摘要
目的研究不同厂家口炎清的质量情况,为提高药品标准、正确评价药品质量提供理论依据。方法采用高效液相色谱(HPLC)法对4个厂家生产的10批口炎清中的主要成分绿原酸、灰毡毛忍冬皂苷乙和川续断皂苷乙的质量分数进行测定,色谱柱为Waters XBridgeTMC18柱(250 mm×4.6 mm,5μm),柱温为30℃,流速为1 m L/min;流动相为乙腈-0.4%(体积分数)醋酸(梯度洗脱),绿原酸采用二极管阵列检测器(PDAD)检测,检测波长为330 nm,灰毡毛忍冬皂苷乙和川续断皂苷乙用蒸发光散射检测器(ELSD)检测,检测条件:雾化室温度60℃,漂移管温度65℃,N2的载气流量1.6 L/min,进样量8μL。结果不同厂家口炎清产品中绿原酸、灰毡毛忍冬皂苷乙和川续断皂苷乙质量分数差别较大。口炎清颗粒剂的质量相比胶囊剂和片剂较好;口炎清胶囊中不但灰毡毛忍冬皂苷乙质量分数非常低,而且检测不到川续断皂苷乙;口炎清片样品中灰毡毛忍冬皂苷乙的质量分数却异常高。结论不同厂家的口炎清产品由于原材料质量、制剂工艺等不同,导致了产品中有效成分的质量分数存在较大差异。
Objective To improve the drug standard and provide a theoretical basis for the quality evaluation of Kouyanqing products from different manufactures. Methods The contents of chlorogenic acid,macranthoidin B and dipsacoside B in 10 batches of Kouyanqing products from 4 manufactures were determined by HPLC. The determination was performed on Waters XBridgeTM-C18（ 250 mm × 4. 6 mm,5 μm） with column temperature set at 30 ℃ and the flow rate was 1 mL / min. The mobile phase was composed of acetonitrile and 0.4% acetum（ gradient elution）. The chlorogenic acid was detected by diode array detector（ PDAD）,and the UV detection wavelength was 330 nm. The atomization chamber temperature was set at 60 ℃ and the drift tube temperature of ELSD was set at 65 ℃,with the nitrogen flow rate of 1. 6 L / min for macranthoidin B and dipsacoside B. The injection volume was 8 μL. Results Significant difference was observed in contents of chlorogenic aicd,macranthoidin B and dipsacoside in Kouyanqing products from different manufactures. Conclusion The quality of the Kouyanqing products varied greatly among different manufactures,which may result from different raw materials and preparation process.
作者
姚小华
匡艳辉
张一凡
张晓燕
YAO Xiaohua KUANG Yanhui ZHANG Yifan ZHANG Xiaoyan(Hutchison Whampoa Guangzhou Baiyun shah Chinese Medicine Co., Ltd., Guangzhou 510515, China)
出处
《广东药学院学报》
CAS
2016年第5期596-600,共5页
Academic Journal of Guangdong College of Pharmacy
