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机构地区:[1]湖北省食品药品监督检验研究院,湖北武汉430064
出 处:《中成药》2013年第6期1216-1218,共3页Chinese Traditional Patent Medicine
摘 要:目的研究建立HPLC法替代TLC-SCAN法测定镇痛口服液(洋金花、制草乌、闹羊花、细辛、姜黄)中生物碱类成分,以控制该制剂质量。方法以十八烷基硅烷键合硅胶为填充剂,以乙腈-0.05 mol/L乙酸钠(含0.012 5mol/L庚烷磺酸钠,用冰醋酸调pH至6.0)(20∶80)为流动相,体积流量1.0 mL/min,检测波长216 nm。结果生物碱类成分,氢溴酸东莨菪碱线性范围为0.498 6~9.297 2μg,平均回收率为91.14%,RSD为2.84%;硫酸阿托品线性范围为0.096 8~1.936 0μg,平均回收率为92.38%,RSD为3.13%。结论本方法所用流动相系统有利于保护色谱柱。HPLC法比TLC-SCAN法能更有效控制产品质量。AIM To establish an HPLC determination of two alkaloids in Zhengtong Oral Liquid(Daturae Flos,Aconiti kusnezoffii Radix cocta,Rhododendri mollis Flos,Asari Herba,Curcumae longae Rhizoma) to replace the TLC-SCAN determination.METHODS Octadecylsilane bonded silica column was used with the mobile phase of acetonitrile-0.05 mol/L sodium acetate(contain 0.012 5 mol/L heptane sulfonate,adjusting pH to 6.0 with glacial acetic acid)(20∶80).The detection wavelength was set at 216 nm,and the flow rate was 1.0 mL/min.RESULTS The linear range of scopolamine hydrobromide was 0.498 6-9.297 2 μg with the average recovery of 91.14% and RSD of 2.84%.The linear range of atropine sulfate was 0.096 8-1.936 0 μg with the average recovery of 92.38% and RSD of 3.13%.CONCLUSION The mobile phase for acetic acid salt and heptane sodium sulfonate obtained in this study is helpful in protecting the chromatographic column.HPLC is more effective than TLC-SCAN to control the quality of this oral liquid.
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