舒肝丸(浓缩丸)质量标准完善研究

Supplementary Study on Quality Standard for Shugan Concentrated Pills

关键词:  舒肝丸(浓缩丸)  质量标准  薄层色谱法  高效液相色谱法

Key words:  Shugan Concentrated Pills  quality standard  TLC  HPLC

摘要:

目的 对舒肝丸（浓缩丸）的质量标准进行完善提高。方法 延胡索、厚朴、木香进行薄层色谱鉴别。HPLC同时测定芍药苷、橙皮苷、柚皮苷及新橙皮苷的含量，采用C₁₈色谱柱，乙腈（A）-0.2%磷酸（B）为流动相梯度洗脱（0~40 min，15% A→25% A），流速为1.0 ml·min^-1；检测波长为230 nm。结果 薄层色谱斑点清晰，分离度好，专属性强，重复性良好。芍药苷、柚皮苷、橙皮苷、新橙皮苷分别在0.023 81~4.762，0.025 65~10.26，0.022 03~2.644 0，0.025 44~5.087 6 μg内线性关系良好，相关系数均为0.999 9；平均回收率分别为102.6%，101.7%，100.5%，102.9%，RSD分别为0.8%，1.2%，2.3%，0.9%。结论 本实验建立的鉴别和含量测定方法为舒肝丸质量标准的修订完善提供了可靠依据。

Abstract:

OBJECTIVE To study supplements for the quality standard for Shugan Concentrated Pills. METHODS The TLC methods of corydalis rhizoma, Magnoliae officinalis cortex and Aucklandiae radix were optimized. The contents of paeoniflorin, naringin, hesperidin and neohesperidin were simultaneous determined by HPLC. The chromalographic separation was proformed on a C₁₈ column with acetonitrile(A)-0.2% phosphoric acid solution(B) with gradient elution as mobile phase(0~40 min, 15%A→25%A). The flow rate was 1.0 mL·min^-1. The detection wavelength was set at 230 nm. RESULTS The calibration curves were linear within the range of 0.023 81-4.762 μg for paeoniflorin, 0.025 65-10.26 μg for naringin, 0.022 03-2.644 0 μg for hesperidin and 0.025 44-5.087 6 μg for neohesperidin. All ingredients showed a good linear relationship (r=0.999 9). The average recoveries were 102.6%, 101.7%, 100.5% and 102.9%, respectively. RSDs were 0.8%, 1.2%, 2.3% and 0.9%, respectively. CONCLUSION The established identification and determination methods can provide references for improvement of quality standards for Shugan Concentrated Pills.