论文部分内容阅读
目的:建立参芍通脉片的制备及质量控制方法,并观察其治疗高血脂的临床疗效。方法:选择芍药苷为指标,建立HPLC法测定其含量。120例高脂血症患者随机分为两组,以辛伐他汀片为对照观察参芍通脉片的临床疗效。结果:芍药苷在1.66～11.59mg·L~(-1)范围内线性关系良好r=0.9999(n=7),平均回收率为100.04%,RSD为1.18%(n=9);参芍通脉片能显著降低高脂血症患者TC、TG、LDC-C及AI(P<0.01),升高HDL-C(P<0.05),调脂疗效与辛伐他汀基本相当(P>0.05)。且对肌酸激酶影响较小。结论:参芍通脉片质量控制方法简便可行,专属性强,准确可靠,用于高脂血症治疗安全有效。
Objective: To establish the method of preparation and quality control of Shen-Shao Tongmai tablet and to observe its clinical effect in treating hyperlipidemia. Methods: Paeoniflorin was selected as an index to establish HPLC method to determine its content. 120 cases of patients with hyperlipidemia were randomly divided into two groups, with simvastatin tablets as a control to observe the clinical efficacy of ShenShao Tongmai tablets. Results: Paeoniflorin had a good linear relationship in the range of 1.66-1.159 mg · L -1 (r = 0.9999, n = 7), with an average recovery of 100.04% and a RSD of 1.18% (n = 9) Cholesterol can significantly reduce TC, TG, LDC-C and AI in hyperlipidemic patients (P <0.01) and increase HDL-C (P <0.05) . And creatine kinase less affected. Conclusion: The method of quality control of Shen-Shao Tongmai tablet is simple, feasible, specific, accurate and reliable for the safe and effective treatment of hyperlipidemia.