康精丸质量标准研究

目的 完善康精丸质量控制方法,建立康精丸中阿魏酸的含量测定方法.方法 显微镜下观察康精丸中当归、桑寄生、白芍、杜仲、川芎的显微特征;采用薄层色谱法对康精丸中熟地黄、赤芍、白芍、当归、川芎进行定性鉴别;采用HPLC法测定康精丸中阿魏酸含量,色谱柱为InertSustain C18(4.6 mm×250 mm,5μm),流动相为乙腈-0.2%磷酸溶液(15:85),流速1.0 ml/min.检测波长316 nm.结果 康精丸中当归、桑寄生、白芍、杜仲、川芎的显微特征明显;所建立熟地黄、赤芍、白芍、当归、川芎薄层色谱法中斑点清晰且阴性对照无干扰.阿魏酸在0.067~0.168μg范围内线性关系良好(r=0.9997),平均回收率为99.84%,RSD为1.22%.结论 建立的方法定性专属性强,定量准确度高,适用于康精丸的质量控制.

Research on the quality standard of Kangjing pill

Objective To improve the quality standard ofKangjing pills.Methods The qualities of Angelica sinensis, Taxillus sutchuenensis, Radix paeoniae Alba, Eucommia ulmoides and Ligusticum chuanxiong Hort in the pills were identified by microscopic examination; the natures of Radix rehmanniae Praeparata, Radix paeoniae Rubra, Radix paeoniae Alba,Angelica sinensis and Ligusticum chuanxiong Hort were detected by thin layer chromatography (TLC); the content of Paeoniflorin were measured by high performance liquid chromatography (HPLC). The operating conditions by HPLC were InertSustain C18 (4.6 mm×250 mm, 5μm ), the mixture of acetonitrile-0.2% Phosphoric acid water (15:85) as mobile phase, 1.0 ml/min as flow speed and wavelength 316 nm.Results The results observed by microscopy were obvious; The results showed that the TLC spots of Radix rehmanniae Praeparata, Radix paeoniae Rubra, Radix paeoniae Alba, Angelica sinensis and Ligusticum chuanxiong Hort were fairly clear, and the according blank test showed no interference. Ferulic Acid showed a good linear relationship within the range of 0.067-0.168μg (r=0.9997) with an average recovery of 99.84% (RSD=1.22%). Conclusions Microscopy, TLC and HPLC are handy, safe and accurate forKangjing pills to determine the quality.