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

Tresnafuty Rasyiida Diina, Indah Suasani Wahyuni, Jutti Levita

Abstrak


Inflamasi dermal, misalnya jerawat (acne vulgaris), secara tradisional, sering diobati menggunakan tanaman, sehingga beberapa riset mengeksplorasi ekstrak tanaman secara in vitro. Namun demikian, penggunaan ekstrak tanaman sebagai obat topikal tetap harus mengikuti Peraturan Kepala Badan Pengawas Obat dan Makanan No. 32/2019 tentang PERSYARATAN KEAMANAN DAN MUTU OBAT TRADISIONAL, yang meliputi tiga aspek yaitu keamanan (safety), mutu (quality), dan efektif (efficacy). Lebih lanjut lagi, keamanan obat topikal dipastikan melalui Uji Toksisitas Akut Dermal, seperti tercantum di dalam Peraturan Kepala Badan Pengawas Obat dan Makanan No. 7/2014 tentang PEDOMAN UJI TOKSISITAS NONKLINIK SECARA IN VIVO.  Kajian pustaka ini merangkum uji toksisitas akut dermal ekstrak tanaman yang telah dilakukan di berbagai negara. Kajian dilakukan menggunakan kata kunci “Acute”, “Dermal”,Toxicity”, “Extract” pada basis data PubMed, dan menghasilkan 15 artikel. Hasil kajian pustaka menunjukkan bahwa semua ekstrak tanaman yang diuji di dalam kelimabelas artikel tersebut dinyatakan aman karena tidak menimbulkan gejala toksisitas ataupun kematian pada dosis di atas 2000 mg/kg BB. Dapat disimpulkan bahwa uji toksisitas akut dermal ekstrak tanaman merupakan faktor penting dalam keamanan pengembangan suatu obat herbal terstandar topikal


Kata Kunci


keamanan obat herbal terstandar, toksisitas akut dermal

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Referensi


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DOI: https://doi.org/10.25077/jsfk.9.2.71-79.2022

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