中药紫苏根质量标准的研究OA
Study on the quality standard of Chinese medicinal Radix Perillae
目的 建立紫苏根饮片的质量标准,为其规范化应用提供科学依据.方法 以15批不同产地的紫苏根饮片为研究对象,以其主要活性成分迷迭香酸作为指标成分,采用薄层色谱法进行定性鉴别,并运用高效液相色谱法测定迷迭香酸含量.同时,依据《中国药典》方法测定水分、总灰分、酸不溶性灰分及浸出物等常规检查项目.结果 对15批不同产地紫苏根饮片的质量分析显示,薄层鉴别中,13批样品(除ZSG0001和ZSG0009外)在与迷迭香酸对照品相应的位置显清晰的蓝色荧光斑点,且分离效果良好;常规检测项目方面,确定了水分含量为7.4%~10.4%(拟定限度≤11.0%)、总灰分为2.0%~4.6%(拟定限度≤5.0%)、酸不溶性灰分均低于0.50%(暂不设限度)、浸出物为 6.0%~9.0%(拟定限度≥5.0%),所有样品均符合拟定标准;高效液相色谱法测定迷迭香酸含量范围为0.044%~0.384%,平均值为0.135%,拟定含量限度为≥0.05%,其中13批样品(除ZSG0001和ZSG0009外)符合要求.结论 该标准体系可有效控制紫苏根饮片质量,保障其临床用药安全性与有效性,并为紫苏根的规范化种植、加工生产及药用推广提供关键技术支撑,具有重要的实际应用价值.
Objective To establish a quality standard for slices of Radix Perillae and provide a scientific basis for its standardized appli-cation.Methods Fifteen batches of Radix Perillae slices from different sources were studied.Using rosmarinic acid as the indicator com-ponent,qualitative identification was conducted by thin-layer chromatography(TLC),and its content was quantified by high-performance liquid chromatography(HPLC).Routine tests including moisture,total ash,acid-insoluble ash,and extractives were per-formed according to the methods specified in Chinese Pharmacopoeia(中国药典).Results TLC analysis showed that 13 batches(except ZSG0001 and ZSG0009)exhibited clear blue fluorescent spots corresponding to the rosmarinic acid reference,with good resolu-tion.The results of the routine tests were:moisture,7.4%-10.4%(proposed limit:≤11.0%);total ash,2.0%-4.6%(proposed limit:≤5.0%);acid-insoluble ash,below 0.50%in all samples(no limit specified);extractives,6.0%-9.0%(proposed limit:≥5.0%).All batches complied with the proposed criteria for these items.The content of rosmarinic acid determined by HPLC ranged from 0.044%to 0.384%,with a mean value of 0.135%.Based on these results,a content limit of not less than(≥)0.05%was pro-posed,which was met by 13 batches(excluding ZSG0001 and ZSG0009).Conclusion A comprehensive quality evaluation system encompassing physicochemical tests,TLC identification,and content determination was established for Radix Perillae slices through analysis of 15 batches from different sources.This system complements existing local standards by providing more comprehensive indica-tors,thereby enabling effective quality control,ensuring clinical safety and efficacy,and offering technical support for the standardized cultivation,processing,and medicinal use of this herb.
杨铭轩;贾晓蕊;王向东;李先宽;柴欣;王跃飞;钱桂英;杨静
天津中医药大学中医药研究院,现代中药创制全国重点实验室,天津市中药化学与分析重点实验室,天津 301617天津中医药大学中医药研究院,现代中药创制全国重点实验室,天津市中药化学与分析重点实验室,天津 301617现代中医药海河实验室,天津 301617天津中医药大学中药学院,天津 301617天津中医药大学中医药研究院,现代中药创制全国重点实验室,天津市中药化学与分析重点实验室,天津 301617||现代中医药海河实验室,天津 301617天津中医药大学中医药研究院,现代中药创制全国重点实验室,天津市中药化学与分析重点实验室,天津 301617||现代中医药海河实验室,天津 301617常熟市中医院(新区医院),江苏 常熟 215500天津中医药大学中医药研究院,现代中药创制全国重点实验室,天津市中药化学与分析重点实验室,天津 301617||现代中医药海河实验室,天津 301617
医药卫生
紫苏根薄层鉴别高效液相色谱迷迭香酸
Radix PerillaeTLC identificationHPLCRosmarinic acid
《时珍国医国药》 2026 (15)
2863-2867,5
天津市科技计划项目(24ZYJDSS00300)苏州市科技计划项目(SKY2021019)常熟市卫生健康委员会科技计划项目(CSWS202120)
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