Studies On The Technology For Extracting Pure β-Ecdysterone And Quality Standards Of β-Ecdysterone

The studies of the extractingβ-Ecdysterone from Cyanotis arachnoidea, purification ofβ-Ecdysterone and the quality standuard of the raw materialβ-Ecdysterone were conducted systematicly. The crudeβ-Ecdysterone was obtained from the macroporous resin and silica gel column chromatography. After recrystallization, the qualified production was obtained. Experiments were conducted to buil the quality control standards ofβ-Ecdysterone. The articl contains the two parts.PART ONE THE STUDY of THE EXTRACTION AND PURIFICATION ofβ- ECDYSTERONEⅠTHE EXTRACTION OFβ- ECDYSTERONEObjective: To build the method of theβ-Ecdysterone extrating pure from Cyanotis arachnoidea. Methods: It adopted the macroporous resin with gradient elution, and silica gel column chromatography to obtain the crudeβ-Ecdysterone. Conclusion: After the identification, it got the conclusion that the crude product was theβ-Ecdysterone.ⅡTHE PURIFICATION OFβ- ECDYSTERONEObjective: The purification ofβ-Ecdysterone. Methods: It adopted the recrystallization to obtain the purified product. Conclusion: The purity ofβ-Ecdysterone could be above the 99.0% from the recrystallization.ⅢCONFIRMING CHEMICAL STRUCTURE ofβ- ECDYSTERONEObjective: The confirming chemical structure of the productionβ-Ecdysterone. Methods: The chemical structure was identified by the mass spectrometer analysis, infrared spectrophometry analysis, elemental analysis and NMR analysis. Conclusion: Through the chemical structure of identification, it got the conclusion that the product wasβ-Ecdysterone.ⅣDISPOSAL of THE WASTE in THE PRODUCTION PROCESSObjective: Recycling of the waste, and reducing the environmental pollution. Methods: The waste liquid was recycled by distillation. The waste residue was treated by incineration to discard to the garbage field.Conclusion: The methods reduce both the environmental pollution and thecost of the prudction.PART TWO THE STUDY of THE QUALITY CONTROL STANDARDObjective: To build the quality control standards of the raw materialβ-Ecdysterone. Methods: It adopt the chemical ident ification and ultraviolet spectrophotometry to identify the structure ofβ-Ecdysterone.The method for the determination ofβ-Ecdysterone by RP-HPLC was established for the related substances and the contant. As the chinese pharmacopeia 2005, we controlled the specific rotation, the color and the clarity of the solution, the moisture and the heavy metal. At the same time, it carried out the study on the influence factors and stability. Conclusion: It built the the quality control standards of the raw materialβ-Ecdysterone. From the study on the influence factors, the results showed thatβ-Ecdysterone was evry unstable to the light, stable to the high temperature and high humidity. After the stability study of the six months'accelerated test and the nine months'long-term test, the quality ofβ-Ecdysterone had not changes, significantly.