痛风消颗粒质量标准研究

摘要

Objective: To establish the methods of qualitative identification and content determination of Tongfengxiao Granule. Method:TLC method was used to qualitatively identify Cortex Phellodendri Chinensis, Salviae Miltiorrhizae Radix et Rhizoma and Radix Angelicae Pubescentis and HPLC was used to determine the content of berberine hydrochlori,the principal component in Cortex Phellodendri Chinensis. Chromatography condition: the chromatographic column was used, with acetonitrile-0.03moL/L NaH2PO4-phosphoric acid(30∶70∶0.08) as the mobile phase and the detection wavelength was at 265 nm. Result: The TLC spots definition was fairy clear,with good resolution and the blank test showed no interference. The injection volume of berberine hydrochlori showed good linear relationship with peak area integral value in the range 0.03296~0.3296µg(r=0.999 9).The average recovery rate was 101.77% and RSD was 1.04%. Conclusion:The established qualitative and quantitative analysis method is applicable for the quality control of Tong Fengxiao Granule.%目的：建立痛风消颗粒的定性鉴别和含量测定的方法。方法：用TLC法定性鉴别痛风消颗粒中黄柏、丹参、独活；用HPLC法测定黄柏中盐酸小檗碱含量。色谱条件为迪马 C18柱，流动相以乙腈-0.03moL/L磷酸二氢钠-磷酸（30∶70∶0.08）洗脱，检测波长265 nm。结果：TLC斑点清晰，分离度好，阴性对照无干扰；盐酸小檗碱进样量在0.03296～0.3296μg范围内与其峰面积积分值呈良好线性关系（r=0.9999）；平均回收率为101.77%，RSD为1.04%。结论：所建立的定性、定量分析方法可用于痛风消颗粒的质量控制。