射干苷标准品质量标准研究

Study on the Quality Standard of Belamcandin Standard Substance

目的:建立射干苷标准品的质量标准。方法:采用定性、定量分析方法,依照2005年版《中国药典》(二部)附录有关规定,对射干苷各项指标进行检测。结果:3批射干苷标准品的比旋度为—28°～—30°([α]2D5,c0.11,吡啶),百分吸收系数(E11%cm)为790～830,熔点为252～254℃,灰分<0.5%,高效液相色谱法测定射干苷含量>99.5%。结论:各项指标均符合标准物质的相关规定,所建标准可用于射干苷标准品的质量控制。

OBJECTIVE： To establish the quality standard of Belamcandin standard substance.METHODS： Different indices of standard elamcandin were examined with quantitative and quantitative analyses according to the corresponding measures stipulated in the Appendix of pharmacopoeia of people＇ s republic of China（part Ⅱ ） published in 2005.RESULTS： The specific rotatory power of 3 batches of standard Belamcandin was -28°--30° （ [ a ] D^25, c0.11, Pyridine） ; the E1cm^1%,was 790- 830; the melting point was 252-254 ℃ and the ash content was less than 0.5% .The content of Belamcandin in the products was above 99.5% as revealed by HPLC.CONCLUSION： All of the indices were shown to meet the standards for standard substances and the established standard can be used for the quality control of standard Belamcandin.