复方当归妇炎微灌肠剂质量控制研究

Study of Quality Control on Compound Angelica Fuyan Micro Enema

关键词:  微灌肠剂  质量标准  当归  赤芍  延胡索

Key words:  micro enema  qualitative standard  Angelicac Sinensis Radix  Paeoniae Radix Rubra  Corydalis Rhizoma

摘要:

目的 建立复方当归妇炎微灌肠剂的质量控制方法。方法 根据处方组成，采用TLC对制剂中的当归、赤芍、延胡索进行定性鉴别。以HPLC测定当归中阿魏酸、赤芍中芍药苷的含量：采用Extend-C₁₈（4.6 mm×250 mm，5 μm）色谱柱；以乙腈-0.1%磷酸（15：85）为流动相等度洗脱；柱温25℃；流速1 mL·min^-1；检测波长320，234 nm。结果 阿魏酸和芍药苷分别在0.002 4~0.011 9 mg·mL^-1（r=0.999 4），0.036 4~0.081 9 mg·mL^-1（r=0.999 2）内呈良好的线性关系；平均加样回收率分别为100.3%，98.9%，RSD分别为1.08%，0.68%。结论 该方法简便、准确、稳定性好，可用于该制剂的质量控制。

Abstract:

OBJECTIVE To establish a method of quality control for Compound Angelica Fuyan Micro Enema. METHODS According to the composition of prescription, the qualitative identification of Angelicac Sinensis Radix, Paeoniae Radix Rubra and Corydalis Rhizoma in Compound Angelica Fuyan Micro Enema was performed by TLC. The content of ferulic acid and paeoniflorin in Compound Angelica Fuyan Micro Enema was determined by HPLC:using Extend-C₁₈ (4.6 mm×250 mm, 5 μm) column; acetonitrile-0.1% phosphoric acid (15:85) was as the flow equality. Column temperature was 25℃; flow velocity 1 mL·min^-1; the detection wavelength was 320, 234 nm. RESULTS Ferulic acid and paeoniflorin had good linear relationship within 0.002 4-0.011 9 mg·mL^-1(r=0.999 4), 0.036 4-0.081 9 mg·mL^-1(r=0.999 2). The average recovery rate was 100.3%, 98.9% and the RSD was 1.08%, 0.68% respectively. CONCLUSION The established method is simple, accurate and stable well, and can be used for the quality control of the preparation.