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Acute and subchronic toxicity of Indonesian House Dust Mites (IHDM) Allergenic Extract for Asthma Allergy Immunotherapy

Background: In developing a pharmaceutical product, it is necessary to conduct pre-clinical and clinical trials to ensure its safety and effectiveness. The toxicity test is conducted to assess the safety of a substance to determine its toxic effect of the substance. Objective: This study aims to det...

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Main Authors: Budiatin, Aniek Setia, Pratama, Yusuf Ali, Fatma Sari, Winda, Rahmadi, Mahardian, Bakhtiar, M. Taher, Zakaria, Zainul Amiruddin, Khotib, Junaidi
Format: Article
Language:English
Published: Fakultas Farmasi Universitas Airlangga 2022
Subjects:
RS Pharmacy and materia medica
Online Access:http://irep.iium.edu.my/99783/2/99783_Acute%20and%20subchronic%20toxicity.pdf
http://irep.iium.edu.my/99783/
https://e-journal.unair.ac.id/JFIKI/
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spelling my.iium.irep.997832022-09-02T01:43:35Z http://irep.iium.edu.my/99783/ Acute and subchronic toxicity of Indonesian House Dust Mites (IHDM) Allergenic Extract for Asthma Allergy Immunotherapy Budiatin, Aniek Setia Pratama, Yusuf Ali Fatma Sari, Winda Rahmadi, Mahardian Bakhtiar, M. Taher Zakaria, Zainul Amiruddin Khotib, Junaidi RS Pharmacy and materia medica Background: In developing a pharmaceutical product, it is necessary to conduct pre-clinical and clinical trials to ensure its safety and effectiveness. The toxicity test is conducted to assess the safety of a substance to determine its toxic effect of the substance. Objective: This study aims to determine the acute and subchronic toxicity of administering IHDM allergenic extract using experimental animal models. Methods: Female BALB/c mice and female and male Wistar rats were used as experimental animal models. While the IHDM allergenic extract was used with the level of Der p1 is 11.3-26.6 ng/mL and was administered by intravenous route. The acute toxicity test was carried out for 14 days on four different dose groups of experimental animals. The subchronic toxicity test was carried out for 28 days using three other dose groups of experimental animals. Results: The administration of a single dose of IHDM allergenic extract at various doses did not cause mice behaviour changes, and no death was shown in each group. Likewise, there was no change in the principal organs by macroscopic observations. Meanwhile, administering IHDM allergenic extract at repeated doses for 28 days could show signs of toxicity. The symptoms were shown in the histopathological structure of the liver, kidney, and heart organs. Conclusion: It can be concluded that the IHDM allergenic extract is safe for single-dose administration but shows toxic signs when given in repeated doses. Further tests are needed for 90 days of subchronic toxicity and satellite testing. Fakultas Farmasi Universitas Airlangga 2022-08-31 Article PeerReviewed application/pdf en http://irep.iium.edu.my/99783/2/99783_Acute%20and%20subchronic%20toxicity.pdf Budiatin, Aniek Setia and Pratama, Yusuf Ali and Fatma Sari, Winda and Rahmadi, Mahardian and Bakhtiar, M. Taher and Zakaria, Zainul Amiruddin and Khotib, Junaidi (2022) Acute and subchronic toxicity of Indonesian House Dust Mites (IHDM) Allergenic Extract for Asthma Allergy Immunotherapy. Jurnal Farmasi dan Ilmu Kefarmasian Indonesia, 9 (2). pp. 185-192. ISSN 2406-9388 E-ISSN 2580-8303 https://e-journal.unair.ac.id/JFIKI/ 10.20473/jfiki.v9i22022.185-192
institution Universiti Islam Antarabangsa Malaysia
building IIUM Library
collection Institutional Repository
continent Asia
country Malaysia
content_provider International Islamic University Malaysia
content_source IIUM Repository (IREP)
url_provider http://irep.iium.edu.my/
language English
topic RS Pharmacy and materia medica
spellingShingle RS Pharmacy and materia medica
Budiatin, Aniek Setia
Pratama, Yusuf Ali
Fatma Sari, Winda
Rahmadi, Mahardian
Bakhtiar, M. Taher
Zakaria, Zainul Amiruddin
Khotib, Junaidi
Acute and subchronic toxicity of Indonesian House Dust Mites (IHDM) Allergenic Extract for Asthma Allergy Immunotherapy
description Background: In developing a pharmaceutical product, it is necessary to conduct pre-clinical and clinical trials to ensure its safety and effectiveness. The toxicity test is conducted to assess the safety of a substance to determine its toxic effect of the substance. Objective: This study aims to determine the acute and subchronic toxicity of administering IHDM allergenic extract using experimental animal models. Methods: Female BALB/c mice and female and male Wistar rats were used as experimental animal models. While the IHDM allergenic extract was used with the level of Der p1 is 11.3-26.6 ng/mL and was administered by intravenous route. The acute toxicity test was carried out for 14 days on four different dose groups of experimental animals. The subchronic toxicity test was carried out for 28 days using three other dose groups of experimental animals. Results: The administration of a single dose of IHDM allergenic extract at various doses did not cause mice behaviour changes, and no death was shown in each group. Likewise, there was no change in the principal organs by macroscopic observations. Meanwhile, administering IHDM allergenic extract at repeated doses for 28 days could show signs of toxicity. The symptoms were shown in the histopathological structure of the liver, kidney, and heart organs. Conclusion: It can be concluded that the IHDM allergenic extract is safe for single-dose administration but shows toxic signs when given in repeated doses. Further tests are needed for 90 days of subchronic toxicity and satellite testing.
format Article
author Budiatin, Aniek Setia
Pratama, Yusuf Ali
Fatma Sari, Winda
Rahmadi, Mahardian
Bakhtiar, M. Taher
Zakaria, Zainul Amiruddin
Khotib, Junaidi
author_facet Budiatin, Aniek Setia
Pratama, Yusuf Ali
Fatma Sari, Winda
Rahmadi, Mahardian
Bakhtiar, M. Taher
Zakaria, Zainul Amiruddin
Khotib, Junaidi
author_sort Budiatin, Aniek Setia
title Acute and subchronic toxicity of Indonesian House Dust Mites (IHDM) Allergenic Extract for Asthma Allergy Immunotherapy
title_short Acute and subchronic toxicity of Indonesian House Dust Mites (IHDM) Allergenic Extract for Asthma Allergy Immunotherapy
title_full Acute and subchronic toxicity of Indonesian House Dust Mites (IHDM) Allergenic Extract for Asthma Allergy Immunotherapy
title_fullStr Acute and subchronic toxicity of Indonesian House Dust Mites (IHDM) Allergenic Extract for Asthma Allergy Immunotherapy
title_full_unstemmed Acute and subchronic toxicity of Indonesian House Dust Mites (IHDM) Allergenic Extract for Asthma Allergy Immunotherapy
title_sort acute and subchronic toxicity of indonesian house dust mites (ihdm) allergenic extract for asthma allergy immunotherapy
publisher Fakultas Farmasi Universitas Airlangga
publishDate 2022
url http://irep.iium.edu.my/99783/2/99783_Acute%20and%20subchronic%20toxicity.pdf
http://irep.iium.edu.my/99783/
https://e-journal.unair.ac.id/JFIKI/
_version_ 1743106850881011712
score 13.211869

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