目的 研究翻白草膠囊的急性毒性及長(zhǎng)期毒性。方法 采用最大耐受量法進(jìn)行小鼠急性毒性試驗(yàn)，30 g/kg翻白草膠囊ig給予小鼠，間隔6 h給藥2次，觀察體質(zhì)量、進(jìn)食情況、外觀情況、行為活動(dòng)、是否出現(xiàn)死亡現(xiàn)象等，連續(xù)觀察1周；將清潔級(jí)別的80只大鼠隨機(jī)分為對(duì)照組和翻白草膠囊高、中、低劑量（4.8、2.4、1.2 g/kg）組，每天ig給藥1次，每周給藥6次，連續(xù)給藥90 d，并停藥觀察15 d，觀察大鼠外觀體征、飲食、體質(zhì)量等情況，并進(jìn)行一般形態(tài)學(xué)、血液學(xué)、臟器形態(tài)學(xué)、血液生化學(xué)、組織病理學(xué)檢測(cè)。結(jié)果 急性毒性試驗(yàn)期間內(nèi)無小鼠死亡現(xiàn)象，小鼠對(duì)藥物的最大耐受量為30 g/kg，相當(dāng)于人臨床用藥劑量的320倍。長(zhǎng)期毒性試驗(yàn)結(jié)果表明，翻白草膠囊高劑量組在給藥初期，部分動(dòng)物出現(xiàn)精神萎靡、厭食、大便偶見溏稀化、口周出現(xiàn)青紫狀斑點(diǎn)等現(xiàn)象，連續(xù)給藥后可自行緩解；與對(duì)照組比較，翻白草膠囊組血液學(xué)、臟器形態(tài)學(xué)、血液生化學(xué)指標(biāo)均未出現(xiàn)劑量相關(guān)性的顯著變化，無明顯藥物毒性反應(yīng)；給藥90 d后，翻白草膠囊高劑量肺組織切片光鏡下偶見局部出現(xiàn)點(diǎn)狀炎癥細(xì)胞，卵巢偶見炎癥細(xì)胞并伴有膿細(xì)胞，停藥15 d后癥狀消失。結(jié)論 在本實(shí)驗(yàn)條件下，翻白草膠囊對(duì)受試動(dòng)物無明顯毒性反應(yīng)，安全劑量范圍大，在有效劑量下，長(zhǎng)期用藥安全。

Objective To investigate possible acute and chronic toxicities of Potentilla discolor Capsules (PDC) for clinical reference.Methods Maximal tolerated dose was established in mice for acute toxicity evaluation. PDC of 30 g/kg was ig given to mice 2 times at 6 h intervals. The body mass, eating condition, appearance, behavior, and death were observed for one week. In the chronic toxicological study, 80 rats were randomly divided into control group, PDC high, medium, and low dose groups, and given intragastrically for 6 times weekly for 90 d. The patients were then followed for 15 d for recovery without treatement. The signs, diet, body weight, and other signs of the rats were observed, and the morphology, hematology, organ morphology, blood biochemistry, and histopathology were examined.Results No death was observed in mouse acute toxicity test. The maximal tolerated dose was 30 g/kg, quivalent to 320 times of the clinically recommended dose for human. The long-term toxicity test results showed that parts of mice in the PDC high dose group had the abnormal phenomena of listlessness, anorexia, occasionally loose stool, perioral bruising spots and other phenomena in the initial administration, which were relieved after continuous administration. Compared with control group, there were no significant changes in the hematology, visceral morphology, and blood biochemical indexes in PDC group, and there was no significant drug toxicity. After continuous administration for 90 d, lung tissue sections of PDC high dose group showed occasional punctiform local inflammatory cells under the light microscope, the inflammatory cells combined with pus cells were seen in ovarian pairs, the symptoms were disappeared 15 d after withdrawal.Conclusion Under the conditions of this experiment, the capsule has no obvious toxic reaction to the tested animals with large safe dose range and long-term medication safety in effective dosage.

黑龍江中醫(yī)藥大學(xué)?？蒲谢鹳Y助；黑龍江省科技攻關(guān)計(jì)劃（GC06C40504）