接骨七厘胶囊质量标准研究

Study on Quality Standard for Jieguqili Capsule

目的建立接骨七厘胶囊的质量标准。方法采用薄层色谱法对乳香进行鉴剐。用高效液相色谱法测定骨碎补中柚皮苷含量，色谱柱为Agilent TC C18枉（250mm×4．6mm，5μm），流动相为甲醇-0．1％磷酸（30：70），柱温为35℃，流速为0．8mL／min，检测波长为283nm。结果薄层色谱图斑点清晰；柚皮苷对照品进样量在0．02192～2．192μg范围内与峰面积线性关系良好（r=0．9999），平均回收率为92．79％，RSD为2．04％（n=6）。结论该法简便、可靠、准确，可用于该制剂的质量控制。

Objective To establish the quality standard for Jieguqili Capsule. Methods The TLC method was adopted to identify frank- ineence. The naringin content in Drynariae Rhizoma was determined by HPLC,the chromatographic column was the Agilent TC C18 col- umn（250 mm×4.6 mmx5 μm） with the mobile phase of methanol-0. 1% phosphoric acid （30：70） at the column temperature of 35 ~C. The flow rate was 0. 8 mL/min and the detective wavelength was 283 nm. Results The TLC spots were quite clear;the sample size of naringin reference substance within the range of 0. 021 92-2. 192 μg showed the good linear relation with the peak area（ r = 0.999 9）,the average recovery rate （n=6） was 92.79% （RSD=2.0%）.Conclusion This method is simple,reliable,accurate and can be used for the quality control of this preparation.