Prado Silvia Berisa, Ayora Ana Cristina Riestra, Campa Adrián Trelles
Pharmacy Services, Instituto Oftalmológico Fernández Vega, Oviedo, Spain.
Int J Pharm Compd. 2019 Sep-Oct;23(5):418-421.
There are multiple studies in the literature that support the use of povidone iodine in the preparation of the surgical field of cataract as the most effective means to reduce the bacteria present in the ocular surface and the risk of infection. The concentration of free iodine is related to the antiseptic activity of these compounds, being, therefore, a good indicator of its effectiveness. The objective of this study was to determine the amount of free iodine and the evolution of it in different formulations of povidone iodine eye drops. The povidone iodine 5% eye drops were prepared starting from Betadine 10% dermal or the active principle and using a solvent, phosphate-citrate buffer solution, and sodium chloride 0.9% or sterile water for injection. Aliquots of 5 mL were packed in low-absorption absorption eye drops, topaz glass vials, and polyethylene syringe. The determination of free iodine was made by volumetric titration. Titration was performed with 0.1 M sodium thiosulfate using a starch solution as an indicator. Of the 0.1 M sodium thiosulfate, 1 mL is equivalent to 12.69 mg of available iodine, and it is expressed as a percentage of free iodine in the iodized povidone (% free iodine). Eyewash titrations were performed by replacing the substance with 5 mL of eye drops and following the remaining steps. Valuations were made on days 0, 7, and 14, as well as the measurement of pH and osmolarity. The results show that there are no differences between the average results at the three measurements taken on days 0, 7, and 14. We conclude that the free iodine remains stable during the stability period of 14 days. Regarding the pH and osmolarity data, the authors believe that the best tolerated formula will be that elaborated with povidone iodine and a phosphate- citrate buffer solution.
文献中有多项研究支持在白内障手术区域准备中使用聚维酮碘,这是减少眼表细菌和感染风险的最有效方法。游离碘的浓度与这些化合物的抗菌活性相关,因此是其有效性的良好指标。本研究的目的是确定不同配方的聚维酮碘滴眼液中游离碘的含量及其变化情况。5%聚维酮碘滴眼液由10%皮肤用聚维酮碘(碘伏)或活性成分制备,使用溶剂、磷酸盐 - 柠檬酸盐缓冲溶液和0.9%氯化钠或注射用水。将5 mL等分试样包装在低吸收性滴眼液瓶、黄玉玻璃瓶和聚乙烯注射器中。游离碘的测定采用容量滴定法。用0.1 M硫代硫酸钠进行滴定,使用淀粉溶液作为指示剂。0.1 M硫代硫酸钠中,1 mL相当于12.69 mg有效碘,以碘聚维酮中游离碘的百分比(游离碘%)表示。通过用5 mL滴眼液代替物质并遵循其余步骤进行洗眼滴定。在第0天、第7天和第14天进行评估,同时测量pH值和渗透压。结果表明,在第0天、第7天和第14天进行的三次测量的平均结果之间没有差异。我们得出结论,游离碘在14天的稳定期内保持稳定。关于pH值和渗透压数据,作者认为耐受性最佳的配方将是用聚维酮碘和磷酸盐 - 柠檬酸盐缓冲溶液配制的配方。