TEDY HIDAYAT, - (2024) PENGKAJIAN REGISTRASI SEDIAAN KAPSUL KOMBINASI EKSTRAK SECANG (Caesalpinia sappan L.), LADA (Piper albi linna) DAN KUNYIT (Curcuma domestica rhizome) SEBAGAI KANDIDAT OBAT TRADISIONAL KATEGORI JAMU. Skripsi thesis, Sekolah Tinggi Farmasi Indonesia.
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Abstract
Obat bahan alam yang beredar di masyarakat harus memiliki izin edar yang dikeluarkan oleh BPOM. Registrasi obat bahan alam dilakukan untuk menghindari penyalahgunaan bahan obat tersebut karena harus memperhatikan persyaratan keamanan dan mutu obat bahan alam. Sediaan kapsul kombinasi ekstrak secang (Caesalpinia sappan L), lada (Piper albi linna) dan kunyit (Curcuma domestica rhizome) merupakan salah satu kandidat obat bahan alam yang akan diregistrasikan untuk memiliki izin edar, penelitian ini dilakukan untuk mengetahui pemenuhan persyaratan keamanan dan mutu untuk proses perizinan sediaan kapsul tersebut sesuai dengan peraturan BPOM. Metode penelitian yang digunakan yaitu metode deskriptif kualitatif. Hasil pengujian persyaratan keamanan dan mutu sediaan kapsul kombinasi ekstrak secang, lada dan kunyit yang mencakup pengujian organoleptik, kadar air, waktu hancur, keseragaman bobot, cemaran mikroba, aflatoksin total dan cemaran logam berat telah memenuhi persyaratan, sediaan kapsul ini telah dilakukan pengumpulan dokumen-dokumen persyaratan proses registrasi dan selanjutnya dilakukan tahap registrasi. Kesimpulan menunjukkan bahwa sediaan kapsul tersebut telah memenuhi persyaratan keamanan dan mutu sesuai dengan standar yang ditetapkan oleh BPOM. ---- Natural medicines circulating in the community must have a distribution permit issued by BPOM. Registration of natural medicines is carried out to avoid misuse of these medicines because it must pay attention to the safety and quality requirements of natural medicines. The combination capsule preparation of secang extract (Caesalpinia sappan L), pepper (Piper albi linna) and turmeric (Curcuma domestica rhizome) is one of the candidates for natural medicines that will be registered to have a distribution permit, this study was conducted to determine the fulfillment of safety and quality requirements for the licensing process of the capsule preparation in accordance with BPOM regulations. The research method used is a qualitative descriptive method. The results of testing the safety and quality requirements for the combination capsule preparation of secang extract, pepper and turmeric which include organoleptic testing, water content, disintegration time, weight uniformity, microbial contamination, total aflatoxin and heavy metal contamination have met the requirements, this capsule preparation has been collected documents for the registration process requirements and then the registration stage is carried out. The conclusion shows that the capsule preparation has met the safety and quality requirements in accordance with the standards set by BPOM.
| Item Type: | Thesis (Skripsi) |
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| Uncontrolled Keywords: | Sediaan kapsul, Persyaratan keamanan, Registrasi. ----- Capsule preparations, Safety requirements, Registration. |
| Subjects: | R Medicine > R Medicine (General) R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine |
| Divisions: | Program Studi S1 Farmasi |
| Depositing User: | pustakawan - - |
| Date Deposited: | 14 Nov 2024 02:12 |
| Last Modified: | 14 Nov 2024 02:12 |
| URI: | http://repository.stfi.ac.id/id/eprint/1492 |
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