INVESTIGATION OF STABILITY OF KOREAN GINSENG IN HERBAL DRUG PRODUCT

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 t_1/2 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.