口鼻吸入给药系统在GLP体系下性能验证方法的建立
Establishment of a performance verification method for oral and nasal inhalation system under GLP conditions
夏赵云 1廖海锋 1吴心如 1黄泽鹏 1郭健敏 1杨威1
作者信息
- 1. 广州湾区生物医药研究院,广东莱恩医药研究院有限公司,广东省药物非临床评价研究与重点实验室,国家中药现代化工程技术研究中心中药非临床评价分中心,广东省创新药物评价与研究工程技术研究中心,广州 510990
- 折叠
摘要
目的 建立口鼻吸入给药系统在药物非临床研究质量管理规范(Good Laboratory Practice,GLP)体系下的性能验证方法.方法 通过吸入试验相关文献中吸入系统的检测参数、质量控制关注点,以及结合仪器性能要求,在精准气溶胶吸入给药系统上建立口鼻吸入给药系统性能评价的方法,验证内容包括系统压力、进气流量可靠性、暴露浓度均一性、暴露系统稳定性等.结果 系统压力偏差为-1.52%～1.00%;系统进气流量CV值在-1.84%～3.40%范围内;液态吸入给药暴露浓度孔间RSD为 7.70%,粉末吸入给药暴露浓度孔间RSD为 15.75%;连续雾化 30min,液态暴露浓度RSD为 5.50%,粉末暴露浓度RSD为 7.22%,温度、湿度、O2 浓度、CO2 浓度均在合格标准范围内,精准气溶胶吸入给药系统在本实验验证条件下各项性能指标均符合仪器使用的要求.结论 上述性能指标验证方法准确可靠,能够满足药物安全性评价的需要,可以为口鼻吸入给药系统在GLP体系下的性能验证提供参考.
Abstract
Objective To establish a method to verify the performance of a Oral and nasal Inhalation System under GLP conditions.Methods Combining the testing parameters and concerns of the inhalation system in the literature related to the inhalation tests,and then combining the instrument factory performance standards,the performanceevaluation of the oralnasal inhalation system is established based on the precise aerosol inhalation system.The validation includes system pressure,inlet flow reliability,exposure concentration homogeneity,and exposure system stability.Results The system pressure deviation was-1.52%～1.00%.The CV of the system intake flow was within the range of-1.84%to 3.40%.The RSD between the exposed concentration pores for liquid inhalation administration was 7.70%,while the RSD between the exposed concentration pores for powder inhalation administration was 15.75%.Continuous atomization for 30 minutes,liquid exposure concentration RSD was 5.50%,powder exposure concentration RSD was 7.22%,temperature,humidity,O2 concentration,CO2 concentration were all within the qualified standard range,Under the test conditions in our laboratory,the performance parameters of the Nose-Only inhalation exposure System for Rodents and Canines were in accordance with the technical requirements of the Manufacturer's standard.Conclusion The above method is accurate and reliable,and can meet the needs of drug safety evaluation.It can provide a useful reference for the performance verification of Oral and nasal Inhalation System under GLP conditions.
关键词
吸入系统/吸入给药/吸入制剂/性能验证/药物非临床研究质量管理规范Key words
Inhalation System/Inhalation/Inhalationpreparation/Performance verification/GLP引用本文复制引用
基金项目
广东省重大人才工程项目(210183503006)
广东省实验室建设项目(2023B1212070029)
广东省省级促进经济高质量发展专项(粤自然资合[2023]37)
出版年
2024
NETL
NSTL
万方数据