腰息痛胶囊定性定量方法研究

目的建立腰息痛胶囊定性定量方法。方法采用薄层鉴别方法进行定性鉴别并对腰息痛胶囊中乌头碱限量进行检查。运用高效液相色谱法测定欧前胡素的含量。结果确立了制剂中当归、白芷、三七、赤芍鉴别方法,确立了制剂中乌头碱限量检查方法。通过方法学系统考察,建立了欧前胡素的含量测定方法,其欧前胡素的线性范围为0.033 6～0.268 8μg,回归方程Y=39.09X＋3.720（r=0.999 97）,平均加样回收率97.8%,RSD=0.6%（n=6）。结论建立的鉴别、检查和含量测定方法简便、准确、重复性好,适用于腰息痛胶囊的质量控制。

Qualitive and quantitative method for Yaoxitong capsule

Objective To establish the qualitive and quantitative standards for Yaoxitong capsule. Methods The thin layer chromatography（TLC） was adopted for qualitative identification, We inspect the limited quanlity of aconitine in Yaoxitong capsule by TLC; imperatorin was detected by HPLC. Results The identification method of Angelicae Sinensis Radix, Angelicae Dahuricae Radix, Notoginseng Radix et Rhizome and Paeoniae Radix Rubra was established. The identification method of the limited quantity of aconitine was established. The determination method forthe content of imperatorin was established. The calibration curve of imperatorin was linear at 0.033 6- 0.268 8 μg. The regression equation was Y = 39.09X ＋ 3.720（r = 0.999 97）. The average recovery was 97.8% and RSD was 0.6%（n = 6）. Conclusion The method is simple, accurate and reproducible. It can be used for the quality control of Yaoxitong capsules.