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Eruditio : Indonesia Journal of Food and Drug Safety

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Published by Badan Pengawas Obat dan Makanan

ISSN : 27472493 EISSN : 28076222 DOI : https://doi.org/10.54384

Core Subject : Health, Science, Agriculture,

Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemistry Medicine & Pharmacology Public Health

Eruditio : Indonesia Journal of Food and Drug Safety adalah jurnal yang diterbitkan oleh Pusat Pengembangan Sumber Daya Manusia Pengawasan Obat dan Makanan (PPSDM POM), Indonesia. Jurnal ini memuat hasil kajian dan kajian literatur di bidang keamanan Obat dan Makanan.

Arjuna Subject : Pharmacology, Toxicology and Pharmaceutics - Ilmu Farmasi

Articles 6 Documents

Search results for , issue "Vol 1 No 2 (2021): Edisi Juni" : 6 Documents clear

Analisis kemurnian dan konsentrasi DNA hasil isolasi pada pembuatan DNA baku spesies tikus: Analisis kemurnian dan konsentrasi DNA hasil isolasi pada pembuatan DNA baku spesies tikus Alfi Sophian; Andi Syukur
Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Analysis of the purity and concentration of isolated DNA in the manufacture of standard rat DNA was carried out to see whether the isolation carried out could produce good quality DNA. The purpose of this study is to provide information on the manufacture of raw DNA in species DNA testing where the raw material that has been purchased so far made from synthetic materials can be more economical if using DNA material derived from the meat raw material of the target species. The DNA extraction method used is the column spin method or column centrifuge using the Intron Patho Gene-Spin (Viral DNA/RNA) extraction kit. Analysis method of concentration and purity of isolated DNA was analyzed based on the average value of concentration and purity which was read using a nanophotometer. Based on the results of the research conducted, the results of the isolated DNA concentration values were in the concentration range of 41,250 ng/ mL to 42,300 ng/mL, with the average concentration of isolated DNA was 41,777 ng/mL. For the value of the purity of the isolated DNA whose absorbance was read using a nanophotometer at a wavelength of A260/A280, the results were between 2,301 to 2,384 with the average value of purity being at 2,326. This study concludes that all the extracted samples that showed the results of the DNA analysis produced were included in the good DNA category.

Tantangan Kebijakan Pengawasan Obat dan Makanan dalam Mendukung Peningkatan Daya Saing, Ekonomi dan Bisnis di Indonesia: Sebuah Studi Analisis Perdhana Ari Sudewo
Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

In line with Indonesia's target to become a developed country by 2045, structural reforms in the industrial sector in Indonesia will continue to be carried out with a target in 2030 to be able to contribute 30% to Indonesia's Gross Domestic Product (GDP). In structural reforms, the Drug and Food Industry is a priority industry. It requires a Drug and Food Control policy issued by the Indonesian Food and Drug Authority (Indonesian FDA) to support increasing competitiveness by creating a business ecosystem that supports Indonesia's economic growth. This study aims to analyze the challenges of Drug and Food Control policies in increasing the competitiveness of the Drug and Food Industry to support economic growth, expand employment, and create a good business ecosystem in Indonesia. The study was conducted using secondary data through literature studies from books, journals, reports, study results, articles, and internal Indonesian FDA documents. The results of the study show that the Indonesian FDA must be ready and adaptive to face various supervisions, including challenges that have never been faced by the Indonesian FDA before, the impact of government demands, the digitization of the Industrial sector, and the development of Food and Drug Science. The Indonesian FDA must formulate appropriate policies and prepare adequate resources to be able to face these challenges. This study is expected to provide benefits for policymakers and employees at the Indonesian FDA and relevant stakeholders in preparing, compiling, and establishing appropriate policies to support competitiveness, economy, and business in Indonesia.

Desain Primer dan Analisis in Silico untuk Amplifikasi Gen mt-Co1 pada Tikus got (Rattus norvegicus) Maria A E D Sihotang; Yola Eka Erwinda; Eniek Suwarni; Erita Lusianti
Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Brown rat or commonly called sewer rat (Rattus norvegicus) meat is one of ingredients that is usually used to counterfeit beef meatballs to reduce the production prices. These issues can be very detrimental to consumers, in terms of health and halal reasons. Thus, this condition has prompted the development of test methods to detect sewer rat meat in processed foods. Several method developments in detecting the content of sewer rat meat in processed food have been carried out. One of the simplest and fastest methods to identify sewer rat meat is Polymerase Chain Reaction (PCR). Most method developments for detecting sewer rat meat have used endpoint PCR, but this method still has several shortcomings in terms of specificity and promptness in obtaining results. Therefore, developing a sewer rat meat detection method using real-time PCR and combined with a more sensitive and specific TaqMan probe can be an alternative for detecting sewer rat meat in processed foods. Primer and probe design is the first and crucial step in the development of detection methods with real-time PCR. This study aims to design primers and probes for the detection of the mt-CoI gene in sewer rats. The mt-CoI gene sequence of Rattus norvegicus (NC_001665.2) was obtained from the National Center of Biotechnology Information (NCBI) database. Primer was designed using Primer3Plus software. Then, several candidates of primers and probes were analyzed in silico for specificity of the mt-CoI gene using software, including Primer-BLAST and Nucleotide-BLAST. The result of this study is primers and probes which are specific to the mt-CoI gene in sewer rats (Rattus norvegicus), with the sequence of forward primer (5’-ATGAGCAAAAGCCC ACTTTG-3’), reverse primer (5’-CGGCCGTAAGTGAGATGAAT-3’), and probe (5’-GCAGGGATACCTCGTCGTTA-3’). The result can be used to develop methods for detecting sewer rat meat in meatballs or other processed foods using real-time PCR and TaqMan probes.

Penetapan Limit of Detection (LOD) dan Sensitivitas Metode Deteksi Pseudomonas aeruginosa dalam Berbagai Matriks Sediaan Obat Nur Aini; Maria Purba; Sitoresmi Triwibowo; Nenden Sholihatul; Ratna Wulandari
Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Contamination of certain microorganisms in pharmaceutical products can potentially reduce or even inactivate therapeutic activity and harm patient health. Pharmacopoeia monograph determine the microbiological quality in medicinal products. One of them is P. aeruginosa parameters which should not be present in pharmaceutical preparations. Pharmacopoeia states that microbial detection methods must be able to detect microorganisms, including P.aeruginosa not more than 100 colonies, but the actual detection limit has never been set quantitatively and many variables can affect the microorganism recovery. This study aims to determine the range of Limit of Detection (LOD) values and the sensitivity of the P. aeruginosa method on pharmaceutical products. Detection method of P. aeruginosa refers to the specific microbial test of the Indonesian Pharmacopoeia VI (2020) is culture media methods. Experiments used eight pharmaceutical products representing five dosage forms contaminated with P. aeruginosa ATCC 9027 with three levels of concentration. The results determined LOD range and sensitivity of P. aeruginosa detection method in pharmaceutical products, and analyzed descriptively. This study shows that pharmacopeia method of P. aeruginosa testing can detect P. aeruginosa in various drug preparation matrices with a detection limit of 1-10 colonies and a sensitivity of 100%. Results of this study can be used as reference for LOD value in the verification of the P. aeruginosa detection in medicinal product.

Profil Peredaran Obat Disfungsi Ereksi Ilegal Fauqi Elfarabi; Fuji Handayani; Yovia Rizki Arrahman; Ari Andriano Santoso
Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Indonesian FDA's data of supervision and law enforcement from 2008 - 2018 show that the trend of finding illegal drugs circulating in Indonesia continued to increase. Erectile dysfunction therapy class drugs dominate the trend of findings, also strengthened by the Indonesian FDA's Public Warning data and the Post Market Alert System report from 2015 - 2017, were widely found traditional medicines containing erectile dysfunction drugs. A study about Profile of Illegal Erectile Dysfunction Drug Circulation is arranged based on data and findings above, in implementing the function of preventing drug and food crime as one of the Indonesian FDA's responsibilities for the availability of efficacious, safe, and qualified medicines. The study aims to identify circulation (including users), the potential value of the circulation of illegal erectile dysfunction drugs in Indonesia, and the potential diversion in the distribution of raw materials for erectile dysfunction drugs using qualitative and quantitative methods. Qualitative methods are carried out through field observations to obtain distribution descriptions, internet surveys, and investigations by undercover, surveillance, and controlled delivery. Quantitative methods are carried out through market surveys using purposive and non-random sampling techniques in 8 (eight) regions in Indonesia, i.e., Jabodetabek, Serang, Padang, Bandung, Semarang, Surabaya, Bali, and Samarinda. The results showed that the distribution of erectile dysfunction drugs offline through permanent kiosks/stalls/carts in Indonesia is still widely found. The online circulation of erectile dysfunction drugs has also increased with the expansion of the market through websites, social media, and e-commerce. The profile of erectile dysfunction drug users is in the productive age group (30-45 years) with income levels between IDR 2,000,000 to IDR 4,000,000, per month and the most consumed brand is Viagra. Potential diversion of the circulation of raw materials for erectile dysfunction drugs occurs in importing raw materials and distributing them from each PBF/importer to the pharmaceutical industry.

Analisis Hasil Pengawasan Iklan/Promosi Suplemen Kesehatan Sebelum dan Selama Masa Pandemi COVID-19 Angelia Puspita Nugraheni; Sarmauli Purba; Devi Riani; Wahyuri; Nurizati
Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

For entrepreneurs, advertising/promotion is a means to introduce a product. For the public, it is a means to get information about a product, so that people become very dependent on advertising/promotion. Data from BPS shows a sharp spike in online sales during the Corona Virus Disease-19 (COVID-19) pandemic, which was influenced, among other things, by government policies to limit activities outside the home. As a result, the need for health supplements has increased during the COVID-19 pandemic; several times, there have been stock shortages due to panic buying. Business actors can use this momentum for advertising/promote products that do not comply with the provisions to increase product sales, thus possibly resulting in a significantly different level of advertising/promotional violations from before the COVID-19 pandemic. This study aims to analyze the results of supervision of health supplement promotion/advertising before the COVID-19 pandemic (2018-2019) and during the COVID-19 pandemic (2020-July 2021) to determine the significance level of differences in advertising/promotional violations before and during the pandemic, the types of media that were reported to have the most violations during the COVID-19 pandemic, the types of advertising/promotional violations and the fifth regions in Indonesia that reported the highest levels of offenses. The data analyzed is secondary data from the supervision of advertisements/promotions throughout Indonesia, collected from 2018 to September 5, 2021, obtained from the Directorate of Traditional Medicines and Health Supplements Control. The data was processed descriptively and using the chi-square method to see the significance, with the results that there were significant differences in advertising/promotion violations before and during the COVID-19 pandemic, the media that committed the most violations was internet media, with the highest type of violation being advertising/promoting products with exaggerated claims. The two regions in Indonesia that included the ten most extensive offenses before and during the COVID-19 pandemic were Jakarta and Makassar.

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Listia Ningsih

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Gedung Batik Lt.5 - Badan POM Jl. Percetakan Negara No. 23 Kel. Johar Baru, Kec. Johar Baru, Jakarta Pusat 10560

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Kota adm. jakarta pusat,

Dki jakarta

INDONESIA

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Home Page

OAI Link

Editorial Team

Contact

Reviewer

Google Scholar

Contact Name Listia Ningsih

Contact Email listia.n@pom.go.id

Phone +6281395105898

Journal Mail Official eruditi@pom.go.id

Editorial Address Gedung Batik Lt.5 - Badan POM Jl. Percetakan Negara No. 23 Kel. Johar Baru, Kec. Johar Baru, Jakarta Pusat 10560

Location Kota adm. jakarta pusat, Dki jakarta INDONESIA

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Contact Name
Listia Ningsih

Contact Email
listia.n@pom.go.id

Phone
+6281395105898

Journal Mail Official
eruditi@pom.go.id

Editorial Address
Gedung Batik Lt.5 - Badan POM Jl. Percetakan Negara No. 23 Kel. Johar Baru, Kec. Johar Baru, Jakarta Pusat 10560

Location
Kota adm. jakarta pusat,

Dki jakarta

INDONESIA