The objective of Project 2 is to provide non-clinical safety data and pharmacological evidence of a Chinese? herbal preparation used in the treatment of irritable bowel syndrome (IBS). To achieve this objective, this? Project proposes to carry out toxicity tests and pharmacological studies of the prescription. Toward this end,? in vitro and in vivo models will be established for toxicity and pharmacological evaluations. Toxicity tests? include acute (single-dose), subacute (multiple-dose for 14 days), and chronic toxicity (multiple-dose for 3? months) tests in rodents, mutagenicity tests using bacteria (Ames test), animal cells (chromosome aberration? test), as well as intact animals (micronucleus test). Functional assays for in vitro intestinal contractility will be? set up to test for anticholinergic (against acetylcholine), antiserotonic (against histamine), antimuscarinic (M3? antagonism), and opioid agonistic effects of the herbal preparation as well as individual plant extracts.? Receptor binding assays will be used to confirm the effects if necessary. The therapeutic potential of the? Chinese medicinal recipe will be evaluated in an animal model of visceral hyperalgesia induced by neonatal? maternal separation. In addition we will provide bioassay facilities to aid the isolation of active principles from? the medicinal herbs. At the end of this study, it is anticipated that (1) Non-clinical safety data will be generated? to supplement human traditional experience in defining safe use of the prescription, and thus supporting the? clinical applications; (2) Pharmacological actions of the prescription will be characterized so as to provide a? better insight for further development of the herbal prescription.?
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