关键词: font-size:13.3333px, ">复方穿心莲片；穿心莲内酯；脱水穿心莲内酯；对照制剂；质量评价

Abstract: Objective： On account of the reference drug，a new quality evaluation model for Fufang Chuanxinlian tablets (FCT) was established based on multi-component determination. Methods： Simultaneous determination of andrographolide and dehydroandrographolide in FCT was performed on a Waters XBridge C18 column (4.6 mm×250 mm， 5 μm) with acetonitrile-water (27∶73) as the mobile phase at a flow rate of 1.0 mL·min-1 .The column temperature was 35 ℃ and the detection wavelength was 225 nm and 254 nm. To evaluate the quality of the samples， the reference drug of FCT was prepared according to prescription and standard technology， which was used as a companion control to determine the above two components in the samples. Results： Andrographolide and dehydroandrographolide showed good linear relationships between the concentration and the peaks area in range of 0.002 189-0.218 9 mg·mL-1 and 0.002 044-0.204 4 mg·mL-1， respectively (r=1.000 0 both). The average recovery (n=6) was 96.3% (RSD=1.1%) and 95.3% (RSD=0.3%)， respectively. According to the test results of reference drug and samples， an appropriate quality limit of FCT was developed and the qualified samples were divided into three grades. Among 40 batches of samples from 10 manufacturers， there were 4 batches of grade I and grade II products respectively， which both accounted for 10% of the total samples， and 25 batches of unqualified samples accounted for 62.5%. The research showed that the quality of FCT should be improved immediately and there were significant differences among the products from different manufacturers. Conclusion： The research results show that the established quality evaluation model can preliminarily reflect the quality situation of FCT and provide a scientific and reliable technical support for the quality supervision.
 

Key words: font-size:13.3333px, ">Fufang Chuanxinlian tablet； Andrographolide； Dehydroandrographolide； Reference drug； Quality evaluation