首乌精口服液制备与质量控制研究
二苯乙烯苷；,稳定性；,高效液相色谱；,何首乌,,二苯乙烯苷；,稳定性；,高效液相色谱；,何首乌,1仪器与材料,2处方与制备,3质量控制,4二苯乙烯苷稳定性研究,5讨论,参考文献：
摘要：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SymmetryC18(250 mm×3.9 mm，5 μm)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pH 5.8条件下不稳定，在室温，避光，pH 7.0~7.5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。关键词：二苯乙烯苷； 稳定性； 高效液相色谱； 何首乌
The Preparation of Shouwujing Oral Solution and Investigation on its Quality Control
WANG Chunhua, SHEN Yan, ZHANG Wei*
(Medical College in Nantong University, Nantong, Jiangsu,226001,China)
Abstract：ObjectiveTo make Shouwujing Oral Solution and investigate its quality control. MethodsMother 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.ResultsLinear correlation was found between the content of stilbene glucosidal (0.45～1.8μg) and peak area. Content of active ingredient (stilbene glucosidal) in mother 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. ConclusionThe preparation of Shouwujing Oral Solution is feasible and its quality can be control. ......
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