不同介质中头孢克洛干混悬剂溶出曲线相似性比较研究

发布时间：2018-01-21 22:50

本文关键词： 头孢克洛干混悬剂溶出曲线相似性　出处：《中国抗生素杂志》2017年05期 　论文类型：期刊论文

【摘要】：目的比较不同企业头孢克洛干混悬剂在4种溶出介质中的溶出行为,为评价药品质量提供依据。方法采用桨法,转速50r/min,分别以pH1.2盐酸溶液、pH4.0醋酸盐缓冲液、pH6.8磷酸盐缓冲液和水各900m L为溶出介质,HPLC法在波长254nm检测并绘制溶出曲线,采用单点法进行比较分析。结果以Lilly苏州制药有限公司产品为参比制剂,6家企业产品的溶出曲线在4种溶出介质中均与参比制剂相似,其余4家企业产品各有1条溶出曲线与参比制剂不相似。结论溶出曲线测定反映出4家企业生产的头孢克洛干混悬剂与参比制剂质量存在差异,生产工艺及辅料可能是影响其溶出行为的主要因素。
[Abstract]:Objective to compare the dissolution behavior of cefaclor dry suspension in four kinds of dissolution media in different enterprises, and to provide the basis for evaluating the quality of drugs. PH1.2 hydrochloric acid solution, pH 4.0 acetate buffer, pH 6.8 phosphate buffer, and water, respectively, were used as dissolution media. HPLC method was used to detect and draw the dissolution curve at 254 nm. Results the product of Lilly Suzhou Pharmaceutical Co., Ltd was used as reference preparation. The dissolution curves of the products of 6 enterprises were similar to those of reference preparations in four kinds of dissolution media. Conclusion the determination of dissolution curve shows that the quality of cefaclor dry suspension produced by four enterprises is different from that of reference preparation. The production process and auxiliary materials may be the main factors affecting its dissolution behavior.
【作者单位】：山西省食品药品检验所;
【分类号】：R927.1
【正文快照】： 头孢克洛为广谱半合成头孢菌素类抗生素,对多种革兰阳性菌和革兰阴性菌均具有很强的杀灭作用,属第二代口服头孢菌素[1]。头孢克洛由美国Lilly公司于1976年开发研制,于1979年首次在美国、英国等国家上市,上市剂型包括混悬剂。头孢克洛干混悬剂国内现有批准文号19个,有0.125、0.

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