各國中草藥質量標準比較：以藥材三七為例

Comparison of national standards of Pharmacopeia using Panaxnotoginseng

背景：臺灣中藥材多仰賴進口，因此制定《臺灣中藥典》以建立中藥材品質標準，保證中藥材的質量與安全。隨著中醫藥在全球興起，許多國家逐漸建立中草藥質量標準，有鑑於各國藥典對於中草藥質量標準規範有異，本研究透過分析不同國家藥典（臺灣、香港、中國大陸、歐洲、美國、日本、韓國）對於三七藥材品質之規範進行探討。三七（Panaxnotoginseng （Burk.） F. H. Chen）為雲南白藥的主要成分之一，傳統記載上三七具有活血化瘀、消腫止痛之功效，被譽為傷科聖藥，素有「金不換」、「南國神草」之稱，近年來研究發現三七也具有抑制癌細胞增殖和生長、促進癌細胞凋亡、誘導癌細胞分化、反轉癌細胞抗藥性及抑制癌細胞轉移等功效，因此三七被廣泛應用在藥品、健康食品、化妝品⋯⋯等商業前景，但要如何確保三七品質為首要之一大問題。方法：本研究利用Pubmed、Medline、中國期刊網、各國藥典（臺灣、香港、中國大陸、歐洲、美國、日本、韓國）⋯等藥典與資料庫，搜尋三七相關活性成分研究進展，以及各國對於三七品質規範，以做全面性回顧探討。結果：綜合上述文獻，《臺灣中藥典》和《中國人民共和國藥典》質量標準規定較為一致；《韓國草藥典》與《日本藥局方外生藥規格》著重於重金屬與農藥殘留的檢查；而《歐洲藥典》質量標準規定較寬鬆；《美國藥典草藥法典》的質量標準較為完善、圖文並茂，測定五種皂苷類成分含量，對重金屬、農藥殘留、黃麴毒素（aflatoxin）和微生物進行濃度規範，還附有皂苷類與三七素的TLC圖片、HPLC和UHPLC指紋圖譜圖片，相當重視三七的品質與安全性；《香港中藥材標準》與其他藥典不同的是，對三七有栽培年限之記述，還有橫切面與粉末顯微之鑒別圖片。結論：透過比較各國藥典，了解各國質量標準差異，結合三七在臺灣的使用與發展情況，除了能更完善《臺灣中藥典》三七質量標準及安全性，進而推廣做為日後訂定中藥材質量標準依規之考量，還可作為中藥進入國際市場的參考，促進中藥國際化。 Background: Chinese herbal medicines in Taiwan are mainly imported based on the established safety and quality standards of the 'Taiwan Herbal Pharmacopeia'. With the development of Chinese herbal medicine worldwide, many other countries have established their own quality standards of Chinese herbal medicines. By reviewing the reference standards in the pharmacopeias across different countries (Taiwan, Hong Kong, China, Europe, U.S.A, Japan, Korea), we could draw a standardized quality control for Panaxnotoginseng of the 'Taiwan Herbal Pharmacopeia'. Panaxnotoginseng, one of the key herb used in Yun Nan Bai Yao concoction, has been traditionally used for treating external injuries. It is known for its properties in promoting blood circulation and removing blood stasis, and thus reducing swelling and easing pain. Recent studies found Panaxnotoginseng to be effective in inhibiting cancer cells proliferation and growth, promoting cancer cell apoptosis, reversing cancer drug resistance and inhibiting cancer cell metastasis. As such, Panaxnotoginseng is widely used in medicines, supplements and cosmetics. The industrial development of Panaxnotoginsenghas great future prospects and commercial values, so it is important to set quality control over Panaxnotoginseng. Methods: Literature related to the research on active ingredients in Panaxnotoginseng and its reference standards are reviewed. The databases searched included Pubmed, Medline, China Academic Journals and pharmacopeias of different countries (Taiwan, Hong Kong, China, Europe, U.S.A, Japan, Korea). Results: The reference standards between 'Taiwan Herbal Pharmacopeia' and 'Pharmacopeia of the People's Republic of China' are similar, 'The Japanese standards for non-Pharmacopeia crude drugs' and 'The Korean Herbal Pharmacopeia' focus on the presence of heavy metals and pesticide residues, whereas the 'European Pharmacopeia' is less stringent. The' USP Herbal Medicines Compendium', which has the most comprehensive monograph of Panaxnotoginseng, not only included detailed illustrations, but has also identified the five saponins, heavy metals, pesticide residues, Aspergillus flavus toxins and microorganisms contents. In addition, it includes the TLC, HPLC and UHPLC fingerprints of Panaxnotoginseng and its saponins. In comparison, the 'Hong Kong Chinese Materia Medica' included the description of the plantation and microscopic imaging of Panaxnotoginseng (cross-section and powder). Conclusions: By comparing across the different pharmacopoeias and combining the informations on the use and development of Panaxnotoginseng across different geographical locations, we could conclude a standardised reference of Panaxnotoginsengand thus, control the quality and safety use of Panaxnotoginseng. In addition, it can promote the international acceptance of Chinese herbal medicines and also serve as a reference for international market.

Background: Chinese herbal medicines in Taiwan are mainly imported based on the established safety and quality standards of the 'Taiwan Herbal Pharmacopeia'. With the development of Chinese herbal medicine worldwide, many other countries have established their own quality standards of Chinese herbal medicines. By reviewing the reference standards in the pharmacopeias across different countries (Taiwan, Hong Kong, China, Europe, U.S.A, Japan, Korea), we could draw a standardized quality control for Panaxnotoginseng of the 'Taiwan Herbal Pharmacopeia'. Panaxnotoginseng, one of the key herb used in Yun Nan Bai Yao concoction, has been traditionally used for treating external injuries. It is known for its properties in promoting blood circulation and removing blood stasis, and thus reducing swelling and easing pain. Recent studies found Panaxnotoginseng to be effective in inhibiting cancer cells proliferation and growth, promoting cancer cell apoptosis, reversing cancer drug resistance and inhibiting cancer cell metastasis. As such, Panaxnotoginseng is widely used in medicines, supplements and cosmetics. The industrial development of Panaxnotoginsenghas great future prospects and commercial values, so it is important to set quality control over Panaxnotoginseng. Methods: Literature related to the research on active ingredients in Panaxnotoginseng and its reference standards are reviewed. The databases searched included Pubmed, Medline, China Academic Journals and pharmacopeias of different countries (Taiwan, Hong Kong, China, Europe, U.S.A, Japan, Korea). Results: The reference standards between 'Taiwan Herbal Pharmacopeia' and 'Pharmacopeia of the People's Republic of China' are similar, 'The Japanese standards for non-Pharmacopeia crude drugs' and 'The Korean Herbal Pharmacopeia' focus on the presence of heavy metals and pesticide residues, whereas the 'European Pharmacopeia' is less stringent. The' USP Herbal Medicines Compendium', which has the most comprehensive monograph of Panaxnotoginseng, not only included detailed illustrations, but has also identified the five saponins, heavy metals, pesticide residues, Aspergillus flavus toxins and microorganisms contents. In addition, it includes the TLC, HPLC and UHPLC fingerprints of Panaxnotoginseng and its saponins. In comparison, the 'Hong Kong Chinese Materia Medica' included the description of the plantation and microscopic imaging of Panaxnotoginseng (cross-section and powder). Conclusions: By comparing across the different pharmacopoeias and combining the informations on the use and development of Panaxnotoginseng across different geographical locations, we could conclude a standardised reference of Panaxnotoginsengand thus, control the quality and safety use of Panaxnotoginseng. In addition, it can promote the international acceptance of Chinese herbal medicines and also serve as a reference for international market.