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目的:制备生血汤,建立质量控制标准,并进行临床观察。方法:采用HPLC测定生血汤中党参炔苷的含量,以KY- WG-C18为固定相,乙腈-水(15∶85)为流动相,检测波长为267 nm。采用对照法观察临床疗效。结果:党参炔苷在0．14-O．01 mg·ml-1浓度范围内与峰面积呈线性关系,回归方程为Y=2．16×104X-1．38×104,r=0．999 6,平均回收率为99．32％,RSD为1．89％(n=5)。治疗再生障碍性贫血36例,总有效率77．08％。结论:该制剂制备工艺可行,质量标准可靠,治疗再生障碍性贫血效果良好。
Objective: To prepare Shengxue Tang, establish quality control standards, and conduct clinical observation. Methods: The content of Dangshen glucoside in Shengxue Tang was determined by HPLC. The stationary phase was KY-WG-C18, the mobile phase was acetonitrile-water (15∶85), and the detection wavelength was 267 nm. The control method was used to observe the clinical efficacy. Results: Codonopside in 0.14-O. In the concentration range of 01 mg·ml-1, there was a linear relationship with the peak area. The regression equation was Y=2.16×104X-1.38×104, r=0.999 6. The average recovery rate was 99.32%. This is 1.89% (n=5). Treatment of aplastic anemia in 36 cases, the total effective rate of 77.08%. Conclusion: The preparation process is feasible, the quality standard is reliable, and the effect of treating aplastic anemia is good.