蒙药复方制剂壮伦-5汤质量标准提升研究  

Investigation on improving the quality standard of Mongolian medicine compound preparation Zhuanglun-5 decoction

作　　者：安文源 郝俊生 嵇增云 井佳楠 盛雪 王燕燕 拉喜那木吉拉 AN Wenyuan;HAO Junsheng;JI Zengyun;JING Jianan;SHENG Xue;WANG Yanyan;LA Xinamujila(Tongliao Market Inspection and Testing Center,Tongliao 028000,China;School of Mongolian Medicine and Pharmacy,Inner Mongolia Minzu University,Tongliao 028000,China;Key Laboratory for Mongolian Medicine R&D Engineering of the Ministry of Education,Inner Mongolia Minzu University,Tongliao 028000,China)

机构地区：[1]通辽市市场检验检测中心,内蒙古通辽028000 [2]内蒙古民族大学蒙医药学院,内蒙古通辽028000 [3]国家药品监督管理局中药(蒙药)质量控制重点实验室,内蒙古通辽028000

出　　处：《中国药品标准》2024年第2期141-146,共6页Drug Standards of China

基　　金：国家药品监督管理局中药(蒙药)质量控制重点实验室开放基金项目[MDK2021067];中国药品监管科学行动计划第二批重点项目-蒙药复方制剂壮伦-5汤质量标准提升研究(NMPAJGKX-2023-054);内蒙古自治区药品监督管理局药品安全监管科研项目-常用含草乌蒙药医疗机构制剂质量标准提升研究[NMYJ-KJ-202308]。

摘　　要：目的:建立蒙药复方制剂壮伦-5汤处方中肋柱花药材的定性和定量方法,解决肋柱花材代被替代现象。方法:采用显微鉴别法观察粉末中花粉粒;獐牙菜苦苷对照品和肋柱花药材为对照,以乙酸乙酯-甲醇-水-甲酸(12∶2∶2∶0.5)为展开剂进行薄层鉴别研究;采用Agilent Eclipse Plus C 18色谱柱(250 mm×4.6 mm,5μm),0.2%磷酸溶液(A)-乙腈(B)为流动相,梯度洗脱,检测波长238 nm,以獐牙菜苦苷为对照品对不同厂家壮伦-5汤,进行含量测定。结果:12批壮伦-汤中8批次为肋柱花,2批次为紫花地丁,2批次为其它药材。8批壮伦-汤中獐牙菜苦苷含量范围较大,在0.2~11.7 mg·g^(-1)之间。结论:建立的鉴别方法简单、有效,含量测定方法稳定、专属性强,可为该制剂的监管提供技术支撑,对传统中蒙药制剂标准的提升具有借鉴作用。Objective:To establish the qualitative and quantitative methods of Lomatogonium carinthiacum(Wulf.)Reichb.in the prescription of Mongolian medicine Polypill Zhuanglun-5 decoction,and solve the phenomenon of Lomatogonium carinthiacum(Wulf.)Reichb.being replaced.Methods:Microscopic identification method was used to observe the pollen grains in the powder;The reference substance of swertiamarin and Lomatogonium carinthiacum(Wulf.)Reichb.were used as the control,and the ethyl acetate methanol water formic acid(12∶2∶2∶0.5)was used as the developing agent for TLC identification;HPLC was used under the condintion including Agilent Eclipse Plus C 18(250 mm×4.6 mm,5μm)as chromatographic column and 0.2%phosphoric acid solution(A)-acetonitrile(B)as mobile phase with gradient elution at 238 nm of detection wavelength were used.Contents of Zhuanglun-5 decoction from different manufacturers were determined with swertiamarin as reference substance.Results:Among the 12 batches of Zhuanglun-5 decoction,8 batches were Lomatogonium carinthiacum(Wulf.)Reichb.,2 batches were Viola yedoensis,and 2 batches were other medicinal materials.The content of swertiamarin in 8 batches of Zhuanglun-5 decoction ranged from 0.2 to 11.7 mg·g^(-1).Conclusion:The established identification method is simple and effective,and the content determination method is stable and has strong specificity.It can provide technical support for the supervision of the preparation,and has a reference effect for the improvement of traditional Chinese and Mongolian pharmaceutical preparation standards.

关 键 词：蒙药 壮伦-5汤 獐牙菜苦苷 质量评价 HPLC 

分 类 号：R921.2[医药卫生—药学]