Processes for establishing a standard specification for a medicinal plant material, for providing a sample of a medicinal plant material, and for providing a standard specification for a medicinal plant material

摘要

"PROCESSES TO ESTABLISH A STANDARD SPECIFICATION FOR MEDICINAL PLANT MATERIAL, TO PROVIDE A SAMPLE OF MEDICAL PLANT MATERIAL, AND TO PROVIDE A STANDARD SPECIFICATION FOR MEDICAL PLANT MATERIAL". A process for establishing a standard specification for a medicinal plant material comprises: (i) preparing a test solution or extract for testing a sample of medicinal plant material that is considered to possess the or each required property for the standard; (ii) subjecting said solution or extract to two or more analytical methods including (a) a combination of NMR spectroscopy with computerized pattern recognition technique, and (b) one or more techniques for obtaining a biological profile; (iii) obtain results from the analytical methods used in step (ii); and (iv) establish a standard specification for said plant material based on the results obtained in step (iii). Candidate samples of medicinal plant material can subsequently be tested for compliance with the standard. They can be accepted or rejected depending on whether they provide analytical results that fall within or outside part or the entire specification set out in step (iv). This standardization and quality control approach is particularly applicable to mixtures of medical plant materials.