Investigation of Preparation Process of Fengtongling Plaster and Its Determination of Methyl Salicylate

ZHANG Run-rong; YE Xue-feng; GAO Jin; CHEN Hai-yan

doi:10.13422/j.cnki.syfjx.2016130027

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Investigation of Preparation Process of Fengtongling Plaster and Its Determination of Methyl Salicylate

更新时间：2024-01-04

- Investigation of Preparation Process of Fengtongling Plaster and Its Determination of Methyl Salicylate
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 22, Issue 13, Pages: 27-30(2016)
- 作者机构：
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.2016130027
  CLC： R283.6;R286.0
- Published：2016
- 稿件说明：
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ZHANG Run-rong, YE Xue-feng, GAO Jin, et al. Investigation of Preparation Process of Fengtongling Plaster and Its Determination of Methyl Salicylate[J]. Chinese journal of experimental traditional medical formulae, 2016, 22(13): 27-30.
DOI：

ZHANG Run-rong, YE Xue-feng, GAO Jin, et al. Investigation of Preparation Process of Fengtongling Plaster and Its Determination of Methyl Salicylate[J]. Chinese journal of experimental traditional medical formulae, 2016, 22(13): 27-30. DOI： 10.13422/j.cnki.syfjx.2016130027.

摘要

目的: 确立风痛灵膏的最佳成型工艺并及建立其有效成分水杨酸甲酯的气相色谱测定法

为该制剂的工业化生产与质量控制提供参考。方法: 以熔点、光泽、软硬度、细腻度为综合评价指标

采用正交试验确定基质间(石蜡、蜂蜡、白凡士林、羊毛脂)的最佳配比。采用气相色谱法测定水杨酸甲酯含量

PEG-20M毛细管柱(0.25 mm×30 m

0.25μm)

程序升温(初始温度100℃

以15℃·min-1升温至190℃

保持9 min)

分流比50:1

检测器温度300℃

进样口温度250℃。结果: 石蜡、蜂蜡、白凡士林、羊毛脂最佳配比分别为4%

药液温度65~75℃。制备的3批样品均符合《中国药典》2010年版软膏剂项下的规定。水杨酸甲酯的线性范围0.66~13.25 g·L-1

平均加样回收率98.94%

RSD 0.7%。结论: 优选的制备工艺稳定可行

建立的含量测方法简便、快速、准确

可用于风痛灵膏的质量控制。

Abstract

Objective: To optimize molding process of Fengtongling plaster and develop GC for assay of methyl salicylate in this preparation. Method: Orthogonal test was adopted to optimize molding technology of Fengtongling plaster with melting point

gloss

hardness and smooth as indexes.The content of methyl salicylate was determined by GC

chromatographic conditions was PEG-20M column (0.25 mm×30 m

0.25 μm)

split ratio was 50:1. Result: The best proportion of paraffin wax

beeswax

white petrolatum and lanolin were 4%

5% and 3%

respectively

liquid temperature was 65-75℃.Three batches of products conformed standards of the 2010 edition of Chinese Pharmacopoeia on ointments.The linear range of methyl salicylate was 0.66-13.25 g·L-1

average recovery was 98.94% with RSD of 0.7%. Conclusion: This optimized molding process is feasible and stable

this determination method is simple

rapid and accurate for quality control of Fengtongling plaster.

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Related Institution

Shenzhen Municipal Institute for Drug Control

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Jiangsu Province Engineering Research Center of Famous Classical Formulas，School of Pharmacy，Nanjing University of Chinese Medicine

Institute of Chinese Materia Medica，China Academy of Chinese Medical Sciences

Gansu Taikang Pharmaceutical Co. Ltd.

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