国产诺氟沙星口服固体制剂的质量评价  

Quality evaluation of domestic oral solid preparations of norfloxacin

作　　者：宋丽娟 孙荧 鲍实 吴蔚 刘晨曦 Song Li-juan;Sun Ying;Bao Shi;Wu Wei;Liu Chen-xi(Hubei Institute for Drug Control,Wuhan 430075;Hubei Engineering Research Center for Drug Quality Control,Wuhan 430075)

机构地区：[1]湖北省药品监督检验研究院,武汉430075 [2]湖北省药品质量检测与控制工程技术研究中心,武汉430075

出　　处：《中国抗生素杂志》2023年第3期257-266,共10页Chinese Journal of Antibiotics

摘　　要：目的对国产诺氟沙星胶囊和片的质量现状进行评价并提出意见。方法采用法定标准对288批胶囊和13批片抽检样品进行了检验,并对有关物质、杂质谱分析、遗传毒性杂质、溶出曲线和水分等关键项目进行探索性研究。结果301批样品法定检验合格率为100%。探索性研究优化了有关物质测定方法,并对杂质来源进行了归属;建立了遗传毒性杂质(杂质2)的LC/MS检测方法;发现过评胶囊与未过评胶囊质量存在明显差异,表现为二者的溶出曲线存在显著差异,过评胶囊的溶出量明显高于未过评胶囊,且过评胶囊和片剂的水分控制相对较好,采用PVC加套袋包装可以有效地阻隔水分的侵入。结论诺氟沙星片质量总体一般,胶囊质量总体较差;通过一致性评价企业的片/胶囊质量整体优于未过评企业的产品。建议现行标准应优化有关物质和溶出度测定方法;增订杂质2和水分检查;建议片/胶囊生产企业对原料的晶型与粒度、产品包装形式进行严格把控;尽快开展一致性评价工作。Objective To evaluate the quality of domestic norfloxacin capsules and tablets and put forward a series of improvement suggestions.Methods 288 batches of capsules and 13 batches of tablets were tested using the legal standards;and exploratory studies were carried out on key items like impurity spectrum,genotoxic impurity,dissolution curves and water.Results The qualified rate of 301 batches of samples was 100%.Through the exploratory studies,testing methods of related substance were optimized,source of major impurities were attributed and analysis methods of genotoxic impurity were established.In addition,according to dissolution curves tests,the dissolution of capsules passing the consistency evaluation were higher than that of unevaluated varieties and the water content of the over-evaluated capsules and tablets were controlled in low level,and the PVC plus sleeve packaging form could effectively block the intrusion of moisture.Conclusion The quality of norfloxacin tablets was under general standards.However,the quality of norfloxacin capsules was of poor quality.It is recommended that the detection methods of related substances and dissolution determination should be optimized,adding the method of genotoxic impurity and water.It is also suggested that the tablet/capsule manufacturers should strictly control the crystal shape and particle size of raw materials and product packaging forms,and carry out the consistency evaluation as soon as possible.

关 键 词：诺氟沙星胶囊 诺氟沙星片 质量评价 有关物质 杂质 溶出度 水分 包材 

分 类 号：R978.1[医药卫生—药品]