Pharmacokinetic-interaction of Vitex negundo Linn. & paracetamol.

BACKGROUND & OBJECTIVES: Currently, herbal preparations are clinically used as functional food, food supplements or as add on therapy, which affects the bioavailability and also the net therapeutic potential of co-administered allopathic drugs. Therefore, it is important to assess the interaction among these two classes of drugs. Here we studied the interaction between orally-administered ethanolic extract of leaves of Vitex negundo Linn. (Verbenaceae) (VN extract) and paracetamol in albino rats. METHODS: Solvent free dried extract of VN leaves was orally given to experimental rats in different doses (62.5-1000 mg/kg/b.wt.), daily for six consecutive days. On days 3 and 6, paracetamol (100 mg/kg/b.wt.) was orally administered to these extract treated rats and control rats (drug vector). At various time intervals (5 min-120 min), blood was collected from each animal and paracetamol concentration was determined in plasma by using HPLC with UV detector at 249 nm. Various pharmacokinetic parameters were calculated by non compartmental model. RESULTS: A significant decline in plasma concentration of paracetamol with time-gap was recorded with the increasing dose of VN extract, without affecting its T(max) (maximum time to achieve peak plasma concentration). There was a significant decrease in the extent of absorption and decline in intensity of therapeutic response (as evidenced by reduced AUC value and decline in C(max)). Further, compared to control, the relative bioavailability of paracetamol, in presence of VN extract, decreased significantly. INTERPRETATION & CONCLUSIONS: VN extract or its ayurvedic formulation if co-administered with allopathic drug like paracetamol, the dose of allopathic drug needs to be adjusted in order to achieve desired therapeutic response of paracetamol.

Studies on metals and pesticide content in some Ayurvedic formulations containing Bacopa monnieri L.

OBJECTIVE: Ayurvedic formulations are preferred over other formulations as well as commercialized on broad level to treat various ailments. The World Health Organization has established certain guidelines for quality control of heavy metals and pesticide residues. Bacopa monnieri, a popular herb with immunomodulator and memory-enhancing properties is the chief constituent of several Ayurvedic formulations, which include Brahmi Vati (BV), Brahmi Ghrita (BG) and Saraswat Churna (SC), etc. In view of the World Health Organization guidelines, two products of each formulation from six different manufacturers were purchased from Ayurvedic Pharmacy, Bulanala-Varanasi, India for testing heavy metal and pesticide residue. METHODS: In the present study, all the formulations--BV, BG and SC--were selected for estimation of four heavy metals namely lead (Pb), cadmium (Cd), chromium (Cr) and nickel (Ni) by a plasma emission spectrophotometer. Organochlorine pesticidal residues were estimated for dichlorodiphenyl trichloroethane, isomers of hexachlorocyclohexane (HCH) and α-endosulfan, etc. in total 12 samples of test formulations containing Bacopa monnieri L. using gas chromatography technique. RESULTS: Out of 12 samples, Pb, Cd, Cr and Ni were present in all samples but below the permissible limit. Although atrazine, aldrin, dialdrin were in below detection limit, but other pesticides were detected in some samples as oxamyl, hexachlorocyclohexanes (α-HCH, ß-HCH and γ-HCH), dichlorodiphenyl trichloroethane and dichlorodiphenyl dichloroethylene. CONCLUSION: The presence of heavy metals in the formulations was low to cause toxicity. However evaluation of heavy metals and pesticide residue in every batch is necessary.

In-house preparation and characterization of an Ayurvedic bhasma: Praval bhasma.

OBJECTIVE: To prepare the Praval bhasma (PB) and to perform its characterization. METHODS: The preparation was performed strictly as per method prescribed in Ayurvedic formulary of India followed by preliminary tests including Nischandratva, Rekhapurnatvam, Varitaramtavm, Nisvadutvam and Amla pariksha. The physicochemical characterization was done with the use of instrumental techniques such as Fourier transform infrared (FTIR) spectroscopy, scanning electron microscopy (SEM), X ray diffraction (XRD), and energy dispersive X-ray (EDAX). RESULTS: The FTIR bands appearing in final product spectra showed a significant shift in infrared vibration frequency as well as intensity when compared with the raw material, which was indicative of formulation of bhasma. The XRD analysis revealed that raw material contained CaCO3 whereas in case of final product of bhasma, CaO was identified. SEM analysis revealed the difference in particles size of bhasma (10-15 µm) and raw material (100-150 µm). The EDAX analysis showed presence of different concentration of carbon in both the samples. CONCLUSION: It may be concluded that modern analytical techniques may be involved to evaluate the quality aspects of PB. The findings of the present research work may be helpful for further formulation and standardization of PB in routine analysis.

HPLC analysis and standardization of Brahmi vati - An Ayurvedic poly-herbal formulation.

OBJECTIVES: The aim of the present study was to standardize Brahmi vati (BV) by simultaneous quantitative estimation of Bacoside A3 and Piperine adopting HPLC-UV method. BV very important Ayurvedic polyherbo formulation used to treat epilepsy and mental disorders containing thirty eight ingredients including Bacopa monnieri L. and Piper longum L. MATERIALS AND METHODS: An HPLC-UV method was developed for the standardization of BV in light of simultaneous quantitative estimation of Bacoside A3 and Piperine, the major constituents of B. monnieri L. and P. longum L. respectively. The developed method was validated on parameters including linearity, precision, accuracy and robustness. RESULTS: The HPLC analysis showed significant increase in amount of Bacoside A3 and Piperine in the in-house sample of BV when compared with all three different marketed samples of the same. Results showed variations in the amount of Bacoside A3 and Piperine in different samples which indicate non-uniformity in their quality which will lead to difference in their therapeutic effects. CONCLUSION: The outcome of the present investigation underlines the importance of standardization of Ayurvedic formulations. The developed method may be further used to standardize other samples of BV or other formulations containing Bacoside A3 and Piperine.