Conventional treatments for liver damage exist but not within the reach of low middle-income countries (LMIC) populations. Due to the awareness of this limitation, traditional healers use plants that they consider effective for the treatment of local diseases. One of the most popular herbal plant is Phyllanthus amarus used as a decoction, but without assurance 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. For this reason, tests of hepatoprotective activity, acute toxicity and a 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 medicine. 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. A Traditional Improved Medicine (MTA) was pre-formulated 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, pre-formulation, quality control

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