以Sprague-Dawley大鼠之28天口服重複劑量亞急性毒性試驗評估「清冠一號」之安全性

臺灣「清冠一號」（NRICM101）是一種新型的傳統中藥配方。它已被臺灣衛生福利部批准用於治療COVID-19確診病例。為了評估其安全性，吾等從莊松榮製藥廠有限公司取得單日份包裝，以自來水將其煮沸並濃縮1.3倍做為測試物質，然後根據經濟合作與發展組織（OECD）的“28天重複劑量亞急性毒性試驗”的OECD407-2008準則，進行亞急性毒性試驗。雄性和雌性Sprague-Dawley（SD）大鼠各6隻分別口餵給予NRICM101水萃取物，劑量為10.0 mL/Kg b.w./day，連續28天，每天進行臨床觀察，每週測量體重和攝食量。對於對照組，給予相同隻數的雄性和雌性SD大鼠相同容量的逆滲透水，並以與試驗大鼠相同的方式進行檢查。在試驗結束時，沒有大鼠出現任何異常的臨床症狀或死亡。眼睛檢查結果顯示大鼠均無異常，試驗結束後，所有大鼠都被犧牲，並於犧牲後採血。然後進行血液學、血清生化學、尿液學和病理學檢查。所有血液學和血清生化學檢查以及尿液分析結果都是正常的。除了一些經過處理的雌性大鼠的絕對器官重量和每日飼料消耗量有不明顯的差異外，任何器官都沒有形態學或病理學變化。在28天重複劑量亞急性毒性試驗中，NRICM101對大鼠沒有任何不良影響，以1.3倍為本試驗無毒性顯現劑量計算，人體安全邊際係數為2.72倍。

關鍵字

台灣「清冠一號」（NRICM101）； 28天重複劑量亞急性毒性試驗； Sprague-Dawley（SD）大鼠

並列摘要

The Taiwan Chingguan Yihau (NRICM101) is a novel traditional Chinese medicine formulation. It has been approved by the Ministry of Health and Welfare of Taiwan for treatment of confirmed COVID-19 cases. To evaluate its safety, a single day packs of NRICM101 was obtained from Chuang Song Zong Pharmaceutical Co., Ltd. (Kaohsiung, Taiwan), and boiled in tap water to form aqueous concentrates as the test substance. The subacute toxicity test was then conducted according to the OECD 407-2008 guideline for "Repeated Dose 28-Day Oral Toxicity Study in Rodents" from the Organization of Economic Co-operation and Development (OECD). Six each of male and female Sprague-Dawley (SD) rats were given water extract of NRICM101 at the dose of 10.0 mL/kg b.w./day for 28 consecutive days with daily clinical observations and weekly measurements of body weight and food intake. For the control, the same number of both male and female SD rats were given the same amount of reverse osmosis water and examined in the same ma nner as the test rats. At the end of the test, none of the rats showed any abnormal clinical signs and died, and results of all hematology, serum biochemistry and urinalysis were normal. Eye examination showed no abnormalities in any of the rats. Other than an insignificant difference in absolute organ weights and daily feed consumption in some treated female rats, there was no morphological or pathological change in any organs. NRICM101 did not have any adverse effects on rats in the 28-day repeated dose subacute toxicity test. Based on 1.3 times the NOAEL obtained in this test, the margin of safety for humans is 2.72 times.

並列關鍵字

Taiwan Chingguan Yihau (NRICM101) ； Repeated Dose 28-Day Oral Toxicity Study ； Sprague-Dawley (SD) rats

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