Conventional treatments for liver damage exist but not accessible to low middle-income countries (LMIC) populations. Due to this limitation, traditional healers use plants that they consider effective for the treatment of local diseases. One of the most popular herbal plants is Phyllanthus amarus used as a decoction, but without insurance of safety, efficacy and quality. The objective of this work was to develop a drug based on this plant according to the requirements of the international pharmacopoeia. Thus, tests of hepatoprotective activity, acute toxicity and galenic preformulation were carried out. Phytochemical screening showed the presence of polyphenols, flavonoids, cardiac glycosides, tannins and coumarins. The aqueous extract of the plant was administered to rats at different doses (100, 200 and 400) mg/kg/PC for seven days and paracetamol was administered on the fifth day at a dose of 2000 mg/kg/PC to induce disease; sylimarine was used as the reference standard drug. The results showed good protection of the liver at the dose of 400 mg/kg/PC. As for acute toxicity, the dose of 2000 mg/kg/PC of extract showed no signs of harm. An Improved Traditional Medicine (ITM) was preformulated as a capsule from the aqueous extract of this plant. The pharmaceutics controls carried out on these capsules made it possible to conclude that this Improved Traditional Medicine conformed to the production standards of the International Pharmacopoeia.
Keywords: Phyllanthus amarus, metabolites, hepatoprotection, preformulation, quality control
Headlines: Introduction, Experimental section, Results, Discussion, Conclusions, Know-How Transfer