维生素E软胶囊溶出度方法的建立

Establishment of a Dissolution Method of Vitamin E Soft Capsules

关键词:  维生素E  溶出度  溶出曲线  高效液相色谱法

Key words:  vitamin e  dissolution  dissolution curves  HPLC

摘要:

目的 建立维生素E软胶囊溶出度测定方法,考察不同生产场地样品溶出行为的差异。方法 系统考察了不同溶出装置(流通池法、浆法(加沉降篮))、不同溶出介质(表面活性剂种类、浓度)、不同转速等关键参数对维生素E软胶囊溶出行为的影响,并建立高效液相色谱法对各取样点的溶出度进行测定。结果 采用流通池法,维生素E溶出缓慢且各时间点溶出度差异较大；在表面活性剂筛选试验中,曲拉通X-100较十二烷基硫酸钠显著提高了维生素E在水溶液中的溶解度；通过参数优化发现,转速100r.min_-1^以及10%的曲拉通X-100浓度可有效促进维生素E从油相向水相的转移；最终确定采用浆法(加沉降篮)、10%曲拉通X-100的浓度、转速100r.min_-1^{考察维生素}E软胶囊溶出行为。结论 所确定的溶出方法可用于维生素E软胶囊的质量控制,为维生素E软胶囊的一致性评价以及油脂类软胶囊的溶出方法的开发提供思路。

Abstract:

OBJECTIVE This study aimed to establish a dissolution test method for vitamin E soft capsules and to evaluate the dissolution profile differences among samples from different manufacturing sites. METHODS A systematic investigation was conducted on the effects of critical parameters, including dissolution apparatus (flow-through cell vs. paddle apparatus with sinker), dissolution medium (types and concentrations of surfactants), and rotation speed on the dissolution behavior of vitamin E soft capsules. A high-performance liquid chromatography (HPLC) method was developed for dissolution quantification at each sampling point. RESULTS The flow-through cell exhibited slow dissolution kinetics with significant variability across time points. In surfactant screening tests, Triton X-100 significantly enhanced the solubility of vitamin E in aqueous media compared to sodium dodecyl sulfate (SDS). Parameter optimization revealed that a rotation speed of 100 rpm and a Triton X-100 concentration of 10% effectively promoted the transfer of vitamin E from the oil phase to the aqueous phase. The final dissolution conditions were established as the paddle apparatus (with sinkers), 10% Triton X-100, and a rotation speed of 100 rpm. CONCLUSION The validated dissolution method is suitable for quality control of vitamin E soft capsules and provides a methodological reference for dissolution method development and consistency evaluation of lipid-based soft capsules .