障眼明分散片制备工艺与葛根素含量测定研究

Preparation Technology of Zhangyanming Dispersible Tablet and Determination of Puerarin by HPLC

目的:研究障眼明分散片提取与制剂成型工艺;以葛根素作为对照品,建立HPLC法控制障眼明分散片的质量。方法:制备工艺以葛根素提取总量与崩解时限等为考察指标;含量测定采用Hypersil BDS C18色谱柱(5μm,4.6mm×200mm),用甲醇-水(25∶75)为流动相,检测波长250nm,柱温30℃,流速1.0mL/min。结果:障眼明分散片在3min内迅速崩解且全部颗粒通过2号筛,分散均匀,葛根素含量在0.1699～1.3594μg范围内呈良好线性关系,得回归方程y=3.054×106x-24019(r=0.9998),平均加样回收率及RSD分别为100.03%和1.79%。结论:障眼明分散片制备新工艺合理可行,以葛根素为对照品,采用HPLC法控制障眼明分散片质量的方法简便快速、准确可靠、重现性好、专属性强。

Objective： To study the extraction and pharmeeutics technology of Zhangyanming dispersible tablet and establish the method for determining the content of puerarin by HPLC. Methods ： Using total extracted puerarin and disintegrating time as evaluation indexes and the conditions for determination were as follows： Hypersil BDS C18 column （5 μm,4. 6 mm× 200 mm） , Methanol-H2O（25 ： 75） as the mobile phase, the detection wavelength at 250 nm, the column temperature at 30℃, and 1.0 mL/min as the mobile phase speed. Results： The calibration curve was linear at the range of 0. 1699 to 1. 3594 μg for the puerarin content and the linear equation was y =3. 054 × 10^6x -24019（r =0. 9998）. The average recovery, ratio was 100. 03% and the relative standard deviation was 1.79%. Conclusions： The new preparation technology is reasonable and HPLC can be used to determine the content of puerarin in Zhangyan- ruing dispersible tablet because the operation was convenient, fast, easy to repeat, and the analysis results were accurate and especial.