VERFAHREN FÜR DIE QUALITÄTSKONTROLLE UND STANDARDISIERUNG VON MEDIZINISCHEN PFLANZENPRODUKTEN

摘要

A process for establishing a standard specification for a medicinal plant material comprises: (i) preparing a test solution or test extract of a sample of the medicinal plant material which is known to possess the or each property required for the standard; (ii) submitting the said solution or extract to two or more analytical methods including (a) a combination of NMR spectroscopy and a computer-based pattern recognition technique, and (b) one or more biological profiling techniques; (iii) obtaining results from the analytical methods used in step (ii); and (iv) establishing a standard specification for the said plant material on the basis of the results obtained in step (iii). Candidate samples of the medicinal plant material may subsequently be tested for compliance with the standard. They can be accepted or rejected depending on whether they give analytical results which fall within or outside either part or all of the specification established in step (iv). This approach to standardization and quality control is particularly applicable to mixtures of medicinal plant materials.