煨粉葛质量标准研究

Study on Quality Standard of Puerariae Thomsonii Radix Praeparata

目的研究煨粉葛的显微特征及薄层色谱,水分、总灰分、二氧化硫残留量、重金属及有害元素及浸出物,葛根素的含量等情况,以完善煨粉葛的质量标准。方法用正置显微镜观察饮片粉末特征,采用对照品法考察饮片的薄层色谱行为,参照《中国药典》2015年版四部通则考察饮片的水分、总灰分、二氧化硫残留量、重金属及有害元素及浸出物等情况,选用以十八烷基硅烷键合硅胶为填充剂(4.6×250mm,5μm)的色谱柱,以甲醇-水(25∶75)为流动相,流速为1.0mL·min^-1,流量柱温为35℃,检测波长为250nm,进样量为10μL,测定葛根素的含量。结果粉末鉴别,以淀粉粒、晶纤维及具缘纹孔导管为特征重点。薄层鉴别,以对照品为参考,特征斑点明显,Rf值适宜。增加水分、总灰分、二氧化硫残留量及浸出物等的限度范围,饮片中含有铅、镉、砷、汞、铜等重金属及有害元素的量较低,葛根素在0.0814~3.2567μg范围内线性关系良好,平均回收率为99.9%(RSD=1.5%)。结论所建质量标准方法简便、准确、耐用性好,为确保饮片质量,指导临床用药,提供了参考依据。

OBJECTIVE To study the microscopic characteristics and TLC,moisture,total ash,Sulfur dioxide residues、heavy met als and harmful elements、extracts and puerarin content of Puerariae thomsonii Radix Praeparata,in order to improve the quality standard of Puerariae thomsonii Radix Praeparata.METHODS The powder characteristics of the decoction pieces were observed under a positive microscope,Study on TLC Behavior of decoction pieces by reference material method,referring to the four general principles of the Chinese Pharmacopoeia 2015 edition,the water content,total ash content,sulfur dioxide residue,heavy met als,harmful elements and extracts of the decoction pieces were investigated.A chromatographic column with Octadecyl silane bonded silica gel as filler(4.6×250mm,5μm)and methanol-water(25∶75)as mobile phase was selected.The flow rate was 1.0mL·min^-1,the flow column temperature was 35℃,the detection wavelength was 250nm,and the injection volume was 10μL.The content of Puerarin was determined.RESULTS Powder identification is characterized by starch granule,crystal fibers and edged pitted ducts.TLC identification,with reference to the reference substance,has obvious characteristic spots and suitable Rf value.Increasing the limit range of moisture,total ash,sulfur dioxide residue and extracts,the amount of heavy met als and harmful elements such as Pb,Cr,As,Hg and Cu in the slices was lower,the linear relationship of Puerarin was good in the range of 0.0814~3.2567μg,the average recovery was 99.9%(RSD=1.5%).CONCLUSION The established quality standard method is simple、accurate and durable.It provides a reference basis for ensuring the quality of decoction pieces and guiding clinical medication.