痤疮消炎洗剂的制备和质量标准研究

Preparation and Quality Standard of Cuochuang Xiaoyan Lotion

目的:研究和制定痤疮消炎洗剂的质量标准,用于控制该制剂的质量。方法:参照《中国药典》制备痤疮消炎洗剂,检测pH、装量和微生物限度;采用薄层色谱法(TLC)对小檗碱进行鉴别,采用高效液相法色谱法(HPLC)同时鉴别和测定洗剂中黄芩苷、蒙花苷、大黄酸三种成分。结果:痤疮消炎洗剂的性状、pH、装量和微生物限度符合规定;TLC色谱中斑点清晰,与小檗碱对照品一致;在HPLC色谱图中三种成分的保留时间与对照品相同;三种成分与相邻色谱峰完全分离,黄芩苷、蒙花苷、大黄酸的进样浓度与峰面积呈良好的线性关系,线性方程为:Y_(黄芩苷)=9.208X_(黄芩苷)-0.099 4,r=0.999 9,浓度范围83.97~839.70μg/m L;Y_(蒙花苷)=3.062 8X_(蒙花苷)-0.003 8,r=0.999 9,浓度范围34.75~347.49μg/m L;Y_(大黄酸)=1.022 5X_(大黄酸)-0.028 6,r=0.999 9,浓度范围63.20~632.00μg/m L。结论:该制剂制备工艺简单,制定的质量标准精密度和重复性好,含量测定结果准确,样品处理方法简便,为控制痤疮消炎洗剂的质量提供了科学依据。

Objective： To study and formulate the quality standard of Cuochuang Xiaoyan lotion,in order to control the quality of the preparation. Methods： According to the demands of ＂Chinese Pharmacopoeia ＂（2015 version）,Cuochuang Xiaoyan lotion was prepared,and checked for the pH value,quantity of contents and microbial limit. Berberine was also identified by thin layer chromatography（TLC）,and three components（baicalin,linarin,rhein） of the lotion were simultaneous identified and determinated by high performance liquid chromatography（HPLC）. Results： The examinations of lotion,including character,pH value,quantity of contents and microbial limit were all met the quality standard. The berberine spots on TLC were clear and consistent with the reference substance. The retention time of the three ingredients in HPLC chromatogram were in common with the reference substances. Three studied ingredients were completely separated from the adjacent peaks,and showed good linearity between sample concentrations and integral areas. The linear equations were as follow： Y_（Baicalin）= 9. 208X_（Baicalin）-0. 099,4,r = 0. 999,9,concentration range was 83. 97-839. 70 μg/m L. Y_（Linarin）= 3. 062,8X_（Linarin）-0. 003,8,r = 0. 999,9,concentration range was 34. 75-347. 49 μg/m L. Y_（Rhein）= 1. 022,5X_（Rhein）-0. 028,6,r = 0. 999,9,concentration range was 63. 20-632. 00 μg/m L. Conclusion： The HPLC method is simple,accurate and reproducible,which is effective in controlling the quality of cuochuang xiaoyan lotion.