| 摘要: |
| 目的：建立炎可宁丸质量标准。方法：采用显微鉴别法鉴别黄连。采用薄层色谱法（TLC）鉴别黄柏、大黄、黄芩、板蓝根、黄连。采用高效液相色谱（HPLC）法测定大黄素与大黄酚的含量,使用Phenomenex Luna C18色谱柱（4.6 mm ×250 mm,5μm）,以甲醇-0.1%磷酸溶液（85∶15）为流动相,流速为1.0 ml/min,柱温为30℃,检测波长为254 nm。采用HPLC法测定黄芩苷的含量,使用CAPCELL PAK C18色谱柱（4.6 mm×250 mm,5μm）,以甲醇-0.1%磷酸溶液(45∶55)为流动相,流速为1.0 ml/min,柱温为30℃,检测波长为280 nm。结果:薄层色谱斑点清晰;大黄素和大黄素酚的线性范围分别为9.3～465.0 ng、11.6～580.0 ng,加样回收率分别为93.3%、98.0%,RSD分别为1.8%、2.7%;黄芩苷的线性范围为68～3400 ng,加样回收率为97.2%,RSD为1.2%。结论:本法简便可靠、结果准确,可用于该制剂的质量控制。 |
| 关键词: 炎可宁丸 质量标准 实验研究 |
| DOI： |
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| Quality assessment of Yankening pills |
| LUO Huiming,PENG Yanmei,CHENG Xueqing |
| (Hunan Institute for Drug Control/Hunan Pharmaceutical Excipients Testing and Inspection Center,Changsha 410001,Hunan,China;Hunan Academy of Chinese Medicine,Changsha 410006,Hunan,China;Hunan Provincial Engineering Technology Research Center for Drug Quality Evaluation,Changsha 410001,Hunan,China) |
| Abstract: |
| Objective：To establish the quality standard for Yankening pills.Methods：Microscopic identification was used to identify Coptis chinensis.Thin-layer chromatography was used for the identification of Phellodendri Chinensis Cortex,Rheum officinale,Scutellaria baicalensis,Radix Isatidis,and Coptis chinensis.High-performance liquid chromatography (HPLC) was used to measure the content of emodin and chrysophanol on a Phenomenex Luna C18column (4.6 mm×250 mm,5 μm) with the mobile phase of methanol-0.1% phosphoric acid solution at a flow rate of 1.0 ml/min,a column temperature of 30℃,and a detection wavelength of 254 nm.HPLC was used to measure the content of baicalin on a CAPCELL PAK C18column (4.6 mm×250 mm,5 μm) with the mobile phase of methanol-0.1% phosphoric acid solution at a flow rate of 1.0 ml/min,a column temperature of 30℃,and a detection wavelength of 280 nm.Results：There were clear spots on TLC.Emodin and chrysophanol had a linear range of 9.3-465.0 ng and 11.6-580.0 ng,respectively,with recovery rates of 93.3% (relative standard deviation ［RSD］=1.8%) and 98.0% (RSD=2.7%),respectively.Baicalin had a linear range of 68-3400 ng,with a recovery rate of 97.2% (RSD=1.2%).Conclusion：This method is simple,convenient,and reliable with accurate results and can thus be used for the quality control of this preparation. |
| Key words: Yankening pills quality standard experimental study |
