酪萨维片质量标准及药效学研究

Quality standards and pharmacological effect of Laosawei tablets

目的建立酪萨维片的质量标准,并对其主要药效学进行研究。方法采用TLC法对酪萨维片中蔷薇红景天进行定性鉴别;采用HPLC法同时测定蔷薇红景天中红景天苷和酪萨维的含量。采用小鼠负重游泳、常压缺氧、耐高温和耐低温实验,观察酪萨维片的抗疲劳和抗应激作用;通过小鼠肿瘤抑制率实验,观察酪萨维片的抗肿瘤活性;采用碳粒廓清实验、绵羊红细胞致小鼠溶血素抗体生成法和小鼠外周血液T淋巴细胞百分计数,观察酪萨维片对荷瘤小鼠免疫功能的作用。结果 TLC鉴别中,蔷薇红景天特征斑点清晰,分离度良好;含量测定中,红景天苷在0.0601~0.601μg与峰面积线性关系良好(r=0.9999),平均回收率为99.9%,RSD为1.7%;酪萨维在0.0501~0.501μg与峰面积线性关系良好(r=0.9998),平均回收率为100.9%,RSD为1.4%。酪萨维片能够显著延长小鼠在负重游泳、常压缺氧和高温条件下的存活时间,提高小鼠低温条件下存活率;酪萨维片对H22荷瘤小鼠的抑制率为31.1%~55.4%;酪萨维片明显增强荷瘤小鼠网状内皮系统吞噬功能,提高半数溶血值,增加小鼠外周血液中T淋巴细胞百分比。结论本方法简便易行,专属性强,可用于酪萨维片的质量控制;酪萨维片可增强小鼠抗疲劳、抗应激能力,具有抗肿瘤作用,可增强荷瘤小鼠细胞免疫、体液免疫和非特异性免疫功能。

Objective To establish quality standard and evaluate the pharmacodynamic effect of Laosawei tablets. Methods Thin layer chromatography(TLC) was used to identify Rhodiola rosea. The content of salidroside and rosavin in Rhodiola rosea was determined by HPLC. Anti-fatigue and anti-stress effects of Laosawei tablets were observed by weight-bearing swimming test, anti-hypoxia test, high-temperature resistance and low-temperature resistance test. The antitumor activity of Laosawei tablets was observed by the experiment of mice tumor inhibition rate. The immunomodulation effect of Laosawei tablets was evaluated by the expectorant carbonclearance, level of serum hemolysin antibody and the percentage of peripheral blood T lymphocytes in the mice. Results The TLC spots were clear, highly identified and well separated. The linear range of salidroside was 0.0601-0.601 μg(r = 0.9999). The average recovery was 99.9% with RSD = 1.7%. The linear range of rosavin was 0.0501-0.501 μg(r = 0.9998). The average recovery was 100.9% with RSD = 1.4%. Laosawei tablets significantly increased the loaded swimming time, the anti-hypoxia under atmospheric pressure time and high-temperature time, improved the survival rate of the mice under low temperature. Tumor growth inhibitionratio of Laosawei tablets was 31.1%-55.4%. Laosawei tablets significantly increased the englobement of the reticulo-endothelial system, HC50 and the percentage of peripheral blood T lymphocytes in the H22 bearing mice. Conclusion The method is simple, specific and can be used as the quality control method for Laosawei tablets. Laosawei tablets increase the anti-fatigue and anti-stress ability of mice, and increase the cellular immunity, humoral immunity and non-specific immune function of tumor-bearing mice.