Pre-Clinical And Clinical Studies On Pachymaran Powder

Poria cocos for traditional Chinese medicine, is the dried sclerotium. Traditional Chinese medicine thinks, Poria cocos is flat, mild, sweet, spleen, kidney, heart, lung, spleen, with dampness effect.For the treatment of phlegm dizziness palpitations, spleen eat less, edema, oliguria, hung up, insomnia and other symptoms of clinical.The main component of Poria cocos is Poria polysaccharide and three terpene. Research shows that, polysaccharide compounds can activate the natural killer cells, macrophages, lymphocytes and other immune cells; at the same time, can promote cytokine production, complement activation and so on, through a variety of ways, play a role in regulation of the immune system. The present report, Poria polysaccharide has obvious anti-tumor effected and protected the liver, to enhance the immune effect of clear. Poria cocos has enhanced immune function. This topic studies on immunomodulatory activity of pachymaran powder (Wuhan Huisheng biological technology limited company),identifies and evaluates the toxicity of pachymaran powder.These provides a full range of research data in the evaluation of efficacy and safty of pachymaran powder.Pharmacodynamic of pachymaran powder studies is to determine immunomodulatory activity of pachymaran powder; through the study on acute toxicity of of pachymaran powder, determination of pachyman powder by LD50; 30 days feeding test is to determine harmful effect dose, the nature of the cytotoxicity and target organ of pachymaran powder on rat and estimate the risk of sub-chronic intake to provide a reference for the design of clinical trials dose ang main outcome measures; target animal safety trails is to evaluate the tolerance of pigs, and observe the toxicity thar may occur when pigs use the excessive pachymaran powder;clinical efficacy trials is to explore the different does of pachymaran powder effect on the immune dynamics of soecific immunity (swine fever and swine pseudorabies).The experiment is conducted according to the relevant provisions of the Ministry of Agriculture veterinary drug registration method and 442 bulletin.1.Study on pharmacodynamics of pachymaran powderIn this study, Animal models with immune fuction inhibition were constructed by hydrocortisone injecta. Levamisole and astagalus polysaccharide were taken as positive controls. The mice were divided into three groups and orally administered pachymaran as a single dose of 200mg/kg,100mg/kg and 50mg/kg body weight after normal saline for 14 days, respectively. The pharmacodynamics of Poria powder was determined in three aspects by six tests, which were the macrophage function test(macrophage phagocytosis of chicken red blood cells and carbon particle clearance which reflected the effects of Poria powder on nonspecific immune function of mice), celluar immune function test(effects of Poria powder on immune organs of mice and the induction of dinitrofluorobenzene to delayed allergic reaction), and humoral immunity assays(detections of antibody-producing cells and serum hemolysin). Results:All the three groups of Poria powder could significantly improve the activity of phagocytic cells of the low immunity mice (P<0.05) and the results were positive.The high dose group and the middle dose group could remarkably increase the weight of the spleen and thymus (P<0.05) and enhance the action of delayed hypersensitivity (P<0.05),which indicated the positive results of cell immune function. Three dose groups of Poria powder could notably increase the number of antibody-producing cells in mice (P<0.05) and the level of serum agglutinin (P<0.05),which showed the positive results of the humormal immune function. And the middle dose had the best effect. Conclusions:Poria powder had certain enhancement effect of immune function to immunsuppressed mice.2. Acute toxicity text of pachymaran powderAccording to Notice No.442 of the Ministry of Agriculture and test guide which enacted in August 2009 by the Veterinary Bureau of Ministry of Agriculture, SPF KM mice have to be tested by feeding poria cocos polysaccharide oral powder in acute toxicity test. Following the guide, maximum gavage which is 0.4ml/10g.bw have to be adopted, three cumulative given 1.2ml/10g.bw. The result:both male and female SPF Kunming mice MTD test>10248mg/kg·bw,which means the test sample is nontoxic according to the veterinary medicine guiding principle.3.30 days feeding test of pachymaran powderAccording to Notice No.442 of the Ministry of Agriculture and 30-day and 90-day feeding test guides which enacted in August 2009 by the Veterinary Bureau of Ministry of Agriculture, SPF Wistar mice have to be tested by feeding Fuling polysaccharide oral powder for 30 days in acute toxicity test. Following the guides, maximum gavage which is 20.0ml/kg BW once per day for 30days have to be adopted. The result:we divide these 80 mice into 4 groups. A control group feed with distilled water and three tested groups with different test quantity as427mg/kg·bw、854mg/kg·bw、1708mg/kg·bw(of Pachymaran). After 30 days no death or obviously poisoned appears. The differences were not significant (P> 0.05), in terms of rat body weight, food intake, food utilization, hematology, blood biochemistry, organ weight, dirty/body ratio and pathological histology and other indicators of the tested samples with the negative control group, which means the test sample is nontoxic.4. Clinical target animals safety test of pachymaran powderIn this study, Duroc crossbred weaned piglets were divided into four groups of 24, each group of six male and female. Four groups were fed blank feed and other feed per 1kg of feed to add 100mg,300mg and 500mg (of Pachymaran). Results:the blank control group animals showed no symptoms of poisoning and death. Compared tested samples of each dose group of pig weight、food utilization、changes in body temperature、hematology、blood biochemical indicators with the blank control group, there was no significant difference (P> 0.05). The result was not found the test sample had no apparent toxic effects. This experiment illustrated that pigs were well adapted to Pachymaran scattered.5. Clinical efficacy test of pachymaran powderTo verify the clinical efficacy of Pachymaran scattered to swine fever and porcine pseudorabies,60 healthy pigs were tested to be immunized swine fever and porcine pseudorabies and establish a model. On the other hand, choosing 60 pigs to fed feed which was added Dexamethasone Sodium Phosphate, to establish a immunocompromised model, to be immunized swine fever and porcine pseudorabies and establish a model, was to to verify the clinical efficacy of Pachymaran scattered to swine fever and Porcine pseudorabies. Results:Compared with the negative control group, Pachymaran scattered had a significant effect on pigs infected with swine fever and porcine pseudorabies that be used immunosuppressant or not (P<0.05).Among of them, adding in what proportions, middle dose (100mg/kg) or high dose(200mg/kg)(of Pachymaran) to feed, there was no significant differences on the results. (P>0.05)In summary, the subject clarified the immune regulating activity and clinical efficacy of Pachymaran scattered, in terms of efficacy, toxicology, safety of target animal, clinical efficacy. The results provide comprehensive information of Pachymaran scattered to pigs in the evaluation of the effectiveness and safety, provide a scientific basis for the reasonable use of the pig and confirmed Pachymaran scattered can used in pig production and disease prevention as a safe and effective new Chinese- veterinary drugs.