疏清微丸质量标准研究
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摘要
目的:建立疏清微丸质量标准。方法:采用薄层色谱法对疏清微丸中大青叶、甘草、桑叶、芦根进行定性鉴别实验,采用草酸铵沉淀法-醋酸铅沉淀法定性检测石膏中的Ca~(2+)和硫酸盐,采用RH-HPLC-DAD法对微丸中靛玉红进行含量测定。结果:大青叶、甘草、桑叶、芦根的薄层色谱图均斑点清晰,Rf值适中,分离度好,阴性对照均无干扰,石膏阴性对照不产生白色沉淀对石膏定性鉴别无干扰,靛玉红回归方程为Y=1,471.279,9X-52.679,8(r=0.999,2),靛玉红在为0.057～0.46μg范围内线性关系良好,测得靛玉红平均回收率为100.32%,RSD%为0.75%(n=6)。结论:本实验方法操作简单、重复性好,可用于疏清微丸的质量控制。
Objective: To establish quality standard of Shuqing Mini-pill. Methods: The qualitative identification experiments of Daqingye(Folium Isatidis), Gancao(Licorice), Sanye(Mulberry Leaves) and Lugen(Reed Rhizome) were carried out by thin layer chromatography. The calcium oxalate and sulphate in Shigao(gypsum)were determined qualitatively by ammonium oxalate precipitation method and lead acetate precipitation method.Indirubin was detected by using RH-HPLC-DAD detector. Results: TLC images of Daqingye(Folium Isatidis),Gancao(Licorice), Sanye(Mulberry Leaves) and Lugen(Reed Rhizome) were clear spots with suitable resolution and proper Rf value, no interference with negative control and no white precipitate with gypsum negative control,which had no interference on qualitative identification of Shigao(gypsum). The regression equation of indirubin was Y=1471.2799 X-52.6798(r=0.9992). The linear range of indirubin ranged from 0.057 μg to 0.46 μg, and showed a good linear relationship. The average recovery rate of indirubin was 100.32% and RSD% was 0.75%(n=6). Conclusion: All the experimental methods are simple and reproducible, and can be used for the quality control of Shuqing Mini-pill.
Objective: To establish quality standard of Shuqing Mini-pill. Methods: The qualitative identification experiments of Daqingye(Folium Isatidis), Gancao(Licorice), Sanye(Mulberry Leaves) and Lugen(Reed Rhizome) were carried out by thin layer chromatography. The calcium oxalate and sulphate in Shigao(gypsum)were determined qualitatively by ammonium oxalate precipitation method and lead acetate precipitation method.Indirubin was detected by using RH-HPLC-DAD detector. Results: TLC images of Daqingye(Folium Isatidis),Gancao(Licorice), Sanye(Mulberry Leaves) and Lugen(Reed Rhizome) were clear spots with suitable resolution and proper Rf value, no interference with negative control and no white precipitate with gypsum negative control,which had no interference on qualitative identification of Shigao(gypsum). The regression equation of indirubin was Y=1471.2799 X-52.6798(r=0.9992). The linear range of indirubin ranged from 0.057 μg to 0.46 μg, and showed a good linear relationship. The average recovery rate of indirubin was 100.32% and RSD% was 0.75%(n=6). Conclusion: All the experimental methods are simple and reproducible, and can be used for the quality control of Shuqing Mini-pill.
引文
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[4]章为,李文波,李文莉,等.妇科白带膏质量标准研究[J].中医药导报,2010,16(7):105-107.
[5]李湘平,袁檖樑,李汶.薄层色谱法定性鉴别胃可舒片中的陈皮、甘草、木香[J].中国医药指南,2014,12(10):51-53.
[6]冯健,胡昌江,张秀环,等.桑叶配方颗粒质量标准研究[J]中国药业,2012,21(19):38-39.
[7]刘佩沂,赖岳晓,田素英.以阿魏酸为指标研究肺热清解口服液的质量标准[J].现代中药研究与实践,2014,28(1):60-62.
[8]曾晓瑜,贺英菊,李建萍,等.风热感冒颗粒的薄层色谱鉴别[J].中国药业,2008,17(5):17-18.
[9]靳然,赵百孝.气相色谱指纹图谱在中药分析及质量评价中的应用[J].现代科学技术,2010,2(1):122-126.
[10]王璐璐,汪仁芸,郑稳生.板蓝根脂溶性成分-PVPK30固体分散体的研究[J].中国新药杂志,2006,15(13):1078-1081.
[11]Motohiro Kanazawaa,Yoshiko Satomib,Yoichi Mizutania,et al.Isoliquiritigenin in hibits the growth of prostate cancer[J].European Urology,2003(43):580-586.
[12]阴新负,彭效明,李翠清,等.桑叶生物碱和多糖的分离纯化研究进展[J].中医药导报,2016,22(14):108-113.
[13]赖玲林,彭小芳.中药桑叶药理作用的研究进展[J].安徽医药,2016,20(12):2210-2213.
[14]孙淑玲.中药芦根的药理作用及临床应用[J].中西医结合心血管病杂志,2016,4(36):165.
[15]崔伟亮,李慧芬,刘江亭.大青叶抗病毒抑菌作用研究进展[J].山东中医杂志,2014,33(5):410-411.