Abstract
This study was designed to investigate long term stability of K-Gin capsules, a herbal medication that contains korean ginseng. Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product. Conducting long term stability studies following the guidelines issued by ICH, WHO and USP. The drug was stored under different climatic conditions: (25±1°C, humidity: 75%) Chamber 1(CH1); (30±1°C, humidity: 75%) Chamber 2(CH2) and (40±1°C, humidity 75%) Chamber 3(CH3) for 24 months,evaluation of capsulestchemicaly (ginsenosides Rg1 and Rb1), physicaly and microbiologicaly, besides determination of certain elements including heavy metals, detection of pesticides residues and mycotoxins. The activation energies were found to be 10.99 and 10.2 (k.cal.mol-1) for Rg1 and Rb1 respectively. The calculated t1/2 values for Rg1 were found to be 94 months in (CH1), 68.4 months in (CH2) and 51 months in (CH3). For Rb1 were found to be 100.3 months in (CH1), 73.39 months in (CH2) and 56.7 months in (CH3). Capsules assay results for Rg1 after 24 months period of study were found to be 98.93% in (CH1), 97.13% in (CH2) and 96.43% in (CH3). For Rb1 96.93% in (CH1), 96.83% in (CH2) and 96.13% in (CH3). Studies on the elemental composition confirmed absence of toxic heavy metals. Microbiological studies revealed no significant changes in total viable aerobic count of bacteria and fungi. The capsules were found to be free from any pesticides residues and the mycotoxins content was 723 ng kg-1. The methods involved in this study covered, High Performance Liquid Chromatography (HPLC), Atomic Absorption Spectroscopy (AAS), Gas Chromatography-Mass Spectrometry (GC-MS) and ELISA. The results were found to be within the allowable limits stated in the guidelines. From this study K-Gin capsules were proved to be stable chemicaly and physicaly under studied storage conditions for 24 months.
Highlights
Asian medicine and is considered an adaptogen
Korean ginseng is officially registered in Saudi Arabia for its anti-diabetic and anti-inflammatory effects, as well as cardiovascular protection with a recommended dose of 700 mg twice daily
The present study was designed to investigate the stability of Korean ginseng capsules, besides carrying the general chemical, physical and microbiological quality control measurements for it
Summary
Asian medicine and is considered an adaptogen. Panax death in the world, many reports have focused on ginseng C.A. Korea and more than 30 ginseng saponins (ginsenosides) pharmacological actions of ginseng are attributed to a have been isolated as the main biologically active variety of ginsenosides, which are triterpenoid saponins constituents that include anti-carcinogenic, anti-diabetic (Attele et al, 1999; Huang et al, 2005). Since ginsenosides produce effects that differ from one another and a single ginsenoside initiates multiple actions, the overall pharmacology of ginseng is complex. Korean ginseng is officially registered in Saudi Arabia for its anti-diabetic and anti-inflammatory effects, as well as cardiovascular protection with a recommended dose of 700 mg twice daily. Stability data is not reported in the official registration files of Korean ginseng. The present study was designed to investigate the stability of Korean ginseng capsules, besides carrying the general chemical, physical and microbiological quality control measurements for it
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