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儿科药物的腐蚀性和致龋性潜力:理化参数研究。

Erosive and cariogenicity potential of pediatric drugs: study of physicochemical parameters.

机构信息

Department of Preventive Dentistry, School of Dentistry, State University of Paraiba, Avenida das Baraunas, S/N, Bodocongo, Campina Grande, PB 58109-970, Brazil.

出版信息

BMC Oral Health. 2013 Dec 10;13:71. doi: 10.1186/1472-6831-13-71.

Abstract

BACKGROUND

Pediatric medications may possess a high erosive potential to dental tissues due to the existence of acid components in their formulations. The purpose was to determine the erosive and cariogenic potential of pediatric oral liquid medications through the analysis of their physicochemical properties in vitro.

METHODS

A total of 59 substances were selected from the drug reference list of the National Health Surveillance Agency (ANVISA), which belong to 11 therapeutic classes, as follows: analgesics, non-steroidal anti-inflammatory, corticosteroids, antihistamines, antitussives, bronchodilators, antibacterials, antiparasitics, antiemetics, anticonvulsants and antipsychotics. Measurement of pH was performed by potentiometry, using a digital pH meter. For the Total Titratable Acidity (TTA) chemical assay, a 0.1 N NaOH standard solution was used, which was titrated until drug pH was neutralized. The Total Soluble Solids Contents (TSSC) quantification was carried out by refractometry using Brix scale and the analysis of Total Sugar Content was performed according to Fehling's method. In addition, it was analyzed the information contained in the drug inserts with regard to the presence of sucrose and type of acid and sweetener added to the formulations.

RESULTS

All drug classes showed acidic pH, and the lowest mean was found for antipsychotics (2.61 ± 0.08). There was a large variation in the TTA (0.1% - 1.18%) and SST (10.44% - 57.08%) values. High total sugar contents were identified in the antitussives (53.25%) and anticonvulsants (51.75%). As described in the drug inserts, sucrose was added in 47.5% of the formulations, as well as citric acid (39.0%), sodium saccharin (36.4%) and sorbitol (34.8%).

CONCLUSION

The drugs analyzed herein showed physicochemical characteristics indicative of a cariogenic and erosive potential on dental tissues. Competent bodies' strategies should be implemented in order to broaden the knowledge of health professionals, drug manufacturers and general consuming public about the risks from the consumption of medicines potentially harmful to dental tissues.

摘要

背景

由于儿科药物制剂中存在酸性成分,因此可能对牙齿组织具有较高的腐蚀性。本研究旨在通过体外分析其理化性质来确定儿科口服液体药物的腐蚀性和致龋性。

方法

从巴西国家卫生监督局(ANVISA)的药物参考清单中选择了 59 种物质,这些物质属于 11 种治疗类别,分别为:镇痛药、非甾体抗炎药、皮质类固醇、抗组胺药、镇咳药、支气管扩张剂、抗菌药、驱虫药、止吐药、抗惊厥药和抗精神病药。采用电位滴定法用数字 pH 计测定 pH 值。采用 0.1N NaOH 标准溶液进行总可滴定酸度(TTA)化学测定,直至药物 pH 值中和。采用糖锤度计折射法测定总可溶性固体含量(TSSC),根据费林氏法测定总糖含量。此外,还分析了药物说明书中关于制剂中添加蔗糖和酸及甜味剂类型的信息。

结果

所有药物类别均呈酸性 pH 值,抗精神病药的最低平均值为 2.61 ± 0.08。TTA(0.1%-1.18%)和 SST(10.44%-57.08%)值差异较大。镇咳药(53.25%)和抗惊厥药(51.75%)的总糖含量较高。药物说明书中添加了蔗糖(47.5%),还添加了柠檬酸(39.0%)、糖精钠(36.4%)和山梨糖醇(34.8%)。

结论

本文分析的药物具有致龋和腐蚀性潜力的理化特性。应实施相关机构的策略,以拓宽卫生专业人员、药品制造商和广大消费者对潜在有害于牙齿组织的药物消费风险的认识。

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