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All Journal Acta Pharmaciae Indonesia : Acta Pharm Indo Majalah Farmasetika
Salim, Prayoga Drajat Pangestu
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Medicine & Pharmacology

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Comparative solvent evaluation for protein extraction from Channa striata and development of a stable capsule formulation for nutritional supplementation Salim, Prayoga Drajat Pangestu; Karim, Dewi Damayanti Abdul; Aziz, Syaikhul
Acta Pharmaciae Indonesia Vol 13 No 1 (2025): Acta Pharmaciae Indonesia: Acta Pharm Indo
Publisher : Pharmacy Department, Faculty of Health Sciences, Jenderal Soedirman University, Purwokerto, Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.20884/1.api.2025.13.1.16152

Abstract

Background: Channa striata is a protein-rich freshwater fish with therapeutic potential, yet systematic optimization of extraction methods and stable formulation development remain limited. Objective: To compare protein extraction efficiency using three solvents (1% HCl, 0.9% NaCl, and distilled water) and develop optimized capsule formulations. Methods: Protein was extracted at 1:4 (w/v) ratio and quantified using the Lowry method at 595 nm. The method was verified for linearity (R = 0.998), accuracy (98-102%), and precision (RSD <2%). Extracts were formulated into capsules at 0, 300, 400, and 500 mg (F0-F3) and evaluated for quality parameters and 28-day stability at -4°C, 24°C, and 40°C. Data were analyzed using one-way ANOVA with Duncan's post-hoc test. Results: The 1% HCl yielded highest protein content (4.947 ± 0.071 mg/mL) and extraction efficiency (21.390%) compared to 0.9% NaCl and distilled water (p <0.05). All formulations met pharmaceutical standards. Notably, F3 maintained protein retention >95% across all storage conditions (97.1-99.3%), while F0-F2 failed this criterion. Conclusion: The 1% HCl demonstrated optimal extraction efficiency. F3 (500 mg) exhibited superior stability and dissolution characteristics, representing a promising candidate for C. striata-based nutritional supplements.
Artikel Review: Parameter dalam pembuatan Standar Operasional Prosedur (SOP) evaluasi penerapan Computer System Validation (CSV) Salim, Prayoga Drajat Pangestu; Megantara, Sandra; Maknun, Shofiyah Durin
Majalah Farmasetika Vol 11, No 1 (2026)
Publisher : Universitas Padjadjaran

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.24198/mfarmasetika.v11i1.69580

Abstract

Industri farmasi diwajibkan untuk mematuhi pedoman Cara Pembuatan Obat yang Baik (CPOB) sebagai upaya menjamin mutu, keamanan, dan efektivitas produk, termasuk dalam pengelolaan sistem komputerisasi melalui penerapan Computerized System Validation (CSV). Kajian berkala terhadap sistem CSV dilakukan untuk memastikan bahwa sistem komputerisasi tetap berada dalam kondisi tervalidasi, beroperasi sesuai dengan tujuan penggunaannya, serta memenuhi ketentuan regulatori yang berlaku, seperti CPOB 2024, GMP Annex 11, USP <1058>, dan ISO/IEC 27001. Penelaahan mencakup aspek pengendalian perubahan (change control), penanganan penyimpangan (deviation review), tinjauan keamanan dan pengelolaan akses sistem, evaluasi audit trail, verifikasi mekanisme backup–restore, serta pemantauan kinerja dan keandalan sistem secara berkelanjutan. Hasil kajian menunjukkan tidak ditemukannya indikasi penyimpangan operasional, penurunan performa sistem, maupun risiko terhadap integritas dan keamanan data. Seluruh aktivitas pengelolaan perubahan dan pemeliharaan sistem dilaksanakan secara terencana, terdokumentasi, dan tervalidasi dengan baik, termasuk penerapan Disaster Recovery Plan (DRP) yang mendukung kesinambungan operasional. Selain itu, sistem komputerisasi telah memenuhi prinsip ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, dan Available), sehingga menjamin akurasi, keterlacakan, serta perlindungan data dari akses yang tidak sah. Secara keseluruhan, kajian ini menunjukkan bahwa sistem komputerisasi di industri farmasi dapat beroperasi secara andal dan stabil serta selaras dengan persyaratan CPOB, GMP, dan ISO/IEC 27001 dalam mendukung kegiatan produksi dan pengawasan mutu. 
Co-Authors Damayanti Abdul Karim, Dewi Maknun, Shofiyah Durin MEGANTARA, SANDRA Syaikhul Aziz