吡罗昔康片质量分析  

Quality Analysis of Piroxicam Tablets

作　　者：谭菊英 邓鸣 何虹 黄丽丽 孙煜 朱建萍 戴向东 卢日刚 Tan Juying;Deng Ming;He Hong;Huang Lili;Sun Yu;Zhu Jianping;Dai Xiangdong;Lu Rigang(Guangxi Institute for Food and Drug Control,Nanning 530021,China)

机构地区：[1]广西壮族自治区食品药品检验所,南宁530021

出　　处：《中国药师》2018年第10期1868-1871,共4页China Pharmacist

摘　　要：目的:评价吡罗昔康片的质量现状及存在问题。方法:按照法定标准对样品进行检验,并进行探索性研究,对数据结果进行统计分析。结果:按法定标准检验138批次样品,135批样品合格,合格率为97. 8%。不合格样品3批的不合格项目均为溶出度。探索性研究表明吡罗昔康片所用原料存在两种晶型,不同晶型的原料采用相同处方、相同工艺生产为片剂后其溶出量有区别,晶型1溶出量小于晶型2;建立有关物质检查方法,共检出14种杂质,推测其中8个杂质的结构,杂质主要来源于原料,多批样品单个最大杂质含量超过0. 5%,总杂质含量超过1. 0%;通过GC测定及GC-MS确认13批片剂中检出一类溶剂1,2-二氯乙烷;通过溶出度一致性评价试验发现不同企业产间的产品溶出行为差异较大。结论:目前国内吡罗昔康片的总体质量一般,部分厂家生产工艺需要改进。Objective： To evaluate the quality status of piroxicam tablets. Methods： The samples were examined by the statutory standard,and the exploratory studies were carried out. The results were statistically analyzed. Results： Totally 138 batches were examined according to the statutory standard,and among them,135 batches were qualified with the qualified rate of 97. 8%. The unqualified item of 3 unqualified batches was dissolution. The exploratory studies showed that there were two crystal forms of piroxicam used in the tablets,and the dissolution of the two crystal forms was different with form 1 less than form 2. An inspection method for the relative substance was established. Totally 14 impurities were detected out and the structures of 8 impurities were identified. The impurities were mainly derived from the raw materials,and many batches of samples were with single largest impurity content exceeding 0. 5%,and the total of impurity content above 1. 0%. A class I solvent 1,2-dichloroethane was detected out in 13 batches of tablets by GC and confirmed by GC-MS. Through the dissolution consistency test,it was found that there was a great difference in the dissolution behavior among the products from different manufacturers. Conclusion： The overall quality of piroxicam tablets is not ideal,and the production process of some manufacturers needs to be improved.

关 键 词：吡罗昔康片 质量分析 评价性抽验 

分 类 号：R917[医药卫生—药物分析学]