CHEMICAL COMPLEXING DIRECTIONAL SEPARATION AND PURIFICATION METHOD FOR PREPARING HIGH-PURITY BETA-ELEMENE RAW MATERIAL MEDICAMENT

摘要

Method for producing highly pure beta-elemene used as pharmaceutical raw material by chemical complexing directional separation and purification method, involves subjecting raw material containing 1% or more beta-elemene to silica gel column chromatography, removing volatile oil composition having high polarity, and removing impurity composition having low polarity from the remaining oil-phase by performing silver nitrite complex extraction process or silica gel column chromatography method involving silver nitrate binding, finally obtaining 95-99.9% content of beta-elemene through vacuum distillation or rectification. The pharmaceutical raw material containing beta-elemene can be blended with suitable excipients and formulated into oral delivery dosage form, such as oral emulsion, capsules, parenteral drug delivery formulation, such as injection, transdermal delivery drug, spray and suppository. The method is simple, low cost and high yield.