市售双氯芬酸钠肠溶片探索性研究  

An exploratory study on commercially available diclofenac sodium enteric-coated tablets

作　　者：巩峰贤 齐衍超 李子静 谭颖 杨丽蓉 赵海鹏 GONG Fengxian;QI Yanchao;LI Zijing;TAN Ying;YANG Lirong;ZHAO Haipeng(Weifang Inspection and Testing Center,Shandong,Weifang 261200,China;Shandong Medical College,Shandong,Linyi 276000,China)

机构地区：[1]潍坊市检验检测中心,山东潍坊261200 [2]山东医学高等专科学校,山东临沂276000

出　　处：《中国医药科学》2022年第13期106-110,共5页China Medicine And Pharmacy

摘　　要：目的 对山东省内销售的44批次双氯芬酸钠肠溶片的质量及质量标准进行探索性研究,为该品种的安全监管和质量标准完善提供参考。方法 采用法定质量标准对来自山东省药品质量风险监测抽检的44批次样品进行检验,将检验结果进行统计分析。主要围绕不合格项目溶出度进行探索性研究,建立了该品种溶出度新的HPLC检测方法。结果 法定检验结果显示,44批次双氯芬酸钠肠溶片中1批次不合格,合格率为97.7%;探索性研究结果显示,现行标准在溶出度的检测方法的专属性方面尚存在不足;与原研药比较,其他国内企业该品种的溶出曲线批间波动较大,产品质量有待提升。结论 目前大部分双氯芬酸钠肠溶片的质量能达到现行标准的要求。但通过探索性研究发现,与原研药比较,国内双氯芬酸钠肠溶片溶出均一性较差,企业在制剂工艺或包衣工艺存在一定缺陷;溶出度检验方法专属性不强,质量标准需进一步提高。Objective To conduct an exploratory study on the quality and quality standard of 44 batches of diclofenac sodium enteric-coated tablets commercially available in Shandong Province, so as to provide reference for the safety supervision and quality standard improvement of this variety. Methods The 44 batches of samples sampled by Shandong Drug Quality Risk Monitoring Center were inspected in accordance with statutory quality standards, and the inspection results were statistically analyzed. An exploratory study was conducted mainly on the dissolution of unqualified items, and a new high performance liquid chromatography(HPLC) method for the dissolution of this variety was established. Results The statutory inspection results showed that 1 batch of the 44 batches of diclofenac sodium enteric-coated tablets was unqualified, with a qualified rate of 97.7%. The results of the exploratory study showed that the current standard does not well match the specificity of the dissolution test method. Compared with the original drug, the dissolution curve of this variety from other domestic enterprises fluctuated largely from batch to batch, and the product quality needed to be improved. Conclusion At present, the quality of most diclofenac sodium enteric-coated tablets can meet the requirements of the current standard. However, through exploratory study, poorer dissolution uniformity of domestic diclofenac sodium enteric-coated tablets is found compared with the original drug, and there are some defects in terms of preparation process or coating process in domestic enterprises. In addition,the dissolution test method has no good specificity, and the quality standard needs to be improved.

关 键 词：双氯芬酸钠肠溶片 溶出度 探索性研究 非甾体消炎药 

分 类 号：R927.1[医药卫生—药学]