摘要
目的提高骨质增生丸的质量标准。方法以薄层色谱(TLC)法定性鉴别制剂中骨碎补、鹿衔草、熟地黄;以高效液相色谱法测定柚皮苷的含量,色谱柱为YMC-Triart C18柱(250 mm×4. 6 mm,5μm),流动相为乙腈-0. 1%磷酸溶液(19∶81,V/V),流速为1 m L/min,检测波长为283 nm,柱温为30℃,进样量为10μL。结果骨碎补、鹿衔草、熟地黄的TLC图斑点清晰,分离度好,阴性对照无干扰,精密度、重复性、稳定性试验的RSD均小于3%;平均回收率为99. 97%,RSD为1. 90%(n=9)。结论所建立的标准操作简便、准确,精密度、稳定性、重复性好,可用于骨质增生丸的质量控制。
Objective To improve the quality standard of Guzhi Zengsheng Pills. Methods TLC method was used for qualitative identification for Drynariae Rhizoma,Pyrola calliantha and Rehmanniae Radix Preaparata. HPLC method was used for the content determination of naringin,the chromatographic column was YMC-Triart C18 column( 250 mm × 4. 6 mm,5 μm),the mobile phase was acetonitrile-0. 1% phosphoric acid solution( 19 ∶ 81,V/V),the flow rate was 1 m L/min,the detection wavelength was 283 nm,the column temperature was 30 ℃,and the sample size was 10 μL. Results The TLC spots of Drynariae Rhizoma,Pyrola calliantha and Rehmanniae Radix Preaparata were clear and well separated,the negative control had no interference,the RSDs of precision,repeatability and stability test were less than 3%. The average recovery rate was 99. 97% and RSD was 1. 90%( n = 9). Conclusion The established standard is simple,accurate,it has good precision,stability and repeatability,which can be used for the quality control of Guzhi Zengsheng Pills.
作者
蒲志强
陈华
金伟华
于波涛
宋宗辉
PU Zhiqiang;CHEN Hua;JIN Weihua;YU Botao;SONG Zonghui(Department of Pharmacy,General Hospital of Chengdu Military Region of PLA,Chengdu,Sichuan,China 610083)
出处
《中国药业》
CAS
2019年第10期35-37,共3页
China Pharmaceuticals
