[1]陈苑君 童冰妮 麦志雄 冼卫清.注射用血栓通（冻干）包装系统密封性研究[J].大众科技,2023,25(9):30-33.
　Study on Sealability of Packaging System of Xueshuantong (Lyophilized) for Injection[J].Popular Science & Technology,2023,25(9):30-33.
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注射用血栓通（冻干）包装系统密封性研究()
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《大众科技》[ISSN:1008-1151/CN:45-1235/N]

卷:
25
期数:
2023年9
页码:
30-33
栏目:
轻工与化工
出版日期:
2023-09-20

文章信息/Info

Title:
Study on Sealability of Packaging System of Xueshuantong (Lyophilized) for Injection
作者:
陈苑君1; 2 童冰妮1; 2 麦志雄1; 2 冼卫清1; 2
（1.广西梧州制药（集团）股份有限公司，广西 梧州 543002；2.广西三七综合利用技术重点实验室，广西 梧州 543002）
关键词:
注射用血栓通（冻干）; 包装系统密封性; 真空衰减法
Keywords:
Xueshuantong (lyophilized) for injection;  sealability of packaging system;  vacuum decay method
文献标志码:
A
摘要:
目的：建立测试注射用血栓通（冻干）包装系统密封性的真空衰减测定方法。方法：利用密封性测试仪、气体流量计及设置的不同样品组，摸索最优的方法参数并完成验证，并与微生物挑战法进行方法比对，用经过验证的真空衰减法测试注射用血栓通（冻干）包装的密封完整性。结果：该方法在0.03～1.65 cc·min-1流量值（模拟泄漏率）范围内线性关系良好，r=0.999 9。可检测的最小泄漏孔径为3 μm。判定不同泄漏等级（漏孔尺寸）样品准确率达100%，高于微生物挑战法。结论：该方法灵敏度及准确性高，操作简单，可有效用于注射用血栓通（冻干）的包装系统密封性试验。
Abstract:
Objective: To establish a vacuum decay measurement method for testing the sealability of packaging system of Xueshuantong (Lyophilized) for injection. Methods: Using the sealing tester, gas flowmeter and different sample sets, the optimal method parameters were explored and verified, and compared with the microbial challenge method. The sealing integrity of the packaging of Xueshuantong (lyophilized) for injection was tested using a proven vacuum decay method. Results: The linear relationship of the method was good in the range of 0.03~1.65 cc·min-1 flow rate (simulated leakage rate), r=0.999 9. The minimum leak aperture that can be detected is 3 μm. The accuracy of determination of samples with different leak grades (leak hole size) was 100%, higher than that of microbial challenge method. Conclusion: The method has high sensitivity, high accuracy and simple operation, and can be effectively used in the sealing test of the packaging system of Xueshuantong (lyophilized) for injection.

参考文献/References:

[1]　The United States Pharmacopeial Convention. (1207) Package integrity evaluation-sterile products[EB/OL]. (2018-4-6) [2022-11-30]. https://www.doc88.com/p-5426418036578. html．[2] 陆维怡，蔡荣. 国内外药品包装系统密封完整性研究与保障药品质量安全的思考[J]. 中国药事，2021，35(7): 828-834.[3] 马骏威，郭涤亮，刘涓，等. 胶塞/玻璃瓶容器密封完整性研究的探讨[J]. 中国新药杂志，2021，30(5): 394-398.[4] 史春辉，尹翔，张肖宁，等. 包材密封性微生物挑战法实验方案探讨[J]. 中国药物警戒，2022，19(11): 1181-1185.

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备注/Memo

备注/Memo:
【收稿日期】2023-06-02【基金项目】中央引导地方科技发展资金项目（桂科ZY22096004）；梧州市科技计划项目（202202020）。【作者简介】陈苑君（1986－），女，广西梧州制药（集团）股份有限公司工程师，研究方向为质量标准研究及质量控制。【通信作者】童冰妮（1986－），女，广西梧州制药（集团）股份有限公司高级工程师，研究方向为药品质量标准建立、质量风险管理与生产质量管理。
更新日期/Last Update: 2023-10-07