| Traditional Chinese medicine Paiqi formula is a traditional Chinese medicine compound preparation composed of seven traditional Chinese medicines such as Cistanche deserticola,Magnolia officinalis,Aucklandia and Fructus aurantii.Clinically,it is mainly used to accelerate the recovery of gastrointestinal function,accelerate Paiqi and defecation,and prevent postoperative ileus.It has good curative effect.Objective:The traditional Chinese medicine Paiqi decoction has been mainly used in our hospital.Because the decoction is difficult to preserve,inconvenient to carry and is not suitable for industrial production,this experiment will develop the traditional Chinese medicine Paiqi decoction into sugar free particles on the basis of preliminary experiments.Methods:Firstly,the extraction process and preparation molding process of medicinal materials were investigated,and the quality standard of granules was formulated;At the same time,the pharmacodynamics of traditional Chinese medicine Paiqi decoction was investigated.Finally,the mechanism of traditional Chinese medicine Paiqi granule in the treatment of postoperative intestinal obstruction was predicted by using network pharmacology technology,in order to provide a more sufficient theoretical basis for the clinical application of traditional Chinese medicine Paiqi granule.（1）Taking the content of neohesperidin and magnolol and the yield of extract as the detection indexes,and the water heating reflux as the extraction method,the extraction process was investigated by single factor experiment and L9（3~4）orthogonal experiment,and the best extraction process was selected.（2）Taking the formability,hygroscopicity and fluidity as the inspection indexes,the auxiliary materials were investigated first,and the optimal auxiliary materials of sugar free particles were preliminarily selected;For the investigation of the ratio of extract to excipient,the concentration of wetting agent and drying temperature,the preparation molding process was investigated by single factor experiment and L9（3~4）orthogonal experiment,and the best preparation process was selected.At the same time,the solubility,bulk density and critical relative humidity of the particles were investigated.Finally,the pilot scale experiment was carried out with the optimized process.（3）The Fructus aurantii in traditional Chinese medicine Paiqi granules was identified by thin layer chromatography.The reference material of Fructus aurantii and the reference materials of neohesperidin and naringin were used as reference,the lower solution of chloroform methanol water（13∶6∶2）was used as developing agent,and the 3%aluminum trichloride ethanol solution was used as chromogenic agent.It was heated at 105℃for about 5 minutes and examined under ultraviolet light（365nm）;TLC identification of Magnolia officinalis was carried out.With Magnolia officinalis reference material,magnolol and magnolol reference material as the reference,petroleum ether ethyl acetate formic acid（85∶25∶2）as the developing agent and 5%vanillin sulfuric acid solution as the color developing agent,the spots were heated at 105℃until the color was clear;The medicinal materials of Cistanche deserticola were identified by TLC.With the reference materials of Cistanche deserticola and the reference materials of Echinacea glycoside and Mullein glycoside as the reference,the polyamide thin-layer plate was used,methanol acetic acid water（2∶1∶7）was used as the developing agent,and the examination was carried out under ultraviolet light（365nm）.According to the requirements of the general principles of the fourth part of the Chinese Pharmacopoeia,the properties,particle size,loss on drying,solubility and moisture of the granules are tested,and the pilot test samples are tested.The commercial package is 10g per bag,and the minimum of the quality standard is formulated as the quality control standard.（4）Using the classic postoperative ileus modeling method,C57BL/6J male mice were used to establish the postoperative ileus model,which was divided into sham operation group,model group,mosapride group（positive drug group）and Paiqi Decoction group.Except the sham operation group,which did not stimulate the small intestine of mice after opening the abdominal cavity,the other groups stimulated the small intestine of mice according to the standardized operation to establish the postoperative ileus model.Paiqi Decoction group was perfused with Paiqi decoction,mosapride citrate group with Mosapride,sham operation group and model group with the same volume of normal saline.All indexes were tested to complete the pharmacodynamic investigation of traditional Chinese medicine Paiqi granules.（5）Using network pharmacology technology and tcmsp database,the main chemical components and predicted targets of traditional Chinese medicine Paiqi formula were retrieved,and Cytoscape 3.7.2 construct the active ingredient target network diagram;The disease targets of postoperative ileus（POI）were retrieved from OMIM and genecards databases,and crossed with the Paiqi side targets to obtain the key targets.The protein-protein interaction（PPI）network was constructed by using string database.Finally,David database is used to analyze the go function and KEGG signal pathway enrichment of key targets.Results:（1）The optimum water extraction process was as follows:10times the volume of water was heated and refluxed for 3 times,each time for 30 minutes,and the process was verified to be stable and reliable.（2）The optimum preparation process was as follows:dextrin was used as auxiliary material,and the relative density of the extract was 1 At about 38（60℃）,the ratio of extract to excipient was 1:3,70%ethanol was used as wetting agent,and drying at 70℃was the best preparation process.After that,three batches of pilot granules were prepared,and the comprehensive score RSD%of the three batches of granules was0.42%。（3）In the TLC of the three batches of granules,the same color and fluorescent spots were displayed at the corresponding positions of the chromatogram of the control substance or the control medicinal material of Fructus aurantii,Magnolia officinalis,Cistanche deserticola,and the negative control had no interference.Each bag（10g）of traditional Chinese medicine Paiqi granules contains at least 90 mg neohesperidin,and the quality standard of magnolol is 1.2mg。（4）Through the pharmacodynamic investigation of traditional Chinese medicine Paiqi decoction,compared with the model group of mice,it is found that this compound can effectively reduce the gastrointestinal dysfunction caused by postoperative ileus,reduce the inflammatory reaction of gastrointestinal tract and accelerate the recovery of gastrointestinal function.（5）After screening,a total of 23 potential active components were collected in the traditional Chinese medicine Paiqi formula,including 6Cistanche deserticola,8 Magnolia officinalis,4 Fructus aurantii and 5Aucklandia.234 action targets were obtained after deleting duplicate targets,of which 61 were the key targets of Paiqi formula in the treatment of POI.18 core targets were obtained by PPI network analysis.Go function enrichment analysis（P<0.01）and gokegg signal pathway enrichment analysis were carried out on these core targets to obtain the potential targets and pathways of traditional Chinese medicine Paiqi formula in the treatment of POI.Conclusion:（1）The extraction and preparation process of traditional Chinese medicine Paiqi granules were optimized,and three batches of pilot scale production were established,and a stable and reliable preparation production process was established;At the same time,the quality standard of granules was studied,and the project standards such as qualitative identification,content determination and methodological investigation were established,which provided a basis for the quality assurance of granules and a reliable basis for the later application of hospital preparations.（2）The pharmacodynamics of Paiqi decoction was investigated to verify its efficacy in the treatment of postoperative ileus;At the same time,the results of network pharmacology analysis show that the traditional Chinese medicine Paiqi formula plays a therapeutic role in the treatment of postoperative ileus through multi-component,multi-target and multi-channel synergy. |
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