明目固本颗粒质量控制与药效学评价

目的：提高和完善明目固本颗粒的质量控制方法，并评价其体内效能。方法采用TLC法对方中菊花、枸杞子进行鉴别；采用HPLC法测定样品中绿原酸的含量。色谱条件：色谱柱为Welchrom C18柱（200 mm×4.6 mm，5μm）；流动相∶乙腈-0.4%磷酸水（10∶90，V/V）；流速为1.0 ml/min；检测波长：327 nm；柱温：25℃。并利用大鼠白内障、出血性视网膜病变和腺嘌呤诱导的肾功损害模型对明目固本颗粒的体内药效进行了评价。结果薄层定性鉴别的斑点清晰，分离效果良好；绿原酸含量在2.5~90μg/min范围内线性关系良好（r=0.9998），平均加样回收率为96.93％，RSD为2.65％（n=6）。服用明目固本颗粒能够改善大鼠视力和肾功能，发挥对其白内障、出血性视网膜病变和腺嘌呤诱导的肾功损害的保护作用。结论本方法结果准确、操作简单，重复性良好，适合作为该制剂的质量控制标准。

Quality standard and pharmacodynamic evaluation for Mingmu Guben granule

Objective To establish a quality standard and in vivo efficacy system for Mingmu Guben granule. Methods Chrysanthemi flos and Lycii fructus were identified by thin layer chromatography(TLC)method. The content of chlorogenic acid in Mingmu Guben granule was determined by HPLC. The Welchrom C18(200 mm×4.6 mm,5μm)column was used. The mobile phase consisted of acetonitrile-0.4%phosphoric acid of water(10∶90,V/V)at a flow rate of 1.0 ml/min. The detection wavelength was at 327 nm under 25℃. The in vivo efficacy of Mingnu Guben granule was measured by cataract,retinal ischemia and renal dysfunction rat model. Results The spots in the were clear. The chlorogenic acid showed a good linear relationship within the range of 2.5-90μg/min(r=0.9998). The average recovery was 96.93%,and the RSD was 2.65%. Moreover,the in vivo efficacy of Mingnu Guben granule was measured. The results indicated that orally taking Mingnu Guben granule prevent rat from cataract,retinal ischemia and renal dysfunc?tion induced by adenine. Conclusion By establishing simple,accurate and repeatable methods and measuring in vivo efficacy,our present work provides a quality control system for Mingmu Guben granule.