Fuhrman L C, Stroman R T
Department of Pharmacy Practice, College of Pharmacy, University of South Carolina, Columbia 29208, USA.
Am J Health Syst Pharm. 1998 Jul 1;55(13):1386-8. doi: 10.1093/ajhp/55.13.1386.
The stability of vancomycin 31 mg/mL (as the hydrochloride) in an artificial tears solution at -10, 4, 25, and 40 degrees C was studied. Vancomycin power was reconstituted with sterile water for injection to a concentration of 50 mg/mL. Artificial tears solution containing 0.3% hydroxypropyl methylcellulose, 0.1% dextran 70, 0.01% benzalkonium chloride, and 0.05% edetate disodium was used to produce a final concentration of 31 mg/mL. Triplicate solutions for each storage temperature and sampling time were prepared. The solutions were stored at -10, 4, 25, and 40 degrees C. Samples were taken initially and at 3, 7, 10, 21, 30, 45, and 60 days for visual inspection and analysis by high-performance liquid chromatography. All solutions remained clear and colorless at -10, 4, and 25 degrees C throughout the study period. By day 3, crystalline particles formed in the solutions stored at 40 degrees C. No substantial change in pH was observed at any time. At -10 degrees C, the solutions retained more than 90% of their initial vancomycin concentrations throughout the study period. The solutions retained a mean of at least 90% of the initial drug concentration for 21 days at 4 degrees C and for 7 days at 25 degrees C. For the solutions stored at 25 or 40 degrees C, less than 85% of the initial vancomycin concentration remained after 10 and 3 days, respectively. Vancomycin 31 mg/mL (as the hydrochloride) in an artificial tears solution was stable for 45 days at -10 degrees C, 10 days at 4 degrees C, and 7 days at 25 degrees C in the tears solution's original container.
研究了31毫克/毫升（以盐酸盐形式）的万古霉素在人工泪液溶液中于-10℃、4℃、25℃和40℃下的稳定性。将万古霉素粉用注射用水复溶至浓度为50毫克/毫升。使用含有0.3%羟丙基甲基纤维素、0.1%右旋糖酐70、0.01%苯扎氯铵和0.05%乙二胺四乙酸二钠的人工泪液溶液制成最终浓度为31毫克/毫升的溶液。针对每个储存温度和取样时间制备三份溶液。溶液分别储存在-10℃、4℃、25℃和40℃。最初以及在第3、7、10、21、30、45和60天取样，进行目视检查并通过高效液相色谱法分析。在整个研究期间，所有溶液在-10℃、4℃和25℃下均保持澄清无色。到第3天，储存在40℃的溶液中形成了结晶颗粒。在任何时间均未观察到pH有实质性变化。在-10℃下，整个研究期间溶液中万古霉素的初始浓度保留率超过90%。在4℃下，溶液在21天内平均至少保留初始药物浓度的90%；在25℃下，溶液在7天内平均至少保留初始药物浓度的90%。对于储存在25℃或40℃的溶液，分别在10天和3天后，万古霉素的初始浓度剩余量低于85%。31毫克/毫升（以盐酸盐形式）的万古霉素在人工泪液溶液中，于泪液溶液的原装容器中，在-10℃下可稳定保存45天，在4℃下可稳定保存10天，在25℃下可稳定保存7天。
