国产四环素片质量分析-中国抗生素杂志.pdfVIP

. 348 . 中国抗生素杂志年月第卷第期 文章编号：-()-- 国产四环素片质量分析 张琼 张肖宁 肖宇 姜晶 娄志红* ( 黑龙江省食品药品检验检测所，哈尔滨) 摘要：目的 综合评价不同企业生产的四环素片的质量。方法 采用现行法定标准检验结合探索性研究结果，对市场上 家企业生产的批四环素片的质量进行系统比较，通过对原料药和制剂含量测定、有关物质及水分等项目的考察，结合稳 定性试验，分析不同企业产品的质量差异。结果 法定标准检验批四环素片，合格率为% ；探索性研究显示，法定标准 中有关物质及水分检查项的缺失，导致质量控制不到位。结论 国内四环素片整体质量一般，现行质量标准有待提高。 关键词：四环素片；质量分析；含量测定；有关物质；水分测定 中图分类号：R. 文献标志码：A Quality analysis of domestic tetracycline tables Zhang Qiong, Zhang Xiao-ning, Xiao Yu, Jiang Jing and Lou Zhi-hong (Heilongjiang Institute for Food and Drug Control, Harbin 150080) Abstract Objective Objective To evaluate the quality status of tetracycline tables. Methods Using statutory testing methods and combining with the exploratory research to systematically compare the quality of 200 batches of tetracycline tables of 24 production enterprises, based on the components of raw materials and preparation, related substances and water determination, the stability test, and the analysis of different enterprise product quality differences. Results Statutory tests showed the pass rate was 100% for the 200 batches tetracycline tables. Exploratory research showed that the lack of the related substances and water method leaded to poor quality control. Conclusion The overall quality of domestic tetracycline tables is normal, and quality standard needs to be improved. Key words Tetracycline tables; Quality analysis; Component; Related material; Water determination 四环素是从放线菌金色链霉菌的培养液中分离 司开发，我国于年代初试制成功并投产。因其高效、 出来的抗菌物质，属广谱抗生素，于年辉瑞公 广谱、经济等优点被广泛用于革兰阳性菌、革兰阴 收稿日期：-- 作者简介：张琼，女，生于年，副主任药师，研究方向为药品检验和药物分析，E-mail: juanbing @.com * 通讯作者，E-mail: louzhihong @