摘要

本研究探討臺灣對比中國市售骨碎補藥材的基原混淆問題，並分析醫療機構使用安心藥材的重要性，以提供市場監管、臨床用藥安全及消費者選購的建議。骨碎補 (Drynaria roosii Nakaike) 是補腎強骨藥，為中醫傷科要藥。指標成分柚皮苷(Naringin)，具促進骨細胞增生與強骨作用。然而，市場上常見多種混淆品，可能影響臨床療效。本研究於臺灣臺北（迪化街、內湖區）及中國福建（廈門、東山島）進行市售調查，發現臺灣市售骨碎補混淆情形相當嚴重，以大葉骨碎補Davallia formosana Hayata 為主，與2020 年政府全臺抽驗結果一致。安心藥材指的是產地透明，經過基原鑑定，並通過二氧化硫、重金屬、黃麴毒素、農藥殘留等各項檢驗，由符合藥品優良製造規範藥廠生產之藥材；本研究以某醫學中心送檢之安心藥材為例，說明安心藥材的品管機制能確保用藥安全。目前臺灣中藥市場雖有藥事法規範，但基原鑑定未納入邊境查驗，且市場監管仍有不足。未來應加強基原鑑定標準、推動藥材溯源管理，並提升中藥從業人員的鑑別能力，提升民眾用藥安全，促進中藥產業的健全發展。鑑於現行法規尚未全面建置完整的中藥材溯源與標準化制度，本文提出實務層面的具體建議，包含如何進行藥材外觀辨別、管理藥材來源與審查檢驗報告以供藥師同儕參考。

 

ABSTRACT

This study investigates the botanical misidentification of Drynariae Rhizoma in herbal markets of Taiwan and China, and emphasizes the importance of using quality-assured herbal products in medical institutions. Drynaria roosii Nakaike, a commonly used tonic in traditional Chinese orthopedics, contains naringin, which promotes osteoblast proliferation and bone strengthening. However, various misused and confused herbs are frequently found in the market, potentially affecting clinical efficacy and safety. We conducted a market survey in Taipei, Taiwan (Dihua Street and Neihu District), and Fujian, China (Xiamen and Dongshan Island), and revealed a high rate of misidentification in Taiwan, with Davallia formosana being the predominant misused and confused herbs. This finding is consistent with the 2020 nationwide sampling results reported by government monitoring programs. Qualityassured herbs, produced by GMP-certified manufacturers, undergo rigorous origin authentication and testing for heavy metals, aflatoxins, and pesticide residues. This study demonstrates how the stringent quality-control mechanisms of quality-assured herbs safeguard clinical Chinese herbal medicine safety by a test report of Drynaria roosii sample from a medical center. Although Pharmaceutical Affairs Act exist, botanical authentication is not included in border inspections, and market oversight remains insufficient. The government should strengthen authentication standards, promote traceability systems, and enhance training for traditional Chinese medicine practitioners to ensure the circulation of authentic herbs, improving public medication safety, and promoting the sustainable development of the herbal industry. Given that current regulations have yet to establish a comprehensive traceability and standardization system for Chinese herbal medicine, this paper proposes practical recommendations—such as methods for appearance identification, managing material sources, and reviewing test reports—to serve as a reference for fellow pharmacists.

 

 

Submitted for publication: 2025.03.25; Accepted for publication: 2025.07.18