Saisyo Atsuyuki, Shimono Rima, Oie Shigeharu, Kimura Kazuhiro, Furukawa Hiroyuki
Pharmaceutical Service, Yamaguchi University Hospital.
Biol Pharm Bull. 2017;40(2):182-186. doi: 10.1248/bpb.b16-00688.
Multiple-dose ophthalmic preparations that do not contain preservatives carry high risks of microbial contamination. However, there are various types of hospital preparations, with different physicochemical properties. In the present study, we evaluated the association between physicochemical properties and microbial contamination in ophthalmic preparations. The investigated hospital preparations included ophthalmic preparations of physiological saline, 0.2% fluconazole, 0.5% vancomycin hydrochloride, and 2% cyclosporine. We investigated the microbial dynamics of each ophthalmic preparation and microbial contamination in ophthalmic preparations used by patients. Remarkable growth of Pseudomonas aeruginosa, Burkholderia cepacia, and Serratia marcescens was observed in ophthalmic preparations of physiological saline and 0.2% fluconazole. All tested microorganisms displayed decreased counts after inoculation in 0.5% vancomycin hydrochloride. In 2% cyclosporine, all investigated microorganisms were below the limit of detection after inoculation for 6 h. The microbial contamination rates of ophthalmic preparations used by patients were 16.7% (3/18 samples) for 0.5% vancomycin hydrochloride and 0% (0/30 samples) for 2% cyclosporine. All detected contaminants in 0.5% vancomycin hydrochloride were Candida spp., one of which was present at a level of 1×10 colony-forming units/mL. The storage method for in-use ophthalmic preparations should be considered on the basis of their physicochemical properties.
不含防腐剂的多剂量眼科制剂存在较高的微生物污染风险。然而，医院制剂种类繁多，其理化性质各不相同。在本研究中，我们评估了眼科制剂的理化性质与微生物污染之间的关联。所研究的医院制剂包括生理盐水、0.2%氟康唑、0.5%盐酸万古霉素和2%环孢素的眼科制剂。我们调查了每种眼科制剂的微生物动态以及患者使用的眼科制剂中的微生物污染情况。在生理盐水和0.2%氟康唑的眼科制剂中观察到铜绿假单胞菌、洋葱伯克霍尔德菌和粘质沙雷氏菌显著生长。在接种于0.5%盐酸万古霉素后，所有测试微生物的数量均减少。在2%环孢素中，接种6小时后所有调查的微生物均低于检测限。患者使用的眼科制剂中，0.5%盐酸万古霉素的微生物污染率为16.7%（3/18个样本），2%环孢素的微生物污染率为0%（0/30个样本）。0.5%盐酸万古霉素中所有检测到的污染物均为念珠菌属，其中一种的含量为1×10菌落形成单位/毫升。应根据其理化性质考虑正在使用的眼科制剂的储存方法。
