EFEKTIVITAS DAN AKTIVITAS BIOLOGI FITOFARMAKA DARI STANDARISASI BAHAN ALAM HINGGA UJI PRAKLINIK DAN KLINIK

Abstrak

Latar Belakang Efektivitas dan aktivitas biologis fitofarmaka berdasarkan proses standarisasi bahan alam serta hasil uji praklinik dan klinik yang telah dipublikasikan. Masyarakat Indonesia banyak menggunakan obat tradisional, namun rendahnya standar ilmiah dan mutu produk menjadi kendala dalam penggunaannya oleh tenaga kesehatan. Oleh karena itu, Kementerian Kesehatan dan BPOM menerapkan regulasi dan pendampingan uji klinik untuk memastikan obat berbahan alam memenuhi standar farmasitikal dan dapat dipertanggungjawabkan secara ilmiah. Tujuan penelitian untuk mengkaji efektivitas (keberhasilan suatu perlakuan ) dan aktivitas (kemampuan) biologis beberapa tumbuhan fitofarmaka yang prosesnya telah memenuhi syarat dari fitofarmaka dimulai dari standarisasi bahan, uji praklinik dan uji klinik. Metode penelitian ini menggunakan tinjauan literatur dengan pengumpulan, skrining, dan seleksi dari berbagai sumber.  Hasil kajian menunjukkan bahwa beberapa tanaman sudah masuk pada tumbuhan fitofarmaka yang dapat dikonsumsi karena telah memenuhi proses standarisasi bahan, uji praklinik dan uji klinik Efektivitas biologis ditunjukkan melalui respon klinis maupun fisiologis yang signifikan, seperti penurunan parameter inflamasi, perbaikan fungsi metabolik, peningkatan fungsi imun, serta perbaikan kondisi klinis tertentu. Aktivitas biologis yang mendasari efek tersebut meliputi aktivitas antiinflamasi, imunomodulator, antihipertensi, antidiabetes, analgesik, diuretik, dan laktagogum, yang berkaitan dengan kandungan senyawa bioaktif seperti flavonoid, alkaloid, terpenoid, dan polifenol. Hasil ini mendukung potensi tanaman obat sebagai fitofarmaka. Kesimpulannya, perlakuan menggunakan sediaan tanaman obat fitofarmaka yang telah melalui proses standarisasi bahan, uji praklinik, dan uji klinik menunjukkan keberhasilan yang terukur menghasilkan kemampuan biologis tanaman, yang diwujudkan melalui efektivitas biologis seperti penurunan peradangan dan nyeri, pengendalian kadar glukosa dan tekanan darah, peningkatan respon imun, perbaikan kualitas tidur, kelancaran fungsi saluran kemih, serta peningkatan kecukupan ASI dan aktivitas biologi : antiinflamasi munomodulator, antidiabetes, antihipertensi, analgesik, diuretik, sedatif-hipnotik, dan laktagogum. 

Background The effectiveness and biological activity of phytopharmaceuticals are based on the standardization process of natural ingredients and published results of preclinical and clinical trials. Indonesians widely use traditional medicines, but low scientific standards and product quality are obstacles to their use by healthcare professionals. Therefore, the Ministry of Health and the Food and Drug Authority (BPOM) implement regulations and clinical trial assistance to ensure that natural medicines meet pharmaceutical standards and can be scientifically justified. The purpose of this study is to assess the effectiveness (success of a treatment) and biological activity (ability) of several phytopharmaceutical plants whose processes have met the requirements of phytopharmaceuticals starting from material standardization, preclinical and clinical trials. This research method uses a literature review with collection, screening, and selection from various sources. The results of the study indicate that several plants have been included in the phytopharmaceutical plants that can be consumed because they have met the process of material standardization, preclinical and clinical trials. Biological effectiveness is demonstrated through significant clinical and physiological responses, such as reduced inflammatory parameters, improved metabolic function, increased immune function, and improvements in certain clinical conditions. The biological activities underlying these effects include anti-inflammatory, immunomodulatory, antihypertensive, antidiabetic, analgesic, diuretic, and lactagogic activities, which are related to the content of bioactive compounds such as flavonoids, alkaloids, terpenoids, and polyphenols. These results support the potential of medicinal plants as phytopharmaceuticals. In conclusion, treatment using phytopharmaceutical medicinal plant preparations that have gone through the process of material standardization, preclinical testing, and clinical testing shows measurable success in producing the biological capabilities of plants, which are manifested through biological effectiveness such as reducing inflammation and pain, controlling glucose levels and blood pressure, increasing immune response, improving sleep quality, smoothing urinary tract function, and increasing breast milk sufficiency and biological activities: anti-inflammatory immunomodulator, antidiabetic, antihypertensive, analgesic, diuretic, sedative-hypnotic, and lactagogum.