNAL
2013年
13期
45-49
,共5页
注射用头孢曲松钠%质量对比%含量%杂质%理化性质
註射用頭孢麯鬆鈉%質量對比%含量%雜質%理化性質
주사용두포곡송납%질량대비%함량%잡질%이화성질
ceftriaxone sodium for injection%quality comparative studies%content%impurity%physicochemical property
目的：对比上海新亚药业与原研企业生产的两注射用头孢曲松钠产品质量的异同。方法：采用反相高效液相色谱、液质联用、手性分析、粒度分布等多种方法，对两企业产品进行检测分析。结果：两企业终产品在含量、有关物质、手性及异构体杂质、聚合物杂质上无明显差异，临床用药稳定性及输液器截留等用药环节测定结果无差异。粒度分布测定显示原研品粒径95%小于9.82μm，新亚样品95%粒径小于51.84μm。结论：在本实验范围内，影响产品安全与疗效的关键质量项无明显差异。临床用药稳定性及输液器截留等用药环节对产品有效量的影响无差异。
目的：對比上海新亞藥業與原研企業生產的兩註射用頭孢麯鬆鈉產品質量的異同。方法：採用反相高效液相色譜、液質聯用、手性分析、粒度分佈等多種方法，對兩企業產品進行檢測分析。結果：兩企業終產品在含量、有關物質、手性及異構體雜質、聚閤物雜質上無明顯差異，臨床用藥穩定性及輸液器截留等用藥環節測定結果無差異。粒度分佈測定顯示原研品粒徑95%小于9.82μm，新亞樣品95%粒徑小于51.84μm。結論：在本實驗範圍內，影響產品安全與療效的關鍵質量項無明顯差異。臨床用藥穩定性及輸液器截留等用藥環節對產品有效量的影響無差異。
목적：대비상해신아약업여원연기업생산적량주사용두포곡송납산품질량적이동。방법：채용반상고효액상색보、액질련용、수성분석、립도분포등다충방법，대량기업산품진행검측분석。결과：량기업종산품재함량、유관물질、수성급이구체잡질、취합물잡질상무명현차이，림상용약은정성급수액기절류등용약배절측정결과무차이。립도분포측정현시원연품립경95%소우9.82μm，신아양품95%립경소우51.84μm。결론：재본실험범위내，영향산품안전여료효적관건질량항무명현차이。림상용약은정성급수액기절류등용약배절대산품유효량적영향무차이。
Objective:To compare the quality of ceftriaxone sodium for injection made by the original company and Shanghai Xinyapharm company so as to get the breakthrough points to improve the product quality. Methods:Two products were analyzed by RP-HPLC, LC-MS, chiral analysis, particle size distribution and so on. Results:There is no significant difference in content, related substances, chiral isomer impurities and so on between two products and the stability in clinical use and the interception of infusion apparatus are almost same. However, there is a little difference in the appearance and the particle size distribution. Conclusion:There is no significant difference in the key quality items.
