Volume 7 - Issue 4

S.NO Title & Authors Name page
M. S. K. Choudhuri
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Basakarista (BSK), a well-known ayurvedic preparation, is widely used as a traditional medicine in the treatment of cough and respiratory trouble. In this study, effect of BSK on organ toxicity profile was evaluated after chronic administration of this drug to female Sprague-Dawley rats. The acute pharmacological study of BSK recorded no death or any signs of toxicity even at the highest dose of 80 ml/Kg body weight. For chronic pharmacological evaluation, the animals were divided into two groups. The first group was given BSK preparation at a dose of 40 ml/kg body weight for 35 days while the second group that served as the control received water for the same period. All throughout the experimental period, the BSK treated animals were always maintaining negligible decrease in body weight, in the body weight study, but it was not significant. There is a statistically significant (p=0.05) decrease in the absolute and relative weight of rat heart, kidney, spleen and thymus. The drug (BSK) also significantly decrease the tissue hydration index in heart and lung. These results demonstrate that BSK should not be administered chronically at a higher dose.

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Milon Mondal
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A simple, rapid reverse phase high-performance liquid chromatographic method has been developed and validated for the estimation of Daclatasvir Di-hydrochloride (DTDH) in bulk and in a pharmaceutical dosage form. Chromatography was carried out by Spherical Octyl Silane (C8 silica, column 250 x 4.6mm internal diameter was 5-μm), using mobile phase of composition of tri-ethylamine buffer (pH 5.00): acetonitrile (50:50 (v/v)). The flow rate was 1.0 mL min-1 and a peak was observed at about 6.13 minute as detected by a UV detector at 315 nm. The method was validated according to ICH guideline, checking the different analytical parameters such as linearity, precision, accuracy, specificity and robustness. The calibration curve was found to be linear (r2 =0.9997) for the analyte DTDH in the concentration range of 15-45μg/mL. The average recovery was found to be 98.42% to 100.64% for DTDH.

An in-vitro evaluation of cytotoxic activity of Wrightia tinctoria
Ashish Dixit
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The objective of the study was to analyze the anticancer property of the leaves of Wrightia tinctoria on HeLa Cells. Cancer has been estimated as the second leading cause of death in humans. So there has been an intense search on various biological sources to develop a novel anti-cancer drug to combat this disease. The anti-cytotoxic effect of methanolic extract was evaluated in-vitro by employing MTT assay. The potency of each plant extract concentration was calculated in terms of percent decrease in viable HeLa cells as compared to the control value. The extract showed dose dependent anticancer activity. The MTT assay showed an antiproliferative activity (IC50) at 76.1 μg/ml of crude extract.

Vaishali S. Kadam
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The objective of this work was to formulate extended release tablets of highly water-soluble Trazadone Hydrochloride using natural gums xanthum, guar and acacia gum as cost effective, nontoxic, easily available and suitable hydrophilic matrix systems by direct compression method and to study the effect of different concentration of polymers like xanthum gun, guar gum, and acacia on release rate from tablet. FTIR analysis does not show any interaction of drug with Excipients. Formulation was optimized on the basis of acceptable pre and post compressional parameters. The results of dissolution studies indicated that Batch F6 exhibited drug release of 93% at the end of 12h to provide sufficient concentration for achieving satisfactory therapeutic value for extended period of time. The drug release from Batch F6 formulation was sustained up to 12 h. Fitting in-vitro drug release data from optimized matrix formulation to zero order followed by Higuchi model indicated that diffusion could be mechanism of drug release. The n value indicates a non-fickian or anomalous diffusion pattern. This means that both the diffusion and erosion mechanisms were prevalent.

M. S. K. Choudhuri
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Naradiya Laksmivilasa Rasa (NMB) is a classical Ayurvedic formulation, indicated for the treatment of sinusitis, chronic skin diseases, diabetes, obesity, rheumatoid arthritis, headache, gynaecological disorders and urinary tract infections. However, till date, no safety profile of this formulation has been reported. That is why, the present study was conducted to evaluate the effect of conventionally prepared NMB on different kidney profile parameters in experimental animals. Acute toxicity study was conducted to determine the median lethal dose (LD50) of the drug. The LD50 study of NMB recorded no death or any signs of toxicity even at the highest dose of 4000 mg/Kg body weight. To find out the effect of chronic administration of NMB on serum kidney profile, it was administered chronically to the male Sprague-Dawley rats at a dose of 400 mg/kg for 43 days. Naradiya Laksmivilasa Rasa significantly decreased albumin and A/G ratio and significantly increased globulin, urea and Blood Urea Nitrogen (BUN) level. BUN/Creatinine and Urea/Creatinine level were significantly increased in NMB treated rats when compared to normal control. The drug (NMB) did not affect total protein and creatinine level significantly. This experimental data will help the clinician for the logical use of NMB in different disease conditions.

M. S. K. Choudhuri
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Chintamanichaturmukh Ras (CMC) is an Ayurvedic preparation used as a traditional medicine in the treatment of vertigo in the rural population. To find out the toxicological characteristic of CMC, it was administered chronically to the male Sprague-Dawley rats at a dose of 40 mg/kg for 28 days. After 28 days chronic administration of the CMC preparation, the following toxicological changes were noted. All throughout the experimental period the CMC treated animals were always maintaining decrease in body weight but it was not significant. There was a statistically significant (p=0.039; 9.28 % decrease) decrease in the relative percent weight of the male rat heart. There was a statistically significant decrease in the absolute weight of the male rat liver (p=0.018; 19.04 % decrease) and a statistically highly significant decrease was noted in case of relative percent weight of the liver (p=0.01; 18.61 % decrease). There was also a statistically highly significant (p=0.002; 4.31 % decrease) decrease in the organ water content of the rat liver.

M. S. K. Choudhuri
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Chandrangshu Ras (CDR) is an ayurvedic preparation used as a traditional medicine in the treatment of vulvodynia. In this study, effect of CDR on organ toxicity profile was evaluated after chronic administration of this drug to male Sprague-Dawley rats. The acute pharmacological study of CDR recorded no death or any signs of toxicity even at the highest dose of 4000 mg/Kg body weight. For chronic pharmacological evaluation, the animals were divided into two groups. The first group was given CDR preparation at a dose of 100 mg/kg body weight for 32 days while the second group that served as the control received water for the same period. After 32 days of chronic administration of the CDR preparation, the following effects on the organ toxicity profile were noted. All throughout the experimental period the CDR treated animals were always maintaining negligible decrease in body weight, in the body weight study, but it was not significant. The drug (CDR) did not affect any absolute or relative percent weight of different organs of the body and also water content of these organs significantly. So, the results of the present prospective study showed that ayurvedic treatment with Chandrangshu Ras is safe for oral administration

A simple and rapid determination of candesartan in human plasma by LC-MS/MS
Venkateswarlu Ponneri
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The authors described a novel liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for the determination of candesartan in human plasma. The method employs isotope labelled compound, candesartan d4 as internal standard (IS). A simple and one step solid phase extraction (SPE), was used to extract the analyte and the IS. An isocratic mobile phase composed of methanol–5mM ammonium acetate (70:30, v/v) was used to separate the components on C18 column. The method was validated in the range of 1.03–307.92 ng/mL as per the US FDA guidelines. Precision and accuracy results were calculated using five successful calibration curves. All stability tests were well within the acceptable limits. A total run time was set at 2.5 min, which allow us to analyze more number of samples in a single run.

Evaluation of Cytotoxic Activity by Brine Shrimp Lethality Bioassay of Ethanol Extract and Its Different Fractions of Anogeissus acuminata (Roxb.) Leave
Mahmudul Hasan
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Background: The purpose of the investigation was to ascertain whether the leaf extracts of Anogeissus acuminata holds any significant medicinal properties. Methods: Leaves of A. acuminata was extracted with pure ethanol (EEAA), then methanol extract fractioned with n-hexane (NHFEEAA), chloroform (CHFEEAA), ethyl acetate (EAFEEAA) and methanol (MFEEAA). Cytotoxic assay was done by using brine shrimp lethality bioassay for measuring LC50. Results: Ethanol extract and its different fractions of leaves of A. acuminata showed moderate to well cytotoxic effect. In brine shrimp lethality bioassay, MFEEAA and CHFEEAA revealed the highest cytotoxic activity having LC50 values 215.32 ± 3.02 µg/ml and 234.56 ± 2.01 µg/ml, respectively. Conclusions: The overall results of the study indicated significant cytotoxic activity of ethanol extract and its different fractions of leaves of A. acuminata. Furthermore, this plant deserves further investigation for other paramount pharmacological activities and comprehensive research and isolation of the active constituents responsible for these activities and establishes the mechanism of action.

Assessment of Quality Of Life and Functional Disability among Hemophilia A Patients
Hrishikesh G
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Hemophilia is characterized by spontaneous and post-traumatic bleeding and its complications in joints and muscles leads to severe pain, severe joint damage, disability, and a dramatic impairment of quality of life (QOL). The purpose of the study is to access the QOL and to determine the functional disability affecting the individuals with hemophilia A. 102 patients of hemophilia A of age > 5 years and on clotting factor concentrate treatment (on- demand protocol) were included in the study. QOL was assessed with SF-36 questionnaire which includes 36 questions measuring physical and mental health with respect to eight health domains. Functional evaluation was done by World Federation of Hemophilia (WFH) approved Gilbert scoring system. Pearson Correlation explored the association between age of diagnosis, functional disability and QOL. In our study, QOL of hemophilia A patients was seems to be satisfactory and negative correlation was found between the quality of life and functional disability in hemophilic patients

Evaluation of Changes in Health Related Quality of Life (HRQoL) before and after Coronary Artery Bypass Grafting (CABG)
Pere Vishwas
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Coronary Artery Disease (CAD) is a major cause of morbidity and mortality in developing countries. Coronary Artery Bypass Grafting (CABG) has become the most frequently used treatment for CAD. Measuring and understanding the current status of Health Related Quality of Life (HRQoL) of patients before and after CABG is essential to manage the disease more effectively. We conducted 6 months Prospective, observational study at Narayana Hrudayalaya Hospital (tertiary care) with 98 CAD patients to evaluate the changes in HRQoL before and 3-months after CABG using SF-36 questionnaire. Demographics of patients including clinical parameters such as medical history, diagnosis of CAD and disease severity were collected. All the 8 domains of SF-36 (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health) improved significantly (P<0.05) from before to 3-months after CABG. The results of the study quantify the benefits of CABG on HRQoL of patients. This study also revealed the desired prognosis of our patients.

Naproxen-Soluplus® Nano formulations for Enhanced Oral Bioavailability
K. Venkataramaniah
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Naproxen-Soluplus Nanoformulations (NFs) prepared via wet milling, using a conventional Retsch Planetary ball mill have been studied for their phase solubility behavior, physico-chemical characteristics, cytotoxicity, and morphology and dissolution enhancement. The highest dissolution enhancement of 172% over that of pure the drug was achieved for the formulation with Naproxen-Soluplus® ratio of 1:4. The ability of amphiphillic surfactant carriers to accelerate in vitro dissolution of poorly water-soluble drugs has been attributed to wetting, miceller solubilization, and/or deflocculation. The Korsemeyer–Peppas model most aptly fits the in vitro dissolution data and gives an insight into the possible drug release mechanisms predominated by anomalous non-Fickian diffusion which improves the physicochemical characteristics of naproxen towards its dissolution enhancement and the increase in the oral bioavailability of the drug without any adverse cytotoxic consequences.

Stabity indicating Dissolution Method Development for Estimation of Paracetamol & Chlorzoxazone in Combine Dosage form
H.N khan
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The present work concerns with development and validation of dissolution test for Paracetamol and Chlorzoxazone in combine tablets dosage form using spectrophotometric method. 0.1M HCl (pH 1.0, 900 mL) was used as dissolution medium, using a paddle apparatus, stirring rate was 50 rpm. The percent drug release was determined by UV spectrophotometric method the wavelength selected for analysis are 242.80 nm for Paracetamol and 279.80 nm for Chlorzoxazone from results it can be concluded that the method developed consists in an efficient alternative for assay of this tablets combination. The method was validated to meet requirements for a global regulatory filing which includes validation parameters as linearity, accuracy, precision, ruggedness and robustness which are as per ICH guidelines. In addition, filter suitability and drug stability in medium were demonstrated.

Hermansky-Pudlak Disorder (HPS)
Mandava Mahima Swaroopa
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Hermansky-Pudlak disorder (HPS) is a multisystem disease that is acquired in an autosomal latent way and is portrayed by tyrosinase-positive oculocutaneous. Hermansky-Pudlak disorder (HPS), the most penetrant of the hereditary pneumonic fibrosis disorders, gives a convincing criterion to concentrate the cell pathogenesis of aspiratory fibrosis. At present, OMIM (On line Mendelian Inheritance of Man) portrays 10 hereditary subtypes of HPS: sort 1 (because of changes in HPS1), sort 2 (AP3B1), sort 3 (HPS3), sort 4 (HPS4), sort 5 (HPS5), sort 6 (HPS6), sort 7 (DTNBP1), sort 8 (BLOC1S3), sort 9 (BLOC1S6), and sort 10 (AP3D1) product of 8 of the 10 HPS genes. Hermansky-Pudlak disorder platelets and wild-sort (WT) endothelial cells. Typically, platelets contain two sorts of granules as alpha and delta granules. The diagnosis of Hermansky-Pudlak disorder (HPS) is set up by clinical disclosure of oculocutaneous albinism in blend with a draining diathesis of variable seriousness. There is no compelling treatment for aspiratory fibrosis because of HPS, Desmopressin can be utilized as prophylactic treatment.

Therapeutic Effect of Thymoquinone against Methotrexate-Induced Damage on Sperm Parameters in Mice
Zahra Keshtmand
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Background: Methotrexate drug is commonly used to treat cancer and caused reproductive damage. Thymoquinone, as a natural component of herbs has many health benefits shown in researches. The present study amid to investigate probable therapeutic effect of Thymoquinone against Methotrexate- induced damage on sperm parameters in mice. Material and methods: In this experimental study, 30 male mice (25-30 g) were divided into five groups of six in each. The mice were received normal saline (control group), Methotrexate (20 mg/kg), Methotrexate (20 mg/kg) + Thymoquinone (2, 10 and 20 mg/kg) by intraperitoneal injection. On the day after the last injection, the sperm parameters including motility, viability and count of sperms were assessed. Data analysis was performed using one-way ANOVA followed by Turkey test. Results: Methotrexate alone leaded to a significant reduction in sperm parameters compared to the control group (P=0.00). In groups treated with Methotrexate and Thymoquinone, sperm parameters (motility, viability, count sperm) did not showed any significant differences with control group (P=0.00). Conclusion: Thymoquinone, as a potent antioxidant, could compensate for the toxicity induced by Methotrexate. These medical trend may be useful for diminish the side effects of Methotrexate on male reproductive system.

Self-emulsifying Drug Delivery System of Rosuvastatin Calcium
Dr. Meenal Rane
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Introduction: Oral route is the preferred route for higher patient compliance. Rosuvastatin Calcium is BCS class II drug and its oral bioavailability is 20%. To overcome this problem, studies were performed to enhance the solubility of the Rosuvastatin Calcium in order to improve the bioavailability. Materials and methods: Different permutations and combinations of oils such as Castor oil, Cottonseed oil, Olive oil, Soyabean oil, Olyl alcohol, Peceol, Rice bran and Sunflower oil, surfactants Tween 20, Tween 80, Kollisolve PEG 400, Cremophore RH 40, Cremophore EL and co-surfactants PEG 200, PEG 400, Transcutol HP were tried in order to deduce the compatible oils and (co)surfactants to prepare pseudo-ternary phase diagram. Results and discussion: The optimized batch of Rosuvastatin Calcium SEDDS was prepared using Peceol (10%), Tween-20 (30%) and Transcutol (30%) having average particle size 76.88nm, polydispersibility index 0.555 and zeta potential of -24.5 mV. In addition, drug entrapment in the optimized batch was found to be 95.89%. The stability studies data of 3 months shows that the emulsion was stable for at least 3 months with drug entrapment 91.60 ± 0.02%. The formulation showed approximately 95% drug release within 15 min as compared to the pure drug, which showed drug release of 36.56% in phosphate buffer pH 6.8. Conclusion: From the above study, it can be concluded that SEDDs can be a promising approach to improve the solubility and in order to improve the oral bioavailability of Rosuvastatin Calcium.

A Trial for Smoking Cessation during Ten Days through using Antidepressant Imipramine 25 mg daily
Jubran K. Hassan
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Purpose: This study explores the possible positive effect of imipramine on daily cigarettes smoking and if it may enforce stopping smoking during ten days by using 25 mg once at night orally. Methods: Using placebo control study. In which adult smokers\' volunteers were assigned to one of study groups; control (N=52) or Imipramine group (N=102). All volunteers take their medications as single daily dose at night and start to report number of cigarettes smoked daily for 10 days with reporting side effects appeared during the study. Results: Imipramine group showed significant declining in number of cigarettes daily smoked as compared with day 1 of study and as compared with control group. 94.1% of volunteers reduced daily smoking also 11.8% of volunteers stop smoking at the end of study. Side effects reported in the study were drowsiness and headache and sleep disturbance. Conclusions: Imipramine was effective to reduce number of daily cigarettes smoked and may help to stop this habit.

Evaluation of Antibacterial Effect of Ethanol Extract and its Different Fractions of Anogeissus acuminata [Roxb] Leaves by Disk Diffusion Technique
Syed Md. Abdul Kader
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Background: The reason of the present study was to assessment of antibacterial effect of leaves extract of Anogeissus acuminata [Roxb.] and its different fractions. Methods: Leaves of A. acuminata was extracted with pure ethanol [EEAA], then methanol extract fractioned with n-hexane [NHFEEAA], chloroform [CHFEEAA], ethyl acetate [EAFEEAA] and methanol [MFEEAA]. Antibacterial activity was measured by observing zone of inhibition for each extract and fractions on both gram positive and negative bacteria. Results: The highest antimicrobial potential observed for MFEEAA [12.0 ± 0.50] mm of zone of inhibition with 43.47% relative percentage of inhibition at 1000 μg/disc compared to Kanamycin 30 μg/disc and EEAA extract showing 41.33% of relative percentage of inhibition at 1000 μg/disc. Conclusions: In a nutshell, results of the present experiments indicated significant Antibacterial action of the extract and fractions of leaves of A. acuminata. Moreover, this plant warrants additional research for other supreme pharmacological activities and inclusive research and isolation of the dynamic constituents accountable for these activities and set up the mechanism of action.

Phytochemical and Gc-Ms Analysis of Bioactive Components in Ethanolic Bulb Extract of Allium Porrum
Odeyemi Omonike S
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The present study investigated the phytochemical and biochemical composition of the crude ethanolic extracts of A. porrum plant. High polarities solvents (ethanol) were used for extraction of A. porrum. Qualitative phytochemical analysis of the plant extracts was followed by gas chromatography mass spectrophotometry (GC-MS) to determine the bioactive constituents. The phytochemical investigation of crude ethanolic extract of A. porrum plant showed the presence of flavonoids, alkaloids, saponins, cardiac glycoside and terpenoids. GC-MS indicated the presence of (ten) 10 different types of high and low molecular weight biocompounds including fatty acids, esters and heterocyclic compounds. Hexadecanoic acid ethyl ester (38.63%), octadecanoic acid (18.11%) and docosanoic acid ethyl ester (16.88%), constituted the major biocomponents of the ethanolic fraction of A. porrum. This study established the biochemical composition of the bulb of A. porrum which have a commendable bioactivity and can be advised as a plant of phytopharmaceutical importance as used in traditional medicine.

Phytochemical and Pharmacological Evaluation of Methanolic Extract of Euphorbia hirta L
Abid Newaz Shihab
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Background: Euphorbia hirta is a plant mostly known as dudhiya in locally; belonging to the family Euphorbiaceae has been investigated for the presence of its secondary metabolites and evaluation of biological activities of the crude extractives with special emphasis to the antibacterial, anti-inflammatory and hypoglycemic activities. The phytochemical constituents of the dried powdered plant parts were extracted using organic solvents (methanol).Methods: Primary phytochemical screening was accomplished by using established methods. Antibacterial activity tested on three gram-positive and three gram-negative bacteria by disk diffusion method. In vitro anti-inflammatory effect tested on the human RBC cell caused by the control group and comparing it with the positive and test group. The in vivo action was done using mice of both sexes. Hypoglycemic effect evaluated by oral glucose tolerance test (OGTT).Results: In our study of the antibacterial assay, we have tried Euphorbia hirta preparations against some gram positive and gram-negative bacteria. The extract at two different concentrations 1000 μg/disc and 700 μg/disc showed significant as compared with standard Kanamycin 30 μg/disc showed zone of inhibitions against Gram-positive Staphylococcus aureus (Nil), Bacillus subtilis (10.0 ± 1.00,7.0 ± 0.50), Bacillus cereus (Nil), Salmonella typhi (9.5 ± 0.50, 8.0 ± 0.29), Salmonella paratyphi (11.0 ± 0.50, 7.5 ± 0.50), Escherichia coli (12.5 ± 0.50, 8.5 ± 0.50) respectively. The percentage of membrane stabilization for methanolic extract of Euphorbia hirta is effective in inhibiting the heat-induced hemolysis of HRBC at different concentrations (1000, 500, 250, 125 μg/ml). Hence anti-inflammatory activity of the extracts was concentration dependent. In OGGT, the percentage of decrease of blood glucose level in glucose-induced mice after 2 hours with different treatment. MEEH at the highest dose of 800 mg/kg decreased blood glucose level (24.34%) than other treatments, accept standard Glibenclamide.Conclusion: The present research suggests that that Euphorbia hirta leaf extract has significant antibacterial, anti-inflammatory and hypoglycemic activities. We can say that the obtained results support for the uses of this plant as traditional medicine.