质量提取法测试盐酸法舒地尔注射液玻璃安瓿包装容器的密封完整性  

Mass extraction method for the closure integrity testing of fasudil hydrochloride injection packaged in the glass ampoule packaging container

作　　者：聂蕾 刘玉美 赵延轲 王国民 文慧英 王俊苏 NIE Lei;LIU Yu-mei;ZHAO Yan-ke;WANG Guo-min;WEN Hui-ying;WANG Jun-su(Yunnan Province Medical Instrument Testing Research Institute,Kunming 650106,China;School of Pharmaceutical Science&Yunnan Key Lab.of Pharmacology for Natural Products,Kunming Medical University,Kunming 650500,China;Kunming Medical University,Kunming 650500,China;Chongqing customs technology center,Chongqing 400020;Chongqing Aokai technology Co.,Ltd.,Chongqing 401121,China)

机构地区：[1]云南省医疗器械检验研究院,昆明650106 [2]云南省天然药物药理重点实验室昆明医科大学,昆明650500 [3]昆明医科大学,昆明650500 [4]重庆海关技术中心,重庆400020 [5]重庆奥凯科技有限公司,重庆401121

出　　处：《药物分析杂志》2023年第12期2113-2120,共8页Chinese Journal of Pharmaceutical Analysis

基　　金：云南省天然药物药理重点实验室开放基金项目(YKLPNP-G2022);重庆市科学技术局基金项目重庆市科研机构绩效激励引导专项(cstc2021jxjl130015)。

摘　　要：目的:通过测试盐酸法舒地尔注射液玻璃安瓿包装容器的密封完整性,研究质量提取法在玻璃安瓶包装密封完整性考察上的运用。方法:采用质量提取法测试,进行方法参数开发及检测限、准确度、重复性等方法学验证。采用经过验证的方法,对盐酸法舒地尔注射液玻璃安瓿包装的进行加速和长期0、3月稳定性的密封完整性检测。结果:建立了盐酸法舒地尔注射液玻璃安瓿包装的密封完整性质量提取法测试方法,关键时间参数总泄漏抽真空时间(预抽真空1)、大漏抽真空时间(预抽真空2)、微漏抽真空时间(抽真空2)、微漏稳定时间(稳定2)分别优化确立为4、3、20、8 s;检测限为2μm;准确度为100%区分阴性阳性样品,重复性好。结论:质量提取法可以应用于小容量玻璃安瓿包装的密封完整性测试,该方法灵敏度高,稳定性好,结果真实可靠,能有效测试注射剂玻璃安瓿包装容器密封完整性。Objective: To study the application of the mass extraction method in the inspection of the glass ampoule packaging through testing the sealing integrity of fasudil hydrochloride injection packaged in the glass ampoule packaging container. Methods: The mass extraction method was used to test the sealing integrity of injection packaging. The parameters of the method was developed. Detection limit, accuracy and repeatability of the method was verified. The sealing integrity of Fasudil hydrochloride injection packaged in the glass ampoule packaging was tested after 0 and 3 months acceleration and long-term stability experiments. Results: The mass extraction method for the closure integrity testing of Fasudil hydrochloride injection packaged in the glass ampoule packaging container was established and validated. The key time parameters: gross leak check evacuation time(Pre-Evac1), large leak check evacuation time(Pre-Evac2), fine leak check evacuation time(Evac2), fine leak check stability time(Stability 2) were optimized and established as 4 s, 3 s, 20 s and 8 s. The detection limit was 2 μm. The accuracy was 100%. The repeatability was good. Conclusion: The mass extraction method can be applied to the sealing integrity testing of small capacity glass ampoule packaging, This method has high sensitivity, good stability and reliable results, which can effectively test the integrity of injection ampoule packaging containers.

关 键 词：质量提取法 容器密封完整性检查 玻璃安瓿包装 注射液 泄漏 质量流量 

分 类 号：R917[医药卫生—药物分析学]