摘要
目的:基于质量源于设计理念,考察卡铂成品输液在一定浓度范围、一定储存条件下的含量稳定性,并建立其质量控制空间。方法:以输液浓度、储存时间及温度为关键影响因素,以卡铂的含量为关键质量属性,采用Box-Behnken响应面法建立关系模型,构建卡铂成品输液的质量控制空间,并进行验证。结果:卡铂成品输液的浓度范围应控制在0.2~4 mg·mL^(-1),储存温度<27℃,储存时间<35 h。在该空间内,卡铂的含量均大于95%,满足临床用药需求。结论:采用质量源于设计理念建立成品输液的质控空间,有助于灵活、稳定、高效地控制成品输液质量,具有重要的临床指导意义。
OBJECTIVE To investigate the stability of carboplatin infusion over certain concentration range and under certain storage conditions,and to establish its quality control space based on the concept of quality by design.METHODS Infusion concentration,storage time and temperature were set as the key influencing factors,and the content of carboplatin was set as the key quality attribute.The relationship model was established by Box-Behnken response surface method,and the quality control space of carboplatin infusion was constructed and verified.RESULTS The concentration range of carboplatin infusion should be controlled within 0.2-4 mg·mL-1,the storage temperature should be controlled below 27℃,and the storage time should be controlled within 35 h.In this space,the content of carboplatin was more than 95%,which met the needs of clinical medication.CONCLUSION The establishment of quality control space for carboplatin infusion based on the concept of quality by design is helpful to control the quality flexibly,stably and efficiently,and has important clinical guiding significance.
作者
王淼
管敏
WANG Miao;GUAN Min(Department of Pharmacy,Affiliated Hospital of Nanjing University of Chinese Medicine,Jiangsu Nanjing 210029,China)
出处
《中国医院药学杂志》
CAS
北大核心
2023年第9期966-970,共5页
Chinese Journal of Hospital Pharmacy
基金
江苏省中医药管理局科技项目(编号:JD2019SZ04)
南京药学会——常州四药医院药学科研基金项目(编号:2020YX013)。
