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308 วารสารการแพทย์แผนไทยและการแพทย์ ทางเลือก ปีที่ 21 ฉบับที่ 2 พฤษภาคม-สิงหาคม 2566

ข้อสรุปและข้อเสนอแนะ: เจลสารสกัดรากทองพันชั่งที่พัฒนามีความปลอดภัยส�าหรับน�าไปใช้ในมนุษย์ สามารถ
น�าไปใช้ศึกษาในระดับคลินิกเพื่อประเมินประสิทธิผลและความปลอดภัยของต�ารับในการรักษาผู้ป่วยโรคผิวหนังจากเชื้อ
ราได้ต่อไป
ค�ำส�ำคัญ: เจลสารสกัดรากทองพันชั่ง, ความปลอดภัย, การระคายเคือง, การกัดกร่อน, การกลายพันธุ์

Safety Evaluation of Rhinacanthus nasutus Root Extract Gel Prepared from
a Pilot Plant

Patamaporn Pruksakorn , Chattraporn Jaima , Praw Suppajariyawat , Virat Sumateewatanakul ,
‡
*
*,‡
†
Kanidsorn Larpardisorn , ChayadaTongkamsen , Warangluk Pimpapai , Archawin Rojanawiwat ,
†
†
‡
†
Pilaslak Akrachalanont *
* Medicinal Plant Research Institute, Department of Medical Sciences, Talat Khwan Sub-District, Muang District,
Nonthaburi 11000, Thailand
† Medical Life Sciences Institute, Department of Medical Sciences, Talat Khwan Sub-District, Muang District,
Nonthaburi 11000, Thailand
‡ National Institute of Health, Department of Medical Sciences, Talat Khwan Sub-District, Muang District,
Nonthaburi 11000, Thailand
§ Corresponding author: patamaporn.p@dmsc.mail.go.th
Abstract
Introduction and Objective: Rhinacanthus nasutus (commonly known as thong phan chang in Thai) root
extract gel preparation, containing 0.1% rhinacanthin C, is an herbal product that was developed as an effective
topical agent for fungal skin infection using knowledge from both scientific research and Thai traditional medicine.
However, the safety of a novel herbal preparation should be assessed before it is approved for use in humans. This
study aimed to evaluate the safety of R. nasutus root extract gel preparation prepared in a pilot plant.
Methodology: Safety study of R. nasutus root extract gel was conducted following the Organisation for
Economic Co-operation and Development (OECD) Guidelines, including the bacterial reverse mutation test (Test
Guideline 471) and the acute dermal irritation/corrosion test (Test Guideline 404). Skin irritation testing in healthy
Thai volunteers was performed using a single patch test. Animal experiments were reviewed and approved ethically by
Institutional Animal Care and Use Committee of the Department of Medical Sciences, code number 63-031 (62-018).
Human experiments were approved by Research Ethic Committee, Department of Medical Sciences Code 4/2563
Results: Topical preparation of R. nasutus root extract was not found to cause any mutations in bacteria,
nor did it irritate or corrode the animal skin. Moreover, it did not cause any skin (Test Guideline 404). reactions in
healthy volunteers during the single patch test.
Discussion: R. nasutus root extract gel preparation, containing 0.1% rhinacanthin C, is categorized as an
herbal product derived from research and development beyond traditional knowledge. Thus, the product needs safety
and efficacy data from animal models and humans for product registration. In order to study the safety profile of the
product according to international standards, the results suggest the R. nasutus root extract gel had non-genotoxic
and non-skin corrosive effects, nor did it cause dermal irritation in both animal models and humans.
Conclusion and Recommendation: R. nasutus root extract gel preparation is deemed to be safe for humans
and we can further proceed to clinical trials for efficacy and safety evaluations in patients with fungal skin infections.
Key words: Rhinacanthus nasutus root extract gel, safety, irritation, corrosion, mutation