摘要
目的建立蒙药扫布德-9味丸的质量标准。方法采用显微鉴别法对制剂中肉豆蔻、红花、木香、甘草、栀子、诃子、决明子、草果药材进行定性鉴别;采用薄层色谱法对制剂中红花、栀子、木香、决明子、甘草药材进行定性鉴别;采用理化鉴别法对制剂中珍珠药材进行定性鉴别;采用高效液相色谱法测定制剂中栀子苷的含量,色谱柱为Thermo Scientific C_(18)柱(250 mm×4.6 mm,5µm),流动相为乙腈-水(17∶83,V/V),流速为1.0 mL/min,柱温为30℃,检测波长为238 nm,进样量为10µL。结果肉豆蔻、红花、木香、甘草、栀子、诃子、决明子、草果分别可见淀粉粒、花粉粒、网纹导管、晶纤维、石细胞、石细胞、种皮栅状细胞、外胚乳细胞的显微鉴别特征。薄层色谱鉴别的斑点清晰,阴性对照无干扰,专属性强。珍珠的理化鉴别特征明显。栀子苷进样量在55.20~1104µg范围内与峰面积线性关系良好(r=0.9996,n=7);精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均回收率为100.00%,RSD为0.21%(n=6)。3批样品中栀子苷的含量分别为3.0076,3.0797,3.1332 mg/g。结论所建立的方法操作简便、专属性强、准确度高、重复性好,可用于蒙药扫布德-9味丸的质量控制。暂订样品中含栀子以栀子苷(C_(17)H_(24)O_(10))计不得少于2.32 mg/g。
Objective To establish the quality standard for Saobud-9 Pills.Methods Microscopic identification method was used for the qualitative identification of Myristicae Semen,Carthami Flos,Aucklandiae Radix,Glycyrrhizea Radix et Rhizoma,Gardeniae Fructus,Chebulae Fructus,Cassiae Semen and Tsaoko Fructus in the preparation.Thin-layer chromatography(TLC)method was used for qualitative identification of Carthami Flos,Gardeniae Fructus,Aucklandiae Radix,Cassiae Semen and Glycyrrhizea Radix et Rhizoma in the preparation.Physical-chemistry method identification method was used for the qualitative identification of pearl in the preparation.High-performance liquid chromatography was used for the content determination of geniposide in the preparation.The chromatographic column was Thermo Scientific C_(18) column(250 mm×4.6 mm,5µm),the mobile phase was acetonitrile-water(17∶83,V/V),the flow rate was 1.0 mL/min,the column temperature was 30℃,the detection wavelength was 238 nm,and the injection volume was 10µL.Results Microscopic identification features of starch grains,pollen grains,reticulated ducts,crystal fibers,stone cells,stone cells,palisade cells of the seed coat,and outer endosperm cells were observed in Myristicae Semen,Carthami Flos,Aucklandiae Radix,Glycyrrhizea Radix et Rhizoma,Gardeniae Fructus,Chebulae Fructus,Cassiae Semen and Tsaoko Fructus,respectively.The TLC spots were clear,and the negative control had no interference,with strong specificity.The physical-chemistry identification characteristics of pearls were obvious.The linear range of geniposide was 55.20-1104µg(r=0.9996,n=7).The RSDs of precision,stability,and repeatability test results were all lower than 2.0%.The average recovery of geniposide was 100.00%with an RSD of 0.21%(n=6).The contents of geniposide in three batches of samples were 3.0076,3.0797,and 3.1332 mg/g,respectively.Conclusion The established methods are simple,sensitive,and accurate,with good reproducibility,which can be used for the quality control of Saobud-9 Pills.The content o
作者
王海荣
锡林其其格
杨德志
赵岩
特木其乐
WANG Hairong;Xilinqiqige;YANG Dezhi;ZHAO Yan;Temuqile(Inner Mongolia Traditional Chinese and Mongolian Medical Research Institute,Hohhot,Inner Mongolia,China 010010;Inner Mongolia Interna-tional Mongolian Hospital,Hohhot,Inner Mongolia,China 010065;Inner Mongolia Medical University,Hohhot,Inner Mongolia,China 010110)
出处
《中国药业》
CAS
2024年第9期101-106,共6页
China Pharmaceuticals
基金
内蒙古自治区科技计划项目[201802145]。
