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Abstract：Objective To set up a HPLC method for the determination of the contents of notoginsenoside R1, ginsenoside Rg1 and Rb1 in Kangliu pills. Methods It was performed on Kromasil C18 (4.6 mm×150 mm, 5 μm), and the mobile phase was acetonitrile-0.05% phosphoric acid with gradient elution system. The flow rate was 1.0 mL/min, the detective wavelength was 203 nm, injection volume was 10 μL and the column temperature was 30 ℃. Results The liner range of notoginsenoside R1 was 82.8～621 μg (r=0.999 9) and the average recovery was 100.057% (RSD=0.399 6%). The liner range of ginsenoside Rg1 was 109.8～823.5 μg (r=0.999 6) and the average recovery was 99.248% (RSD=1.004 6%). The liner range of ginsenoside Rb1 was 112.6～844.5 μg (r=0.999 9) and the average recovery was 99.812% (RSD=1.474 4%). Conclusion The method is simple, accurate and reproducible, and suitable for the content determination of notoginsenoside R1, ginsenoside Rg1 and Rb1 in Kangliu pills.

Key words：Kangliu pills;notoginsenoside R1;ginsenoside Rg1;ginsenoside Rb1;HPLC;determination

抗瘤丸是由三七、何首乌、琥珀等组成的中药复方制剂,其功效为扶正培本、清热解毒、活血化瘀等;用于脑胶质瘤、脑垂体瘤及其它肿瘤的治疗。抗瘤丸质量控制有性状、鉴别、检验等项目,但仍未建立含量测定方法。三七为本方中的君药,三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1为三七的主要有效成分。为了有效地控制该制剂质量,本试验建立了应用高效液相色谱(HPLC)法,测定抗瘤丸中三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1含量的方法。

1 仪器与试药

Agillent1200型高效液相色谱仪,包括四元梯度泵、DAD检测器、自动脱气机、标准自动进样器、柱温箱、化学工作站(美国Agillent公司);L-200SM型电子分析天平(日本Shimadzu公司);KQ-250D型超声波清洗器(昆山市超声波仪器厂)。

抗瘤丸(首都医科大学宣武医院自制,批号20060830、20061031、20061226、20070228);三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1对照品(供含量测定用,中国药品生物制品检定所,批号分别为110745-200415、110703-200424、110704-200420)。乙腈为色谱纯(德国默克公司),水为超纯水,其它试剂均为分析纯。

2 方法与结果