HPLC测定不同厂家复方丹参片中三七皂苷R_1和人参皂苷Re、Rg_1、Rb_1含量

Determination of notoginsenoside R_1,ginsenoside Rg_1,ginsenoside Re and ginsenoside Rb_1 in Compound Danshen Tablets of different pharmaceutical factories by HPLC

目的：建立复方丹参片（丹参，三七，冰片）中三七有效成分的高效液相色谱测定方法。方法：采用Kromasil C18（5μm，250mm×4．60mm）色谱柱；流动相：乙腈-0．05％磷酸水溶液梯度洗脱（0～12min：乙腈浓度为22％；12～20min：乙腈的浓度由22％递升至28％；20～60min：乙腈的浓度由28％递升至43％）；流速为1mL／min，检测波长为203nm。结果：三七皂苷R1和人参皂苷Rg1、Re、Rb1的线性范围分别为0．326～3．260μg（r=0．9997），0．890～8．900μg（r=0．9998），0．144～1．440μg（r=0．9996），0．940～9．400μg（r=0．9998）；平均加样回收率（n=6）分别为99．08％，98．36％，97．54％，96．07％，RSD分别为4．41％，1．64％，2．77％，1．12％。结论：本测定方法简便可行、重复性好，可用于本制剂中三七多种有效成分的含量测定。

AIM： To establish the method for determing effective components of notoginsenoside in Compound Danshen Tablets（Radix et Rhizoma Salviae miltiorrhizae, Radix et Rhizoma Notoginseng, Borneolum Syntheticum ） by RP-HPLC. METHODS ： The contents of notoginsenoside R1 , ginsenoside Rg1 , ginsenoside Re and ginsenoside Rb1 were simultaneously determined by an HPLC system with Kromasil C18 （5 μm, 250 mm ×4.60 mm）, the mobile phase was CH3CN-0.05% HaPO4 （ CH3CN 0-12 min：22% ; 12-20 min：22%-28% ;20-60 min：28%-43% ）. The flow rate was 1 mL/min. The detection wavelength was set at 203 nm. RESULTS ： The linear ranges of notoginsenoside R1 , ginsenoside Rg1 , ginsenoside Re and ginsenoside Rb1 were 0. 326-3. 260 μg（ r = 0. 999 7）, 0. 890- 8. 900 μg （ r = 0. 999 8 ）, 0. 144-1. 440 μg （ r = 0. 999 6 ） , 0. 940-9. 400 μg （ r = 0. 999 8 ） , respectively. Their average recoveries（n =6） were 99.08% , 98.36%, 97.54% and 96.07%, corresponding RSD were 4.41%, 1. 64%, 2.77% and 1.12%, respectgively. CONCLUSION： The results indicate that the HPLC method is simple, accurate, highly selective and reproducible, thus it could be used as quality control in the preparation of Compound Danshen Tablets.