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題名 | 常用中藥製劑對於腎臟致毒性之研究=Study of Nephrotoxicity Induced by Traditional Chinese Medicines Preparation |
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編 次 | (2-1) |
作 者 | 鮑力恒; | 書刊名 | 中醫藥年報 |
卷期 | 3 2014.12[民103.12] |
頁次 | 頁(10)1-(10)70 |
分類號 | 414.52 |
關鍵詞 | 腎毒性; 中藥製劑; 組織切片; 生物標記; 大鼠; 細胞; Nephrotoxicity; Chinese herbal medicines; SD-rat; Cell lines; |
語文 | 中文(Chinese) |
中文摘要 | 本研究目的為評估我國臨床常用中藥複方製劑對腎臟功能之影響。將以臨床常用複方濃縮中藥前 100名中挑選出尚未進行研究過的 10-15種複方製劑為主要研究之對象。本計畫將以二年時間,每年分別進行 10-15種常用中藥複方劑進行腎細胞株之體外篩選以及動物實驗之體內篩選驗證,對於會造成腎臟毒性的中藥複方製劑,則可進一步進行該中藥複方製劑內含之主要成分 /指標成分在動物體內之吸收分佈、代謝排泄之藥物動力學研究,以及腎毒性間劑量 -效應關係探討。 今年度已完成以體外細胞試驗 LLC-PK1(近端腎小管細胞)與 MDCK(遠端腎小管細胞)之存活試驗 (MTT test)評估 3家市售廠牌( A廠、B廠及 C廠) 15種臨床常用複方濃縮中藥於處理後 48小時之細胞存活率。 3家市售廠牌之 15種臨床常用複方濃縮中藥。結果顯示 3家市售廠牌之 15種臨床常用複方濃縮中藥中,對於遠端小管細胞 (MDCK cell)而言,大多沒有顯著之毒性,惟於 B藥廠製造之甘露飲及知柏地黃丸濃縮中藥顯示細胞反應 48小時後之細胞存活率< 75%;對於近端腎小管細胞 (LLC-PK1 cell)而言,除麥門冬湯及天王補心丹外,餘複方濃縮中藥於中高濃度時則表現顯著影響細胞之存活,此亦顯示近端腎小管細胞對於複方濃縮中藥的毒性較遠端小管細胞敏感。另蒐集此 3家 15種臨床常用複方濃縮中藥製劑之檢測報告,只有一家之一種中藥製劑重金屬含量是訂於小於 50 ppm,其餘重金屬含量均小於等於 30 ppm,各廠牌之中藥重金屬含量皆符合標準。 今年度亦已完成連續七天給與 A藥廠之 15種臨床常用複方濃縮中藥,及針對於近端腎小管細胞 (LLC-PK1 cell)顯示出具有較高毒性之 C藥廠複方濃縮中藥,此包括藿香正氣散、荊防敗毒散、止嗽散、知柏地黃丸、甘露飲及當歸芍藥散進行給予複方中藥之動物體內試驗,以評估其腎傷害(病理切片)及其生物活性指標。評估之生物標誌包含:白蛋白 (Albumin)、尿液中的蛋白質 (Total urinary protein)、β2-微球蛋白 (β2-microglobulin)、腎臟損傷分子 -1 (KIM-1)、血清胱蛋白 C (Cystatin C)、尿液凝聚素 (urinary clusterin)、尿液三葉因子 3 (urinary trefoil factor 3)。A藥廠之 15種臨床常用複方濃縮中藥及 C藥廠 6種複方濃縮中藥於 7種生物活性指標之研究結果顯示, A藥廠出產之藿香正氣散、濟生腎氣丸複方濃縮中藥會使大鼠之血清胱蛋白 C (Cystatin C)顯著增加 (p < 0.05);而 C藥廠之藿香正氣散、知柏地黃丸複方濃縮中藥則會顯著增加大白鼠尿液中 β2-微球蛋白 (β2-microglobulin)生物標誌之含量 (p < 0.05)。然於腎傷害病理切片結果則顯示,使用之複方濃縮中藥皆不具腎毒性。綜合以上結果顯示,於短期( 7天)服用所測試之 15種臨床常用複方濃縮中藥製劑並不會造成急性腎臟損傷之危險。 |
英文摘要 | The purpose of this project is to evaluate the effects of frequently used clinical Chinese herbal medicines (CHMs) on kidney functions. Ten to fifteen CHMs that have not been studied before were selected from the top 100 commonly used CHMs for the evaluation. This is a two-year project, which each year the selected CHMs will be screened using kidney cell lines for potential candidates and the particular potential candidates will be tested in the animal study. Any candidates that show significant effects on kidney functions in the animal study will be further evaluated: the major components in the effective CHMs will be further investigated for absorption distribution, metabolism, pharmacokinetics and nephrotoxicity. Screening of CHMs using porcine renal proximal tubular epithelial cell line (LLCPK1) and Mardin-Darby canine kidney cell (MDCK) cell lines were completed. Assessment of 3 different GMP pharmaceutical companies (A, B and C) for the 15 commonly used clinical CHMs were compared. The results indicated that no significant cytotoxicity were shown for the MDCK cell line, except for company B that Gan Lu Yin and Chih Po Ti Huang Wan were shown to have a cell viability of <75%. For the LLC-PK1, on the other hand, every CHMs, except Mai Men Dong Tang and Ten Wang Pu Hsin Tan, indicated significant cytotoxicity. A test result was also obtained indicated that only one company showed the level of heavy metal < 50 ppm, all the other companies were in standard range. The animal study for the 15 commonly used CHMs from company A was completed. We have also tested the animal study for the CHMs, including Huo Hsiang Cheng Chi San, Ching Fang Pai Tu San, Chih Sou San, Chih Po Ti Huang Wan, Gan Lu Yin and Tang Kuei Shao Yao San, from company C that had showed cytotoxicity on LLC-PK1 cell line to evaluate the nephrotoxicity. The categories for assessments include: level of albumin, total urinary protein, β2-microglobulin, KIM-1, cystatin C, urinary clusterin and urinary trefoil factor 3. The results indicated that Huo Hsiang Cheng Chi San and Chi Sheng Shen Chi Wan from company A had significantly increased the level of cystatin C in plasma; and that Huo Hsiang Cheng Chi San and Chih Po Ti Huang Wan showed significant increase of the level of β2-microglobulin in urine. On the other hand, the results of kidney biopsy showed no significant nephrotoxicity. All the results indicated that administration of the 15 commonly used CHMs for 7 days will not induce any acute nephrotoxicity. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。