Herbal Products: Advances in Preclinical and Clinical Development
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0092-8615/99 Copyright 0 1999 Drug Information Association Inc.
HERBAL PRODUCTS: ADVANCES IN PRECLINICAL AND CLINICAL DEVELOPMENT MICHAELHABS, MD Dr. Willmar Schwabe GmbH & Co., Karlsruhe, Germany
Preclinical and clinical development of herbal drugs should follow science-based principles. The presence of numerous constituents in herbal extracts requires an intelligent screening model that can guide the development of specific extracts. The strategy developed in our laboratories to characterize and standardize therapeufically meaningful extracts can be described as an activity-guided fractionation and testing procedure which can ultimately lead to the discrimination of active constituents. Extracts should be standardized in order to provide batch conformity over time. leading to equipotent formulations at the end. If markers are used for standardization. preference should be given to pharmacologically-active principles relevant to the indication in which the jinal drug is used. Drug formulations based on rationally developed extracts need to be documented in well-controlled clinical trials with relevant outcome measurements, The clinical studies should be planned according to the indication investigated, though no specific design is needed for herbal drugs in comparison to chemically defined entities. Modern herbal drugs can be developed and documented in a way leading to a broader acceptance by the scientific community. This paper provides examples which prove that this development strategy can be applied successfully. Key Words: Science-based preclinical and clinical development; Herbal medicines; Crataegus; Hypericum perforatum
INTRODUCTION THE PRECLINICAL AND clinical development of herbal medicines follows the paradigm that pharmacological and clinical studies are suited to describe the mode of action and the clinical efficacy of herbal drugs. In this regard, herbal drugs do not differ from chemically defined drugs, and no alternative
approaches are needed to identify the biological activity of plant-derived drugs and to assess their risk/benefit ratio. An unprejudiced investigation with suitable methods of medical sciences will prove or disprove the riskhenefit ratio of well-defined herbal drugs in clearly circumscribed indications.
PRECLINICAL DEVELOPMENT Presented at the DIA I Ith Annual EuroMeeting “Looking Back to the Pharmaceutical Future,’’ March 3-5, 1999, The Hague, The Netherlands. Reprint address: Michael Habs, MD, Dr. Willmar Schwabe GmbH & Co., Willmar-Schwabe Suasse 4, D76227 Karlsruhe, Germany.
The pharmacological evaluation of medicinal herbs has the aim of obtaining standardized extracts with one or several active components suitable for therapeutic use in patients. One major prerequisite for achieving this
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Michael Habs
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goal is to identify the active constituent(s) and potentially harmful components of the medicinal herb. F'harmacologically-relevant substances (active markers) are chemically-defined c
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