金荞麦片质量标准的实验研究

Quality standard for Jinqiaomai Tablets

目的:建立金荞麦片(金荞麦)质量标准。方法:TLC法鉴别制剂中金荞麦,采用HPLC法同时测定(-)-表儿茶素、原矢车菊素B2含量,采用SymmetryC18色谱柱(5μm,3.9mmid×15mm),水(用磷酸调pH值3.00±0.02)-乙腈(92∶8)为流动相,检测波长:280nm,柱温:35℃。结果:TLC可鉴别出金荞麦的特征斑点。(-)-表儿茶素的进样量在0.1136～2.272μg范围内呈现良好的线性,r=0.999968(n=8);平均加样回收率为97.12%,RSD=0.92%(n=6)。原矢车菊素B2的进样量在0.1664～1.664μg范围内呈良好的线性,r=0.999702(n=8);平均加样回收率为98.26%,RSD=0.61%(n=6)。结论:本法专属性强,重现性好,结果准确,可用于控制金荞麦片质量。

AIM： To establish the quality standard for Jinqiaomai Tablets （ Fagopyri Dibotryis Rhizoma）. METHODS： Fagopyri Dibotryis Rhizoma was identified by TLC. The contents of （-）-epicatechin and procyanidin B2 were determined simultaneously by HPLC,the Symmetry C18 column （5 μm,3. 9 mm id × 150 mm） was used. The water （adjust pH value to 3. 00 ± 0. 02 with phosphoric acid）-acetonitrile （92 ∶ 8） was used as a mobile phase,the detecting wavelength was at 280 nm. The column temperature was at 35 ℃. RESULTS： Fagopyri Dibotryis Rhizoma could be identified. The calibration curve of （-）-epicatechin was linear in the range of 0. 113 6-2. 272 μg with the correlation of 0. 999 968 （n = 8）. The average recovery of （-）-epicatechin was 97. 12% ,RSD = 0. 92% （n = 6）. The calibration curve of procyanidin B2 was linear in the range of 0. 166 4-1. 664 μg with the correlation of 0. 999 702（n = 8）. The average recovery of procyanidin B2 was 98. 26% ,RSD = 0. 61% （n = 6）. CONCLUSION： The method is specific,reliable and accurate,so it can be used for the quality control of Jinqiaomai Tablets.