Amaranthus spinosus particle compound long-term toxicity
【Abstract】 Objective To study the particles of compound Amaranthus spinosus long-term toxicity, provide a reference
for clinical safety of drugs. Methods according to the
original herbs 58.0,29.0,14.5 g / kg, the rats were continuously fed with medicinal extracts of the original six weeks, and withdrawal observed 2 weeks, rats were observed during the administration of the general performance and toxicity. The results of 6-week administration and withdrawal observed during the two weeks no toxic reactions and delayed toxicity. Conclusion The materials to be used according to the clinical dose, means of treatment application is safe.
Key words compound the long-term toxicity in rats Amaranthus
term Toxicity Study of Fufang Cixian Granules on Rats
gang, WU Yu
qiang, ZHEN Zuo
wen, ZHOU Zhi
1. Pharmaceutical Factory of Guangxi Traditional Chinese
Medical University, Nanning 530023, China;
2.Guangxi Institute for Drug Control, Nanning 530021, China
Abstract: ObjectiveTo study the long-term toxicity of
Fufang Cixian Granules on rats to provide some data for its clinical use. Methods80 rats were randomly divided into 4 groups, each group was given the extract of Fufang Cixian Granules intragastrically at doses of 0,58.0 , 29.0,14.5 g / kg for 6 weeks. The animals were observed for 2 weeks after medicine withdraw. Parameters were examined including general condition, bodyweight, blood cell, blood biochemistry, organ index, and histopathological exmination. ResultsNo toxic reaction was observed compared with control group. ConclusionFufang Cixian Granules should be safe in its
clinical use with the recommended dosage.
Key words: Fufang Cixian Granules; Rats; Long term toxicity
Amaranthus spinosus compound particles independently of Guangxi College of Pharmaceutical R & D of new drugs, with a heat dampness, cooling blood to stop bleeding, swelling and other effects Removing silt. Bet for the hot and humid, ?, ?
period of hemorrhoids. The product from Amaranthus spinosus, wind, astragalus, 37, Chinese angelica, rhubarb, Burnet so on. For the safety of clinical use of drugs, while providing a theoretical basis for clinical applications, the varieties of long-term toxicity studies. The results reported as follows.
Healthy Wistar rats were 80 body weight (120 ? 20) g,
male and female in half, from Guangxi Medical Research Institute of Animal rooms available (Qualified证号- Guangxi
Medical dynamic Zi No. 11001). Self-feeding with solid feed.
Laboratory temperature (22 ~ 26) ? (air conditioning),
relative humidity 60% ~ 75%.
The product of the original medicinal herbs extract per milliliter is equivalent to the original 2.14 g, provided by the Guangxi College of Pharmaceutical Factory, batch number 980,326. Experimental Shike Jia deionized water diluted into a
suitable concentration of liquid for the animal enema (IG) to vote medicinal.
Man Ziehl concentrated liquid (Tianjin Development Zone, Zhongshan High-tech Development and Research Institute, batch number 970901); HiCN reference solution (Tianjin Development Zone, Zhongshan Hi-Tech Development and Research Institute of production, batch number 980,123); total protein determination of biuret reagent ( Yuan-sheng of Taiwan-funded Biotechnology
Co., Ltd., batch number 290,097), alanine aminotransferase Kinetic Determination of reagents (Yuan-sheng of Taiwan-funded
Biotechnology Co., Ltd., batch number 223,026), aspartate aminotransferase Kinetic Determination of reagents (Taiwanese yuan Health and Bio-Technology Co., Ltd., batch number
210,056), Enzymatic determination of blood urea nitrogen urea reagent (Yuan-sheng of Taiwan-funded Biotechnology Co., Ltd.,
batch number 340,041), Kinetic determination of creatinine
picric acid reagent (Taiwanese yuan of shares of Biology
Science and Technology Co., Ltd., batch number 210,056); Enzymatic determination of total cholesterol reagent (Australia Hobsbawm Biological Engineering Co., Ltd., batch number 9908), Enzymatic determination of blood glucose reagent (Australia Hobsbawm Biological Engineering Co., Ltd., batch number S1110006).
Semi-automatic biochemical analyzer (Japan ERBA company, CHEM
5); electronic balance (Shanghai the next day flat Instrument Factory, MP120
2, an accuracy of 1 / 1000); Biological Microscope (Wuzhou City, Optical Instrument Factory, XSZ
2 Methods and Results
2.1 Method [1 ~ 3] The rats were randomly divided into
four groups, each with 20 (male and female half and half). High, medium and low measurement group to the subjects of drugs, measurement, respectively of the original herbs 58.0,29.0,14.5 g / kg, control group was given regular water,
ig administration of a daily morning meeting, the groups were administered 30 ml volume of / kg, for 6 weeks. Observed in rats during the administration of the general performance and toxicity; weigh weight 1 times / week, and adjust the dose according to the amount of body weight. The day after the last administration, the 12 rats in each group (male and female half and half) intraperitoneal injection of pentobarbital sodium 40 mg / kg anesthesia, done by the abdominal aortic blood hematology, blood biochemical examination; profile
control a portion of dirty weighing devices, per 100 g body weight contained in the organ weights converted into organ weight index; profile control to take the major organs to do
the naked eye and histological examination. Measured values
will each treatment group compared with the control group, making groups t test. The remaining eight groups of rats were observed 2 weeks after drug withdrawal with the law. Reposted elsewhere in the paper for free download http://
2.2.1 the results of weight gain
Administration and withdrawal period, weighed 1 times / week. Rats in each group activity, stool Dengjun no exceptions, no kill. The results in Table 1. Table 1 long-
poisoning rats body weight growth (omitted)
2.2.2 show the results of pathological examination in general autopsy, rats were sacrificed immediately after the dissection, the removal of major organs, saying that taking organ wet weight, organ index derived. Administration 6 weeks
later the results were shown in Table 2, withdrawal two weeks later the results were shown in Table 3. Table 3 long drug test 2 weeks after drug withdrawal organ index measured results (omitted) Table 2, experiment 6 weeks after the long-
organ toxicity index of measured results (omitted)
2.2.3 Blood tests measure the project results in rats tipped off capillary blood clotting time, and take blood for Blood tests to measure hemoglobin (Hb), red blood cell count (RBC), white blood cell count (WBC), platelet count (BPC ),
reticulocyte (Ret) ratio, neutrophil (N) and lymphocytes (L) ratio of clotting time (CT, capillary method). Administration 6 weeks later the results were shown in Table 4, the results of 2 weeks after drug withdrawal in table 5. Body weight of
drug-treated animals, the growth rate were similar to the control group, no significant difference. The results showed that after 6 weeks of administration and withdrawal 2 weeks
after the treatment group of the heart, lungs, liver, kidney,
uterus, testis, bladder mass index were similar to the control group (P> 0.05). However, after 6 weeks of administration, the spleen weight index of low-dose group were slightly larger
than the control group (P <0.01), may be related to this product Fang wind, astragalus and other immune-enhancing
effects of drugs related to the high-dose group the spleen
weight index and the control group (P> 0.05), and therefore can be considered in the spleen, Low-dose group increased
volatility of the Department is normal and do not have
toxicological significance; withdrawal of all treatment group after 2 weeks of the spleen weight index similar to the control group (P> 0.05), prompted this change is reversible. Table 4 Long 6 weeks after administration of drug tests
hematology determination results (omitted) Table 5 a long drug test 2 weeks after drug withdrawal hematology determination results (omitted)
Animals were killed after the removal of heart, lung, spleen, stomach, small intestine, bladder, testicles and other
organs for microscopic pathological examination. The results showed that after 6 weeks of administration and withdrawal 2 weeks after the profile control rats in each group to take the heart, lungs, spleen, stomach, small intestine, bladder, testis, etc. to the naked eye, are no obvious morphological changes. 6 weeks after delivery Profile Control to take high-
dose group and control group rats, heart, lung, liver, kidney, small intestine, adrenal gland, thymus, uterus, ovaries, testes and other organs for histological examination, no
subjects drug-induced histological changes.
The results showed that 6 weeks after administration of the determination of results, high Hb content of low-dose
group was slightly lower and the control group (P <0.01), but
still within the normal range, while the withdrawal of all treatment group after 2 weeks of the Hb content of the control group were similar (P> 0.05), prompted this change is reversible. After 6 weeks of administration and withdrawal after 2 weeks, each treatment group measured values of other projects with the control group were similar (P> 0.05).
2.2.4 blood tests results of the project to take the blood of rat abdominal aorta, centrifuged and the serum for blood biochemical examination, serum total protein (TP),
albumin (ALB), total bilirubin (Bil), urea nitrogen (BUN), creatinine (Crea), total cholesterol (TCH), glucose (Glu) content and alanine aminotransferase (ALT), aspartate aminotransferase (AST) activity. Administration 6 weeks later
the results were shown in Table 6, the results of 2 weeks after drug withdrawal in table 7. Table 6 long drug test after 6 weeks of administration of blood biochemical determination results (omitted) Table 7 long drug test 2 weeks after the withdrawal of blood biochemical determination results (omitted)
The results showed that after 6 weeks of administration and withdrawal of the determination results after 2 weeks treatment group were all measured values are similar to the control group (P> 0.05), no significant changes in blood
The results showed that after 6 weeks of administration and withdrawal of the determination results after 2 weeks treatment group were all measured values are similar to the control group (P> 0.05), no significant changes in blood biochemistry.
The experimental results show that rats enema per day 58.0 g / kg (body weight) (equivalent to 60 times the clinical dose), 29.0 g / kg (body weight) (equivalent to 30 times the clinical dose), 14.5 g / kg (body weight ) (equivalent to 15
times the clinical dose) administration, administration of 6 weeks and withdrawal for 2 weeks, normal activities from start to finish without any symptoms or death. Weight gain is normal, pathological examination, blood tests and blood biochemistry test results were normal, no toxicological responses and delayed toxicity, stating that the goods to be used according to the clinical dose, means of treatment application is safe, but also for clinical application to
provide theoretical and experimental basis.
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