用HPLC指纹图谱全定性全定量控制通宣理肺丸质量

Overal qualitative and quantitative control of Tongxuan Lifei pills by HPLC fingerprints

目的建立通宣理肺丸HPLC指纹图谱。方法采用反相高效液相色谱法,以色谱指纹图谱指数F为目标函数优化选择指纹图谱条件,以双定性相似度(SF与SF′)和双定量相似度(C与P)评价通宣理肺丸真实质量。结果以黄芩苷峰为参照物峰,确定了77个共有峰,通过聚类分析确定用10个厂家制剂生成对照指纹图谱(RFP),以此评价14个不同厂家的通宣理肺丸质量。结论所建立的HPLC指纹图谱特征性、专属性强且有较好的稳定性,为通宣理肺丸质控提供了新参考。

Objective To establish the HPLC fingerprints of Tongxuan Lifei pills （TLPs）. Methods The quality of TLPs was evaluated by dual qualitative （SF and SF＇） and dual quantitative similarities （Cand P） （DQDQS） as assessing parameters while using chromatographic fingerprint （CFP） index （F） to optimize the CFP conditions. Results A total of 77 co-possessing peaks were selected as the fingerprint peaks when taking Baicalin peak as the reference peak. The reference fingerprints （RFP） of 10 manufacturers were synthesized according to hierarchical cluster analysis. Conclusion The HPLC fingerprints are stable and specific, and can be used for the quality control of Tongxuan Lifei pills.