丹七活血丸质量标准的研究

Quality Standard for Danqihuoxue Pills

目的建立丹七活血丸的质量标准。方法采用显微鉴别法鉴别三七、川芎、党参;采用TLC法鉴别丹参及赤芍;采用HPLC法测定三七皂苷R1、人参皂苷Rg1及人参皂苷Rb1的含量。结果三七的树脂道、川芎的木栓细胞、党参的联结乳管显微特征清晰,专属性好;丹参、赤芍的TLC方法斑点清晰,分离效果好,阴性对照无干扰,耐用性试验良好;三七皂苷R1、人参皂苷Rg1及人参皂苷Rb1在进样量为0.13-3.25μg、0.41-10.25μg、0.43-10.75μg范围内线性关系良好（r〉0.999 7）,平均加样回收率（n=6）分别为99.16%、100.20%、100.55%。结论该方法专属性强、灵敏度高、重复性好,可用于丹七活血丸的质量控制。

OBJECTIVE To establish the quality standard for Danqihuoxue pills. METHODS Notoginseng Radix Et Rhizoma,Chuanxiong Rhizoma and Codonopsis Radix were identified under microscope. Radix Et Rhizoma and Paeoniae Radix Rubra were identified qualitatively by TLC. The contents of notoginsenoside R1,ginsenoside Rg1 and ginsengoside Rb1 were determined by HPLC.RESULTS The resin passage of Notoginseng Radix Et Rhizoma,the cork cell of Chuanxiong Rhizoma and the connecting duct of Codonopsis Radix were clear and typical. The developed TLC spots were clear,separations were good,and the negative tests showed no interference. The notoginsenoside R1,ginsenoside Rg1 and ginsenoside Rb1 showed good linear relationships in the ranges of 0. 13- 3.25 μg,0. 41- 10. 25 μg,0. 43- 10. 75 μg（ r〉 0. 999 7）,respectively. Their average recoveries were 99. 16%,100. 20% and 100.55%,respectively（ n = 6）. CONCLUSION The established method is simple,specific and durable. It can be used for the quality control of Danqihuoxue pills.