文章摘要
孙国栋.肤洁舒搽剂的质量标准研究[J].中国医药导刊,2018,20(7):410-413.
肤洁舒搽剂的质量标准研究
The Quality Control of Fu Jie Shu Liniment
投稿时间:2018-06-16  修订日期:2018-07-26
DOI:
中文关键词: 肤洁舒搽剂  盐酸小檗碱  HPLC  制备工艺  质量控制
英文关键词: Fu jie shu liniment  Berberine hydrochloride  HPLC  Preparation process  Quality control
基金项目:肤洁舒搽剂制备及质量标准研究
作者单位E-mail
孙国栋 菏泽市立医院 sunguodong0723@163.com 
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中文摘要:
      目的:探讨肤洁舒搽剂质量标准。方法:采用水煎提取法和蒸馏浓缩法提取处方中各药材有效成分,并制成肤洁舒搽剂;采用薄层色谱法对搽剂中黄柏、苦参进行鉴别;采用高效液相色谱(HPLC)法测定搽剂中盐酸小檗碱含量。采用Diamonsil C18 ODS色谱柱(4.6 mm×200 mm,5 μm),流动相为甲醇-三乙胺-水(80∶20∶10),流速为1.0 mL·min-1,柱温为30 ℃,检测波长为346 nm,进样量为10 μL。结果:盐酸小檗碱检测浓度在8.00~92.00 μg·mL-1(r=0.9998)范围内线性关系良好。9次重复性试验相对标准偏差(RSD)为1.51 %,检测限为0.1 μg,平均回收率为99.97 %。肤洁舒搽剂制备工艺稳定,黄柏、苦参薄层色谱斑点清晰,阴性对照干扰,HPLC法可用于肤洁舒搽剂质量控制。结论:HPLC法测定搽剂中盐酸小檗碱含量高效、便捷、准确,肤洁舒搽剂制备工艺稳定,质量标准可行。
英文摘要:
      Objective: To discuss the quality standard of fu jie shu liniment.Methods:The effective ingredients of traditional Chinese medicine in the prescription were extracted for fu jie shu liniment by decoction extraction method and distillation concentration method,and fu jie shu liniment was prepared. The thin layer chromatography(TLC) method was used to identify phellodendron and sophora in the lintment.High performance liquid chromatography(HPLC) method was used for determination of berberine hydrochloride content as effective ingredient in the lintment. Diamonsil C18 ODS column (4.6 mm×200 mm, 5 μm) was used with a mobile phase of methanol-triethylamine-water (80∶20∶10) at a flow rate of 1.0 mL·min-1.The column temperature was 30 ℃.The detection wavelength was set at 346 nm, and the injection volume was 10 μL. Results:The linear relationship between berberine hydrochloride detection concentration in the range of 8.00~92.00 mg·mL-1(r=0.9998) was good.The relative standard deviation (RSD) of the nine replicates was 1.51%, the detection limit was 0.1 μg, and the average recovery was 99.97%.Fu jie shu liniment preparation process was stable, phellodendron and sophora had clear spots on the thin layer in the lintment,and negative control was without interference.The established HPLC method could be used for the quality control of fu jie shu liniment.Conclusion: Determination of berberine hydrochloride in liniment by HPLC is efficient, convenient and accurate. The formulation is reasonable,the preparation process is stable, and the quality control method is effective.
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