Development And Pharmacodynamic Analysis Of Yangyintongli Granule

Background:Postoperative intestinal obstruction is a common complication of gastrointestinal motility disorder after surgery,which occurs more recently than surgery.The main clinical manifestations are abdominal distension,abdominal pain,nausea,vomiting,difficulty in defecation and exhaust,etc.In addition,postoperative intestinal obstruction may also cause complications such as dehydration,electrolyte disturbance and sepsis.Yangyintongli Decoction is an intra-hospital agreement prescription which has been used in our hospital for many years.Since the 1970 s,after many years of clinical practice,it has been proved that this prescription has a good effect in preventing intestinal obstruction after operation.Decoction is the main form of medication in traditional Chinese medicine.However,decoction has some drawbacks.Because the pharmacodynamic material basis of traditional Chinese medicine compound preparation is extract,and the extraction of decoction is greatly influenced by the quality of medicinal materials and decocting methods.Generally,the amount of decoction is larger,and it's inconvenient to carry and preserve,and the poor taste of the decoction results in poor compliance of patients.Granules have good stability,which is conducive to storage,portability,storage and transportation,reduce the taking volume,can be added to improve patient compliance,and can standardize the preparation process,ensure the clinical efficacy,more suitable for clinical application and promotion than decoction,so we changed this product into granules.Objective:Through pharmaceutical research,Yangyintongli Decoction was changed into granule,which made it more suitable for clinical application and promotion.Methods:(1)Study on preparation technology: we used ethanol reflux methodto extractthe components of each materialfully.Considering the influence of each factor level on the process,the optimum parameters were selected by orthogonal test.The concentrating process and forming process were investigated,and the optimum preparation process was obtained.(2)Quality standard research: Referring to the Chinese Pharmacopoeia(2015),the quality standard of the preparation was studied.The appearance,identification,inspection and content determination of the product were examined.TLC was used to qualitatively identify the index components of each herb,and high performance liquid chromatography was used to determine the contents of rhein,emodin,chrysophanol,aloe emodin,emodin methyl ether and paeoniflorin in Radix Paeoniae Rubra.The stability of the preparation was preliminarily examined.(3)Pharmacodynamic study: Maximum tolerance test was conducted to evaluate the safety of the prescription,and an animal model of postoperative ileus was constructed.The pharmacodynamic study was carried out with the effect of gastrointestinal motility on experimental animals as an index.The in vitro activity of the preparation was examined by culturing the intestinal tract of mice.Results:(1)The preparation process:combined all herbs according to the prescription amount,adding 8 times of 70% ethanol for reflux extraction,reflux extraction for 3times,1.5 hours each time.The extract was concentrated and dried at condition of0.09-0.1 mpa and 70?.After being processed into powder,equal amount of sugar powder was added to mix evenly.95% ethanol was used for granulation and natural air-drying.(2)Quality standard: The spots of each sample in TLC identification were clearly separated,and the blank control had no interference;the content determination method was reliable.The precision and reproducibility are good,the recovery rate is96%~99%.The content limit of Total Anthraquinone in rhubarb is not less than 7.0mg/g and paeoniflorin is not less than 3.0 mg/g.(3)Pharmacodynamic study:(1)The results of X-ray examination showed that compared with the normal group,intestinal obstruction was obviously formed in themodel group,and the preventive effect of Yangyintongli Granule was shown in each group.(2)Compared with the normal group,the gastric emptying rate in the model group was lower(p < 0.05 or p < 0.01);compared with the model group,the gastric emptying rate in the Yangyintongli granule group and Mosapride group was significantly increased(p< 0.05 or p < 0.01);the small intestinal propulsion rate was significantly increased in the high-dose,middle-dose group and Mosapride group(p <0.05 or p < 0.01).(3)The results of in vitro experiments showed that Yangyintongli Granule could improve the intestinal motility.Conclusion:The preparation technology of Yangyintongli granule is reasonable and feasible,the quality standard method is reliable,and the preparation is stable.Pharmacodynamic experiments show that the granule is safe and effective.