Toksisitas Akut Dermal Ekstrak Tanaman Sebagai Bagian dalam Aspek Keamanan Obat Herbal Terstandar Topikal

Abstract

Dermal inflammation, for example, acne (acne vulgaris), is traditionally treated using plants, therefore, many studies have explored various plant extracts by in vitro method. However, the use of plant extracts as topical drug must follow the Regulation of the Head of The Department of Drug and Food Supervisor (BPOM) No. 32/2019 concerning SAFETY AND QUALITY REQUIREMENTS OF TRADITIONAL DRUGS, which includes three aspects, such as safety, quality, and effectiveness. Furthermore, the safety of topical drugs is ensured through the Dermal Acute Toxicity Test, as stated in the Regulation of the Head of BPOM No. 7/2014 concerning GUIDELINES FOR IN VIVO NONCLINICAL TOXICITY TESTS. This literature review summarizes acute toxicity tests of plant extract dermal that have been carried out in various countries. The study was conducted using the keywords "Acute", "Dermal", "Toxicity", "Extract" in the PubMed database, and resulted in 15 articles. In these articles, all plant extracts tested in the fifteen articles were reported safe because they did not cause symptoms of toxicity or death at doses above 2000 mg/kg BW. It can be concluded that acute dermal toxicity tests of plant extracts are an important factor in the safety of developing a topical standardized herbal drug.