Safety Evaluation Of Galla Chinensis Solution

Galla chinensis is a traditional Chinese medicine which is composed of a large amount of gallotannin, a typical kind of hydrolysable tannin, whose content can exceed 70% of its weight. The yield and quality is the first over the world. Modern pharmacology has demonstrated that Galla chinensis have resistive effects of oxidize and germ and viruses and mutations, as well as kill the sperm. In china, various skin tropic preparations of Galla chinensis are widely used in clinical practice. Despite the wide use of Galla chinensis or its external preparations as herbal medicine for the treatment of a range of diseases, its toxicity is still unknown. This study will provide information on the major toxic effects, provide a comprehensive and effective scientific basis for the safety evaluation of Galla chinensis solution (GCS) and define the safe range of GCS. The main results are showed as follows.1. Fifty Sprague-Dawley (SD) rats were distributed in 5 groups of 10 animals each (5 female and 5 male). The five groups as follows:saline control group, solvent control group,500mg/kg group,1500mg/kg group,2500mg/kg group. Each rat was smeared in the skin of its back with the volume of 0.3mL for 5 days. The effects of GCS on central nervous system were measured by pole test and the versatile recorder of rats’locomotor activity at 0.5h after the last administration. The heart rate and respiratory rate of each group of rats were measured by using BL-420F (multi-channel physiological signal acquisition processing system). The results suggested that GCS had no effect on the central nervous system, respiratory system and cardiovascular system.2. The acute toxicity test was carried out according to "technical guidelines for veterinary medicine research compilation". The LD50 value of GCS by oral administration was greater than 5000mg/kg and the drug is considered as practically non-toxic. A series of tests were used to study the safety of GCS by rabbits. The LD50 value of GCS by acute skin toxicity was greater than 5000mg/kg. The result showed that GCS was no acute skin toxicity. In skin irritation test, no toxicity reaction and irritation reaction occurred in complete skin and in injured skin after applied GCS. The results indicated that the drug was not irritantion to the skin of rabbits. In oral mucous membrane irritation test, a few of mucous is poured out of one rabbit oral only in multiple doses group. The results indicated the drug was not irritantion to oral mucous membrane. In eye irritation test, the corneal were congested with a few red blood cells. But all returned to normal soon afterwards. The result showed that GCS was not irritation to the eyes.3. In 30-day subchronic oral toxicity test, fifty SD rats were distributed in 5 groups of 10 animals each (5 female and 5 male). The five groups as follows:saline control group, solvent control group,500mg/kg group,1500mg/kg group, 2500mg/kg group. Animals were treated daily at 9 a.m by gavage one a day for successive 30 days and observed once daily to detect signs of toxicity. After administered for 30 days, the food consumption in high dose (2500 mg/kg bw-day) group was significantly decreased in male rats compared with the saline control group (P<0.05). In male rats, after GCS treatment at 2500 mg/kg bw-day for 30 days, the body weight was significantly decreased when compared with saline control group (P<0.05); Meanwhile, the body weight were significantly lower at 500mg/kg group and 1500mg/kg group (P<0.05, only in the first week); In female rats, compared with saline control group, the body weight at 2500mg/kg group was lower (P<0.05, only in weeks 3 and 4). The changes of hematology parameters and serum biochemistry were shown that a statistically significant increase in AST was noted at 2500 mg/kg Group (P<0.05). The results of organ coefficient were shown that the organ coefficient of spleen showed significantly decreasing trend at 2500 mg/kg Group (P<0.05). The results of oral administration with GCS for 30 days from the study showed that GCS at 500 mg/kg had no damage on vital organs. The medium doses of GCS (1500 mg/kg bw-day) had mild damages on liver, lung, kidneys, intestine and testicle, such as slight vascular congestion, while at the dose of 2500 mg/kg bw·day, GCS had varying degrees of damages on each organ, mainly detected as granular and vacuolar degeneration in cells, focal necrosis and vascular congestion. The results showed that GCS has subchronic toxicity reaction in rat over the dose of 2500 mg/kg.