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Original
Research Article
In-vivo
Kinetics of Silymarin (Milk Thistle) on Healthy
Male Volunteers
Muhammad Usman*, Mahmood
Ahmad, Asad Ullah Madni, Naveed Akhtar, Waheed Asghar,
Muhammad Akhtar, M Atif and M Qamar-uz-zaman
Department of Pharmacy, the Islamia University of
Bahawalpur, Punjab, Pakistan.
*Corresponding
author: E-mail: minhasiub@hotmail.com
Tel:
092629255243 Fax: 092629255565; Cell:
0092-300-6079361
Received: 24 January
2009
Revised accepted: 24 April 2009
Tropical
Journal of Pharmaceutical Research, August 2009; 8(4):
311-316
Abstract
Purpose:
The study was aimed at evaluating the in vivo kinetics
of silymarin tablets, a product with anti-hepatotoxic
and free radical scavenging activities.
Methods:
Silimarin® (Amson Vaccines & Pharma Pvt Ltd)
was used as the test product while another silymarin
tablet brand, Silliver® (Abbott Laboratories
Pak Ltd) was the reference product. The tablets were
administered to healthy male volunteers orally at a dose
of 200 mg following an overnight fast according to a
randomized cross-over design. Scheduled blood samples
were collected, centrifuged and the plasma assayed using
a sensitive and validated reversed phase high
performance liquid chromatographic (RP-HPLC) method.
Various pharmacokinetic parameters were calculated based
on the non-compartmental model.
Results:
Non-significant difference (p < 0.05) was observed in
the area under the curve (AUC) of the two brands with
values of 10.8 ± 0.4 µg h/ml and 11.2 ± 0.7 µg h/ml,
respectively. There was, however, a significant
difference (p < 0.05) in the Cmax of the two
brands. Other pharmacokinetic parameters evaluated did
not show any statistical difference (p < 0.05) between
the two products except for mean residence time
Conclusion:
The test product can be used as an alternative to the
brand, Silliver®-Abbot (reference), only in
conditions where maximum plasma concentration (Cmax)
is not an important consideration.
Keywords:
In vivo kinetics, Silymarin, Milk thistle, RP-HPLC,
Pharmacokinetics. |
