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商业巴西局部麻醉剂溶液中对羟基苯甲酸甲酯浓度。

Methylparaben concentration in commercial Brazilian local anesthetics solutions.

机构信息

Department of Analytical Chemistry, Institute of Chemistry, University of Campinas, Campinas, SP, Brazil.

出版信息

J Appl Oral Sci. 2012 Jul-Aug;20(4):444-8. doi: 10.1590/s1678-77572012000400009.

Abstract

OBJECTIVE

To detect the presence and concentration of methylparaben in cartridges of commercial Brazilian local anesthetics.

MATERIAL AND METHODS

Twelve commercial brands (4 in glass and 8 in plastic cartridges) of local anesthetic solutions for use in dentistry were purchased from the Brazilian market and analyzed. Different lots of the commercial brands were obtained in different Brazilian cities (Piracicaba, Campinas and São Paulo). Separation was performed using high performance liquid chromatography (HPLC) with UV-Vis detector. The mobile phase used was acetonitrile:water (75:25 - v/v), pH 4.5, adjusted with acetic acid at a flow rate of 1.0 ml.min-1.

RESULTS

When detected in the solutions, the methylparaben concentration ranged from 0.01% (m/v) to 0.16% (m/v). One glass and all plastic cartridges presented methylparaben.

CONCLUSION

  1. Methylparaben concentration varied among solutions from different manufacturers, and it was not indicated in the drug package inserts; 2. Since the presence of methylparaben in dental anesthetics is not regulated by the Brazilian National Health Surveillance Agency (ANVISA) and this substance could cause allergic reactions, it is important to alert dentists about its possible presence.
摘要

目的

检测商业巴西局部麻醉剂盒中对羟基苯甲酸甲酯的存在和浓度。

材料和方法

从巴西市场购买了 12 种商业品牌(玻璃 4 种,塑料 8 种)的牙科用局部麻醉溶液,并进行了分析。从不同的巴西城市(皮拉西卡巴、坎皮纳斯和圣保罗)获得了商业品牌的不同批次。使用高效液相色谱法(HPLC)与紫外可见检测器进行分离。所用的流动相为乙腈:水(75:25-v/v),pH4.5,用乙酸调节,流速为 1.0ml.min-1。

结果

在溶液中检测到对羟基苯甲酸甲酯的浓度范围为 0.01%(m/v)至 0.16%(m/v)。一个玻璃和所有塑料盒都含有对羟基苯甲酸甲酯。

结论

  1. 不同制造商的溶液中对羟基苯甲酸甲酯的浓度不同,且药物包装插页中并未注明;2. 由于巴西国家卫生监督局(ANVISA)并未对牙科麻醉剂中对羟基苯甲酸甲酯的存在进行监管,而且这种物质可能会引起过敏反应,因此提醒牙医注意其可能的存在是很重要的。
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac11/3881820/db5456b9f86e/jaos-20-04-0444-g01.jpg

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