0.05% 洗必泰葡萄糖酸盐作为玻璃体内注射防腐剂的长期稳定性、无菌性和成本效益。

IF 1.9 4区 医学 Q2 OPHTHALMOLOGY Journal of Ocular Pharmacology and Therapeutics Pub Date : 2024-11-01 Epub Date: 2024-08-22 DOI:10.1089/jop.2024.0071
Asad F Durrani, Bita Momenaei, Viren Soni, Matthew Tennant, Jason Hsu, James Vander, Marc Spirn, Eugene Yu-Chuan Kang, Yih-Shiou Hwang, Gagan Kaushal, Sunir J Garg
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引用次数: 0

摘要

本研究评估了 0.05% CHG 开封后 30 天内的稳定性和无菌性,并比较了其与聚维酮碘(PI)用于玻璃体内注射防腐的成本。方法:将 0.05% CHG 等分到 1 毫升注射器中,在室温或冷藏条件下保存。进行浊度、pH 值、高效液相色谱 (HPLC) 和无菌测试。进行了成本分析。结果0.05% CHG 在至少 30 天内保持稳定。结论:0.05% CHG 在开封后至少 30 天内保持稳定和无菌。CHG 开封后可使用至少 30 天,这大大降低了使用成本。
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Long-Term Stability, Sterility, And Cost-Effectiveness of 0.05% Chlorhexidine Gluconate as Antisepsis for Intravitreal Injection.

Purpose: Commercially available chlorhexidine gluconate (CHG) has a beyond-use date of 24 h. This study evaluated the stability and sterility of 0.05% CHG for 30 days after opening and compared its cost to povidone iodine (PI) for intravitreal injection antisepsis. Methods: 0.05% CHG was aliquoted into 1-mL syringes and stored at room temperature or refrigerated. Turbidity, pH, high-performance liquid chromatography (HPLC), and sterility testing were performed. A cost analysis was conducted. Results: 0.05% CHG remained stable for at least 30 days. All samples had measured turbidity <0.5 nephelometric turbidity units. The pH of all samples remained between 5.0 and 7.0. HPLC demonstrated CHG concentration at day 30 relative to day 0 of 98.52% ± 4.16% at room temperature and 99.99% ± 3.38% at 2°C -6°C. The cost per week to perform 150 injections using 0.05% CHG was $463.25 when opening a new bottle daily compared with $16.73 for 5% PI. This cost decreased to $23.16 when utilizing a bottle of CHG for 30 days. Conclusion: 0.05% CHG remains stable and sterile for at least 30 days after opening. The ability to use CHG for at least 30 days after its opening significantly decreases its utilization expense.

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来源期刊
CiteScore
4.60
自引率
4.30%
发文量
72
审稿时长
1 months
期刊介绍: Journal of Ocular Pharmacology and Therapeutics is the only peer-reviewed journal that combines the fields of ophthalmology and pharmacology to enable optimal treatment and prevention of ocular diseases and disorders. The Journal delivers the latest discoveries in the pharmacokinetics and pharmacodynamics of therapeutics for the treatment of ophthalmic disorders. Journal of Ocular Pharmacology and Therapeutics coverage includes: Glaucoma Cataracts Retinal degeneration Ocular infection, trauma, and toxicology Ocular drug delivery and biotransformation Ocular pharmacotherapy/clinical trials Ocular inflammatory and immune disorders Gene and cell-based therapies Ocular metabolic disorders Ocular ischemia and blood flow Proliferative disorders of the eye Eyes on Drug Discovery - written by Gary D. Novack, PhD, featuring the latest updates on drug and device pipeline developments as well as policy/regulatory changes by the FDA.
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