新型包装的拉坦前列素滴眼液在使用过程中的微生物研究

发布时间：2019-02-12 09:02

【摘要】：目的研究新型包装的拉坦前列素滴眼液在使用过程中的微生物污染程度。方法将配制的滴眼液分别标记为普通滴眼液组(A),自带过滤装置组(B)和含抑菌剂组(C);模拟使用过程,存放于高温[H,(40±2)℃],常温[N,(30±2)℃]和冷藏条件[L,(6±2)℃]。于开启后1、7、14、21和28 d取样,进行细菌和真菌培养实验。结果采用LSD法计算A组与B组、C组细菌阳性率具有显著性差异(P=0.000);B组与C组细菌阳性率差异无统计学意义(P=0.828);三种存放条件的阳性率,两两比较差异均无统计学意义。结论自带过滤装置的新型滴眼液与含抑菌剂滴眼液能有效降低无抑菌剂的滴眼液使用过程中的微生物污染,较含抑菌剂产品本研究产品更有利于长期安全用药。
[Abstract]:Objective to study the degree of microbial contamination in the new packaged latanprost eye drops. Methods the prepared eye drops were labeled as (B) in (A), filter device group and (C); in bacteriostasis group respectively in common eye drops group. The simulated process was stored in high temperature [H, (40 卤2) 鈩僝, room temperature [N, (30 卤2) 鈩僝 and cold storage condition [L, (6 卤2) 鈩僝. The culture of bacteria and fungi was carried out on the 21st and 28th days after opening. Results the positive rate of bacteria in group A was significantly different from that in group B by LSD method (P < 0. 000). There was no significant difference in bacterial positive rate between group A and group C (P0. 828). There was no significant difference in the positive rate of the three storage conditions. Conclusion A new type of eye drops with filter device and eye drops containing bacteriostatic agents can effectively reduce the microbial contamination in the use of non-bacteriostasis eye drops, which is more beneficial to long-term safe drug use than the products containing bacteriostatic agents.
【作者单位】：沈阳何氏眼产业集团有限公司;沈阳市兽药饲料监察所;辽宁何氏医学院;
【基金】：沈阳市科技局科技资助项目(F15-135-9-00)
【分类号】：R927.1

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