健脑益神丸质量标准研究
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摘要
目的建立健脑益神丸的质量标准。方法对健脑益神丸中的炙甘草、葛根、酸枣仁、益智仁进行显微鉴别,对川芎、葛根采用薄层色谱法(TLC)进行定性鉴别,并采用高效液相色谱法测定健脑益神丸中葛根素的含量,色谱柱为美国Agilent Zorbax Extend-C_(18),柱温为室温,流动相为甲醇-水(25∶75),流速为1.0 mL/min,检测波长为250 nm,进样量10μL。结果该制剂的显微鉴别明显;TCL斑点清晰,阴性样品无干扰;葛根素在40～240μg/mL浓度范围内与峰面积呈良好的线性关系(r=0.999),平均回收率为99.98%,RSD为0.44%。结论该方法稳定、可行,且专属性高,可有效控制健脑益神丸的质量。
Objective To establish the quality standard of Jiannao Yishen Pills. Methods Microscopic identification of Prepared Radix Glycyrrhizae, Pueraria lobata, Semen Zizyphi Spinosae and Alpinia oxyphylla in Jiannao Yishen Pills was carried out. Thin layer chromatography(TLC) was used for qualitative identification of Ligusticum Chuanxiong and Pueraria lobata. The content of Puerarin in Jiannao Yishen Pills was determined by high performance liquid chromatography. The column was Agilent Zorbax Extend-C18, the column temperature was room temperature, the mobile phase was methanol-water(25:75), the flow rate was 1.0 mL/min, the detection wavelength was 250 nm, and the injection volume was 10 μL. Results The microscopic identification of the preparation was obvious; the spots in TCL were clear,and the negative samples had no interference; puerarin showed a good linear relationship with the peak area in the concentration range of 40-240 g/mL(r = 0.999), with an average recovery of 99.98% and RSD of 0.44%. Conclusion The method is stable, feasible and specific. It can effectively control the quality of Jiannao Yishen Pills.
Objective To establish the quality standard of Jiannao Yishen Pills. Methods Microscopic identification of Prepared Radix Glycyrrhizae, Pueraria lobata, Semen Zizyphi Spinosae and Alpinia oxyphylla in Jiannao Yishen Pills was carried out. Thin layer chromatography(TLC) was used for qualitative identification of Ligusticum Chuanxiong and Pueraria lobata. The content of Puerarin in Jiannao Yishen Pills was determined by high performance liquid chromatography. The column was Agilent Zorbax Extend-C18, the column temperature was room temperature, the mobile phase was methanol-water(25:75), the flow rate was 1.0 mL/min, the detection wavelength was 250 nm, and the injection volume was 10 μL. Results The microscopic identification of the preparation was obvious; the spots in TCL were clear,and the negative samples had no interference; puerarin showed a good linear relationship with the peak area in the concentration range of 40-240 g/mL(r = 0.999), with an average recovery of 99.98% and RSD of 0.44%. Conclusion The method is stable, feasible and specific. It can effectively control the quality of Jiannao Yishen Pills.
引文
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[3]王萍,付玲,聂继红,等.参浮化痰丸质量标准的研究[J].中成药,2013,35(2):306-312.
[4]杨丽,胡昌江,周维,等.川芎配方颗粒质量标准研究[J].中国药业,2012,21(10):28-29.
[5]李希,黄嫣,李远辉,等.大川芎鼻用原位凝胶质量标准研究[J].中医药导报,2014,20(2):68-71.
[6]闫春风,刘井利,朱磊,等.柴芩软胶囊质量标准研究[J].中国医药导报,2013,10(27):100-103.
[7]陆萍,谭兴起,郭良君,等.降脂护肝胶囊质量标准研究[J].中国医药导报,2010,7(34):49-51.
[8]单玉,白鹏.防风通圣丸的质量标准研究[J].中华医药学刊,2009,27(5):1069-1071.
[9]高展,孙玉侠,阚红玉,等.养血清脑颗粒质量标准研究[J].广东药学院学报,2011,27(5):483-488.
[10]杨玉兰,柴彦,任爱农,等.舒糖络颗粒质量标准研究[J].中成药,2015,37(4):785-792.
[11]骆慧琳,谢燕,李国文,等.参葛颗粒质量标准研究[J].中成药,2012,34(9):1720-1725.
[12]毛红兵,张爱华,刘梦媛,等.葛连解糖颗粒的质量标准研究[J].中国新药杂志,2013,22(4):486-491.
[13]孙丹丹,闫雪生,李岩.菊葛天麻颗粒质量标准研究[J].中国实验方剂学杂志,2012,18(8):86-88.
[14]范桂强,宋更申,路伦,等.六味颈康胶囊质量标准的建立[J].中国药师,2016,19(8):1605-1608.
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[17]楚楚,徐绍静,吴琼琼,等.HPLC同时测定生脉饮(党参方)中多组分的含量[J].中药材,2013,36(5):820-823.
[18]张勇慧,张锦文,阮汉利,等.参芪扶正注射液中党参药材HPLC指纹图谱研究[J].中药材,2006,29(12):1355-1358.
[19]王珍,李矗.补肾健脾颗粒质量标准研究[J].中成药,2010,32(7):1252-1255.
[20]李松,隆龙.党参颗粒的质量标准研究[J].中草药,2006,37(8):1173-1174.
[21]徐小芳,陈文婷,刘敏,等.复方附子口服液质量标准的研究[J].中成药,2016,38(4):815-819.
[22]乐佳美,熊筱娟,张凤,等.祛斑口服液的质量标准研究[J].药学实践杂志,2016,34(1):66-71.
[23]杨诚芳,何悦,谢勇.生脉糖浆质量标准研究[J].广州化工,2010,38(8):208-210.
[24]崔淑云,王登旭.益肝康口服液的制备及质量标准研究[J].中国药房,2008,19(3):192-194.
[25]郭青,宁青.益气止血颗粒质量标准研究[J].中成药,2008,30(3):375-380.
[26]崔明超,程斌,陈宏降,等.玉涎胶囊的质量标准研究[J].安徽医药,2014,18(5):815-819.