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杀菌止痒洗液质量标准研究
Study on Quality Standard of Shajun Zhiyang Lotion
【摘要】 目的 建立杀菌止痒洗液的质量标准。方法 采用薄层色谱(TLC)法对蛇床子、黄柏、地肤子和百部进行定性鉴别;采用高效液相色谱法测定菊苣酸含量。色谱柱为Thermo Scientific Syncronis C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.2%磷酸溶液(16:84,V/V),流速为1.0 mL/min,检测波长为326 nm,柱温为30℃,进样量为5μL。结果 蛇床子、黄柏、地肤子和百部的TLC图斑点清晰,分离度良好,阴性对照无干扰。菊苣酸进样量在0.032 15~0.289 35μg范围内与峰面积的线性关系良好(r=0.999 9,n=5);精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率为99.04%,RSD为1.76%(n=6)。3批样品中菊苣酸的平均含量为59.27μg/mL,暂定制剂中菊苣酸含量不得少于35.79μg/mL。结论 该研究中建立的质量标准操作简便,结果稳定可靠,可用于杀菌止痒洗液的质量控制。
【Abstract】 Objective To establish quality standard of Shajun Zhiyang Lotion.Methods Thin-layer chromatography(TLC) was used to identify Cnidii Fructus,Phellodendri Chinensis Cortex,Kochiae Fructus,Stemonae Radix. The content of chicoric acid was determined by high performance liquid chromatography. The chromatographic column was Thermo Scientific Syncronis C18column(250 mm × 4. 6 mm,5 μm),the mobile phase was acetonitrile-0. 2% phosphoric acid solution(16∶84,V/V),the flow rate was1. 0 mL/min,the detection wavelength was 326 nm,the column temperature was 30 °C and the injection volume was 10 μL.Results The TLC spots of Cnidii Fructus,Phellodendri Chinensis Cortex,Kochiae Fructus,Stemonae Radix were clear and well separated,and the negative control had no interference. The linear range of chicoric acid was 0. 032 15-0. 289 35 μg(r =0. 999 9,n = 5). The RSDs of precision,stability and repeatability tests were all lower than 2. 0%. The average recovery was99. 04%,and the RSD was 1. 76%(n = 6). The average content of chicoric acid in three batches of samples was 59. 27 μg/mL,and the content of chioric acid in the tentative preparation should not be lower than 35. 79 μg/mL.Conclusion The quality standard established in this study is simple,stable and reliable,and can be used for the quality control of Shajun Zhiyang Lotion.
【Key words】 Shajun Zhiyang Lotion; content determination; chicoric acid; quality standard;
- 【文献出处】 中国药业 ,China Pharmaceuticals , 编辑部邮箱 ,2025年16期
- 【分类号】R286.0
- 【下载频次】24