参杞强精胶囊急性毒性及抗应激作用实验研究

目的 研究参杞强精胶囊的急性毒性和抗应激作用.方法 参杞强精胶囊采用最大浓度及最大给药体积的药液对实验组小鼠灌胃给药,对照组给予等体积的溶媒,连续观察14 d,记录小鼠毒副反应情况;采用游泳实验、耐缺氧和耐低温实验,考察其抗应激作用.结果 观察14 d后,给药组与对照组全部动物健存;给药组及对照组小鼠体质量平均增长分别为46.33％、47.15％,无明显差异(P＞0.05),未见任何毒性反应.计算其最大给药量为40.5 g·kg-1体质量,相当于成人1日用量的506倍.参杞强精胶囊中、高剂量能延长小鼠游泳时间、耐缺氧时间和耐低温时间(P＜ 0.05或P＜0.01).结论 参杞强精胶囊毒性较小,具有提高小鼠的抗疲劳、抗应激能力的作用.     

颐脑胶囊对心气虚模型动物的应激作用实验研究

目的 研究颐脑胶囊对心气虚模型动物的应激作用。方法 采用剥夺睡眠加注射垂体后叶素的方法，制备心气虚动物模型，造模后连续给药7d，测定模型小鼠常压耐缺氧能力，强迫游泳不动时间，悬挂不动时间和肌张力。结果 颐脑胶囊可明显延长模型小鼠常压耐缺氧时间，强迫游泳不动时间，悬挂不动时间和降低肌昆张度。结论 颐脑胶囊明显增强心气虚模型动物的应激能力。     

活络舒腰颗粒急性毒性实验

活络舒腰颗粒由丹参、白芍、当归尾、五灵脂、郁金、青皮、延胡索、桂枝、防风、乳香、没药、香附、厚朴、甘草组成,临床用于治疗瘀血型腰痛,疗效显著,为了给临床安全用药和长期毒性试验剂量设计提供参考,我们对其进行了急性毒性     

蟾酥的急性毒性和丹羚心舒胶囊急性毒性研究

目的:研究蟾酥的急性毒性及丹羚心舒胶囊的急性毒性。方法:以急性毒性为指标,研究蟾酥和丹羚心舒的LD50,并在整个观察期间进行宏观测定。结果:蟾酥75%乙醇提取物的LD50为0.6006g/kg,丹羚心舒的75%乙醇提取物LD50为33.23g/kg。丹羚心舒复方组方中蟾酥用量比为1:23.83,折合为其中所含蟾酥的LD50应为1.39g/kg,表明丹羚心舒组方中蟾酥的LD50约为单味蟾酥LD50的2.31倍。蟾酥的中毒表现主要为上消化道炎症、抽搐、呼吸先停于心脏,丹羚心舒的中毒表现与蟾酥相比性质类似,但毒性反应要低。结论:①蟾酥有明显的急性毒性,但丹羚心舒组方中其毒性明显降低。②丹羚心舒胶囊(0.16g/粒)中蟾酥的含量为0.0068g/粒,根据实验数据,丹羚心舒组方中蟾酥的LD50=1.39g/kg,相当于丹羚心舒临床剂量的5148倍,所以丹羚心舒胶囊的安全性良好。     

心舒灵胶囊的药效学实验研究

心舒灵胶囊是治疗冠心病的中药制剂，临床效果显著，经药效学实验研究表明，本品具有显著的抗急性心肌缺血，增加冠脉流量，改善缺血心电图及提高耐缺氧等作用，其作用优于复方丹参对照组（Ｐ〈０．０５），为临床治疗冠心病提供了现代科学依据。     

人参养荣汤的急性毒性及抗疲乏抗应激的研究

目的:观察人参养荣汤的急性毒性以及抗疲劳、抗应激作用。方法:选择SPF级KM种小鼠为受试对象,采用急性经口毒性试验测定最大耐受量,采用抗疲劳、耐缺氧以及耐高低温试验,进行抗应激作用的评价。结果:人参养荣汤的最大耐受量为>160 g生药/kg,相当于人临床每天口服用量的76.2倍。与空白对照组比较,人参养荣汤的高、中剂量组(按生药量计为42.0,21.0 g·kg-1)和十一味参芪片组(1 g·kg-1)可延长小鼠不间断走动疲劳过度从转棒上跌落的时间;人参养荣汤的高剂量组可延长小鼠断头后喘息时间和小鼠常压下的窒息时间;人参养荣汤的高、中剂量组和十一味参芪片组具有延长小鼠45℃高温下死亡的时间和小鼠-5℃低温下死亡时间,具有统计学意义(P<0.05或P<0.01)。结论:人参养荣汤的最大耐受量按生药量计>160 g·kg-1,相当于人临床每天口服用量的76.2倍。人参养荣汤可以提高小鼠的抗疲劳、耐缺氧和耐高低温能力,具有抗疲劳和抗应激作用。     

脑心舒口服液质量检验探讨

脑心舒口服液由密环菌、蜂王浆、蜂蜜３味药物组成。其功能为滋补强壮、镇静抗惊。主要用于头痛、眩晕、神经衰弱、冠心病。由于该制剂吉林省药品标准１９８６年版对它只有性状和常规检验,云南省药品标准１９９３年版也只加些试管反应作为定性鉴别,对其主药密环菌不能作...     

抗感宁胶囊的抗炎作用及急性毒性研究

目的：观察抗感宁胶囊的抗炎作用及急性毒性。方法：以大鼠蛋清,角叉菜胶足跖注射致炎法和分组法。结果：抗感宁灌胃给药（０．８,０．４,０．２ｇ／ｋｇ）对二种致炎模型有明显抗炎作用,用３０ｍｉｎ开始起效,可维持６ｈ之外,３剂量间存在量效关系。用ｂｌｉｓｓ法算得大鼠和小鼠灌胃的ＬＤ５０分别为１０．４６ｇ／ｋｇ和４．６８ｇ／ｋｇ。结论：抗感宁具有明显抗炎作用,且毒性较小。     

律复康胶囊对小鼠抗应激能力的影响的实验研究

目的：通过观察律复康胶囊对小鼠抗应激能力的影响,为临床用药提供依据。方法：取实验小鼠100只,均分为正常对照组（等容量蒸馏水）、阳性对照组（7.020g生药/kg）、律复平颗粒小（2.582g生药/kg）、中（5.164g生药/kg）、大剂量（10.328g生药/kg）组,连续给药7d后,观察药物对小鼠常压耐缺氧及耐寒、耐力能力的影响。结果：律复康胶囊各剂量组能够增加小鼠常压耐缺氧以及耐寒、耐力的能力,延长小鼠的存活时间,与正常对照组比较有显著性差异（P〈0.05）。结论：律复康胶囊能够提高小鼠的抗应激能力。     

脑舒胶囊对免疫低下小鼠免疫功能的调节作用

目的 研究脑舒胶囊对免疫低下小鼠免疫功能的影响.方法 环磷酰胺0.02g/kg皮下注射制备免疫低下小鼠模型;碳粒廓清法观察小鼠单核巨噬细胞吞噬功能;溶血素抗体测定法观察小鼠溶血素抗体生成;足垫增厚法观察小鼠迟发型超敏反应.结果 1.33g/kg脑舒胶囊能提高免疫低下小鼠单核巨噬细胞吞噬功能;0.67g/kg和1.33g/kg脑舒胶囊能增加免疫低下小鼠溶血素抗体生成,并拮抗环磷酰胺诱导的免疫低下小鼠足垫肿胀度减轻.但两剂量组间无明显量-效关系.结论 脑舒胶囊在一定程度上能改善环磷酰胺所致小鼠免疫低下的非特异性免疫功能,增加其特异性细胞免疫和体液免疫功能.     

降糖通脉无糖型颗粒急性毒性试验

目的：研究降糖通脉无糖型颗粒的毒性反应,对临床应用的安全性进行评价。方法：以临床单日剂量的218．88倍为最高剂量,按1：0．8为剂间比例,分别给5组小鼠灌胃给予降糖通脉（给药剂量分别为410．4,328．3,262．7,210．1,168．1g生药/kg）,观察小鼠的死亡率。采用改良寇氏法计算小鼠的半数致死量（LD50）。结果：降糖通脉无糖型颗粒LD50为269．15g生药／kg,可信限为239．33g生药／kg～302．69g生药／kg。结论：该药毒性较小,在临床上可以安全使用。     

Acute oral toxicity and genotoxicity of Dryopteris crassirhizoma

Ethnopharmacological relevance

Dryopteris crassirhizoma has been traditionally used for the treatment of tapeworm infestation, the common cold and cancer in Korea, China and Japan. Despite various pharmacological properties of Dryopteris crassirhizoma, there is no available information about the safety of Dryopteris crassirhizoma.

Aim of this study

To ensure more information about the safety of Dryopteris crassirhizoma, we performed the acute oral toxicity and genotoxicity tests of Dryopteris crassirhizoma.

Materials and methods

The acute oral toxicity test of Dryopteris crassirhizoma was performed in rats. Genotoxicity of Dryopteris crassirhizoma was evaluated by bacterial reverse mutation, chromosomal aberration and bone marrow micronucleus tests.

Results

In acute toxicity test, Dryopteris crassirhizoma exhibited no mortality, body weight and behavioral changes and adverse effects in male and female rats. Dryopteris crassirhizoma did not significantly increase the number of the bacterial revertant and chromosomal aberration in both in vitro assays. Moreover, the Dryopteris crassirhizoma-related increases of micronucleated polychromatic erythrocytes (MNPCE) in mouse bone marrow were not observed.

Conclusion

Therefore, Dryopteris crassirhizoma is non-genotoxic in a three standard battery of tests and the oral LD₅₀ of Dryopteris crassirhizoma is >2000 mg/kg.     

金石穿胶囊急性毒性试验

对金石穿胶囊进行动物急性毒性试验。结果表明：经灌胃给药小鼠的最大耐受量倍数为１２４．８,超过人口服用量的１００倍。提示临床应用本品是安全可靠的     

天钩降压胶囊的毒理学研究

目的:观察天钩降压胶囊的急性毒性和长期毒性,以评估天钩降压胶囊用药的安全性.方法:以最大给药体积的天钩降压胶囊(0.345 g·mL-1)给予小鼠,24h内分2次灌胃给药,连续观察14d32.记录动物外观、行为活动、精神状态、呼吸变化、中毒反应及死亡情况;存活小鼠每天记录体重及饲料量.用低、中、高剂量(32.4,64.8,129.6g·kg-1,按生药计)的天钩降压胶囊灌胃给予大鼠,连续给药6个月,停药恢复1个月,分阶段观察大鼠的一般行为、体重增长、食量消耗、血液学及血液生化学指征、尿常规检查、心电图、系统尸解及组织病理学检查.结果:小鼠1d内2次灌胃给予天钩降压胶囊的最大给药量为534.86 g·kg-1,相当于临床成人拟用日剂量(60g·d-1)的534.86倍,未见明显的急性毒性反应.长期毒性实验中与同期对照组比较,天钩降压胶囊低、中、高3个剂量组动物行为活动、进食量、心电图等检查均未见异常;血液学指标、血液生化指标和尿液指标及病理组织学检查未发现存在与供试品有关的异常改变.结论:天钩降压胶囊低剂量为相对安全剂量;中、高剂量在6个月给药期内引起体重减少,在临床研究中应予以注意.     

Acute and subchronic oral toxicity of Galega officinalis in rats

Galega officinalis L. (Papilionaceae) is widely used in folk medicine as antidiabetic or for increasing lactation. There is a little information about its possible toxicity. In this study, acute and subchronic toxicity of aerial parts of Galega officinalis in Wistar rats have been evaluated. For the acute toxicity study, the animals received orally four different single dose of plant suspension and were kept under observation for 14 days. The results indicated that LD50 of Galega officinalis is higher than 5 g/kg. In the subchronic study, 48 rats were divided into four groups and were fed a diet containing 0%, 0.15%, 1.5% and 3% (w/w) of Galega officinalis. After 90 days blood and tissue samples were taken for hematological, biochemical and histopathological determinations. An increase in serum levels of cholesterol, creatine phosphokinase, lactate dehydrogenase and total and conjugated bilirubin was observed. Some parameters such as calcium, albumin, albumin/globulin ratio, hematocrit, WBC and platelet counts were decreased. In microscopic examination, sinusoidal congestion in liver and alveolar hemorrhage was observed. Other parameters showed non-significant difference between treatment and control groups. Present data suggest that liver and lung could serve as target organs in oral toxicity of this plant.     

Evaluation of the anti-stress and anticonvulsant activities of leaf extract of Alchornea cordifolia in mice

Aim of the study

The extract of the leaves of Alchornea cordifolia (AC) is extensively used in ethnomedicine for ulcers, rheumatic pains, febrile convulsions and for enhancing physical performance. In this study, the anti-stress and anticonvulsant activities of the aqueous leaf extract of Alchornea cordifolia were investigated in mice.

Materials and methods

The anti-stress activity was assessed based on the ability of the extract to alter the duration of immobility, in the forced swim endurance test, whilst a picrotoxin-treated animal, was employed as the model for convulsive seizures.

Results

The extract (100–400 mg/kg) given orally was found to significantly (p < 0.05) reduce the duration of immobility, which suggest an anti-stress/anti-fatigue property. However, AC when tested at doses between 100 and 400 mg/kg did not prevent convulsions induced by picrotoxin in mice. The acute toxicity study carried out in mice revealed that the extract was well tolerated by the animals, as no death was observed at oral doses of 500–4000 mg/kg.

Conclusions

The results of this preliminary study provide evidence, which may support the use of Alchornea cordifolia against stress or fatigue in ethnomedicine.     

降压滴丸急性毒性及其药效学研究

目的:研究降压滴丸对高血压的用药安全及其药效。方法:采用急性毒性试验连续观察给降压滴丸后14 d内动物的行为反应。药效学实验采用肾动脉结扎的方法建立大鼠肾性高血压模型,通过空白对照组、模型组、阳性对照组、降压滴丸高剂量组、中剂量组、低剂量组的建立,从而比较观察其降压效果;并通过记录小鼠耳微动脉、微静脉血管管径变化,比较降压滴丸的扩血管作用。结果:降压滴丸急性毒性实验连续观察14 d,未发现动物死亡,体重均有所增长,肉眼观察未见明显毒性反应。药效学实验发现高、中、低3个剂量组均可降低肾性高血压大鼠血压,并能扩张小鼠耳微动脉、微静脉血管。结论:初步证明降压滴丸是安全的并具有一定的降血压作用。     

生品、沙烫品及醋煮品马钱子的急性毒性试验

目的：探讨不同制品马钱子的急性毒性效价,为优选炮制工艺提供参考。方法：用生品、沙烫品和醋煮品马钱子不同剂量的混悬液灌胃小白鼠,观察中毒表现和急性死亡情况,概率单位回归建立剂量-死亡关系方程,计算LD50。结果：①死亡概率单位方程：生品：Probit（P生）=7.007（1g剂量）-13.604。沙烫品：Probit（P沙）=7.007（1g剂量）-14.276。醋煮品：Probit（P醋）=7.007（1g剂量）-14.990。②生品、沙烫品和醋煮品的LD50分别是87.400mg/Kg（95%CI：77.654～98.483）、109.014mg/Kg（95%CI：97.003～122.685）和137.848mg/Kg（95%CI：122.199～155.939）。③毒力效价比较生品LD50/沙烫品LD50=0.802（95%CI：0.650～0.952）;生品LD50/醋煮品LD50=0.634（95%CI：0.474～0.768）;沙烫品LD50/醋煮品LD50=0.791（95%CI：0.639～0.924）,均不包含1。结论：生品、沙烫品及醋煮品马钱子的毒力存在差异,以醋煮品的毒性较低。     

Acute and sub-chronic oral toxicity profiles of the aqueous extract of Polygala fruticosa in female mice and rats

Polygala fruticosa (P.J. Bergius) is one of the most popular medicinal plants in South Africa but to date there is no documented evidence corroborating its safety. This study thus aimed to determine the toxicity profile of the aqueous extract of Polygala fruticosa by determining its effects after acute and sub-chronic oral administration in female mice and rats, respectively. In adult mice, single oral administrations of the aqueous extract of Polygala fruticosa (2–20 g/kg body weight) induced an increase in the incidence of general behavioural adverse effects. The mortality rate also increases with increasing dosage (LD₅₀ = 10.8 g/kg). In rats, daily single oral doses of Polygala fruticosa aqueous extract (0.1 and 1 g/kg) were well tolerated behaviourally after 31 days of dosing (LD₅₀ much higher than 1 g/kg) and induced no significant changes in body and organs weights. However, haematological and biochemical parameters showed a significant decrease in platelet count and significant increases in ALT, AST and creatinine levels suggesting disturbances of haemopoiesis, liver and kidney functions.     

Acute and sub-chronic toxicity studies of Danshen injection in Sprague-Dawley rats

Ethnopharmacological relevance

Salvia miltiorrhiza Bunge named Danshen in China has been used for hundreds of years in both China and other countries. Danshen injection made from the aqueous extract of Danshen which is widely adopted in China is one of the traditional Chinese medicine injections for preventing and treating cardiovascular diseases in most of the time. The present study was carried out on re-evaluating the safety of Danshen injection by determining toxicity after acute and sub-chronic administration in Sprague-Dawley (SD) rats.

Materials and methods

In acute toxicity study, rats (10 males and 10 females) were intravenously administered Danshen injection dose of 32 g/kg body weight, two times in one day. General behavior, adverse effects and mortality were recorded for up to 14 days post treatment. In the sub-chronic study, Danshen injection was given intravenously at the doses of 0, 1.92, 5.76, and 19.20 g/kg per day (n = 15/group each sex) for 13 weeks to rats. Animal body weight and food intakes were observed weekly. Hematological, biochemical parameters and organ weight were determined in all animals at the end of the 13-week administration and 2-week recovery. However, histological examinations were carried out in the control and high-dose groups only.

Results

In acute study, the sign of struggling was observed in some animals at the moment of intravenous administration. No deaths and other signs of toxicity occurred in any of the animals tested during the 14 days of the study. In sub-chronic study, Danshen injection did not result to death, adverse effects or dose-dependent changes in food consumption, but had an effect on body weight gain. Some statistically significant differences were observed in hematological and biochemical parameters, as well as in some organ weights of both male and female rats treated with Danshen injection. In these changes, the significant decrease in triglycerides and increase in total bilirubin were considered related to treatment, indicating the lipid-modulating activity of Danshen. Histopathological examinations of the injection site showed that Danshen injection could cause dose-dependent focal inflammation. There was no abnormality of other organs noted in both gross and histopathological examinations.

Conclusions

The results showed that acute or sub-chronic administration of Danshen injection was low or non-toxic in male and female rats, and the no-observed-adverse-effect-level for sub-chronic administration of Danshen injection dose was 5.76 g/kg bw/day, which was suggested that it was safe in clinical use.