Toxicological effects of polyherbal formulations for malaria, yellow fever and haemorrhoids in Ilorin metropolis, Nigeria, on male Wistar rats: A comparative biochemical and histological study

This study evaluated the toxicological effects of polyherbal formulations used for the treatment of malaria (Agbo iba, AI), yellow fever (Agbo kojupon, AK) and haemorrhoids (Agbo jedi, AJ) on the function indices and histoarchitecture of liver and kidney of male Wistar rats. Forty rats were randomised into two groups (A and B) of twenty animals each such that the 20 rats in group A were further reassigned into A1, A2, A3 and A4 and administered distilled water (0.5 ml), and AI, AK and AJ at 21 mg/kg body weight respectively for 4 days. Animals in group B were correspondingly assigned and treated like those of group A except that the administration lasted for 10 days. The results revealed that AI, AK and AJ contained alkaloids, saponins, phenolics and flavonoids whilst anthraquinones were not detected. The AI and AK contained tannins whereas AK and AJ contained cardiac glycosides. The AI, AK and AJ reduced the liver- and kidney-body weight ratios, activities of both the liver alkaline phosphatase and aspartate aminotransferase, levels of serum total protein, albumin, globulin, total bilirubin and conjugated bilirubin, and increased the activities of liver alanine aminotransferase, serum alkaline phosphatase, serum aspartate aminotransferase, Na+ and Cl- on days 4 and 10. The AK and AJ significantly (p<0.05) reduced the activity of serum alanine aminotransferase and increased K+. The AK, AI and AJ increased serum creatinine content on day 4 whereas only AK increased it by day 10. Serum uric acid was not altered by all the treatment on days 4 and 10. The administration of AK and AJ induced moderately swollen hepatocytes, congested and dilated blood vessels in the liver as well as imposed glomeruli and renal tubules in the kidney whereas the lobules, glomeruli and tubules were within normal liver and kidney histology after the administration of AI. Overall, the AK and AJ exhibited both functional and structural toxicities whilst the AI displayed only functional toxicity at 21 mg/kg body weight and during the 10 days of administration. The Agbo jedi exhibited the highest degree of toxicity whilst the Agbo iba was the least toxic with respect to the dose and duration of the study

Studies on two polyherbal formulations (ZPTO and ZTO) for comparison of their antidyslipidemic, antihypertensive and endothelial modulating activities

Background Cardiovascular disorders (CVDs) are the leading cause of disease burden worldwide. Apart from available synthetic drugs used in CVDs, there are many herbal formulations including POL-10 (containing 10 herbs), which have been shown to be effective in animal studies but POL-10 was found to cause tachycardia in rodents as its side effect. This study was designed to modify the composition of POL-10 for better efficacy and/or safety profile in CVDs. Methods To assess the antidyslipidemic, antihypertensive and endothelial modulatory properties of two herbal formulations, (ZPTO and ZTO) containing Z: Zingiber officinalis, P: Piper nigrum, T: Terminalia belerica and O: Orchis mascula, different animal models including, tyloxapol and high fat diet-induced dyslipidemia and spontaneously hypertensive rats (SHR) were used. Effect on endothelial function was studied using isolated tissue bath set up coupled with PowerLab data acquisition system. The antioxidant activity was carried out using DPPH radical-scavenging assay. Results Based on preliminary screening of the ingredients of POL-10 in tyloxapol-induced hyperlipidemic rats, ZPTO and ZTO containing four active ingredients namely; Z, P, T and O were identified for further studies and comparison. In tyloxapol-induced hyperlipidemic rats, both ZPTO and ZTO caused significant reduction in serum triglyceride (TG) and total cholesterol (TC). In high fat diet-fed rats, ZPTO decreased TC, low-density lipoproteins cholesterol (LDL-C) and atherogenic index (AI). ZTO also showed similar effects to those of ZPTO with additional merits being more effective in reducing AI, body weight and more importantly raising high-density lipoproteins. In SHR, both formulations markedly reduced systolic blood pressure, AI and TG levels, ZTO being more potent in reversing endothelial dysfunction while was devoid of cardiac stimulatory effect. In addition, ZTO also reduced LDL-C and improved glucose levels in SHR. In DPPH radical-scavenging activity test, ZTO was also more potent than ZPTO. Conclusion The modified formulation, ZTO was not only found more effective in correcting cardiovascular abnormalities than ZPTO or POL-10 but also it was free from tachycardiac side-effect, which might be observed because of the presence of Piper nigrum in ZPTO

Advance In-Vivo Activities of Polyherbal Formulations (Foeniculum Vulgare, Emblica Officinalis and Ocimum Sanctum) with Different Pharmacological Studies

Herbal products with potential therapeutic and nutritional values are gaining importance among people around the world. Herbal products are typically regarded as safe for use on humans. The preparation and marketing of extracts from various herbal items or purified bioactive components takes many different forms. Products with more than two herbal extracts are called polyherbal products. They are frequently regarded as prophylactically or therapeutically useful due to their complimentary and/or potentiating functions as a result of the advantages of one another. The phytochemical screening was performed for presence of various phytoconstituents. Our interest was to study the effect of polyherbal formulation (PHF), composed of Foeniculum vulgare, Emblica officinalis and aerial part of Ocimum sanctum. The anxiolytic activity of polyherbal formulations were examined by using the elevated plus maze test (EPMT), open field test (OFT), and motor coordination test assessed by Rota rod test (RT) and hole board test (HST). The present study is designed to evaluate the Acute toxicity studies, anti-stress effect and anti-anxiety effect of extract of Foeniculum vulgare, Emblica officinalis and aerial part of Ocimum sanctum using various experimental models in rodents. A current investigation concluded that PHF exhibited a strong anti-stress effect and anti-anxiety effect

Proximate composition and functional analysis of some polyherbal formulations as potential botanical candidates for antidiabetic screening: A Preliminary study

Polyherbal formulations improve therapeutic action while lowering single herb concentration, thereby reducing possible side reactions. Proximate composition and functional properties of tomato, garlic, and carrot formulations were studied. Fresh samples of the botanicals were collected, identified and authenticated. Equal amount of each sample (500 g) was weighed, shed-dried and crushed into fine powdered particles. The proximate composition and functional properties of each formulation were determined according to a standard assay guideline. The result on proximate composition analysis revealed a significant (p ˂ 0.05) higher moisture content of tomato and carrot formulations when compared to other formulations. The content of ash and crude protein were significantly (p ˂ 0.05) higher in all garlic containing formulations. The garlic formulation was observed to have lower fat content and greater carbohydrate content than all other formulations (p˂ 0.05). However, when compared to single formulations, all mixed formulations had significantly higher crude fiber content. Furthermore, there was a significant (p ˂ 0.05) variation in glucose adsorption capacity, oil adsorption capacity and water adsorption capacity among all the formulations. The outcome of this study have led us to conclude that employing safe combinations of these herbal formulations for the production of nutraceuticals is recommended

Safety Evaluation of Two Nigerian Polyherbal Formulations (Fidson Bitter® And Daily Living Bitter®) In Male Wistar Rats

Background: Herbal bitters are used for diverse diseases based on the manufacturers’ assertions. However, little is known about their toxicity profile.Objective: The safety profile of two commonly used herbal bitters in Nigeria (Fidson bitter® and Daily living bitter®)was evaluated in rats.Materials and Methods: Single oral dose, 2 g/kg, of each reconstituted bitter extract was administered to male and female rats in acute toxicity test. Animals were observed for 14 days for behavioral changes and mortality. In sub-acute oral toxicity experiment, 250 mg/kg and 500 mg/kg of each bitter was separately administered daily to different groups of male Wistar rats for 30 days. Safety profile of concurrent administration of these bitters was also assessed. Histopathological, hematological, and clinical chemistry indices were evaluated.Results: The LD50 was found to be >2 g/kg. Daily living bitter® (DLB) had no significant effect on any of the indices evaluated (P>0.05). However, Fidson bitter® caused significant reductions in white blood cells count (WBC) compared with the control. Concomitant administration of the bitters resulted in significant (P<0.05) weight gain (up to 33 %), reduction in WBC and congestion of the liver without corresponding increase in liver biomarkers.Conclusion: Daily living bitter® was safe in sub-acute administration while Fidson bitter®and combination of the two bitters reduced white blood cell count. Hence, caution should be exercised in using Fidson bitter® or combination of the two bitters in humans as findings suggest possibility of immune suppression.Keywords: Toxicity profile, Polyherbal, Herbal bitters, Hematology, Wistar rats

Polyherbal Formulation used in the Treatment of Jaundice

Plants have traditionally served as man\u27s most important weapon against pathogens. Herbal medicines are widely used by all sections of the community, either as folk remedies or as medicaments in the indigenous as well as modern system of medicine. The present work was performed to enumerate the medicinal herbs that tribes and rural people uses for the treatment of jaundice. Data were collected by interviewing local traditional therapists and tribes of the region. Details of 10 herbs and 03 formulations were gathered along with their doses, duration and formulations during the course of present investigation in the study area. Our study revealed that all above herbs and their formulations have been used since quite a long time by the tribes and rural people and no side/ adverse effects were reported

Prevention of AIDS and sexually-transmitted infections

Abnormal vaginal discharge due to reproductive tract infections (RTls) is widely prevalent in the country. According to WHO, over 300 million new cases of sexually-transmitted infections (excluding HIV) occur each year. In addition to these, HIV infection is spreading rapidly in the country with over 3.7 million sero-positive cases (from zero) within 15 years. The predominant mode of transmission of HIV is by heterosexual route. The multidrug regime for treatment is expensive (about $10.000 per year) which is beyond the reach of most of the people. No viable vaccine preventing AIDS infection is in sight. Under these circumstances, safe sex is the best recourse, which demands consistent and proper use of condoms. This does not take place to the extent necessary for preventing the transmission of HIV and other sexually-transmitted infections. A polyherbal tablet for intravaginal use by women has been developed. and a polyherbal cream, for use by both men and women, which has a wide spectrum antimicrobial action. Amongst others, these inhibit the growth of Neisseria gonorrhea (including strains resistant to penicillin). normal and multidrug-resistant isolates of urinary tract E. coli, Candida albicans. Candida krusei and Candida tropicalis. Applied intravaginally, these prevent the transmission of Herpes simplex 2 and Chlamydia trachomatis in progestin-sensitised mice. Studies conducted at the lnstitut Pasteur. Paris and Conrad Norfolk, USA, have demonstrated high virucidal action of these formulations against HIVI. Both formulations have undergone phase I clinical trials in five major centres in lndia and abroad. which have indicated the complete safety of these products without any local or systemic side effects. The Drug Controller of India and the Institutional Ethics Committees have approved phase [I clinical trials. The first of these trials was conducted in 88 women with abnormal vaginal discharge due to genital pathogens at the Postgraduate Institute of Medical Education and research. C handigarh. Every woman who used the praneem polyherbals, once every night for seven days, experienced relief clinically, irrespective of the nature of the causative pathogen

Phytochemical constituents and antioxidant activities of two Nigerian retailed polyherbal formulations

Oxidative stress has been implicated in many neurodegenerative diseases, cancers and even ageing processes. This warrants that dietary antioxidants are needed to complement endogenous antioxidant defence system and prevent the development of these chronic diseases. In this study, the phytochemical constituents and antioxidant activities of two retailed Nigerian polyherbal formulations (DRHM® and GCHM®) were evaluated in vitro using DPPH radical scavenging activity, total antioxidant capacity (TAC) and ferric reducing antioxidant power (FRAP) models. Aside for saponins, glycosides, anthraquinones and anthocyanins which were higher in DRHM and alkaloids which were higher in GCHM, there was no significant (p < 0.05) difference among the amount of other phytochemicals detected in the two polyherbal formulations. The DPPH radical scavenging effect exhibited by DRHM (EC50 = 1.62x106 µg/ml) was significantly (p < 0.05) higher than GCHM (EC50 = 574.5 µg/ml) but that of ascorbic acid (EC50 = 10.58 µg/ml) was significantly (p < 0.05) higher than both DRHM and GCHM. Similarly, GCHM (EC50 = 0.005414 µg/ml) had higher FRAP than DRHM (EC50 = 5.302 µg/ml). However, the TAC of GCHM (EC50 = 1675 µg/ml) was significantly (p < 0.05) higher than that of DRHM (EC50 = 6.101 µg/ml). These findings suggest that the two polyherbal formulations possess appreciable antioxidant potentials which could be attributed to the presence of phytochemicals with antioxidant potentials. The polyherbal formulations can further be explored for possible harnessing of their antioxidant effect in prevention and management of oxidative stress-related disorders and ageing process. Keywords: polyherbal formulations, phytochemicals, antioxidants, DPPH, FRAP, TA

IN-VITRO ASSIMILATION OF TRIMYRISTIN IN THE SEEDS OF MYRISTICA FRAGRANS AND IN POLY HERBAL AYURVEDIC FORMULATION BY UFLC METHOD

The present study was aimed to develop a simple and validated chromatographic method for the estimation of Trimyristin in the API and in poly herbal Ayurvedic formulations by UFLC method, along with stress induced degradation studies of the drug and validate the method as per the ICH guidelines. The analysis was carried out under isocratic conditions using dichloromethane and acetonitrile in the ratio of 95:5 as mobile phase with a flow rate of 1.0 ml/min at 210nm. The method was simple, specific, precise, and accurate with retention times 0.904 and 0.906 minutes for the API and isolated product. The system obeys the Beer's law in the concentration range of 10-90μg/ml. The percentage recovery studies performed showed a percentage recovery of 98.3 -101.6%w/v and found to be linear with a correlation coefficient (r2) of 0.9993. The method was found to be precise with relative standard deviation of less than 2%, detection limit and quantitation limit was estimated to be 4.58μg/ml, 15.27μg/ml respectively. The method was found to be robust even by change in mobile phase ratio of ±5%, change in wavelength and change in flow rate of ±0.1 ml/min.  This validated method was sensitive and reproducible enough to be used for routine analysis of Poweromin tablet and Makaradhwaj vatti in time and cost effective manner. Keywords: Trimyristin, Poweromin, Makaradhwaj vatti, UFLC, isocratic elution, validation and stress degradatio

Concept of Oushadha Samyoga in Ayurveda

Ayurvedic medicines have an exceptional way of pharmacodynamics and pharmacokinetics. The pharmacological actions of Ayurvedic drugs were explained through Rasa, Guna, Virya, Vipaka, Prabhava etc. Ayurveda is well known for both single and polyherbal formulation, among them poly herbal formulations have prime role because of its multiple pharmacological actions. Various basic concepts of Ayurveda such as Samyoga, Samskara, Rasapanchaka, Anupana etc were playing behind the formation of polyherbal formulation. The concept of Samyoga, is the essential norm behind the formation of Polyherbal preparations. Thus, literary review mainly intended to know the role of Samyoga in the preparation of various Ayurvedic poly herbal preparations and to highlight their importance of Oushadha Samyoga (multidrug/ polyherbal formulation) in the present era