连虎丹烧伤膏皮肤用药急性毒性试验

目的研究连虎丹烧伤膏家兔皮肤局部用药的急性毒性。方法连虎丹烧伤膏10g/只、30g/只内分2次给予完整皮肤和破损皮肤家兔。结果动物行为活动、毛发、眼睛、体重增长等连续观察7d,未出现任何中毒症状。无1只死亡。结论提示连虎丹烧伤膏家兔皮肤局部用药毒性较小。     

连虎丹烧伤膏治疗小面积Ⅲ度烧伤创面

烧伤创面的修复是烧伤治疗的重要环节。对大面积Ⅲ度创面多采用手术治疗的方法，而小面积的Ⅲ度创面可以选用非手术的治疗方法。为了探寻一种比较理想的烧伤创面外用药。从1991年起笔者按照国家新药研究的有关要求，研制了中药连虎丹烧伤膏，在完成了各种动物实验的基础上用于临床研究。     

连虎丹烧伤膏中丹皮酚提取工艺设计

连虎丹烧伤膏是自1991年起研制并应用于治疗烧伤烫伤的外用新药。为了保证新药的质量，按国家新药研究的有关要求，用正交设计法提取工艺进行了研究。     

气相色谱法测定连虎丹烧伤膏中冰片的含量

目的建立连虎丹烧伤膏中冰片含量的测定方法。方法以水杨酸甲酯为内标物,采用气相色谱法:DB-FFAP毛细管色谱柱,柱温140℃,进样口温度200℃,氢火焰离子化检器,检测器温度为250℃。结果冰片在0.0424⁰.212 mg/m L浓度范围内呈良好的线性关系,r=0.9997,(n=5),回收率为100.68,RSD为1.16%(n=9)。结论本法测定的冰片的含量方便、快速、准确、重现性好,可用于本制剂质量控制。     

芦荟冰片烧伤膏的皮肤毒性实验

目的：考察芦荟冰片烧伤膏的安全性。方法：对健康大鼠皮肤进行急性毒性实验；采用20％甲醛作阳性对照．对健康家兔进行皮肤刺激实验；用健康豚鼠进行皮肤过敏实验。结果：芦荟冰片烧伤膏对健康大鼠完整皮肤和破损皮肤均未引起急性毒性反应，对家兔完整皮肤和破损皮肤无刺激性；且对豚鼠皮肤无致敏作用。结论：芦荟冰片烧伤膏外用安全、无毒。     

高原护唇膏对家兔皮肤长期毒性的实验研究

目的观察动物对高原护唇膏的急性及长期毒性反应,为临床用药的安全剂量提供参考。方法 （1）急性毒性试验：采用最大给药量法测定小鼠口服高原护唇膏的最大耐受量。（2）长期毒性试验：将家兔按体重性别随机分为3组,采用2个剂量组（480mg/kg、160mg/kg）和赋形剂组连续涂抹家兔皮肤90d,观察家兔的一般情况。剩余动物停药恢复7d后重复上述检查。结果小鼠口服高原护唇膏最大给药量为含药量1.5%,120ml/kg。家兔连续给药90d后护唇膏大、小剂量组对家兔的一般情况、血液、血液生化学、脏器系数均无明显影响,未发现长期毒性及中毒靶器官,恢复期亦无延迟性毒性反应。结论高原护唇膏在规定剂量下使用是安全可靠的。     

紫虎烧伤膏成型工艺的研究

目的：优选紫虎烧伤膏的成型工艺。方法采用L9（34）正交设计优化成型工艺条件,对可能影响紫虎烧伤膏成型工艺的4个因素,在3个水平上进行试验考察,并对试验结果进行直观分析和方差分析。结果紫虎烧伤膏以提取药油65℃左右加入30％蜂蜡熔融后,搅拌均匀至冷却成型为最佳成型工艺条件。结论优化得到的成型工艺操作简便,工艺设计科学合理,可用于工业化生产。     

湿润烧伤膏治疗慢性皮肤溃疡53例临床观察

目的：探讨应用湿润烧伤膏（MEBO）治疗慢性皮肤溃疡的临床效果。方法：对压迫性溃疡13例16个创面,创伤性溃疡17例18个创面,静脉性溃疡11例13个创面,糖尿病溃疡12例13个创面用MEBO治疗。结果：治疗14d愈合37个创面,21d愈合8个创面,28d愈合12个创面,超过28d愈合3个创面;死亡1例,失访2例。结论：MEBO治疗慢性溃疡总体效果好,可作为首选药物,同时对不同病因的慢性溃疡疗效也有差异。     

法半夏罗汉果川贝枇杷膏的长期毒性试验研究

目的 观察法半夏罗汉果川贝枇杷膏对大鼠的长期毒性作用。方法以健康SD大白鼠为受试对象,法半夏罗汉果川贝批杷膏分别按63．9、19．2及9．6g,kg体重灌胃给药,连续给药30d。给药前后及停药15d后,分别测定受试大鼠的体重、血液学及血生化学、重要器官脏器系数并做病理学检查等指标。结果口服法半夏罗汉果川贝枇杷膏30d,大鼠一般状况未见明显差异,对大鼠的体重增长、外周血象、血液生化学指标、脏器系数及各组织器官的病理形态均未见有显著影响,与对照组基本一致。结论法半夏罗汉果川贝枇杷膏给药30d对大鼠无明显毒性反应,未见延迟性毒性,表明该品口服应用是安全的。     

黑素再生颗粒的急性毒性实验研究

目的测定黑素再生颗粒对小鼠的急性毒性反应,为临床安全用药提供依据。方法实验组以黑素再生颗粒混悬液按0.3 mL.(10 g)-1体重24 h灌胃给药3次,对照组给予同体积的生活饮用水。观察并记录小鼠在给药后的行为活动、饮食、大便等情况及急性毒性反应和死亡数,连续观察7 d。结果小鼠在给药后观察期间状态良好,未出现明显毒性反应及死亡等情况。结论实验表明黑素再生颗粒毒性极低,临床使用安全性好。     

调经种子丸对大鼠的长期毒性研究

目的 观察调经种子丸对大鼠长期毒性的影响.方法 调经种子丸分别以12、6、3 g·kg~(-1)·d~(-1) ig大鼠,连续6个月,停药后观察2周.分别测量大鼠的体重,计算脏器系数,测定血液学和血液生化学指标,并作组织病理学检查.结果 调经种子丸给药组大鼠的外观体征、行为活动、体重、脏器系数、血液学和血液生化学指标与正常对照组比较,均无明显差异;病理检查未见与药物毒性相关的明显病变,停药后也未见药物延迟性毒性反应.结论 调经种子丸长期用药对大鼠无明显毒性,提示临床拟用剂量安全.     

大黄颗粒对大鼠的长期毒性试验研究

目的观察连续灌胃给予大黄颗粒对大鼠产生的毒性反应,为临床合理应用提供依据。方法将120只大鼠按体重随机分为对照组和大黄颗粒高、中、低剂量组,每组30只,雌雄各半。各剂量组分别灌胃给予大黄颗粒10、5、2.5g/kg（生药）,对照组给予等体积纯化水,1次/d,连续给药26周,大鼠每周称重,给药结束时测试大鼠尿常规、血常规、血生化、脏器系数及病理组织学变化。结果高剂量组大鼠排稀便,体重增长缓慢,精神萎靡,尿蛋白阳性,血糖、氯离子轻度升高,肾小管上皮细胞轻度肿胀。中、低剂量组大鼠各项检测结果未见与用药相关的毒性变化。结论大黄颗粒长期连续灌胃安全剂量为≤5g/kg。     

Relationship between the development of hepato-renal toxicity and cadmium accumulation in rats given minimum to large amounts of cadmium chloride in the long-term: preliminary study

We wished to clarify the relationship between the sensitivity to induce hepato-renal toxicity and the level of cadmium (Cd) in the organs of rats exposed to minimum to large amounts of cadmium chloride (CdCl₂). For this purpose, groups of female Sprague-Dawley (SD) rats, each consisting of 24 animals, were fed diet containing CdCl₂ at concentrations of 0, 8, 40, 200, and 600 ppm for 2, 4, and 8 months from 5 weeks of age. All surviving rats given 600 ppm Cd were killed at 4␣months because of deterioration of their general condition. Animals of this group showed anemia and decreased hematopoiesis in the bone marrow, in addition to reduction of cancellous bone in their femurs. Hepatotoxicity was observed after 2 months in the groups treated with 200 ppm. By 4 months, the rats in the 600 ppm group had developed periportal liver cell necrosis. Renal toxicity characterized by degeneration of proximal tubular epithelia was apparent in the groups treated with 200 ppm from 2 months, becoming more prominent in the high-dose rats at 4 months. Hepatic accumulation of Cd increased linearly with the duration of treatment. In contrast, the concentration of Cd in the renal cortex of rats treated with 600 ppm reached a plateau level of ∼250 μg/g within the first 2 months. The renal concentration of Cd in the 200 ppm group when renal toxic lesions were first detected at 2 months ranged from 104 to 244 μg/g. No renal lesions were observed in the 40 ppm group after 8 months, despite the presence of 91–183 μg/g of Cd in the kidneys. The results thus suggest that renal toxicity would not be induced by treatment with minimum amounts of CdCl₂ for periods longer than 8 months, although accumulation of Cd might gradually progress. A further 2-year feeding study of CdCl₂ and Cd-polluted rice is now in progress. Received: 26 January 1998 / Accepted: 26 May 1998     

黄连水提取物药膜的制备及毒性实验

目的应用黄连水提取物,制备成牙周药膜,进行毒性实验,观察该药膜临床应用的安全性。方法将Wistar大鼠随机分为3组,每组各3只大鼠:①黄连药膜组:将黄连水提取物制备成药膜贴于大鼠的双侧颊黏膜;②空白药膜组:将空白药膜贴于大鼠的双侧颊黏膜;③空白对照组:大鼠颊黏膜不做任何处理。24h后切取颊黏膜组织行病理学检查,观察药膜对口腔黏膜有无毒性刺激作用。结果应用黄连水提取物制备的牙周药膜,贴敷到Wistar大鼠颊黏膜,24h后切取颊黏膜组织行病理学检查,结果无明显病理变化,实验组与对照组相比,亦未见有明显炎症细胞浸润。结论应用黄连水提取物制备成牙周药膜,对口腔组织没有明显的毒性刺激作用,可以应用于临床试验。     

复方冰甲乳膏长期毒性试验研究

目的:观察复方冰甲乳膏对大鼠的长期毒性。方法:将80只SD大鼠,雌雄各半,随机分为4组,分别是空白对照组和受试药高剂量组(3.00 g·kg-1)、中剂量组(1.50 g·kg-1)、低剂量组(0.75 g·kg-1),每组20只,每天皮肤涂抹一次,每周6 d,连续给药13周,停药恢复2周。观察一般状况、体质量及进食量。同时检测大鼠的血常规、血生化、脏器系数和组织病理学改变。结果:各剂量组大鼠外观体征、行为活动等无明显异常,体质量、摄食量增加正常;血常规指标、血生化指标、脏器系数与对照组比较差异均无统计学意义(P>0.05),组织病理学检查未出现任何异常改变。结论:复方冰甲乳膏对SD大鼠皮肤涂抹给药13周,未出现明显的毒性作用。     

Toxicological assessment of combined lead and cadmium: Acute and sub-chronic toxicity study in rats

The exposure to chemical mixtures is a common and important determinant of toxicity and receives concern for their introduction by inhalation and ingestion. However, few in vivo mixture studies have been conducted to understand the health effects of chemical mixtures compared with single chemicals. In this study, the acute and 90 day sub-chronic toxicity tests of combined Pb and Cd were conducted. In the acute toxicity test, the LD₅₀ value of Pb(NO₃)₂ and CdCl₂ mixture by the oral route was 2696.54 mg/kg by Bliss method. The sub-chronic treatment revealed that the low-dose combination of Pb and Cd exposures can significantly change the physiological and biochemical parameters of the blood of Sprague–Dawley (SD) rats with dose–response relationship and causes microcytic hypochromic anemia and the damages of liver and kidney of the SD rats to various degrees. Histopathological exams showed that the target organs of Pb and Cd were testicle, liver, and kidneys. These observations suggest that Pb and Cd are practically additive-toxic for the SD rats in oral acute toxicity studies. The lowest observed adverse-effect level in rats may be lower than a dose of 29.96 mg/(kg bw day) when administered orally for 90 consecutive days.     

Prenatal developmental toxicity study of ethyl tertiary-butyl ether in rabbits

Ethyl tertiary-butyl ether (ETBE) is commonly used as an oxygenated gasoline additive. In this study, the prenatal developmental toxicity of ETBE was determined in rabbits. New Zealand white rabbits were given ETBE by gavage at 100, 300, or 1,000?mg/kg/day on gestational days (GDs) 6–27, and the pregnancy outcome was determined on GD 28. Neither death nor abortion occurred in the pregnant rabbits at any dose. Slightly and significantly suppressed maternal body-weight gain and transiently decreased maternal food consumption were found at 1,000?mg/kg/day during the administration period. At this dose, no changes in clinical or macroscopic finding were noted in dams. No treatment-related changes were observed in any dam treated at 300?mg/kg/day or less. There was no significant effect of ETBE on the numbers of corpora lutea, implantations, live fetuses, resorptions and dead fetuses, incidences of pre- and postimplantation loss, viability of fetuses, fetal body weight, sex ratio of fetuses, or weights of gravid uteri. No significant difference was detected in the incidences of fetuses with malformations or variations between the ETBE-treated and control groups. Also, no adverse effects on the progress of ossification were noted in fetuses of dams given ETBE. Based on these findings, it is concluded that the no observed adverse effect levels of ETBE were 300?mg/kg/day for dams and 1,000?mg/kg/day for fetuses in rabbits.