苯扎溴铵酊处方改进及苯扎溴铵的含量测定.docVIP

苯扎溴铵酊处方改进及苯扎溴铵的含量测定 　　[摘要] 目的 改进苯扎溴铵酊处方，并建立容量分析法测定苯扎溴铵醇溶液（苯扎溴铵酊去除曙红成分）中苯扎溴铵的含量。 方法 在建立容量分析法测定苯扎溴铵的含量时，发现曙红在不同程度上均能影响含量测定结果，故将曙红成分从处方中删去。采用四苯硼钠（0.02 mol/L）为滴定液，滴定苯扎溴铵醇溶液中苯扎溴铵的含量。 结果 苯扎溴铵酊制剂更改为苯扎溴铵醇溶液，在含量测定中，滴定终点变化明显，易于判断。苯扎溴铵在浓度0.4～1.4 mg/mL的范围内与消耗四苯硼钠滴定液体积呈良好线性关系，r = 0.9995，回归方程为V=18.3C-0.32。高、中、低3种剂量苯扎溴铵的平均回收率为99.12%，RSD为0.84%。 结论 本实验方法简便、快捷、准确，可作为苯扎溴铵醇溶液的质量控制标准。 　　[关键词] 苯扎溴铵酊；苯扎溴铵；滴定分析法；质量控制 　　[中图分类号] R927.2 [文献标识码] A [文章编号] 1673-7210（2015）07（c）-0011-03 　　[Abstract] Objective To improve prescription of Benzalkonium Bromide Tincture and establish a titration method in determination for content of benzalkonium bromide in Benzalkonium Bromide Alcoholic Solution （eosin was removed from Benzalkonium Bromide Tincture）. Methods The content of benzalkonium bromide was detected by setting up capacity analysis method， and found eosin can affect the result of content determination at different degree， therefore eosin composition was removed from the prescription. The content of benzalkonium bromide in Benzalkonium Bromide Alcoholic Solution was detected by titration method with tetraphenylboron sodium volumetric solution （0.02 mol/L）. Results Benzalkonium Bromide Tincture changed to Benzalkonium Bromide Alcohol Solution， in content determination， the change of titration end point was obvious and easy to judge. Within the range from 0.4 mg/mL to 1.4 mg/mL， benzalkonium bromide presented a good linear relationship with the consumption volume of tetraphenylboron sodium volumetric solution （r = 0.9995）， and the equation of linear regression was V=18.3C-0.32. The average recovery of benzalkonium bromide in low， middle and high dose was 99.12%， and RSD was 0.84%. Conclusion The method is simple， fast and accurate， it can be used for the quality control of Benzalkonium Bromide Alcoholic Solution. 　　[Key words] Benzalkonium Bromide Tincture；Benzalkonium bromide； Titration analysis； Quality control 　　苯扎溴铵酊为原《中国医院制剂规范》[1]收载品种，又名新洁尔灭酊，其主要成分为苯扎溴铵、曙红等；苯扎溴铵是最常用的表面活性剂之一，具有杀菌、消毒、防