首乌精口服液制备与质量控制研究

The Preparation of Shouwujing Oral Solution and Investigation on its Quality Control

目的 制备首乌精口服液,并对其进行质量控制考察。方法 以55%乙醇,7倍量,45 min,提取何首乌有效部位,制成首乌精口服液母液;并在10,20和30 d,以Symmetry-C18（250 mm×3.9 mm,5μm）为固定相,乙腈-水（17∶83）为流动相,检测波长为320 nm,流量1 ml/min,应用HPLC测定其有效成分（二苯乙烯苷）。结果二苯乙烯苷在0.45-1.8μg与峰面积线性关系良好。口服液中有效成分（二苯乙烯苷）在强酸、强碱和pH5.8条件下不稳定,在室温,避光,pH7.0-7.5条件下30 d内含量变化很小,其t0.95值估计为120 d。结论 首乌精口服液的制备方法是可行的,质量可控。

Objective To make Shouwujing Oral Solution and investigate its quality control. Methods Mother liquid was made by 55% alcohol of seven double doses after Shouwujing （stilbene glucosidal ）extracted in 45 min. On the 10 th ,20 th ,30 th days,active ingredient （ stilbene glucosidal ） was respectively detected by an HPLC with fixed phase of Symmetry - C18 （250 mm × 3.9 mm ,5 μm） and mobile phase composed of water -acetonitrile - （83： 17）. The detection wavelength was 320 nm and the flow rate was 1.0 ml · min^-1. Results Linear correlation was found between the content of stilbene glucosidal （0.45 -1.8μg） and peak area. Content of active ingredient （stilbene glucosidal） in n＇tother liquid wasn＇t stable in a strong acid, strong basic or pH 5.8 condition, but it altered marginally under the condition of regular temperature away from light and pH 7.0 - 7.5 within 30 days time. The value of t0.95 was 120 days. Conclusion The preparation of Shouwujing Oral Solution is feasible and its quality can be control.