摘要
目的评价国内注射用阿莫西林钠/氟氯西林钠的质量,并对质量标准进行完善。方法采用法定检验方法结合探索性研究对2019年国家药品抽验中得到的47批次样品进行检验。通过对杂质谱、水活度、温度、药物与胶塞相容性等项目的考察,分析本品的质量状况。结果按法定标准检验,47批次样品的合格率为100%。采用新建立的杂质谱分析方法,确证了各杂质的结构及来源;证明水活度与温度对样品的降解有促进作用;胶塞中环硅氧烷类化合物及抗氧剂有向药品中迁移的趋势。结论注射用阿莫西林钠/氟氯西林钠总体质量较好;现行质量标准仍应提高,建议修订有关物质检查方法,增加对特定杂质的控制;严格控制药品生产、流通、贮藏过程中的温、湿度;建议企业选择与本品具有更好相容性的优质胶塞。
Objective To evaluate the quality of domestic amoxicillin sodium and flucloxacillin sodium for injection, and improve the quality standards. Methods 47 batches of samples from national drugs in 2019 were tested by adopting the statutory standard methods combined with exploratory researches. The quality of the product was analyzed using the impurity spectrum, water activity, temperature, drug compatibility with rubber plugs. Results According to the statutory standards, the qualified rate of the 47 batches was 100%. The impurity spectrum analysis method was established to confirm the structure and source of each impurity. It was proved that water activity and temperature promoted the degradation of the samples. The cyclosiloxane compounds and antioxidants in the rubber plug tended to migrate to the drugs. Conclusions The quality of amoxicillin sodium and flucloxacillin sodium for injection was generally under good control. However, the quality control specification needs to be improved. It was suggested to revise the method of the related substances and increase the control of specific impurity. The temperature and humidity were controlled strictly during the production, circulation, and storage of drugs. It was suggested that the enterprise choose the high quality rubber plug that had better compatibility with this product.
作者
刘亚妮
周晓溪
姚羽
秦爱方
田方
Liu Ya-ni;Zhou Xiao-xi;Yao Yu;Qin Ai-fang;Tian Fang(Shanxi Institute for Food and Drug Control,Taiyuan 030031)
出处
《中国抗生素杂志》
CAS
CSCD
2020年第3期212-217,共6页
Chinese Journal of Antibiotics
关键词
注射用阿莫西林钠/氟氯西林钠
质量评价
杂质谱
Amoxicillin sodium and flucloxacillin sodium for injection
Quality evaluation
Impurity spectrum
