| 1 Preparation of senna leaf granules1.1 Study on the extraction process of sennoside A and BTo study the optimum extraction conditions of sennoside A and B in senna leaf.The contents of sennosides A and B were used as evaluation indicators.The stability of the sennosides A and B in different solvents was investigated with the temperature and time using the classic isothermal method.A multi-factor orthogonal experiment was used to optimize and screen the process route for ethanol concentration,ethanol dosage,extraction temperature,and extraction time.Results: The best extraction process was 10 times the dose of 50% ethanol heating soak 2 times,each extraction 20 min.Conclusion: The determined technology is reasonable,stable,reproducible,and the extraction rate of effective ingredients is high,which provides basis for the research and actual production of senna granules.1.2 Research on Forming Process of Senna Leaf GranulesOrthogonal tests were conducted to evaluate the formability,bulk density,angle of repose,meltability,and moisture absorption of the pellets,and normalized and composite scores were used(weight coefficient: 0.20:0.20:0.20:0.20:0.20).The optimal excipients,excipient ratio,ethanol dosage and volume fraction of the granules were selected.Results: The optimal excipients selected by wet granulation were saccharose and dextrin,the ratio of sucrose and dextrin was 2:1,the volume fraction of ethanol was 80%,and the amount of ethanol(g)was 6.7%.Drying temperature is 50°C,drying time is 5h,and the ambient humidity needs to be controlled below 73%;Conclusion: The granules selected are of reasonable excipients and the moldingpreparation process is feasible,which is in line with the requirements of Part II of the 2015 edition of the Chinese Veterinary Pharmacopoeia.1.3 Establishment of Senna Leaf Quality StandardTo establish a HPLC method for the determination of sennoside A and sennoside B in senna leaf granules for quality control of senna leaf granules.Linearity,precision,stability,specificity,sample recovery,detection and quantitation limits were examined.Results:The linear ranges of sennoside A and B were 2.42-155.04 ?g·mL-1(r=0.9999)and 2.95-189.20 ?g·mL-1(r=0.9999),respectively.The average recovery of the method(n=6)was 98.92%(RSD=1.03%)and 98.90%(RSD=0.73%),respectively.The detection limits were 2.09 and 0.92 ?g mL-1,respectively.The limits of quantification were 5.39 and 1.84 ?g mL-1,respectively.Conclusion: The established analytical method is simple,rapid,stable and specific.It increases the quality control indicators that can reflect the clinical efficacy of senna granules and provides a basis for the improvement of existing national standards.2 The study on the Efficacy of Senna granules for treating the constipation of mice that were caused by oralthe compound Diphenoxylate tabletresearch the optimal dosage of compound Diphenoxylate tablet on causing the constipation of mice and evaluate the efficacy of Senna granules by intragastricadministration.(1)the 77 KM mice were randomly divided into 7 groups and the dosage of 0,5,10,20,30,40,50mg/kg compound Diphenoxylate tablet(as Diphenoxylate)were used to make the constipation model of mice after intragastricadministration.the time of the first black stool,the quantity and weight of stools in 8 hours,and the weight of per stool were chosen to the decision index for successfully developing constipation model of mice.(2)the mice of constipation were randomly divided into negative control group(the mice of constipation),positive control(oral mosapride),treatment group(oral senna granules),all of the change that the time of the first black stool,the quantity and weight of stools in 8 hours,the weight of mice and intestinal propulsive rate were used to evaluate the efficacy of senna granules by oral administration.Result:(1)the dosage of 30mg/kg compound Diphenoxylate tablet(as Diphenoxylate)was defined to the optimal dosage for developing the constipation of mice,the time of the first black stool was delayed about 79.67 min,the quantity andweight of stools in 8 hours had significantly decrease that were compared with blank control.(2)the first time of defecation was significantly cut down 31.66 min,the quantity and weight of stools were significantly increased,the intestinal propulsive rate was significantly improved about 20.57% after oral the dosage of 600mg/kg senna granules.Conclusion:the good stable constipation of mice were established by significantly restraining intestinal peristalsis after oral administration the dosage of 30mg/kg compound Diphenoxylate tablet(as Diphenoxylate).(2)the symptom of constipation,intestinalperistalsis and the residence time of intestinal contents were significantly changed because of Diphenoxylate after oral senna granules.3 Senna granules promote gastrointestinal motility mechanisminvestigate the effect of Senna Leaf Granules on serum gastrointestinal hormone levels and NO in compound diphenoxylate constipation mice.SPF mice were randomly divided into blank control group(11),model control group(11),positive drug group(11)and senna granule treatment group(11)4 groups.Compound diphenoxylate method to establish a constipation mouse model.The positive drug group was given mosapride suspension(1.875 mg·kg-1),the senna granules treatment group was given senna leaf granule suspension(600 mg·kg-1),the model group and the normal control group An equal amount of saline is given.The levels of motilin(MTL),gastrin(GAS),somatostatin(SS)and nitric oxide(NO)in serum of mice in each group were detected by radioimmunoassay and nitrate reductase assay.Results: After the model was established,the residual rate in the stomach increased,the intestinal propulsion rate decreased,the serum MTL and GAS content decreased,and the NO content increased.There was a significant difference compared with the normal group(P<0.01).After administration,the residual rate in the stomach of the treated mice decreased,the intestinal propulsion rate increased,the serum MTL and GAS levels increased,and the NO content decreased.There was a statistically significant difference compared with the model control group(P<0.01);There was no significant difference between the senna granule treatment group and the positive drug treatment group.Conclusion: Senna leaf granules can enhance gastrointestinal motility in mice,and its mechanism may be related to its up-regulation of MTL and GAS expression in serum and down-regulation of NO expression in serum. |
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