黑种草子总皂苷滴丸质量标准研究

Study on Quality Standard of Semen Nigellae Total Saponins Dropping Pill

目的建立黑种草子总皂苷滴丸的质量标准。方法以黑种草皂苷A为对照品,采用薄层色谱法对滴丸中的黑种草子进行定性鉴别,采用比色法对滴丸中总皂苷的含量进行测定,采用高效液相色谱法对滴丸中黑种草皂苷A的含量进行测定。结果薄层鉴别图谱斑点清晰,阴性对照无干扰;总皂苷含量测定中平均回收率为102.6%,RSD=1.96%(n=6),滴丸中总皂苷平均含量为18.13%;黑种草皂苷A含量测定中平均回收率为103.2%,RSD=1.16%(n=6),滴丸中黑种草皂苷A平均含量为14.71%。结论本研究制定的质量标准方法准确可靠、简便易行,可用于黑种草子总皂苷滴丸的质量控制。

Objective To establish the quality standard of semen nigellae total saponins dropping pill.Methods Saponin A was used as the reference substance. TLC was used to identify semen nigellae in the droppingpill. The content of total saponins was determined by vanilin-sulfuric acid colorimetry. The content of Saponin A wasdetermined by HPLC. Results The results of TLC showed the relevant spots were clear without interference againstthe negative sample. The average recovery of total saponins was 102.6%, with RSD of 1.96% (n=6). The content oftotal saponins in the dropping pill was 18.13%. The average recovery of Saponin A was 103.2%, with RSD of 1.16%(n=6). The content of Saponin A in the dropping pill was 14.71%. Conclusion The established method of qualitystandard is accurate, reliable, simple and can be used for quality control of semen nigellae total saponins dropping pill.