基于饮片质量控制的百部酊质量标准提升研究

Promotion on quality standard of Baibu tincture coupled with Stemona tuberosa Lour・control

目的以饮片质量研究为基础,进行百部酊的质量标准提升研究。方法对百部饮片分别采用TLC法进行鉴别和HPLC法测定对叶百部碱的含量;在此基础上分别建立了百部酊的TLC鉴别法和对叶百部碱的HPLC含量测定方法,并进行方法学验证。对3批百部酊制剂进行测定。结果百部饮片、酊剂的TLC鉴别专属性好,HPLC测定对叶百部碱进样量在1.506~20.08 μg范围内与峰面积线性关系良好(r=0.9996),百部饮片平均加样回收率为98.76%(n=9),RSD为2.07%,百部酊平均加样回收率为100.60%(n=9),RSD为1.92%,方法学验证符合要求。3批百部饮片中对叶百部碱平均含量为1.226 mg/g;3批酊剂中对叶百部碱平均含量为0.203 mg/ml。结论方法操作过程简便,结果准确、可靠,重现性好,该质量标准可行,可从源头到产品有效对百部酊进行定性和定量的质量控制。

Objective To study the quality of Radix stemonae and improve the quality standard of Baibu tincture. Methods TLC was used as qualitative identifications of Stemona tuberosa Lour. HPLC Methods were established for the determination of tuberostemonine in Stemona tuberosa Lour. Then,TLC methods were established for qualitative identifications in Baibu tincture. HPLC Methods were established for the determination of tuberostemonine in Baibu tincture.Results Spots about Stemona tuberosa Lour. components and Baibu tincture were specific and distinct in thin layer chromatography respectively. Tuberostemonine showed a good liner relationship within the range of 1.506 to 20.08(r=0.9996), whose average recovery were 98.76%(n=9) with the RSD of 2.07% for Stemona tuberosa Lour. and 100.60%(n=9) with the RSD of 1.92% for Baibu tincture respectively. The average concentration of tuberostemonine of 3 batches of Stemona tuberosa Lour. and Baibu tincture were 1.226 mg/g and 0.203 mg/mL, respectively. Conclusion The methods in this quality standards are simple, accurate and reliable with good reproducibility, which can effectively control the product quality and clinical efficacy of Baibu tincture.