超微田七痛经胶囊的质量标准研究

Study on Quality Standard of Ultramicro Powder of Tianqi Tongjing Capsules

目的建立超微田七痛经胶囊的质量控制方法。方法采用薄层色谱法对处方中三七、延胡索、木香、小茴香、蒲黄、五灵脂、冰片进行定性鉴别;高效液相色谱法同时测定制剂中三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1的含量。结果处方中各药味的薄层鉴别分离度好,专属性强;HPLC的线性关系良好;三七皂苷R1、人参皂苷Rg1、人参皂苷R b1的平均回收率分别为100.6%、99.9%、100.4%,RSD分别为1.1%、1.7%、1.1%。结论所建立的方法可靠,重现性好,可以应用于定性、定量地控制超微田七痛经胶囊的质量。

OBJECTIVE To establish a method for quality control standard of ultramicro powder of Tianqi Tongjing capsules.METHODS Radix Notoginseng,Rhizoma Corydalis,Radix Aucklandiae,Fructus Foeniculi,Pollen Typhae,Faeces Trogopterori,Borneolum Syntheticum in ultramicro powder of Tongjing capsules were identified by TLC. Gensenoside Rg1,Gensenoside Rb1 and Notogensenoside R1 were determined by HPLC. RESULTS A variety of drug in prescription can be identified with a good separating degree and strong specificity by TLC. HPLC had good linear behavior. The average recovery of Notogensenoside R1 was 100. 6% and RSD was 1.1%. The average recovery of Gensenoside Rg1 was 99.9% and RSD was 1.7%. The average recovery of Gensenoside Rb1was100.4% and RSD was 1. 1%. CONCLUSION The method is reliable and reproducible. It can be used for the quality control of ultramicro powder of Tianqi Tongjing capsule.