Faculty of Dentistry of Piracicaba, UNICAMP.
J Appl Oral Sci. 2005 Mar;13(1):41-6. doi: 10.1590/s1678-77572005000100009.
Considering the importance of medication quality control and that mouthrinses for dental caries prevention have commonly been prepared in dispensing pharmacies, this study assessed formulations containing 0.05% NaF acquired from 6 dispensing pharmacies in the city of Piracicaba, S.P. The mouthrinse formulations were purchased in 3 separate periods and coded from A to F. Fluoride ion (F-) concentration was determined in all formulations in the 3 periods, and in those acquired in the 3rd period, the bioavailability of fluoride with dental enamel with caries-like lesions and the pH of products were evaluated. A solution of 0.05% NaF and distilled deionized water were used, respectively, as positive and negative controls. In the bioavailability analysis, fluoride present in dental enamel was determined removing, by acid etching, two layers of enamel; fluoride in the acid extract was determined with a specific electrode. The mouthrinses prepared in 5 pharmacies presented a F- concentration close to the expected value, except for the product prepared in one of them, in which a mean of 0.01% NaF was found. All products were more efficient than the negative control (p<0.05) in terms of reactivity with dental enamel, but differences among them were observed with regard to the positive control (p<0.05). The data suggest that a quality control program should be implemented in dispensing pharmacies to guarantee the quality of fluoridated mouthrinses formulated.
考虑到药物质量控制的重要性,以及预防龋齿的漱口水通常在配药药房中制备,本研究评估了来自圣保罗州皮拉西卡巴市的 6 家配药药房购买的含有 0.05%氟化钠的漱口液配方。这些漱口液配方在 3 个不同时期购买,并分别用字母 A 到 F 进行编码。在这 3 个时期,所有配方中的氟离子(F-)浓度都进行了测定,在第 3 个时期购买的那些配方中,还评估了含有龋齿样病变牙釉质的氟化物生物利用度和产品的 pH 值。分别使用 0.05%氟化钠溶液和去离子蒸馏水作为阳性和阴性对照。在生物利用度分析中,通过酸蚀刻去除牙釉质的两层,来确定牙釉质中存在的氟化物;用特定电极测定酸提取物中的氟化物。除了其中一家药房制备的产品外,其他 5 家药房制备的漱口液的 F-浓度均接近预期值,而在这家药房中发现的产品中,氟的浓度为 0.01%。所有产品与牙釉质的反应性均优于阴性对照(p<0.05),但它们与阳性对照之间存在差异(p<0.05)。数据表明,应在配药药房中实施质量控制计划,以保证所配制的氟化漱口液的质量。