Compound effect of GBE on the long-term toxicity studies in
rats
Author: Hong-Ping Pan, Wei Hua-Ling, Chen Ying,
Zhong Zheng-Xian, CHEN Xue-fen, Li Yan Jing, Lu Mei
【Abstract】 Objective To investigate the compound effect of
GBE on the long-term toxic effects in rats. Methods compound effect of GBE 88.44, 17.69 mg / kg (for the clinical daily dose of 50 times and 10 times) to rats fed with a continuous 13 weeks, withdrawal 2 weeks, body weight were measured to calculate organ coefficient of determination of hematology and blood biochemical indicators and for histopathological examination. Results Ginkgo leaf compound high-and low-dose
group of rats the appearance of signs, behavioral activity, body weight, organ coefficient, hematology and blood
biochemical indicators, with the blank control group, no significant differences; pathological examination and no drug toxicity related to the obvious lesions seen after discontinuation of drug of delayed toxicity. Conclusion The
compound effect of GBE in rats had no significant long-term
drug toxicity, the clinical inference to be dose should be safe.
Key words compound Ginkgo biloba; rats; long-term toxicity
test
Abstract: ObjectiveTo observe the effects of compound
Ginkgo biloba Tablets on rats.Methods60 rats were randomly divided into 3 groups, each group was given compound Ginkgo biloba tablets intragastrically in dose of 88.44,17.69 mg / kg (50 and 10 times of clinic dose) for 13 weeks. Half of the animals were killed immediately after the last administration, and another half of rats were observed for 2 weeks after
medicine withdraw. Parameters were examining including general condition, body weight, food intake, blood cell, blood biochemistry, organ index, and histopathological
examination.ResultsThe outer appearance and behavior, weights, organ coefficient, the indexes of haematology and biochemistry in rats had no significant difference by comparing with control group.The pathological examination did not discover
significant pathological changes related to drug toxicity and the delayed toxicity reaction after drug
administration.ConclusionCompound Ginkgo biloba Tablets has no significant toxicity for long-term administration to rats. It
infers that the drawing up doses in clinic will be safe.
Key words: Compound Ginkgo biloba Tablets; Rats; Long-
term Toxicity
Compound mainly by the Ginkgo leaf extract of ginkgo biloba and Guangxi, such as Pueraria Mirifica extract made from traditional Chinese medicinal compound preparations.
Puerarin and flavonoids are the main active ingredient, with blood circulation Huayu, reduce blood fat, removing free radicals and anti-aging effects and the role of [1,2].
Clinical indications mainly for cardio-cerebral vascular
diseases and old diseases. The purpose of this experiment is to observe the drugs on the toxicity produced by animals, which may occur the first and severity of symptoms may be the target organ for its recovery and development situation and identifying non-toxic reactions dose, safe dose for the
development of clinical use to provide experimental basis, will now be reported in rats following long-term toxicity test
results.
1 Equipment
1.1 Ginkgo biloba drug compound, containing 14.15 mg of
puerarin / tablets, batch number: 20.05103 million, from Guangxi Zhuang Autonomous Region People's Hospital of preparation room provided. Add distilled water when used in different drug concentrations for the preparation of experimental applications.
1.2 kinds of animals, Wistar rats weighing 100 ~ 135 g,
from Guangxi Medical University animal experiment center, certificate: SCXK Gui 2003-0003. Animals, by sex, housed in an air-conditioned cage of experimental animals indoors, at room temperature (22 ? 1) ?, relative humidity (60 ? 5)%. Free
drinking water and fed standard pellets.
1.3 Instrument Model 7170A automatic biochemical analyzer, Hitachi, Japan, East Asiatic Company; NIHON KOHDEN blood cell analyzer (made in Japan) (MEK-6318K).
2 method [3,4]
Select 6 to 8-week-old rats were 60 body weight (120 ?
15) g, male and female in half, were randomly divided into three groups, each with 20. Each group of rats were divided into caged five per cage. Set up the blank control group, high
doses of Ginkgo leaf compound (88.44 mg / kg) and low-dose
(17.69 mg / kg) group. Administration of each group were based on clinical man-days dose of 50 times, 10 times the dose of the compound of Ginkgo biloba to rats gavage, blank control
group was given an equal volume of distilled water, 1 time / d, dose volume of 1.0 ml/100 g body weight, a continuous 13 weeks. Observe the general condition of rats were recorded daily, such as eating, behavioral activity, feces. 1 week, weighed, and promptly adjust the dosage. 24 h after the last administration, each group select 10 rats (male and female half and half), intraperitoneal injection of 10% chloral hydrate anesthesia, blood from the abdominal aorta, collected blood samples in the detection of blood cells, red blood cell
analyzer (RBC), white blood cell (WBC), hemoglobin (HGB), platelets (PLT), lymphoblastoid cell lines (LY), monocyte cell line (MO), coagulation time (CT) and other hematologic indicators. In addition separation of blood serum taken at the
biochemical automatic analyzer of total serum bilirubin (T-
Bil), total protein (TP), albumin (ALB), alanine aminotransferase (ALT), aspartate aminotransferase (AST ), alkaline phosphatase (ALP), blood urea nitrogen (BUN), creatinine (Cr), total cholesterol (TC), glucose (GLU) and other biochemical indicators. And the main organs to conduct a comprehensive autopsy, take heart, liver, spleen, lung, kidney, adrenal gland, thymus and other organs weighed to calculate organ coefficient. Then the above major organs and
the stomach, small intestine, uterus, ovary, testis, brain and other organs in 10% formalin fixed for routine pathological examination. The remaining rats in each group observed two weeks after discontinuation with treatment, and detection of
these indicators. The results for statistical analysis, using t test was significant difference between groups.
3 Results
3.1 The impact of animals, general administration period, the compound effect of GBE each dose group and blank control
group, the appearance of signs of rats, behavioral activity, food intake, and feces were normal animals, no one died. Observed two weeks after drug withdrawal and no significant changes.
3.2 the impact of animal body weight 13 weeks of continuous medication, and withdrawal two weeks, compound Ginkgo biloba high-and low-dose rats of normal weight growth,
with the blank control group, no significant difference in body weight change. The results in Table 1.
Table 1 compound effect of GBE on the impact of weight gain in rats (omitted)
3.3 Coefficient of animal organs to the rats 13 weeks of continuous medication, and withdrawal two weeks after the compound effect of GBE high-and low-dose group and blank
control group rat heart, liver, spleen, lung, kidney, adrenal gland, thymus and other major organ coefficient of comparison, no significant difference (P