Teratogenic effect of unregistered traditional Chinese medicine containing Atractylodis lancea radix, Glycyrrhiza glabra radix, Rheum officinale rhizome, and Angelica dahurica radix on fetal morphology of BALB/c mice
Abstract
Objectives
In Indonesia, several unregistered traditional Chinese medicines (UTCM) are still used to treat gastritis in pregnancy. On the other hand, the safety of medications during pregnancy remains unresolved. This study aims to investigate the teratogenic effect of UTCM containing Atractylodis lancea radix, Glycyrrhizae glabra radix, Rheum officinale rhizome, and Angelica dahurica radix on fetal morphology.
Methods
A total of 80 pregnant mice were divided into four groups including the negative control (N), given vehicle, as well as treatment groups D1, D2, and D3 given a dose of 35.2 mg/kg BW, 70.5 mg/kg BW and 105.65 mg/kg BW daily respectively. The drugs were administered between the 6th and 15th days of organogenesis. On the 18th day of pregnancy, a laparotomy was conducted. The teratogenic effects were determined by measuring maternal and fetal body weight, the number of fetuses, and skeletal abnormalities in mouse fetuses, visualised with Alizarin solution. All data were analysed using ANOVA.
Results
The results showed that in all treatment groups, there was a substantial difference in maternal body weight, fetal number, and fetal body weight (p<0.05). There were open eyelids and clubfoot abnormalities observed in all groups, while 27 fetuses with haemorrhages were found in D3. All treatment groups had sternal, sacral, caudal, phalanges and metacarpal abnormalities.
Conclusions
UTCM administration showed fetal development effects at the early stage of pregnancy in mice. The dose (D3) 105.65 mg/kg BW affected maternal weight gain and fetal skeletal ossification. UTCM administration D1 (35.2 mg/kg BW), D2 0.5 mg/kg BW), and D3 (105.65 mg/kg BW) had no maternal toxicity and fetal teratogenesis.
Funding source: Fakultas Farmasi Universitas Andalas
Award Identifier / Grant number: 22/UN16.10.D/PJ.01/2023
Acknowledgments
We want to thank the Faculty of Pharmacy Universitas Andalas for support funding.
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Research ethics: The study was approved by The Committee of Research and Ethics in the Faculty of Pharmacy, Andalas University (Protocol number: 11/UN 16.10D/KEPK.FF/2023).
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Informed consent: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission. Development of the concept and methodology of the study: Rahmad Abdillah, Fitri Rachmaini, Almahdy. Query–a review and analysis of the literature: Rahmad Abdillah, Fitri Rachmaini, Almahdy. Submission of the application to the appropriate Bioethics Committee: Rahmad Abdillah, Yasherly Permata Sari. Collection of research material: Fitri Rachmaini, Yasherly Permata Sari. Analysis of the research material: Rahmad Abdillah, Fitri Rachmaini, Almahdy Ahmadin, Yasherly Permata Sari. Preparation of draft version of manuscript: Rahmad Abdillah, Fitri Rachmaini. Critical analysis of manuscript draft version: Rahmad Abdillah, Fitri Rachmaini. Statistical analysis of the research material: Fitri Rachmaini, Almahdy, Yasherly Permata Sari. Interpretation of the performed statistical analysis: Rahmad Abdillah, Fitri Rachmaini, Almahdy. Obtaining financial support for research and development: Rahmad Abdillah, Fitri Rachmaini. Technical preparation of manuscript in accordance with the journal regulations: Fitri Rachmaini. Supervision of the research and preparation of the manuscript: Rahmad Abdillah.
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Use of Large Language Models, AI and Machine Learning Tools: None declared.
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Conflict of interest: All authors declare that there is no conflict of interest regarding the publication of this article.
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Research funding: This work was funded by the Faculty of Pharmacy Universitas Andalas, Grant number: 22/UN16.10.D/PJ.01/2023.
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Data availability: Not applicable.
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