黄云通便胶囊质量标准提升研究  

Improvement of Quality Standard of Huangyun Tongbian Capsules

作　　者：方剑儒 赵翠琴 陈晓青 黄保停 FANG Jianru;ZHAO Cuiqin;CHEN Xiaoqing;HUANG Baoting(Zhangye Institute of Quality Inspection and Testing,Zhangye,Gansu,China 734000)

机构地区：[1]甘肃省张掖市质量检验检测研究院,甘肃张掖734000

出　　处：《中国药业》2025年第8期82-86,共5页China Pharmaceuticals

基　　金：甘肃省药品科研项目[2022GSMPA0040]。

摘　　要：目的提升黄云通便胶囊的质量标准。方法对制剂中大黄、陈皮进行显微鉴别;采用薄层色谱(TLC)法对制剂中大黄、陈皮、肉苁蓉进行定性鉴别;采用高效液相色谱法对制剂中芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚进行含量测定,色谱柱:Hypersil ODS2 C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%磷酸溶液(80∶15,V/V),流速为0.9 mL/min,检测波长为254 nm,柱温为40℃,进样量为10μL。结果大黄、陈皮药材显微特征明显;大黄、陈皮、肉苁蓉的TLC图斑点清晰,分离度好,阴性对照无干扰。芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚质量浓度分别在0.0390~0.1950μg/mL、0.0928~0.4644μg/mL、0.0325~0.1628μg/mL、0.0934~0.4670μg/mL、0.1024~0.5124μg/mL(r≥0.9999)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率分别为99.38%,99.69%,100.75%,100.86%,101.04%,RSD分别为0.39%,0.38%,0.85%,0.24%,0.60%(n=6)。结论该研究中建立的质量标准操作简便,结果稳定可靠,可用于黄云通便胶囊的质量控制。Objective Improve the quality standards of Huangyun Tongbian Capsules.Methods Perform microscopic identification of Rhei Radix Et Rhizoma and Citri Reticulatae Pericarpium in the preparation.Thin-layer chromatography(TLC)method was used to qualitatively identify Rhubarb,Tangerine peel,and Cistanche deserticola.The high-performance liquid chromatography(HPLC)method was used to simultaneously determine the contents of aloe-emodin,rhein,emodin,chrysophanol,physcion in the preparation.the chromatography column was the Hypersil ODS2 C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was methanol-0.1%phosphoric acid solution(80∶15,V/V),the flow rate was 0.9 mL/min,the detection wavelength was 254 nm,the column temperature was 40℃,and the injection volume was 10μL.Results The medicinal materials of Rhei Radix et Rhizoma and Citri Reticulatae Pericarpium exhibited distinct microscopic characteristics.The TLC chromatograms of Rhubarb,Tangerine peel,and Cistanche deserticola showed clear spots,good separation,with no interference from the negative reference.The linear ranges of aloe-emodin,rhein,modin,chrysophanol,physcion were in the range of 0.0390-0.1950μg/mL,0.0928-0.4644μg/mL,0.0325-0.1628μg/mL,0.0934-0.4670μg/mL,0.1024-0.5124μg/mL,respectively(r≥0.9999).The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above four components were 99.38%,99.69%,100.75%,100.86%,101.04%,with RSDs of 0.39%,0.38%,0.85%,0.24%,0.60%(n=6),respectively.Conclusion The established method is easy,accurate and reliable,which can be used to control the quality of Huangyun Tongbian Capsules.

关 键 词：黄云通便胶囊 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]