骨伤宁软膏的制备与质量控制

Preparation and Quality Control of Gushangning Ointments

摘要:

目的: 制备骨伤宁软膏并建立其质量控制方法. 方法: 采用乳化法制备骨伤宁软膏.利用TLC及沉淀反应对骨伤宁软膏进行定性分析.运用HPLC同时测定骨伤宁软膏中三七皂苷R₁及人参皂苷Rg₁,Rb₁的含量,流动相乙腈(A)-水(B)(0~12 min,19%A;12~60 min,19%~36%A;60~70 min,36%~19%A;70~73 min,19%A),检测波长203 nm. 结果: 骨伤宁软膏性状稳定,HPLC含量测定中三七皂苷R₁及人参皂苷 Rg₁,Rb₁能够完全分离,线性范围分别为 0.15~3.75,0.45~11.25,0.42~10.5 μg,平均加样回收率分别为98.81%(RSD 3.65%),101.18%(RSD 2.26%),98.90%(RSD 2.92%). 结论: 建立的定性方法准确可靠,HPLC结果准确、回收率高、重复性好,适用于骨伤宁软膏的质量控制.

Abstract:

Objective: To prepare Gushangning ointments and establish its quality control method. Method: Gushangning ointments was prepared by emulsification method.Qualitative analysis of Gushangning ointments was detected by TLC and precipitation reaction.Contents of notoginsenoside R₁ and ginsenoside Rg₁,Rb₁ in Gushangning ointments by HPLC,mobile phase consisted of acetonitrile(A)-water(B) for gradient elution(0-12 min,19%A;12-60 min,19%-36%A;60-70 min,36%-19%A;70-73 min,19%A),dection wavelength was set at 203 nm. Result: Gushangning ointments had stable traits,linear ranges of notoginsenoside R₁ and ginsenoside Rg₁,Rb₁ were 0.15-3.75,0.45-11.25,0.42-10.5 μg,average recoveries of these three components were 98.81%(RSD 3.65%),101.18%(RSD 2.26%),98.90%(RSD 2.92%),respectively. Conclusion: This established qualitative analysis is reliable and accurate,HPLC is reliable,simple and precise,which are suitable for quality control of Gushangning ointments.