Quality Standard for Baihua Dingchuan Tablets / 中国药师

ABSTRACT

Objective:To establish a TLC identification method for three medicinal ingredients and a GC method for the content determination of metnthol in Baihua Dingchuan tablets. Methods:Citrus Reticulata, Ephedra Sinica and Schisandra Chinensis were i-dentified by TLC. GC was used to determine the content of menthol in Baihua Dingchuan tablets. The chromatographic conditions were as followsa DM-5 capillary column(30 m × 0. 53 mm, 1. 5 μm) was adopted. The injection port temperature was 200℃. An FID was used as the detector and the temperature was 300℃. The temperature program was as followsthe initial column temperature was 80℃, and then rose to 120℃ at the rate of 8 ℃· min-1 , finally rose to 185 ℃ at the rate of 15 ℃· min-1 and maintained for 10 min. The carrier gas was nitrogen and the flow rate was 3. 0 ml·min-1 . The sample size was 1 μl. Split injection was performed with the diversion ratio of 15. Results: The three traditional Chinese medicines could be identified by TLC. The content of menthol showed a good linear relationship within the range of 1. 484-74. 200μg · ml-1 ( r =0. 9998 ) by GC. The average recovery was 97. 76% RSD=0 . 58%(n=9). Conclusion:The methods are specific and simple with good reproducibility. They can be used for the quality control of Baihua Dingchuan tablets.