黄芪注射液的安全性试验研究

目的：检测黄芪注射液安全性试验。采用豚鼠过敏试验、体外溶血试验方法,观察黄芪注射液的安全性。结果表明：豚鼠对黄芪注射液未见过敏反应,无溶血现象,对兔静脉血管、肌肉无明显刺激作用。黄芪注射液安全性试验是合格的。     

黄芪注射液的化学成分

采用正、反相硅胶柱层析从黄芪注射液原液中分离纯化出 14个化合物 ,经波谱分析鉴定了它们的结构。其中 6个为异黄酮化合物 ,分别是芒柄花素 (1) ,毛蕊异黄酮 (2 ) ,6″ O 乙酰基芒柄花苷 (3) ,芒柄花苷 (7) ,红车轴草异黄酮 7 O β D 吡喃葡萄糖 (12 ) ,毛蕊异黄酮 7 O β D 吡喃葡萄糖 (13) ;1个紫檀烷化合物 ,结构为 9,10 二甲氧基紫檀烷 3 O β D吡喃葡萄糖 (4) ;1个异黄烷化合物 ,结构为 2′ 羟基 3′ ,4′ 二甲氧基异黄烷 7 O β D 吡喃葡萄糖 (6 ) ;另外 6个为黄芪皂苷类化合物 ,分别是乙酰黄芪皂苷Ⅰ(5 ) ,黄芪皂苷Ⅰ (8) ,异黄芪皂苷Ⅰ (9) ,异黄芪皂苷Ⅱ (10 ) ,黄芪皂苷Ⅱ (11)和黄芪甲苷 (14)。其中化合物 3系首次从黄芪属植物中分离得到。     

高效液相色谱法测定黄芪注射液中黄芪甲甙的含量

本文报道用高效液相色谱法测定黄芪注射液中黄芪甲甙的含量。色谱柱为:NOVA-PAK C_(18)4μm(4.6mm×250mm);流动相:乙腈-0.1％磷酸(33:67),205nm检测,外标定量。结果表明,建立的方法完全适用于黄芪注射液中黄芪甲甙的含量测定。其方法快速、灵敏、重现性好。     

杏丁注射液与黄芪注射液合用治疗冠心病心绞痛临床观察

目的:观察杏丁注射液(银杏叶提取物和双嘧达莫混合物)与黄芪注射液合用治疗冠心病心绞痛的临床疗效。方法:选择符合WHO诊断标准的冠心病心绞痛患者96例,随机分为对照组48例,给予常规治疗加用中药黄芪注射液,治疗组48例除了常规治疗外,加用中药杏丁注射液联合黄芪注射液,以14d为1个疗程,观察1个疗程后控制心绞痛疗效及心电图变化。结果:治疗组临床疗效与心电图疗效总有效率分别为93．75%、87．50%,明显高于对照组的79．17%、66．67%(P＜0．05)。结论:杏丁注射液与黄芪注射液合用具有改善心肌缺血,缓解心绞痛,无明显毒副作用,是治疗冠心病心绞痛的理想药物。     

益母草注射液小鼠急性毒性和Beagle犬重复给药毒性试验研究

通过小鼠单次给药急性毒性试验和Beagle犬重复给药毒性试验,评价益母草注射液(YMC)的安全性。用半数致死剂量法对小鼠进行急性毒性试验,观察小鼠的死亡情况和急性毒性症状,用Bills法计算半致死剂量(LD50)。将32只Beagle犬根据体质量、性别随机分为YMC 240.99 mg·kg~(-1)、120.50 mg·kg~(-1)、60.25 mg·kg~(-1)组和0.9%氯化钠注射液对照组,每组8只。静脉滴注给药,每周给药6 d,连续180 d,停药恢复30 d。对Beagle犬进行临床症状、体质量、心电图、血液学、血液生化学、血清电解质、尿液及组织病理学等检查。YMC小鼠静脉给药LD50为845.64 mg·kg~(-1),急性毒性症状主要表现为跳跃、烦躁、嗜睡、活动减少、阵挛性抽搐、眼球突出、尿失禁。重复给药毒性试验,Beagle犬出现呈剂量反应趋势的流涎、呕吐症状,未见肝、肾毒性,其余各项检测指标也均未见与药物毒性相关的明显异常。YMC小鼠静脉给药LD50相当于临床拟用剂量的394.6倍,YMC重复给药毒性试验对Beagle犬的安全剂量为120.50 mg·kg~(-1),相当于临床拟用剂量的56.2倍。提示YMC具有较高的安全性。     

黄芪注射液在肾病综合征中的应用

肾病综合征是一组由多种原因引起的临床症候群．以浮肿、大量蛋白尿、血浆白蛋白降低、血脂升高为特征,目前主要以激素及细胞毒药物治疗为主．辅以降血脂、控制血压、抗感染等对症治疗。黄芪是具有广泛药理活性的中药,它在肾病治疗中应用广泛。近年来,我们应用黄芪注射液配合强的松治疗肾病综合征,取得了一定的疗效。现将结果报告如下。     

黄芪多糖注射液联合放疗对胃癌患者的疗效观察

目的 探究黄芪多糖注射液联合放射治疗胃癌的疗效,为胃癌患者的临床治疗提供相关依据。方法 选取我院收治的166例胃癌患者,将患者按随机数字表法分为联合治疗组和对照组,每组各83例,对照组患者采用放射治疗,联合治疗组在放射治疗的基础上给予黄芪多糖注射液治疗。治疗前后检测各组患者肿瘤标志物、血常规、免疫细胞和肝肾功能水平。结果 联合治疗组治疗效果好于对照组,同时毒副作用低于对照组;治疗前两组胃癌患者胃癌标志物、血常规、免疫细胞和肝肾功能水平比较的差异无统计学意义（P＞0.05）。与治疗前相比,联合治疗组和对照组胃癌患者经相关治疗后肿瘤标志物（CA199、CEA和CA724）、免疫细胞（CD8+ T细胞）、血常规指标（白细胞、红细胞和血小板）显著降低,免疫细胞（CD3+T细胞、CD4+T细胞和NK）、CD4+/CD8+、肝功能及肾功能指标（ALT、AST、BUN和Cre）显著升高,差异存在统计学意义（P＜0.05）。结论 黄芪多糖注射液与放射治疗的联合治疗具有较高的癌症治疗效率、降低了副作用和血液中肿瘤标志物水平,同时提高了患者的造血功能、免疫功能和肝肾功能水平,对胃癌患者的治疗具有十分重要的临床意义。     

黄芪注射液联合米力农治疗充血性心力衰竭的临床分析

目的:观察黄芪注射液联合米力农治疗充血性心力衰竭的临床疗效及安全性.方法:将76例充血性心力衰竭患者随机分成两组,其中治疗组38人,对照组38人.所有患者均采取使用利尿剂、口服血管紧张素转换酶抑制药等常规治疗,治疗组患者在常规治疗基础上采用米力农联合黄芪注射液治疗,对照组患者在常规治疗基础上采用米力农治疗,从临床疗效、心衰疗效计分、心率、心脏指数、心输出量及左心室射血分数指标进行评价.结果:治疗组的临床疗效、心衰疗效计分、心率、左心室射血分数与对照组相比,有统计学差异(P＜0.05).结论:黄芪注射液联合米力农治疗充血性心力衰竭的临床疗效优于单纯应用米力农.     

高压氧配合黄芪注射液治疗急性一氧化碳中毒的疗效观察

目的观察高压氧配合黄芪注射液治疗急性一氧化碳中毒的疗效。方法对280例急性一氧化碳中毒患者按轻、中、重度进行救治,轻度患者立即进行高压氧治疗,中、重度患者经综合治疗病情稳定后再行高压氧治疗。同时加强心理护理,密切观察病情并做好记录。结果 280例中,痊愈267例,好转13例（留有后遗症）,总有效率100%。结论高压氧配合黄芪注射液治疗急性一氧化碳中毒的疗效好。     

黄芪注射液对慢性心力衰竭患者BNP水平的影响

目的:探究黄芪注射液对慢性心力衰竭患者外周血清B型脑利钠肽水平的影响。方法:选择2013年12月-2015年1月我院收治的慢性心力衰竭住院患者334例,按用药不同分为实验组和对照组。对照组患者采取常规药物口服治疗,实验组患者应用黄芪注射液静脉滴注。观察并比较两组患者治疗前后外周血B型脑利钠肽水平的变化情况。结果:治疗后,两组患者外周血B型脑利钠肽水平均明显下降,且实验组下降更明显,实验组Ⅰ级、Ⅱ级患者比例较对照组显著升高,差异均具有统计学意义(P0.05)。结论:黄芪注射液能够降低慢性心力衰竭患者的外周血B型脑利钠肽水平,改善其心功能,值得临床推广应用。     

黄芪注射液联合TP 化疗方案治疗晚期卵巢癌的临床疗效分析*

目的:观察黄芪注射液联合TP化疗方案治疗晚期卵巢癌的临床疗效及安全性.方法:将62例晚期卵巢癌患者随机分成两组,其中31人为治疗组,接受黄芪注射液联合TP治疗,31人采用TP治疗.从总效率、疾病控制、毒副反应等指标进行评价.结果:治疗组的总效率、疾病控制、骨髓抑制以及肝肾功能与对照组相比,差异无统计学意义(P＞0.05);治疗组的中性粒细胞、心脏毒性、脱发、肌肉关节疼痛、胃肠道反应与对照组相比,差异有统计学意义(P＜0.01).结论:黄芪注射液联合TP化疗方案治疗晚期卵巢癌的临床疗效显著,降低了化疗的毒副反应.     

参芪扶正注射液对大鼠重症急性胰腺炎的治疗作用

目的:研究参芪扶正注射液对重症急性胰腺炎(SAP)的治疗作用。方法:66只Wistar大鼠随机分为:SAP假手术组(SO组),SAP模型组(SAP组)和参芪扶正注射液治疗组(SQ组),胆胰管逆行注射50g.l~(-1)牛磺胆酸钠复制大鼠SAP模型。造模成功后2、4、8、12、24 h检测血清中TNF-α、IL-6和ALT水平,观察肝脏组织病理改变。结果:与SO组相比,SAP组及SQ组血清中TNF-α、IL-6和ALT水平明显升高(P<0.05)。与SAP组相比,从8 h开始SQ组血清中TNF-α、IL-6和ALT水平开始下降(P<0.05),两组的肝脏病理改变无统计学意义。结论:参芪扶正注射液可以降低SAP时血清中ALT、TNF-α和IL-6水平,但不能改善肝脏组织的病理损伤程度,对SAP的发生、发展可能有一定的预防作用。     

Acute and Sub-Chronic Toxicity of D-Allose in Rats

We examined the acute and sub-chronic toxicity of D-allose in rats. In the acute toxicity test, the calculated LD₅₀ value was 20.5 g/kg. In the sub-chronic toxicity test, no difference was found among the four groups in most of the serum chemical and hematological test results. These results suggest that D-allose is not toxic to rats.     

Acute Toxicity of Intravenously Administered Titanium Dioxide Nanoparticles in Mice

Background

With a wide range of applications, titanium dioxide (TiO₂) nanoparticles (NPs) are manufactured worldwide in large quantities. Recently, in the field of nanomedicine, intravenous injection of TiO₂ nanoparticulate carriers directly into the bloodstream has raised public concerns on their toxicity to humans.

Methods

In this study, mice were injected intravenously with a single dose of TiO₂ NPs at varying dose levels (0, 140, 300, 645, or 1387 mg/kg). Animal mortality, blood biochemistry, hematology, genotoxicity and histopathology were investigated 14 days after treatment.

Results

Death of mice in the highest dose (1387 mg/kg) group was observed at day two after TiO₂ NPs injection. At day 7, acute toxicity symptoms, such as decreased physical activity and decreased intake of food and water, were observed in the highest dose group. Hematological analysis and the micronucleus test showed no significant acute hematological or genetic toxicity except an increase in the white blood cell (WBC) count among mice 645 mg/kg dose group. However, the spleen of the mice showed significantly higher tissue weight/body weight (BW) coefficients, and lower liver and kidney coefficients in the TiO₂ NPs treated mice compared to control. The biochemical parameters and histological tissue sections indicated that TiO₂ NPs treatment could induce different degrees of damage in the brain, lung, spleen, liver and kidneys. However, no pathological effects were observed in the heart in TiO₂ NPs treated mice.

Conclusions

Intravenous injection of TiO₂ NPs at high doses in mice could cause acute toxicity effects in the brain, lung, spleen, liver, and kidney. No significant hematological or genetic toxicity was observed.     

Acute Toxicity of Amorphous Silica Nanoparticles in Intravenously Exposed ICR Mice

This study aimed to evaluate the acute toxicity of intravenously administrated amorphous silica nanoparticles (SNPs) in mice. The lethal dose, 50 (LD₅₀), of intravenously administrated SNPs was calculated in mice using Dixon''s up-and-down method (262.45±33.78 mg/kg). The acute toxicity was evaluated at 14 d after intravenous injection of SNPs at 29.5, 103.5 and 177.5 mg/kg in mice. A silicon content analysis using ICP-OES found that SNPs mainly distributed in the resident macrophages of the liver (10.24%ID/g), spleen (34.78%ID/g) and lung (1.96%ID/g). TEM imaging showed only a small amount in the hepatocytes of the liver and in the capillary endothelial cells of the lung and kidney. The levels of serum LDH, AST and ALT were all elevated in the SNP treated groups. A histological examination showed lymphocytic infiltration, granuloma formation, and hydropic degeneration in liver hepatocytes; megakaryocyte hyperplasia in the spleen; and pneumonemia and pulmonary interstitial thickening in the lung of the SNP treated groups. A CD68 immunohistochemistry stain indicated SNPs induced macrophage proliferation in the liver and spleen. The results suggest injuries induced by the SNPs in the liver, spleen and lungs. Mononuclear phagocytic cells played an important role in the injury process.     

Relationship between Cancer Slope Factor and Acute Toxicity in Rats and Fish

The purpose of this study was to examine bivariate relationships among cancer slope factor (CSF) and acute toxicity in rats and salmonid fish. Chemicals (n=43) were selected based on the availability of both oral CSF and acute toxicity data (rat oral median lethal dose [LD50] or salmonid median lethal concentration [LC50]). Rat oral LD50, salmonid LC50, and oral CSF data were log-transformed, and a Bonferroni-adjusted alpha level was set at 0.05 for subsequent correlation analysis. A significant correlation was observed between CSF and rat oral LD50 (r=?0.61) but not for CSF and salmonid LC50 (r=?0.29). Moreover, rat and fish acute toxicity were not significantly correlated (r=0.38). The significant correlation between CSF and rat oral LD50 compares favorably with published results reported in related studies. Accordingly, these results support prediction of carcinogenic potency, expressed as oral CSF, based in part on acute toxicity in rats.