尪痹丸胶囊质量控制方法研究

目的:建立尪痹丸胶囊的质量控制方法。方法:采用薄层色谱法(TLC)对尪痹丸胶囊中的肉桂、桂枝、白芍、赤芍和防风进行定性鉴别;采用高效液相色谱法(HPLC)分别对尪痹丸胶囊中蛇床子素、桂皮醛和肉桂酸进行含量测定。结果:肉桂和桂枝的化学组成成分相近,TLC能清晰鉴别出桂皮醛;白芍、赤芍和防风药材的TLC鉴别的色谱斑点清晰,阴性无干扰;HPLC测定蛇床子素、桂皮醛和肉桂酸含量,其浓度分别在1.0～200.0,5.0～100.0,0.50～15.0 mg.L-1呈良好的线性关系,平均回收率和RSD分别在98.16%～101.6%,1.8%～3.0%。结论:方法灵敏、简便、准确,可作为尪痹丸胶囊质量控制的方法。

Study on Quality Control for Wangbiwan Capsules

Objective: To establish the methods of quality control for Wangbiwan capsules. Method: Cortex Cinnamomum, Ramulus Cinnamomi, Radix Paeoniae Alba, Radix Paeoniae Bubra and Radix Saposhnikoviae were identified by TLC; and the content of osthole, cinnamaldehyde and cinnamic acid in Wangbiwan capsules was determined by HPLC. Result: TLC spots developed were fairly clear and the blank tests showed no interference for Radix Paeoniae Alba, Paeonia lactiflora Pall and Radix Saposhnikoviae, but similar component in TLC were found for Cinnamomum cassia and Ramulus Cinnamomi. The linear ranges of osthole, cinnamaldehyde and cinnamic acid were 1.0-200, 5.0 -100.0 and 0.50-15.0 mg·L^-1respectively with average recovery of 98.16%-101.6%, RSD of 1.9%-3.0%. Conclusion: The TLC and HPLC methods were smiple, accurate and fast, which could be used effectively for the quality control of Wangbiwan capsules.