The Study of Microbiological Quality of Herbal Medicinal Products in Solid Dosage Form

Abstract

Introduction: Today’s consumers are increasingly accepting herbal medicinal products. Manufacturers are responding, with more herbal medicinal products appearing on the market. Microbiological quality is an important problem for products which contain excipients of natural origin. Usually, preservatives are not added to herbal medicinal products in solid dosage form. Although this type of product does not meet the microbiological quality requirement, it is difficult to find any visible signs of contamination. This can lead to carelessness of manufacturers about quality control. Objective: The objective of present study was to study microbiological quality of herbal medicinal products in solid dosage form. The requirement in Thai Herbal Pharmacopoeia was use as microbiological quality standard. Methods: The methods used in this study were modified from USP31. Results: The totals of twenty-six samples were selected from Mahasarakham and neighbor provinces. The results showed that 20 samples (76.29%) met the requirement of total aerobic microbial count, 3 samples (11.54%) met the requirement of total combined yeasts and molds count and 25 samples (96.15%) met the requirement of Salmonella sp. In addition, it was found that all of non-registered products did not comply the standard at least one requirement. Conclusion: These results indicated that microbiological quality, especially yeast and mold contamination problem, was still important problem. Manufacturers were required action in process and quality control system improvement to provide consumer adoption of herbal medicinal products in the aspect of efficacy and safety in order to widely use and can be competitive in international markets.