| 引用本文:姜颖娟1，张丰川1，蔡玲玲1，孔宇虹1，付蓉1，胡博1，聂晶2，邓颖1，李元文1.青石止痒软膏的质量标准研究[J].世界中医药,2018,(11):. |
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| 青石止痒软膏的质量标准研究 |
| Research on Quality Standards of Qingshi Zhiyang Ointment |
| 投稿时间：2018-10-10 |
| DOI：10.3969/j.issn.1673-7202.2018.11.003 |
| 中文关键词: 青石止痒软膏 青黛 苦参 黄柏 质量标准 |
| English Keywords:Qingshi Zhiyang Ointment Indigo Naturalis Radix Sophorae Flavescentis Cortex Phellodendri Quality standards |
| 基金项目:北京市科委十病十药项目(Z131100002513013)——甘石青黛膏的应用和研发;国家中医药管理局十三五重点专科经费资助;北京中医药大学教育科研课题(XJY17001)——中医皮肤病辨病与辨证结合的数据库建立与新型教学软件研发;北京中医药大学横向科研项目(HX201706)——复方紫草油治疗慢性湿疹(血虚风燥证)的临床及动物实验研究 |
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| 中文摘要: |
| 目的:建立青石止痒软膏的质量控制标准。方法:对青石止痒软膏的原辅料进行质量标准检查,检查其装量、粒度及微生物限度;采用薄层色谱法对青石止痒软膏中青黛、苦参和黄柏进行鉴别;采用高效液相色谱法测定甘石青黛膏中靛蓝及靛玉红的含量,色谱柱为Waters Symmetry Shiled-RP18(150 mm×4.6 mm,5 μm),以甲醇-水(65:35)为流动相,流速1.0 mL/min,检测波长285 nm,柱温25 ℃。结果:青石止痒软膏的原辅料、3批甘石青黛膏装量、粒度及微生物限度均符合2010版《中华人民共和国药典》的有关规定;青石止痒软膏中青黛、苦参、黄柏的薄层色谱图斑点明显,阴性对照无干扰;靛蓝在2.35~4.7 μg(r=0.999 8)范围内,靛玉红在0.008 32~0.291 2 μg(r=0.999 6)范围内,与峰面积呈良好的线性关系。结论：本实验建立的方法快速简便,准确可靠,可作为该制剂的质量控制方法。 |
| English Summary: |
| To establish the quality control standards of Qingshi Zhiyang Ointment.Methods:The quality standard was tested on the raw and supplementary material of Qingshi Zhiyang Ointment，including the amount of drug loading，particle size and microbial limit.Indigo Naturalis，Radix Sophorae Flavescentis and Cortex Phellodendri in Qingshi Zhiyang Ointment were detected by thin layer chromatography.The mobile phase was methanol-water (65:35)，the detection wavelength was 285 nm，and the flow rate was 1.0 mL/min.The mobile phase consisted of Waters Symmetry Shiled-RP18 column (150 mm×4.6 mm，5 μm)，and the column temperature was maintained at 25 ℃.Results:The raw materials of Qingshi Zhiyang Ointment，the batches of three batches of calcite，the particle size and the microbial limit were consistent with the relevant provisions of the 2010 edition of the Chinese Pharmacopoeia.The thin-layer chromatograms of Indigo Naturalis，Radix Sophorae Flavescentis and Cortex Phellodendri in Qingshi Zhizhi ointment were obvious，and the negative control had no interference.There was a good linear relationship between the concentration of indigo and indirubin，and the peak area of them were in the range of 2.35-4.7 μg (r=0.9998) and 0.00832-0.2912 μg (r=0.9996).Conclusion:The method of this experiment is simple，accurate and reliable，which can be used as a quality control method of the preparation. |
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