平贝母药材质量标准研究

Study on Quality Standard of Fritillaria Ussuriensis

目的对中药材平贝母的水分、灰分、酸不溶性灰分和贝母乙素含量等进行研究。方法照2010年版《中国药典(一部)》中方法使用水分测定法测定水分,灰分测定法测定总灰分和酸不溶性灰分。采用高效液相色谱法测定贝母乙素含量,色谱柱为Symmetry C18柱(150 mm×3.9 mm,5μm),流动相为CH3CN-100 mmol/L CH3COONH4(43∶57),流速为1.1 mL/min,检测波长为375 nm,柱温为室温,进样10μL。结果中药材平贝母水分不应超过13%,总灰分不高于3.5%,酸不溶性灰分不得高于0.5%;贝母乙素含量测定平均回收率为98.13%,RSD=2.57%(n=6)。结论为建立和完善平贝母的质量标准体系提供了可供参考的依据。

Objective To set up the quality standards of Fritillaria ussuriensis through determination of the moisture, ash, acid- insoluble ash and the content of vertieinone in Chinese medicinal material Fritillaria ussuriensis. Methods According to the method in the Chinese Pharmacopoeia （edition 2010）, the ash determination and water determination were adopted. The content of verticinone was determined by the HPLC method. The chromatographic column was the Symmetry Cls column（150 mm×3.9 mm,5μm） with CH3CN-100 mmol/L CH3COONH4 （43：57） as the mobile phase. The flow rate was 1.1 mL/min. The detection wavelength was 375 nm, the column temperature was the room temperature. The sample size was 10 txL. Results The moisture in Fritillaria ussuriensis should not exceed 13%, with the total ash within 3.5%, the acid- insoluble ash should not be higher than 0. 5%. The average recovery rate of verticinone was 98. 13%, RSD was 2.57% （n =6）. Conclusion These data provide the reference basis for making and perfecting the quality standards system of Fritillaria ussuriensis.