洛索洛芬钠片的质量分析

Quality Analysis of Loxoprofen Sodium Tablets

关键词:  洛索洛芬钠片  质量分析  法定检验  探索性研究

Key words:  loxoprofen sodium tablets  quality analysis  prescribed examination  exploratory research

摘要:

目的 对2017年浙江省药品生产及流通领域的41批次洛索洛芬钠片的质量进行考察分析，评价本品的质量现状并分析存在的问题。方法 将法定检验与探索性研究相结合，针对现行质量标准不完善等问题，采用X-射线衍射法考察晶型；采用HPLC进行手性分离，考察有关物质、溶出度及稳定性；采用电感耦合等离子体发射光谱仪考察溴残留；采用近红外光谱扫描法建立近红外光谱库。对法定检验及探索性研究的结果进行统计分析。结果 法定检验与探索性研究结果之间存在差异。结论 探索性研究结果表明部分法定质量标准不完善，且各厂家的产品质量有差异，应引导企业进行制剂工艺改进，提高质量，并采用更完善的方法全面控制产品质量。

Abstract:

OBJECTIVE To evaluate the current quality situation and problems of loxoprofen sodium tablets by testing and analyzing 41 batches of loxoprofen sodium tablets collected from the realm of drug production and circulation all over the Zhejiang provience in 2017. METHODS The prescribed examination was combined with exploratory research as the current standard could not completely control the product quality. X-ray diffraction method was used to determine the crystal form. HPLC was used to determine the chiral separation, related substances, dissolution and stability. ICP-OES was used to determine the residue of bromine. Near infrared spectrum database was established by near infrared spectroscopy. The results of the prescribed examination and exploratory research were statistically analyzed. RESULTS There were differences between the results of the prescribed examination and exploratory research. CONCLUSION The results of exploratory research show that there are defects in some statutory standards. The product quality of different manufacturers is variant, and it is necessary to guide them to improve the preparation process and the quality. More perfect methods shall be used to completely control the quality.