玻璃酸钠在滴眼剂中最佳用量.docVIP

玻璃酸钠在滴眼剂中最佳用量[摘要] 目的:通过试验摸索玻璃酸钠在滴眼剂中适合工艺生产与临床需要的用量。方法:梯度测定玻璃酸钠甘油溶液通过0.22 μm滤膜时的滤速及动力黏度。结果:玻璃酸钠浓度大于0.03%的甘油溶液很难通过滤芯;大于0.02%时虽能通过但滤速不理想;等于0.02%时滤速接近设计值,制成品经临床验证可靠;各浓度梯度玻璃酸钠甘油溶液动力黏度差异不大。结论:在滴眼剂中,玻璃酸钠与甘油的比例为1∶2~1∶4,玻璃酸钠最佳用量为0.02%。 [关键词] 玻璃酸钠;最佳用量;滴眼剂 [中图分类号]R94 [文献标识码] A[文章编号] 1673-7210(2009)07(a)-088-02 The optimal dosage of sodium hyaluronate in eye drops DUAN Yun1, WU Peiyuan2, ZHU Zuchi3, CHEN Yan3 (1.Department of Pharmacy, the People’s Hospital of Jiangxi Province, Nanchang 330006, China; 2.Department of Pharmacy, the People’s Hospital of Wuyuan County, Jiangxi Province, Wuyuan 333200, China; 3.Jiangxi Boshida Medicine Co., Ltd., Shanggao 336400, China) [Abstract] Objective: To explore the optimal dosage of sodium hyaluronate in eye drops, suitable for production and clinical use. Methods: The dynamic viscosity of sodium hyaluronate solution was determined by passing 0.22 μm filter membrane. Results: It’s difficult for more than 0.03% sodium hyaluronate solution to pass the filter element, more than 0.02% sodium hyaluronate could pass the filter member, but its speed was not very suitable. The speed of 0.02% sodium hyaluronate was close to the hypothesis and its product had passed clinical verification. There was no significant difference in the dynamic viscosity among the different sodium hyaluronate solutions. Conclusion: The proportional region of sodium hyaluronate and glycerine is from 1∶2 to 1∶4 in eye drops and the optimal dosage of sodium hyaluronate is 0.02% based on the study of production and clinics. [Key words] Sodium hyaluronate; Optimal dosage; Eye drops 玻璃酸钠(hyaluronic acid,HA),又称透明质酸钠,是一种线性大分子多糖,由D-葡萄糖醛酸和N-乙酰氨基葡萄糖的双糖单位反复交替连接构成。由于其能延长药物在眼表的停留时间,可保湿、润滑、抗感染和促修复,有效缓解干、涩、痒、疼等眼部不适,故常用于滴眼剂中[1]。 国家食品药品监督管理局当前批准的滴眼剂包装材料有PET、低密度聚乙烯、高密度聚乙烯、聚丙烯等几种,在高温下均易变形,所以不能采用热压灭菌;而辐射灭菌或微波灭菌又会破坏药物的成分,故目前滴眼液要达到无菌,最有效的方法就是终端过0.22 μm的滤膜[2-3]。实验发现,玻璃酸钠在滴眼剂中用量过大时,会使患者眼前产生一层膜,带来极度的不适感。而在滴眼剂生产过程中,玻璃酸钠在水中会产生“溶胀”,体积膨大几十倍甚至几百倍,用量过大,则无法用0.22 μm的滤膜过滤,使得滴眼剂生产