| Ping-wei-shu Capsule was a new compound Chinese medicine which was researched and developed based on the clinical experiences of traditional Chinese medicine by College of Pharmacy, Suzhou University. Ping-wei-shu Capsule was composed by the herbs of Mongolian Milkvetch Root, Pilose Asiabell Root, Common Bletilla Tuber, Largehead Atractylodes Rhizome, White Peony Root, Chinese Goldthread Rhizome, Yanhusuo Tuber and Liquorice Root, having been shown to nourish qi to invigorate spleen, warm spleen-stomach to scatter cold, and regulate qi to alleviate pain, especially effective in curing stomach ulcer, duodenal ulcer, gastritis and duodenitis.Objective:The therapeutical effects, the preliminary mechanism of action and safety evaluation about Ping-wei-shu Capsule were studied to provide reliable experimental reference for clinical experiment and further study.Methods:①The acute impaired model of gastric mucous membrane on rat was made by absolute ethanol. The dots and strip shapes of ulcers were visually observed. The ulcer index was calculated. And the stomach histological examinations were performed.②The chronic gastritis model on rat was stimulated through sodium deoxycholate and ethanol. The acid index of gastric juice, Peptic activity, IL-1β、IL-8and TNF-α were tested. And the histological examination of stomach was also observed.③The function of Ping-wei-shu Capsule on gastrointestinal motility was observed through gastric emptying ability and gastric emptying rate by henolsulfonphthalein experiment and carbo medicinalis experiment on mice.④The analgesia function of Ping-wei-shu Capsule was observed by testing the inhibition rate of writhing response with glacial acetic acid and pain threshold through hot plate experiment on mice.⑤The anti-inflammatory function of Ping-wei-shu Capsule was observed by testing ears’swelling degree with xylene on mice and granuloma weight with agar on rats.⑥The toxicity test of Ping-wei-shu CapsuleIn acute toxicity test, the maximal tolerance dose (MTD) of Ping-wei-shu Capsule was determined, preliminary observate on side effect on i;In chronic toxicity test, rats were administered test samples for three months with different doses. Then1/2animals were detected the safe indexes. Other1/2animals were observed for another month to detect possible slow toxicity and the reversiblity of toxic reaction. The hematologic and biochemic index (WBC, RBC, PLT,Hb,ALT, AST,CRE,BUN,T-Bil,T-cho,TG, etc) were tested. And organs such as heart, liver, spleen, lung, kidney, adrenal, brain, thymus, testis and epididymis (or womb, ovary) were weighed. Organ indexes were calculated and histological examinations of main organs were performed. The main organs in control group and high dose group were histological examined firstly. Other groups were stored and would not be histological examined unless there was abnormity in high dose group.Results:①Compared with model group, the index of stomach ulcer caused by absolute ethanolwas obviously decreased in the high and middle dose group of Ping-wei-shu Capsule (P<0.01). Ping-wei-shu Capsule could improve the gastric mucosa pathological change and mortification. It could decrease the infiltration of phlogocyte among gastric mucosa glands and the dropsy of gastric mucosa muscularis and serosa. It was indicated that Ping-wei-shu Capsule could protect gastric mucosa from acute injury.②Compared with model group, Ping-wei-shu Capsule could increase gastric acidity and stomach peptic activity of rats which having chronic gastritis (P<0.05). Serum content of IL-1β in low dose group, IL-1β, IL-8and TNF-a in high dose group of Ping-wei-shu Capsule were decreased significantly (P<0.05). The pathological section revealed that Ping-wei-shu Capsule could significantly reduce the degree of imflammation. It could improve gastric mucosal lesion. It could also decrease tissue necrosis and exudation, to reduce the edema of gastric mucosa submucosa, muscularis, and serosa. All of these hinted the therapeutic effect of Ping-wei-shu Capsule on chronic gastritis.③Compared with normal group, Ping-wei-shu Capsule could decrease phenolsulfonphthalein concentration in stomach of rats in high and middle dose group (P<0.05-0.01). It could extend carbo medicinalis besiegement distance obviously (P<0.05). All of these indicated that Ping-wei-shu Capsule could promote gastrointestinal motility.④Compared with normal group, Ping-wei-shu Capsule could inhibit writhing response on mice(P<0.01). The effect of high dose group was similar to Aspirin. Ping-wei-shu Capsule could increase pain threshold after being administered1-2hours (P<0.05-0.01). It indicated that Ping-wei-shu Capsule was efficient and effective on analgesia for long time. All of these hinted that Ping-wei-shu Capsule could relieve pain.⑤Compared with normal group, ears’swelling degree in high and middle dose group of Ping-wei-shu Capsule on mice were inhibited (P<0.05～0.001). It could reduce granuloma weight and inhibit granuloma growing (P<0.05). All of these indicated that Ping-wei-shu Capsule was effect on anti-inflammatory.⑥In acute toxicity test, the mice did not die or had apparent anomalism after being administered with MTD (98.5g/kg). Two weeks later, the mice were showed no apparent pathological changes. The MTD of Ping-wei-shu Capsule was about303times than the recommended clinical dose for human.In chronic toxicity test, compared with normal group, body weight, food-intake and organ index on rats of Ping-wei-shu Capsule did not have apparent change except rare exceptions. But after administered3months, the hematologic index results indicated that the percent of WBC,Lym,MCV on rats in middle dose group of Ping-wei-shu Capsule,WBC on rats in high dose group had a statistical significance (P<0.05-0.01). The biochemical index results indicated that CK on rats in low dose group of Ping-wei-shu Capsule,K+on rats in middle dose group,ALP,CK,GLU,Na+,Cl-on rats in high dose group had a statistical significance(P<0.05-0.01);When convalescent in1month, the hematologic index results indicated that the percent of MCHC on rats in low dose group of Ping-wei-shu Capsule,Mid,MCH,MCHC on rats in middle dose group, Mid, RBC on rats in high dose group had a statistical significance(P<0.05-0.01).The biochemical index results indicated that K+on rats in low dose group of Ping-wei-shu Capsule,ALP on rats in middle dose group,CRE on rats in high dose group had a statistical significance (P<0.05-0.001); After administered3months, a half animals of every group were detected the histological examinations,it indicated that one rat in normal group had hepatic steatosis in liver tissue, and there were no apparent changes in internal organs among other rats and not yet pathology change caused by toxicity. When convalescent in1month,the histological examinations of another half animals indicated that one rat in normal group had hepatic steatosis in liver tissue,and there were no apparent change in internal organs among other rats and not yet pathology change caused by toxicity. Detected index and pathological section of acute toxicity test on mice and chronic toxicity test on rats indicated that Ping-wei-shu Capsule was safety. Although some index was changed, the main reason of these may be caused by abnormal index of some rats in normal group. It needed further study to expain these phenomenon.Conclusion:Ping-wei-shu Capsule could protect gastric mucosa from acute injury. It could treat chronic gastritis. It could promote gastrointestinal motility too. It could also relieve pain and eliminate inflammation. Toxicology test showed that Ping-wei-shu Capsule orally was safety. These results could provide certain reference for further clinical experiment and research. |
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