地喹氯铵含片质量控制方法的改进研究
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摘要
目的:改进地喹氯铵含片质量控制方法,统一有糖型和无糖型的质量标准。方法:采用Ultimate AQ C18(4.6 mm×250 mm,5μm)色谱柱,流动相:0.005 mol·L~(-1)庚烷磺酸钠溶液-甲醇(50∶50),柱温:30℃,检测波长:240 nm,流速:1.0 m L·min~(-1),以10片样品分别测定后取平均值计算含量;按崩解时限检查法考察溶化性。结果:地喹氯铵在7.40~13.74μg·m L~(-1)(r=0.9997)范围内线性关系良好,无糖型回收率为99.5%(n=9),有糖型回收率为99.1%(n=9),样品含量在95.5%~103.2%之间;样品溶化时间在7~48 min之间。结论:经方法学验证,所建立方法可同时用于有糖型和无糖型地喹氯铵含片的质量控制,为同类制剂提供参考。
Objective: To improve the quality control method of dequalinium chloride buccal tablets and unify the specification for both the sugar and sugar-free tablets. Methods: The procedure was performed on Ultimate AQ C18( 4. 6 mm × 250 mm,5 μm) with 0. 005 mol·L~(-1) sodium heptane sulfonate solution and methanol( 50∶ 50) as the mobile phase. The column temperature was set at 30 ℃,detection wavelength set as 240 nm,and flow rate was1. 0 m L·min~(-1). The contents of dequalinium chloride were obtained by the average values of 10 tablets test results. The dissolution time was determined by the disintegration test. Results: There was the good linearity in the range of 7. 40-13. 74 μg·m L~(-1)( r = 0. 9997). The average recoveries were 99. 5% for sugar-free type( n = 9)and 99. 1% for sugar tablets( n = 9) respectively. The contents fell into 95. 5%-103. 2%,and the dissolution time was between 7 min and 48 min. Conclusion: This validated method can be used for quality control of both sugar and sugar-free dequalinium chloride buccal tablets,and it can provide a reference for other relevant preparations.
Objective: To improve the quality control method of dequalinium chloride buccal tablets and unify the specification for both the sugar and sugar-free tablets. Methods: The procedure was performed on Ultimate AQ C18( 4. 6 mm × 250 mm,5 μm) with 0. 005 mol·L~(-1) sodium heptane sulfonate solution and methanol( 50∶ 50) as the mobile phase. The column temperature was set at 30 ℃,detection wavelength set as 240 nm,and flow rate was1. 0 m L·min~(-1). The contents of dequalinium chloride were obtained by the average values of 10 tablets test results. The dissolution time was determined by the disintegration test. Results: There was the good linearity in the range of 7. 40-13. 74 μg·m L~(-1)( r = 0. 9997). The average recoveries were 99. 5% for sugar-free type( n = 9)and 99. 1% for sugar tablets( n = 9) respectively. The contents fell into 95. 5%-103. 2%,and the dissolution time was between 7 min and 48 min. Conclusion: This validated method can be used for quality control of both sugar and sugar-free dequalinium chloride buccal tablets,and it can provide a reference for other relevant preparations.
引文
[1]梅艳,汪洋,蔡长清.地喹氯铵含片辅助治疗小儿复发性口腔溃疡75例[J].中国医药导报,2009,1(6):54MEI Y,WANG Y,CAI CQ.The adjuvant therapy of Dequalinium Chloride Buccal Tablets with recurrent oral ulcer in 75 cases children[J].China Med Her,2009,1(6):54
[2]张琳,薛荣奇,董金凤.地喹氯铵喷雾剂治疗急性咽炎30例[J].陕西医学杂志,2006,10(35):1344ZHANG L,XUE RQ,DONG JF.The therapy of Dequalinium Chloride Spray with acute pharyngitis in 30 cases[J].Shaanxi Med J,2006,10(35):1344
[3]朱景申.泰乐奇口含片介绍[J].医药导报,1996,15(5):255ZHU JS.The introduction of Taileqi Buccal Tablets[J].Her Med,1996,15(5):255
[4]国家药品标准·化学药品地方标准上升国家标准[S].第五册,2002:90National Drug Standards(Local standards for chemical drugs raised to national standards)[S].Vol 5,2002:90
[5]EP[S].9.0.2016:1413
[6]中国药典[S].2015年版.四部:118Ch P[S].2015.Vol.Ⅳ:118
[2]张琳,薛荣奇,董金凤.地喹氯铵喷雾剂治疗急性咽炎30例[J].陕西医学杂志,2006,10(35):1344ZHANG L,XUE RQ,DONG JF.The therapy of Dequalinium Chloride Spray with acute pharyngitis in 30 cases[J].Shaanxi Med J,2006,10(35):1344
[3]朱景申.泰乐奇口含片介绍[J].医药导报,1996,15(5):255ZHU JS.The introduction of Taileqi Buccal Tablets[J].Her Med,1996,15(5):255
[4]国家药品标准·化学药品地方标准上升国家标准[S].第五册,2002:90National Drug Standards(Local standards for chemical drugs raised to national standards)[S].Vol 5,2002:90
[5]EP[S].9.0.2016:1413
[6]中国药典[S].2015年版.四部:118Ch P[S].2015.Vol.Ⅳ:118