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Quality of traditional medicine in microbial limit test for traditional medicine registration
  • 1.04.2019
  • 1,260
Quality of traditional medicine in microbial limit test for traditional medicine registration
Owner / Producer Owner / Producer
Thanaphon Iamsa-ard, Santipong Wongpentak, Ananya Suphanwanich, Khwanruedee, Limthongcharoen
Year Year
2019
Pages
1
Details

Bureau of drug and narcotic, Department of Medical Science is the main unit which is responsible for the analysis of microbial contamination in traditional medicine for registration. According to the announcement of Thai FDA regarding the microbiological test of traditional medicine for registration, Staphylococcus aureus/gram, Salmonella spp. /10 grams and Clostridium spp. /10 grams should be absent. The test method used follows the TP Supplement 2005. The microbial count in the 828 samples of the traditional medicine registered at Thai FDA during 2014-2018 was investigated. In 2014, 20 samples from 203 samples (9.85%) failed. In 2015, 39 samples from 235 samples (16.59%) failed. In 2016, 34 samples from 158 samples (21.5%) failed. In 2017, 9 samples from 118 samples (7.62%) failed. In 2018, 17 samples from 114 samples (18.5%) failed. The microbial found in the sample was Clostridium spp. Generally, Clostridium spp. is found in soil and can be diarrhea disease. This indicates that the manufacturing process and quality control of the products need improvement by use raw data of research for manufacture guideline.
Keyword: Clostridium spp.