三種不同生產製程牛樟芝的 安全性評估

SAFETY EVALUATION OF THREE DIFERENT PRODUCTS OF Taiwanofungus camphoratus

吳明儒(Ming-ju Wu)

指導教授 ： 林銘澤

大同大學/工程學院/生物工程學系所/碩士(2012年)

摘要

連續 28 天口服投予 Sprague-Dawley (SD) 大鼠固態栽培牛樟芝子實體 (WS027)、固態培養牛樟芝菌絲體 (GS100) 或液態發酵牛樟芝菌絲體 (SB011)，藉以評估不同製程的牛樟芝產品是否對大鼠具有亞急毒性。

SD 大鼠共 80 隻，依隨機方式分為四組 (每組雄、雌各十隻)，分別為對照組、WS027、GS100 或 SB011 藥劑處理組。藥劑分別投予 3000 mg/kg/day 之 WS027、GS100 或 SB011 之0.5 % CMC 懸浮液，對照組則投予 0.5 % CMC 水溶液 (對照溶液)。3 個藥劑處理組及對照組之投予體積均為 15 mL/kg。
試驗評估項目依據衛生署藥品非臨床試驗安全性規範 (DOH, 2000)，項目包括動物外觀、臨床症狀、死亡率、體重成長/體重增加、食物攝取量、眼睛檢查、臨床病理 (尿液、血液及血清生化)、肉眼病變、臟器重量、臟器與體重比值及組織病理鏡檢。
結果顯示：WS027、GS100 或 SB011 經重複口服投予 28 天後，並不會造成任何動物的死亡；WS027、GS100 或 SB011 藥劑處理組之體重與體重成長均與對照組相似；所有組別之平均飼料攝取量、臟器重量及臟器對體重比值，均無因試驗物質處理的不同而有差異；各藥劑處理組與對照組於臨床病理學並未發現相關變化。

病理檢查除了造成十二指腸黏膜上皮極微至輕度增生與肥大外，不會造成大鼠任何與試驗物質處理相關或顯著之毒性變化或病變，惟考慮十二指腸黏膜上皮之變化尚屬輕微，不認為是顯著的毒性反應。藉由本試驗結果顯示，以劑量 3000 mg/kg 固體栽培樟芝子實體 (WS027)、固態醱酵樟芝菌絲體 (GS100) 或液態醱酵樟芝菌絲體 (SB011) 經連續投予SD大鼠 28 天，均未造成任何毒性症狀或試驗物質處理相關之變化，故以每日人體建議劑量 (2000 mg/day) 之 15倍 (物種代謝率折算)，仍不會造成動物毒性。

關鍵字

Sprague-Dawley (SD) 大鼠 ； 亞急性毒性 ； 牛樟芝

並列摘要

This study is to evaluate the sub-acute toxicity by administrating the extract of solid cultivation fruiting bodies (WS027), solid-state culture mycelium (GS100) or submerged culture mycelium (SB011) of Taiwanofungus camphoratus for consecutive 28 days via oral gavage in Sprague-Dawley (SD) rats.
Eighty Sprague-Dawley (SD) rats will be allocated randomly into four groups (ten males and females per group), including a control group and three treatment groups. Treatment group will be administrated at 3000 mg / kg / day of WS027, GS100 or SB011 suspension, and the control group will be administrated 0.5% CMC solution (control solution). Dosing volume was 15 mL / kg.
Experimental evaluation (DOH, 2000) included the results of the animal appearance, clinical signs, mortality, body weight, food consumption, clinical pathology (urine, blood, and serum biochemical), gross lesions, organ weight, relative organ weight and histopathological examination.
All animal survived to the end of the study. They are similar in body weight and weight growth between the treatment and control groups. No treatment-related changes in food consumption, organ weight, and related organ weight among all groups. No related changes were found in clinical pathology of all groups.
Necropsy and histopathological examination indicated no treatment-related gross lesions. Only minimal to mild hyperplasia and hypertrophy in duodenal mucosal epithelium was observed. However, the change in the duodenal mucosa epithelium is minor and won’t be considered toxic effect.. No toxic signs or treatment-related changes were observed by administrating the extract of solid cultivation fruiting bodies (WS027), solid-state culture mycelium (GS100) or submerged culture mycelium (SB011) of Taiwanofungus camphoratus for consecutive 28 days via oral gavage in Sprague-Dawley (SD) rats. Therefore, it will not cause animal toxicity by administrating15 times of recommended human daily dose (2000 mg / day).

並列關鍵字

Taiwanofungus camphoratus ； Sub-acute toxicity ； Sprague-Dawley (SD) rats

參考文獻

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