Sunita Sharma *; Vijay Thawani **; Lal Hingorani***; Meena Shrivastava****; V.R.Bhate***** and Rajkumar Khiyani******
*MD, Lecturer in Pharmacology, Indira Gandhi Medical College, Nagpur- 440 018.
** MD, Associate Professor in Pharmacology, Govt Medical College, Nagpur – 440 003. *** MSc,PhD, Director Pharmanza (India), 70/1 GIDC,Kansari – 388630.
**** MD, Professor & Head, Department of Pharmacology, Indira Gandhi Medical College,Nagpur – 440 018.
*****PhD, Director, Indtech Analytical, K –227,Ansa Industrial Estate,Mumbai – 400 072 ****** MD,PhD, Lecturer in Rasashastra, Govt Ayurvedic College, Nagpur – 440 028.
Corresponding Author :
Dr Vijay Thawani, 14-A,
Jeevan Jyoti Clarke Town,
Nagpur – 440 004. India.
Tel: +91-712-522977 / 557744
Fax: Care +91-712- 559060
E mail: [email protected]
Twelve healthy adult male volunteers were given capsule WokVel ™ containing 333 mg of Boswellia Serrata Extract, orally, after a seven day washout period. Venous blood samples were drawn through indwelling canula from each volunteer prior to drug administration and at 30, 60, 120, 150, 180, 210, 240, 300, 360, 480, 600, 720, 840 minutes after drug administration. Plasma obtained after centrifuge was analyzed to measure concentration of 11-keto Boswellic acid by HPLC. Various kinetic parameters were then calculated from the plasma concentrations.
The peak plasma levels (128.17 ± 30.06) of BSE were reached at 4.5 ± 1.9 h. The concentration declined with a mean elimination half life of 5.97 ± 3.27h. The apparent volume of distribution averaged 39.711 ± 24.62692 L/kg and the plasma clearance was 4597.88 ± 1296.07 ml/min. The AUC 0 to infinity was 1286.46 ± 324.96 ng/ml h.
Elimination halflife of nearly six hours suggests that the drug needs to be given orally at the interval of six hours. The plasma concentration will attain the steady state after approximately 30 hours. BSE is a safe drug and well tolerated on oral administration. No adverse effects were seen with this drug when administered as single dose in 333mg. Extended pharmacokinetic trial along with clinical correlation is planned.
Traditional medicine from all the ancient civilizations has come upfront during the last decade, throughout the world, as pressing need for the alternatives is mounting. The richness and diversities of these drugs are indeed appealing, enchanting and enticing. In India, Ayurveda has been practiced for ages. There is some overlap in the herbal and Ayurvedic medicines. Effort is on to provide the scientific validity to these medicines by applying the methodology of modern medicine. Many herbal drugs are used without the substantiation of kinetic data. This study is one such attempt to validate the usage of an ancient drug.