Quality standard for Lixieling Pill / 中成药

ABSTRACT

AIM: To establish the quality standard for Lixieling Pill(Herba Andrographis; Radix Sophorae flavescentis etc.). METHODS: Herba Andrographis and Radix Sophorae flavescentis in Lixieling Pill were identified by TLC. Andrographolide, dehydroandrographolide, matrine and oxgmatrine of pill were determined by HPLC together. RESULTS: The characteristic identification by TLC was distinct and highly specific. The quantitative evaluation of andrographolide had the linear range of 0.969 -2.422 ?g, The average recovery was 98.45% and RSD was 0.88. The quantitative evaluation of dehydroandrographolide had the linear range of 0.481 -1.204 ?g , The average recovery was 100.53% and RSD was 0.63. The quantitative evaluation of matrine had the linear range of 1.032 -2.064 ?g , The average recovery was 99.06% and RSD was 1.04. The quantitative evaluation of oxgmatrine had the linear range of 1.016 -2.032 ?g , The average recovery was 99.67% and RSD was 1.20. CONCLUSION: The method is reliable, accurate and specific. It can be used for quality control of Lixieling Pill.