ABSTRACT
OBJECTIVE： To establish the quality standard of Tricyrtis maculata. METHODS： The character and microstructure of T. maculata were identified according to the method stated in 2015 edition of Chinese Pharmacopoeia. The contents of moisture， ash and extract were determined. TLC was used for qualitative identification of quercetin and nicotifiorin in samples. The contents of puerarin， p-hydroxybenzoic acid， nicotiflorin， ferulic acid， quercetin and kaempferol were determined by HPLC. RESULTS： The characters and microscopic identification had specificity. TLC spots of quercetin and nicotifiorin were clear and well-separated without interference from negative control. The water content， total ash content， acid insoluble ash content， alcohol soluble extract and water soluble extract for 10 batches of samples were 0.61％-1.89％，6.28％-8.88％，0.76％-1.79％，1.31％-2.00％ and 9.39％-14.27％， respectively. The linear range of puerarin， p-hydroxybenzoic acid， nicotiflorin， ferulic acid， quercetin and kaeniphenol were 0.031 92-0.111 7 μg （r＝0.999 6）， 0.085 3-0.298 5 μg （r＝0.999 5）， 0.010 76-0.037 66 μg （r＝0.999 8）， 0.070 08- 0.245 3 μg （r＝0.999 8），0.058 56-0.205 0 μg （r＝0.999 4），0.009 860-0.033 88 μg （r＝0.999 4）， respectively. The quantitation limits were 1.06， 0.47， 0.75， 1.40， 1.20， 0.74 ng， and the detection limits were 0.36， 0.12， 0.30， 0.53， 0.60， 0.31 ng， respectively. RSDs of precision， stability and repeatability tests were all less than 2％. The average recoveries were 101.54％， 102.10％， 101.46％， 103.35％， 99.36％ and 96.85％， respectively； RSDs were 1.76％， 1.68％， 1.56％， 1.26％， 0.91％ and 1.96％， respectively （n＝6）； the results of the content were 0.017-0.047， 0.042-0.140， 0.003 8-0.015 0， 0.049-0.180， 0.024- 0.091， 0.003 9-0.011 0 mg/g. CONCLUSIONS： The established quality standard can be used for the quality control of T. maculata.