胆痛立消胶囊的制备与质量控制

Preparation and Quality Control of Dantong Lixiao Capsules

目的制备胆痛立消胶囊(主成分延胡索、大黄、白芍、茵陈)并建立其质量控制方法。方法采用薄层色谱(TLC)法鉴别处方中的白芍;采用高效液相色谱(HPLC)法测定制剂中延胡索乙素:SinoChrom ODS-BP(4.6mm×250mm,5μm)柱,流动相:0.1%磷酸(用三乙胺调节pH值6.0)-甲醇(40:60,V/V),检测波长为281nm。结果 TLC法专属性好,含量测定方法准确可靠,线性关系良好(r=0.9998),平均回收率为(96.85±0.99)%,RSD为1.02%。结论质量控制方法准确、全面,可用于胆痛立消胶囊的质量控制。

Objective To prepare dantong lixiao capsules and establish the quality standard for them. Methods TLC was used to identify Radix Paeoniae Alba. HPLC was used to determine the content of tetrahydropalmatine with SinoChrom ODS-BP （4.6 mm×250 mm,5 μm） column,mobile phase composed of methanol-0.1% phosphoric acid solution （adjusted the pH to 6.0 with triethylamine）（60：40,V/V） and the detection wavelength at 281 nm. Results TLC method was distinguished. HPLC method was accurate and reliable with the recovery as （96.85±0.99）%,with RSD=1.02%. Conclusion This standard is precise and can be used for the quality control of dantong lixiao capsules.