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1.电气专业：主变压器 2.机械专业：煤磨工作原理 3.水泥工艺专业：配料设计 4.自动化专业：控制系统 5.
石油地质勘探 6.企业宣传
7.生物 8.医药 |
原稿
摘要：以临床成人用药量的10倍和50倍剂量，每天灌胃1次，连续90天，观察了金参疏肝对大鼠体重、血液学、血液生化学、重要脏器系数、组织形态学变化，结果对上述观察指标均未见异常变化。
目的：观察连续重复给受试药物后，对动物所产生的毒性反应及毒性反应的靶器官，为临床用药提供参考依据。
一、材料、方法
1、受试物来源：金参疏肝胶囊由黑龙江中医研究院制备，批号：940506。规格：0.3g/粒。服法与用量：1次3粒，1日3次。成人（50kg）临床日治疗量为2.7g（0.054g/kg）。
2、受试物试验样品制备：称取一定量金参疏肝胶囊中药粉，放入乳钵中研细，加适量淀粉浆研匀后，边加水边研磨，制成一定浓度的金参疏肝胶囊药粉混悬液。经预试35%金参疏肝胶囊混悬液为其最大浓度。
3、动物：Wistar种大白鼠，由哈尔滨铁路中心医院供给。
4、试验方法：
动物分组：选用体重80～120g健康大鼠60只，雌雄各半，随机分为三组，每组20只，雌雄各10只。第一组为空白对照组；第二、三组分别为低、高剂量的给药组。
剂量、给药途径：
低剂量组：按0.54g/kg剂量（成人临床日治疗量×10倍），每日给大鼠灌胃5.4%金参疏肝胶囊药粉混悬液1ml/100g一次。
高剂量组：按2.7g/kg剂量（成人临床日治疗量×50倍），每日给大鼠灌胃27%金参疏肝胶囊药粉混悬液1ml/100g一次。
空白对照组：给等容积生理盐水。按上述剂量每天给药，连续90天，每周给药6天，每天给药时间相同，每周应根据体重情况调整给药量。给药剂量按动物每公斤体重金参疏肝胶囊药粉重计算。
二、指标及试验结果
1、一般观察：一般毒性反应，每天一次，每天记录食量，每周称体重一次。结果在整个60天给药过程中，各组大鼠外观体征、行为活动正常；尿、粪便性状无异样，饮食无异常所见，各组动物增重无显著差异，见表1。
2、血液学指标检测结果：在试验给药90日后24小时，进行血液学各项指标的检测，结果表明，金参疏肝胶囊对大鼠红细胞（RBC）、血红蛋白（Hb）、白细胞总数（WBC）及其淋巴细胞（C）、中性粒细胞（S）无显著影响，基本都在正常值范围内，见表2。
3、血液生化学指标检测结果：在停药后24小时，经眼球取血，分别检测各组大鼠的血液生化学项目，结果表明，低、高剂量组与空白对照组比较，对尿素氮（BUN）、肌酐（Grea）、谷丙转氨酶（SAPT）、谷草转氨酶（SOPT）均无显著影响。
4、系统尸解和病理组织学检查结果：于最后一次给药后24小时，每组活杀一半动物，对主要脏器，大体解剖观察后并取出，进行脏器称重，以脏器重量/体重之比，计算脏器系数。然后按常规处理方法，取动物脏器，用10%福尔马林固定，石腊包埋，切片，HE染色，用光学显微镜进行组织学检查。结果表明，低、高剂量给药组与空白对照组比较，其心、肝、脾、肺、肾主要脏器，大体解剖观察未发现异常器官；对大鼠主要脏器系数无显著影响；空白对照组和高剂量组大鼠主要脏器的光镜组织学检查均未见异常改变。
译稿
Abstract: Rats were given 10 and 50 times adult clinic therapeutic dose 90 days continuously through stomach feeding once a day, no abnormal effects of Hepacare capsule on rats’ body weight, hematology, blood biochemistry, parameters of vital organs and histomorphology were observed.
Aim: To observe toxic reactions and correspond target organs of Hepacare capsule for animal after continuous repeated administration to provide references for the clinical application of drugs.
I. Materials and Method
1. At test sample: Hepacare capsule made by Heilongjiang Academy of Traditional Chinese Medicine，batch number：940506. Specification：0.3g/pill. Using method and dosage: 3 pills/time, 3 times/ day. Adult clinic therapeutic dose: 2.7g (0.054g/kg).
2. At test sample preparation: Take some Hepacare capsule Chinese medicine power, grind in mortar, add appropriate amount starch, then add water and grind at the same time, and prepare Hepacare capsule medicine power suspension of certain concentration. The maximum concentration of Hepacare capsule suspension was 35% by pretest.
3. Animal: Wistar rats, provided by Haerbin Railway Center hospital.
4. Method:
Animal grouping: Select 60 healthy rats of weight 80～120g ,with half female and male. Divide rats into 3 groups randomly, 20 rats/group,10 female and 10 male. Take the fist group as contrast, second as low dose administration group and third as high dose administration group.
Dose and administration:
Low dose group: 0.54% medicine powder suspension of Hepacare capsule were administered intragastricly to the animal by a constant-volume manner 1ml/100g everyday as 0.54g/kg dose (adult clinic therapeutic dose ×10 times ).
High dose group: 2.7% medicine powder suspension of hepacare capsule were administered intragastricly to the animal by a constant-volume manner 1ml/100g everyday as 2.7g/kg dose (adult clinic therapeutic dose ×50 times )
Contrast group: equal volume NS was intragastricly administered to the animals as the above dose at the same time for 90 days i.e. 6days per week .The dosage should be adjusted every week fitting for weight status .And the dose was calculated as Hepacare capsule medicine powder weight/per kg of animal weight.
II．Indexes and Results
1. Observation: Observe common toxic reaction once a day, record food intake every day, and take body weight once a week. During the period of 60 days administration, appearance character and behavior of all group rats were normal; there was no abnormality with urine and faeces trait; food intake was normal; and there was no notable difference with body weight gain of each group rats, table1.
2. Results of hematology assess: Assess every index of hematology in 24 hours after 90 days administration. Results indicated that Hepacare capsule had no notable effect on red blood corpuscle (RBC), haematoglobin (Hb), total white blood cells (WBC), achroacyte (C) and heterophil granulocyte (S) of every group rats, all the values fell in to normal range, table2.
3. Results of haemobiochemistry assess: Detect haemobiochemistry indexes of rat blood sampled from bulb of eye in 24 hour after stopping administration. Results manifested that both low and high dose group, compared with contrast group, had no notable effect on urea nitrogen (BUN), creatinine (Grea), glutamate-pyruvate transaminase (SAPT) and glutamic-oxalacetic transaminase (SOPT).
4. Results of anatomy and pathohistology detection: kill half animals of each group in 24 hours after last administration, take out of vital organs after anatomy and observation, weigh the organs and calculate weight ratio of organ and body as the organ coefficient. Then the organs were fixed with 10% formalin, embedded with par, sliced, stained with HE and detected with optical microscope. Results indicated that there was no abnormal organ found through anatomy and observation in low and high dose group compared with contrast; there was no notable effect on vital organs coefficient; and no abnormal change of vital organs of high dose group and contrast was observed by histopathological methods.
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