基于标准汤剂的鲜龙葵果配方颗粒质量标准研究

Quality study of fresh fruit of Solanum nigrum Linn.formula granules based on standarddecoction

目的基于标准汤剂的质量评价方法,建立鲜龙葵果配方颗粒的质量标准。方法制备并计算10批鲜龙葵果标准汤剂及3批配方颗粒的出膏率;以鲜龙葵果药材为对照,采用薄层色谱法(TLC)鉴别鲜龙葵果配方颗粒的专属性;采用超高效液相色谱法(UPLC)测定鲜龙葵果配方颗粒中澳洲茄碱、澳洲茄边碱的含量,并建立鲜龙葵果配方颗粒的特征图谱,确定4个特征峰及其相对保留时间的规定范围。结果标准汤剂出膏率为(18.21±1.87)%,确定的配方颗粒的出膏率范围为12.75%~23.67%,3批配方颗粒的出膏率分别为15.90%、21.26%、18.01%。标准汤剂中澳洲茄碱含量为(24.54±1.24)mg·g^(-1),澳洲茄边碱的含量为(31.34±1.65)mg·g^(-1);3批配方颗粒中澳洲茄碱含量分别为19.3 mg·g^(-1)、18.5 mg·g^(-1)、20.4 mg·g^(-1);澳洲茄边碱含量分别为23.9 mg·g^(-1)、22.9 mg·g^(-1)、25.8 mg·g^(-1)。识别出4个共有特征峰,以澳洲茄碱为参照物峰,其余3个峰的相对保留时间规定值分别为1.13、1.70、1.85。结论本研究证明鲜龙葵果配方颗粒与标准汤剂具有质量一致性,为制定配方颗粒的质量标准提供了数据支持。

Objective To establish the quality evaluation method of fresh fruit of Solanum nigrum Linn.formula granules based on the quality indexes of standard decoction.Methods Ten batches of standard decoction and 3 batches of formula granules of fresh fruit of Solanum nigrum Linn.were prepared and the paste rate was calculated.Thin layer chromatography(TLC)was used to identify the specific properties of the formula granules.The contents of solasonine and solamargine in the formula granules were determined by ultra-high performance liquid chromatography(HPLC).The fingerprint of formula granules was established,and 4 characteristic peaks and their relative retention time were determined.Results The paste rate of standard decoction was(18.21±1.87)%,the paste rate of formula granules ranged from 12.75%to 23.67%,and the paste rates of the three batches of formula granules were 15.90%,21.26%,and 18.01%,respectively.In the standard decoction,the content of solasonine was(24.54±1.24)mg·g^(-1),the content of solamargine was(31.34±1.65)mg·g^(-1).In the three batches of formula granules,thecontents of solasonine were 19.3 mg·g^(-1),18.5 mg·g^(-1),and 20.4 mg·g^(-1),and the contents of solamarginewere 23.9 mg·g^(-1),22.9 mg·g^(-1),and 25.8 mg·g^(-1).Four common characteristic peaks were identified,andthe relative retention time values of the other three peaks were 1.13,1.70,and 1.85 with solasonineas the reference peak.Conclusion This study proved that the quality of formula granules of freshfruit of Solanum nigrum Linn.was consistent with standard decoction,and provided data support forthe formulation of quality standards for the formula granules.