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

Study on microbes of new packaged latanoprost eye drops during use

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。

Objective To study the degree of microbial contamination of new packaged latanoprost eye drops during use. Methods Mark the preparation of lantanoprost eye drops for the common bottle group （ A）, bottle with the filter device group（ B ）and containing antibacterial agent group（C） ;all test samples were simulated medication process, then the drugs were stored in different storage conditions：high temperature [ H, （40 ± 2 ） ℃ ] ,normal temperature[ N, （30 ± 2 ） ℃ ] and cold temperature[ L, （ 6 ±2 ） ℃ ]. The bacterial and fungal culture experiments were performed at 1,7,14,21 and 28 d after opening. Results There was statistically significant between A and B （ P = 0. 000）, A and C （ P = 0. 000）, not statistically significant between B and C （ P = 0. 828 ） ; there was no statistical significance between H and N, H and L, N and L （ P = 0. 362, P = 0. 064 ,P = 0. 333 ）by LSD method. Conclusions These new eyes drops canned in novel bottle with filtering device and containing antibacterial agent ones can both effectively reduce the rate of microbial contamination during use and storage, compared with the antibacterial agent product the research one is more suitable for long time use.