ANDRIAN RAMADHAN, - (2020) VALIDASI METODE UJI KADAR PROTEIN PADA BULK HBsAg PRODUKSI PT. BIO FARMA DENGAN METODE LOWRY SERTA KARAKTERISASI ZETA POTENSIAL. Skripsi thesis, Sekolah Tinggi Farmasi Indonesia.
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Abstract
Bulk HBsAg merupakan bahan utama dalam pembuatan vaksin Hepatitis B rekombinan yang berasal dari antigen permukaan virus Hepatitis B. Sebelum menuju tahap selanjutnya, bulk HBsAg yang telah dirpoduksi harus diukur kadar proteinnya serta dilakukan karakterisasi zeta potensial sebagai salah satu cara untuk mengetahui stabilitasnya. Kadar protein pada bulk HBsAg yang diproduksi oleh PT. Bio Farma diukur menggunakan metode Lowry. Untuk itu, dilakukan validasi pada pengukuran kadar protein dengan metode Lowry dengan menggunakan Bovine Serum Albumin sebagai standar. Pengukuran kadar protein dengan metode uji Lowry pada waktu inkubasi selama 30 menit setelah penambahan pereaksi Folin Ciocalteu’s Phenol telah tervalidasi dapat mengukur protein secara spesifik dengan %recovery dalam batas rentang 90 – 110% pada setiap parameter dengan batas deteksi pada 4 µg/ mL dan dapat terkuantisasi dengan baik pada sampel dengan konsentrasi 8 µg/ mL. Pada analisis ANOVA diperoleh Ho > α (0,05) yang berarti pengujian dengan metode Lowry telah memenuhi kriteria penerimaan validasi. Zeta potensial diuji menggunakan Malvern Zetasizer dan diperoleh nilai zeta potensial bulk HBsAg yang baik sebesar -13.1 mV. --- Bulk HBsAg is the main ingredient in the manufacture of Hepatitis B recombinant vaccine, derived from the surface antigen of the Hepatitis B virus. Before proceeding to the next stage, the protein content of the bulk HBsAg that has been produced must be measured and also the zeta potential characterization was carried out as a way to determine its stability. Protein content in the bulk HBsAg produced by PT. Bio Farma was measured using the Lowry method. For this reason, validation was carried out on the protein content using the Lowry method with Bovine Serum Albumin as the standard. Measurement of the protein content using Lowry method with 30 minutes incubation time after the addition of Folin Ciocalteu's Phenol reagent has been validated to measure protein specifically with % recovery in the range between 90-110% for each parameter with a detection limit of 4 µg / mL and can be quantized well in a concentration of 8 µg / mL. In the ANOVA analysis, it is obtained that Ho> α (0.05), which means that the Lowry method has met the validation acceptance criteria. Zeta potential was tested using the Malvern Zetasizer and obtained a good zeta potential value of HBsAg of -13.1 mV.
| Item Type: | Thesis (Skripsi) |
|---|---|
| Uncontrolled Keywords: | HBsAg, Lowry, validasi, protein, Zeta potensial. --- HBsAg, Lowry, validation, protein, Zeta Potential. |
| Subjects: | Q Science > Q Science (General) R Medicine > R Medicine (General) |
| Divisions: | Program Studi S1 Farmasi |
| Depositing User: | pustakawan - - |
| Date Deposited: | 02 Oct 2024 02:11 |
| Last Modified: | 02 Oct 2024 02:11 |
| URI: | http://repository.stfi.ac.id/id/eprint/1267 |
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