University of Khartoum

Quality Assessment of Two Herbal Drugs (K-Gin and Victoria 1500and 2000) in Bulk and Capsules Form Marketed in Saudi Arabia

Quality Assessment of Two Herbal Drugs (K-Gin and Victoria 1500and 2000) in Bulk and Capsules Form Marketed in Saudi Arabia

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Title: Quality Assessment of Two Herbal Drugs (K-Gin and Victoria 1500and 2000) in Bulk and Capsules Form Marketed in Saudi Arabia
Author: Babiker, Latifa Bashir
Abstract: The main objective of this study is to assesst the quality of Korean ginseng & Victoria (1500 a&2000) capsules, two herbal medications containing ginseng (ginsenosides Rg1&Rb1) and royal jelly(10-hydroxydec-2-enoic acid (10-HDA)) yohimbine and ginseng respectively. The study includes the long term stability of the capsules,also included determination of elements(including heavy metals), studying the microbiological stability, detection of pesticides residue and mycotoxins, for both drugs and running toxicity studies in mice. Methods Stability studies: Both herbal drugs were stored under different simulated climatic conditions: Climatic chamber No. 1(CH1) (25°C  1°C, humidity: 75%); Climatic chamber No. 2(CH2) (30°C  1°C, humidity: 75%) and Climatic chamber No. 3 (CH3)(40°C  1°C, humidity 75%). HPLC methods were adopted to follow ginseng ,yohimbine and 10-hydroxydec-2-enoic acid and good separation for active ingredients was acheived.The optimum separation was obtained using C18 Hypersil column, acetonitile and water as mobile phase, and 205nm for detection of ginsenosides(Rg1&Rb1) , C18 Hypersil column, water and methanol as mobile phase and 225nm for detection of 10-HDA and µ bondaback C-18, methanol and 0,005M octane sulfonic acid salt mobile phase and 254nm for detection of yohimbine. Elemental analysis was done using atomic absorption spectrophotometer. Microbiological analysis was carried out using the standard protocol for the total viable count. The pesticides residues were analyzed by GC-MS usig Column: (1). RTX-5, 30 M, 0.25 mm ID, 0.25 μm (5% diphenyl 95% dimethyl Polysiloxane, (2). RTY-35 MS, 30 M, 0.25 mm ID, 0.25 μm (35% dephenyl-65% dimethyl polysiloxane. Determination of aflatoxins was carried out through antigen antibody reaction using Enzyme linked immunosorbent assay (ELISA). Toxicity studies: The studies were carried out using male and female mice adopting acute, sub-acute and chronic toxicity. Results Stability studies: Physical examination of capsules over the period of 24 months, showed that the powder retained its brown color and no distinctive odor was noticed, except in CH2 and CH3 after 24 months where color changed to dark brown. The developed HPLC methods used for both drugs were validated and found to be accurate, sensitive and precise. The reaction rate constant (K), the half-life (t1/2) and the activation energy were calculated for ginsenosides Rg1&Rb1. K-Gin capsules were proved to be stable chemically and physically under studied storage conditions. Victoria 1500&2000 capsules were found to comply with the given specifications up to six months storage, thereafter, the samples showed physical &chemical instability with a decrease in Rg1,Rb1 and 10-HDA contents but without effect on yohimbine content. Studies on the elemental composition of K-Gin and victoria 1500&2000 capsules confirmed absence of toxic heavy metals. Microbiological studies revealed no significant changes in total viable aerobic count of bacteria and fungi. Both capsules were found to be free from any pesticide residues. The mycotoxin contents were found to be within the allowable limits. Toxicity studies: Hematological studies for capsules revealed an increase in RBC’s and hemoglobin upon acute and sub-acute treatment of male and female mice as compared to the control. Biochemical studies for both capsules during acute and sub-acute toxicity caused a reduction in blood glucose levels . Hematological studies for K-Gin capsules on the chronically treated male and female mice revealed asignificant increase in RBC’s and hemoglobin as compared to the control, while no changes were observed for victoria capsules. Biochemical studies for K-Gin capsules caused a significant reduction in blood glucose levels, while no changes were observed for victoria capsules. Histopathological modifications (heart, liver, kidneys and lungs) were not observed in mice treated with both capsules. Treatment also showed no spermatotoxic activity for victoria capsules Conclusion From the current study K-Gin capsules was found to be stable under the storage conditions and should be stored under the recommended storage conditions, while Victoria 1500&2000 capsules were not comply with the specifications over the given shelf life. Acute toxicity studies revealed that both capsules were devoid of any clastogenic potentials. Hematological and biochemical studies revealed no drastic changes indicating that K-Gin and victoria possess non-significant toxicity. Chronic treatment with K-Gin and victoria induced no clastogenic or cytotoxic effect. Based on the results of the current toxicity studies, it is concluded that K-Gin and Victoria 1500 and Victoria 2000 capsules possess low toxicity and could be used in the labeled dose, without any remarkable side effects.
Description: 171 Pages
URI: http://khartoumspace.uofk.edu/123456789/16816
Date: 2015-10-29


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