续断不同炮制品质量标准研究

Study on quality standards for differently processed products of Dipsaci Radix

目的:通过对10批次续断生品、盐炙品、酒炙品质量标准的研究,建立其质量标准。方法:采用HPLC及UV分别测定川续断皂苷Ⅵ、总皂苷含量;对10批次续断生品进行了显微鉴别、薄层色谱鉴定,对10批次续断生品、盐炙品、酒炙品进行水分、总灰分、酸不溶性灰分、水溶性浸出物、醇溶性浸出物及川续断皂苷Ⅵ、总皂苷含量测定研究,进行分析评价。结果:10个不同产地续断生品的薄层色谱鉴定中,供试品与对照药材及对照品斑点清晰、一致。建议续断生品、盐炙品、酒炙品含水量分别不得超过8.0%、10.0%、9.0%,总灰分分别不得超过12.0%、12.0%、12.0%,酸不溶性灰分分别不得超过3.0%、3.0%、3.0%,水溶性浸出物分别不得少于42.0%、45.0%、44.0%,醇溶性浸出物分别不得少于39.0%、50.0%、44.0%,川续断皂苷Ⅵ含量分别不得少于2.0%、2.0%、1.5%,总皂苷的含量分别不得少于15.0%、13.0%、16.0%。结论:分别建立续断生品、盐炙品、酒炙品饮片量化质控标准评价体系,以便更好的控制其质量。

Through research on the quality of 10 batches of raw,salt processed and wine processed products of Dipsaci Radix,their quality standards were established.The contents of asperosaponin Ⅵ and total saponins were determined by HPLC and UV,respectively,and the 10 batches of raw products were identified by microscopical identification and thin layer chromatography.The contents of water,total ash,acid insoluble ash,water soluble extract,alcohol soluble extract,asperosaponin Ⅵ and total saponins of the 10 batches of raw products,salt processed products and wine processed products of Dipsaci Radix were determined and evaluated.In TLC identification,the spots of 10 Dipsaci Radix samples from different producing areas were clear and consistent with those of the control group.It is recommended that the water content of raw products,salt processed products and wine processed products of Dipsaci Radix do not exceed 8.0%,10.0% and 9.0%,respectively;the total ash content do not exceed 12.0%,12.0% and 12.0%,respectively;the acid insoluble ash do not exceed 3.0%,3.0% and 3.0%,respectively;the water soluble extract be not less than 42.0%,45.0% and 44.0%,respectively;the alcohol soluble extract be not less than 39.0%,50.0% and 44.0%,respectively;the content of asperosaponin Ⅵ be not less than 2.0%,2.0% and 1.5%,respectively;and the total saponins content be not less than 15.0%,13.0%,and 16.0%,respectively.The quality standards for raw,salt processed and wine processed products of Dipsaci Radix have been established.