西洋参提取物固体制剂的基本处方开发

Development of Basic Formulation of Solid Preparations of Panacis Quinquefolii Radix Extract

目的：考察西洋参提取物与药用辅料的相容性,为西洋参提取物固体制剂的基本处方设计提供参考。方法：采用HPLC测定指标成分的含量,流动相乙腈（A）-水（B）梯度洗脱（0~40 min,18%A;40~50 min,18%~22%A;50~70 min,22%~28%A;70~100 min,28%~38%A;100~110 min,38%~18%A）,检测波长203 nm。以外观性状及人参皂苷Rg1,Re,Rb1,Rc,Rb2,Rb3,Rd总量为评价指标,通过影响因素试验考察西洋参提取物与辅料（乳糖、微晶纤维素、羧甲基淀粉钠、硬脂酸镁、十二烷基硫酸钠）的相容性。结果：西洋参提取物及其辅料混合物在高温和光照条件下性质相对稳定,而在高湿条件下各组样品中指标性成分含量下降。高湿条件下各处方总皂苷含量均明显下降,且性状发生改变。结论：乳糖、微晶纤维素、羧甲基淀粉钠、硬脂酸镁可作为西洋参提取物固体机制的适宜辅料。高湿会影响西洋参提取物制剂的稳定性,需密闭保存,防止吸潮。

Objective： To investigate compatibility between Panacis Quinquefolii Radix extract and different pharmaceutical excipient,in order to provide a reference for basic formulation design of solid preparations of Panacis Quinquefolii Radix extract. Method： HPLC was employed to determine contents of ginsenoside Rg1,Re,Rb1, Rc, Rb2, Rb3, Rd with mobile phase of acetonitrile-water for gradient elution and detection wavelength at 203 nm. Taking appearance and total content of index components as indexes,single factor tests were used to investigate compatibility of extract and different pharmaceutical excipient. Result： Contents of ginsenosides decreased significantly under high humidity condition and appearance changed,in other conditions,these indexes relatively stable. Conclusion： Lactose, microcrystalline cellulose, sodium carboxymethyl starch sodium and magnesium stearate can be used as suitable material for solid preparation of Panacis Quinquefolii Radix extract. High humidity condition will affect stability of preparation of Panacis Quinquefolii Radix extract,so it should be kept closed in order to prevent moisture absorption.