DRUG SAFETY IN TRADITIONAL HERBAL MEDICINE
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DRUG SAFETY IN TRADITIONAL HERBAL MEDICINE Abdul Latif, S.Z. Rahman Department of Pharmacology, Jawaharlal Nehru Medical College, AM University, Aligarh, UP, India The safest drugs are essential tools for preventive, curative and rehabilitative health care. Unani Medicine, which is an ancient Traditional system of Herbal medicine and more commonly practiced in Asian countries. Study of Unani Medicine in relation with drug safety and quality assurance is thus imperative. Following rules and procedures must be taken into account to avoid any obnoxious effects before the start of treatment by Unani Drugs: 1. The drugs are classified into four degrees, according to their potencies, temperaments and actions, which help in minimizing adverse drug reactions. 2. Detoxification (Mudabbar) of 3rd and 4th degrees drugs before their use (a unique procedure). 3. Selection of drugs before prescribing 4. Conformity in the principles of treatment with opposite quality of drugs 5. To follow the contraindication of drugs. 6. To choose “substitution” of drugs in the context of ADRs. 7. Careful selection of drugs according to weather and climatic conditions. 8. To decide drugs according to the age and physical condition of a patient. 9. To change the route of drug administration if required, e.g. rectal route. Despite the above precautionary measures, some cases of ADRs are still being reported due to mis-identification. The increase in reports reflects a rising awareness that these natural products may also cause harm. ADR reporting systems for traditional medicines particularly from developing countries must be generated. doi:10.1016/j.vascn.2007.02.094 MODIFIED IRWIN TEST AS DIAGNOSTIC TOOL TO MONITOR NEUROBEHAVIOURAL CHANGES IN MONKEYS Sven Korte a , Antje Fuchs a , Gerhard F. Weinbauer a , Elena Moscardo b , Alessandra Giarola b a Covance Laboratories GmbH, Münster, Germany; b GlaxoSmithKline Research Centre, Safety Pharmacology, Safety Assessment, Verona, Italy The Irwin test a is a standard and consolidated neurobehavioural observation battery for assessing CNS adverse effects in rodents, attempts to adapt this test to non-human primates over the conduct of pre-clinical risk assessment are rare. However, it may be necessary to assess neurobehavioral outcome of either test articles exposure or experimental procedures in these species. For this reason a modified Irwin test in the cynomolgus monkey was established in these laboratories. Two groups of 6 male monkeys, each were intrathecally given 0.9% w/v sodium chloride or sodium phosphate buffers. Prior to study the 12 animals were surgically implanted (lumbar 4/5) with an intrathecal port-catheter system and equipped with a backpack pump system for 28 days of continuous infusion [0.02 mL/kg/h]. To also evaluate the absence of technique-related neurobehavioural changes neurological examinations (sensorimotor expressions, cerebral nerve tests and spinal nerve tests) were performed pre-dose and once weekly over the study conduct. Determinations of neurobehavioural parameters (vocalisation, aggression, convulsion, posture, reaction, alertness, coordination, visual stimuli, muscle tone, stereotypy, locomotor activity, grip strength, grooming, and tremors) were conducted pre-dose, in weeks 1 and 4. In summary, the data showed the absence of neurobehavioural changes when comparing pre-surgery and post-surgery observations. The modified Irwin test proved practical and provided reproducible data. It is concluded that a modified Irwin test is a feasible tool to assess primate neurobehaviour. (a) Irwin, S. (1968): Comprehensive observational assessment. Systematic, quantitative procedure for assessing the behavioural and physiologic state of the mouse. Psychopharmacologia, 13: 222–257. doi:10.1016/j.vascn.2007.02.095 e47 Meeting abstracts
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Transcript of DRUG SAFETY IN TRADITIONAL HERBAL MEDICINE
e47Meeting abstracts
DRUG SAFETY IN TRADITIONAL HERBAL MEDICINE
Abdul Latif, S.Z. Rahman
Department of Pharmacology, Jawaharlal Nehru Medical College, AM University, Aligarh, UP, India
The safest drugs are essential tools for preventive, curative and rehabilitative health care. Unani Medicine, which is an ancientTraditional system of Herbal medicine and more commonly practiced in Asian countries. Study of Unani Medicine in relation withdrug safety and quality assurance is thus imperative. Following rules and procedures must be taken into account to avoid anyobnoxious effects before the start of treatment by Unani Drugs: 1. The drugs are classified into four degrees, according to theirpotencies, temperaments and actions, which help in minimizing adverse drug reactions. 2. Detoxification (Mudabbar) of 3rd and 4thdegrees drugs before their use (a unique procedure). 3. Selection of drugs before prescribing 4. Conformity in the principles oftreatment with opposite quality of drugs 5. To follow the contraindication of drugs. 6. To choose “substitution” of drugs in the contextof ADRs. 7. Careful selection of drugs according to weather and climatic conditions. 8. To decide drugs according to the age andphysical condition of a patient. 9. To change the route of drug administration if required, e.g. rectal route. Despite the aboveprecautionary measures, some cases of ADRs are still being reported due to mis-identification. The increase in reports reflects arising awareness that these natural products may also cause harm. ADR reporting systems for traditional medicines particularly fromdeveloping countries must be generated.
doi:10.1016/j.vascn.2007.02.094
MODIFIED IRWIN TEST AS DIAGNOSTIC TOOL TO MONITOR NEUROBEHAVIOURAL CHANGES IN MONKEYS
Sven Kortea, Antje Fuchsa, Gerhard F. Weinbauera, Elena Moscardob, Alessandra Giarolab
aCovance Laboratories GmbH, Münster, Germany; bGlaxoSmithKline Research Centre, Safety Pharmacology, Safety Assessment,Verona, Italy
The Irwin testa is a standard and consolidated neurobehavioural observation battery for assessing CNS adverse effects inrodents, attempts to adapt this test to non-human primates over the conduct of pre-clinical risk assessment are rare. However, itmay be necessary to assess neurobehavioral outcome of either test articles exposure or experimental procedures in these species.For this reason a modified Irwin test in the cynomolgus monkey was established in these laboratories. Two groups of 6 malemonkeys, each were intrathecally given 0.9% w/v sodium chloride or sodium phosphate buffers. Prior to study the 12 animalswere surgically implanted (lumbar 4/5) with an intrathecal port-catheter system and equipped with a backpack pump system for28 days of continuous infusion [0.02 mL/kg/h]. To also evaluate the absence of technique-related neurobehavioural changesneurological examinations (sensorimotor expressions, cerebral nerve tests and spinal nerve tests) were performed pre-dose andonce weekly over the study conduct. Determinations of neurobehavioural parameters (vocalisation, aggression, convulsion,posture, reaction, alertness, coordination, visual stimuli, muscle tone, stereotypy, locomotor activity, grip strength, grooming, andtremors) were conducted pre-dose, in weeks 1 and 4. In summary, the data showed the absence of neurobehavioural changes whencomparing pre-surgery and post-surgery observations. The modified Irwin test proved practical and provided reproducible data. Itis concluded that a modified Irwin test is a feasible tool to assess primate neurobehaviour. (a) Irwin, S. (1968): Comprehensiveobservational assessment. Systematic, quantitative procedure for assessing the behavioural and physiologic state of the mouse.Psychopharmacologia, 13: 222–257.
doi:10.1016/j.vascn.2007.02.095
