Safety Evaluation Of Sangxing Pingchuan Granules

Being a modified version of Maxing shigan decoction, Sangxing Pingchuan granules consisted ofcortex mori，almond, cypsum, glycyrrhiza, and some other traditional chinese medicine. SangxingPingchuan granules is available for the treatment of porcine respiratory disease. In order to make clearthe safety of Sangxing Pingchuan granules, acute toxicity, subchronic toxicity and safety pharmacologyresearch of Sangxing Pingchuan granules, the experiments were carried out.The acute toxicity of Sangxing Pingchuan granules on mice was disscussed, a total of50Kunmingmice were divided into5groups. The five groups were grvaged with water solutions of SangxingPingchuan granules, respectively. The method of Bliss was used to determine the LD₅₀of the SangxingPingchuan granules. The subchronic toxicity of Sangxing Pingchuan granules on rats was disscussed,80Wistar rats were randomly divided into four groups. The control group was taken normal saline byintragastric administration. The three treatment groups were grvaged with water solutions of sangxingpingchuan granules, respectively. The drug was fed for30days continuously, and changes of bodyweight were recorded. The blood was collected every nine days for the analysis on some blood routineindices and some blood biochemical indices.The heart, liver, spleen, lung and kidney were taken andweighed to calculate organic indexes, then the organs were made into tissue sections forhistopathological analysis. The safety pharmacology research of Sangxing Pingchuan granules was alsodisscussed, and some related indexes of anesthetic dogs were observed to explore the influence ofsangxing pingchuan granules on coronary heart system, respiratory system, urinary system of anestheticdogs. Correlated indexes of spontaneous activity of mice were analyzed to study the influence ofsangxing pingchuan granules on nervous system.In the test of the acute toxicity of Sangxing Pingchuan granules, the method of Bliss was usedto determine the LD₅₀of the Sangxing Pingchuan granules and95%confident limit. The LD₅₀ofthe Sangxing Pingchuan granules was319.16g/（kg·bw）, while95%confidence interval was270.31-363.68g/（kg·bw）.The results of subchronic toxicity of Sangxing Pingchuan granules were as the following:Firstly, during the experiment, as compared with the model control, the clinical signs of eachdosage group were not significantly difference, the weight of rats of each dosage group were notsignificantly difference（P>0.05） compared with the control group; Contrasted with control group, thecardiac coefficient of high and low dose group of rats were significantly decreased（P<0.05）, whilethere was no significant difference between other groups（P>0.05）. The coefficient of liver, spleen, lung,kidney were nonsignificant（P>0.05）.Secondly, the effects of Sangxing Pingchuan granules on blood routine examination of rats Inevery observing time during the experiment, the related indexes of rats blood were not prominentexcept individual index compared with the control group, however, the indicators were within thenormal range of fluctuation. Thirdly, the effects of Sangxing Pingchuan granules on blood biochemical indices of rats duringthe experiment, as compared with the model control, the related indexes of rats blood were notprominent except individual index, the influence of Sangxing Pingchuan granules on liver function,kidney function and heart function based on the comprehensive survey of the indexes, in addition tohigh-dose rats serum Urea and Crea levels both reduced significantly （P<0.05）, there were no changeson the rest of the indicators at the same time.At last, the results of histological examination No obvious abnormality is found, the differencesbetween control group and each dose group were nonsignificant.Safety pharmacology test results showed that the vitamin C of each group in the urine before andafter the test were positive. And the indicators of remaining dose groups compared with the controlgroup showed no significant differences （P>0.05）.As a result, we drew the following conclusions: Sangxing Pingchuan granules hadslight influence on animal organisms, so it was a low toxic and safe traditional Chinese medicinepreparation which was suitable for clinical application.