Rosella (Hibiscuss sabdariffa L) Extract Quality Test for Phase-1 Clinical Trials

Abstract

The use of rosella extract administered to humans must pass the quality process test. This study is intended to prepare high quality rosella extract preparations based on Good Manufacturing Practice (GMP) which will be used in phase 1 clinical trials, including the standardization of the extract qualitatively, description of the sensory evaluation test, physicochemical, microbiological. The method used in the extraction process performed by solvent extraction method by maceration using ethanol in acidic conditions with a ratio of 4: 1. Determination of anthocyanin levels using the method of determining pH differentiation, to determine levels of flavonoids by using the aluminum chloride method, visual description sensory evaluation, and physicochemical. Then the microbiological test was conducted using the Total Plate Number (ALT) method. Screening shows rosella extract contains flavonoids and anthocyanins. Roselle extract contains anthocyanin at 10,6 mg/L and total flavonoids equivalent to quercetin 1,3 % w/w. The description sensory evaluation tests have a dark red, homogeneous appearance, smell and taste character like rosella. Physicochemical test results showed particle size 0,82 mm, water solubility 14,2%, alcohol solubility 5,6 %, loss on drying at a temperature of 70 °C at 9,8 %, density 0.72 g / ml, pH at 25 °C was 2.62. Rosella Extract free from aflatoxin and metal. The result test of microbiological aerobic plate count is <1,1E+3 cfu/g, Yeast and Mold <1,1E+3 cfu / g, Coliform APM negative, Salmonella sp negative, Shigella negative, Escherichia coli negative, Staphylococcus aureus negative, Pseudomonas aeruginosa negative. Conclusion, the qualitative test results of ethanol extract can be administered as ready-to-use products in phase 1 clinical trials.