1.      摘要：目的：观察解毒维康片对昆明小鼠灌胃给药的最大受试物量试验。方法：取昆明小鼠雌雄各半随机分组，试验组一日内灌胃两次，每次灌以解毒维康片最大浓度0.5ml药液/20g鼠，对照组给以相应的溶剂。观察给药后的即时反应，及2周内动物的毒性反应及消失的时间，生存情况，实验始末称取体重的变化。结果：解毒维康片对昆明小鼠灌胃给药的最大受试物量为20g/kg。

  ABSTRACT  Purpose:  To observe maximum oral dose of Jiedu Weikang Tablets in Kunming mice.  Methods:  Kunming mice ( same number of male and female mice  ) were randomly divided into two groups, and Jiedu Weikang Tablets at dose of 0.5 ml/20g bw twice a day were orally administered by mice in test group and corresponding solvent was orally administered by mice in control group. Immediate reaction after the administration and toxic reaction and its disappearance time in two weeks, the survival condition and the changes of body weight at the beginning and end of the test were observed.  Results:  Maximum oral dose of Jiedu Weikang Tablets was 20 g/kg in Kunming mice.

2.      目的：观察解毒维康片对昆明灌胃给药的最大受试物量试验。

　　Purpose: To observe maximum oral dose of Jiedu Weikang Tablets in Kunming mice.

3.      受试药物：　Test drug

3.1 名称：解毒维康片片剂。　Name:  Jiedu Weikang Tablets

3.2 提供单位：西安恒生堂制药有限公司。

　　Providing unit:  Xi’an Hengshengtang Pharmaceutical Co., Ltd

3.3  药品批号：030101。　Batch:  030101

3.4 配制方法：取解毒维康片片剂20片（10g），置于研钵中，捣碎研细，加入少量吐温80湿润，以0.5%CMC-Na溶液研磨，使成混悬液，再以0.5%CMC-Na溶液稀释配制成最大可灌注的浓度（20g小鼠给药体积为0.5ml）。

　　Preparation of test drug:  Twenty tablets of test drug ( 10 g ) were grinded into powder in mortar and then the powder moisted by tween 80 was grinded by 0.5 % Carboxymethyl cellulose sodium ( CMC-Na ) into suspension. The suspension was diluted to administration liquid of maximum concentration by 0.5 % CMC-Na ( oral administered volume was 0.5 ml/ 20 g bw ).

4.      动物。　Animals

4.1 来源  种属  品系：昆明种小鼠由上海医药工业研究实验动物组提供，合格证号为：“沪动合证字第107号”。

　　Origin and strain: Kunming mice were supplied by Experimental Animal Group, Shanghai Academy of Medicinal Industry and certifacate of quality is Hudonghezhengzi No.107.

4.2 体重：19±1克　Body weight:  19 + 1 g

4.3 性别：雌雄各半　Sex:  same number of male and female mice

4.4 动物数：给药组20只昆明种小鼠，空白对照组20只小鼠。

　　Number of animals:  Twenty mice in test drug and control groups each

5.      剂量设置：采用最大可灌注的浓度（20g小鼠每次灌胃体积为0.5ml），10g/kg/次的剂量给药。

　　Dosage: ral suspension at maximum administered concentration ( 0.5 ml/ 20 g bw ), dose of 10 g/ kg of each administration

6.      给药方案：灌胃给药，一日两次。

　　Scheme for administration:  Oral administration, twice a day

7.      试验对照：0.5%CMC-Na溶液，给药体积与给药组相同。

　　Control: 0.5 % CMC-Na liquid.  Volume of 0.5 % CMC-Na in control group was Taken as same volume of test drugin test drug group.

8.      试验主要步骤：取昆明小鼠雌雄各半随机分组，给药组动物灌胃给药10g/kg/次，上下午各一次。观察给药后动物的即时反应。动物给药后继续观察14天，包括所有一般状态，毒性反应及消失的时间，生存情况，实验始末称动物体重，比较给药组与对照组的差异。并得出样品的最大受试物剂量。

　　Main steps: Kunming mice were randomly divided into two groups ( each 20 mice in test drug and control groups each ). The test drug at dose of 10 g/kg, twice a day ( an am and pm )was orally administered by mice. Immediate reaction of mice was observed after the administration. General condition, toxic reaction and its disappeared time, the survival condition were observed for 14 days. And body weight at the beginning and end of test were measured and the difference between test drug and control groups was compared. Then maximum oral dose was counted.

9. 试验结果：

　　昆明种小鼠单次灌胃解毒维康片10g/kg，给药后即时动物未见明显的毒性反应。观察的2周内动物也未出现死亡或消瘦等症状，结束时称取动物体重，两种性别动物均呈现体重增长的趋势，与对照组相比无显著性差异，详见表。实验结束后各组每只动物解剖未见明显实质性变化，给药组与对照组动物情况相似。

Results

　　Single oral dose of test drug at 10 g/kg ( twice a day ) was administered by mice and immediate toxic reaction did not be found. The death and symptom of mice ( such as pathogenic leanness,etc. ) did not be found in two weeks. The body weight at the end of test was measured and the weight of both male and female mice gradually increased and there was no significant difference when compared with control. See below tablet. Each mouse was dissected and no significant degeneration of the important organswas observed, and there was no marked difference between two groups.

9.      试验结论：解毒维康片对昆明种小鼠灌胃给药的最大受试物量为20g/kg。

　　Conclusion:  Maximum oral dose of test drug was 20 g/kg in Kunming mice.

10    表. Tablet.

解毒维康片单次口服给药对昆明种小鼠的体重变化

Effect of test drug at single dose on body weight in Kunming mice

来源：恒生堂