| Codonopsis pilosula,a medicinal and edible food,was recorded for the first time in " Materia Medica from the New".It has the functions on strengthening the spleen and lungs,nourishing the blood and rejuvenating.It is an important medicine used in clinical prescriptions for tonifying qi.Modern pharmacological studies showed that Codonopsis pilosula could play wide acitivies,such as regulating gastrointestinal movement,anti-ulcer,anti-radiation,antihypoxia,reducing blood pressure,enhancing immunity,anti-aging and so on.The granules of traditional Chinese medicine(TCM)are the granular products developed from a TCM through multiple process including water extraction,concentration,drying,granulation and so on.This is a revolutionary product of TCM decoction,which can be used directly in clinical prescription.They are non-decocting,precise,easy to carry,hygienic and so on.In this study,we collected 28 batches of Codonopsis pilosula produced from different areas,and did the studies on the standard decoction,extraction process and granules formulation.In addition,the rat model of hyperuricemia was established in order to evaluate the effect of water extract of Codonopsis pilosula and its main components on hyperuricemia rats.The research methods and results are as follows:(1)Study on the standard decoction of Codonopsis pilosulaWe collected 28 batches of Codonopsis pilosulae which were in line with the 2015 edition of the Chinese Pharmacopoeia.They were prepared as standard decoctions which were further determined with the content of lobetyolin and polysaccharide.The results showed that the content range of lobetyolin is 0.0594 ~ 0.3298 mg/g,and of Codonopsis pilosula polysaccharides is 5.94% ~ 17.34%.In addition the HPLC fingerprint was established for the Codonopsis pilosula standard decoction and 13 common peaks were identified.(2)Study on the preparation of granules formulation for Codonopsis pilosula.In terms of the ratio of extraction,the concentration of lobetyolin and polysaccharide,a three-factor three-level orthogonal test method was performed to investigate the amount of water added,the extraction time,and the number of extractions,The optimized preparation was validated by pilot scale-up test and confirmed as: 1000 g of codonopsis pilosula was added with 9 times of water,soaked for 1 hour and followed by being boiled for 1 hour.The residues was added 7 times of water followed by being boiled for 1 hour.The filtrates were concentrated under reduced pressure and the extract were obtained with a relative density between 1.05 and 1.15(60 °C).The spray drying technology was applied on the extract and the Codonopsis pilosula dispensing granules was made by adding with dextrin and microcrystalline cellulose of.(3)Study on the quality standard and preliminary stability of Codonopsis pilosula dispensing granulesBased on the standard of Codonopsis pilosula in the Chinese Pharmacopoeia 2015 edition,three batches of Codonopsis pilosula dispensing granules were discerned with the particle size,moisture,solubility,loading difference and lobetyolin by TCL..In addition,a method was generated to determine the content of lobetyolin and polysaccharides involved in the three batches of Codonopsis pilosula dispensing granules.No difference was found on the content of the lobetyolin between the decoction and the dispensing granules The longterm stability was performed on the three batches of Codonopsis pilosula dispensing granules,which showed good stability under the above conditions.(4)Study on Hyperuricemia Rats treated with extract of Codonopsis PilosulaeIn order to investigate the effects of TSC and TEC on hyperuricemia-rats,we establish the hyperuricemia-rats induced by a diet mixed with fructose and yeast.The effects of TSC and TEC on the hyperuricemia-rats were evaluated by observing the body weight,the fecal water content,fecal flora OD value,H&E staining,serum biochemical indexes,Glut9 expression and content of short-chain fatty acids contained in the rat feces.The results showed that TSC and TEC could reduce the levels of serum uric acid and serum urea nitrogen,amelorate injury on the colons,down-regulate Glut9 levels in the livers.On the other hand,gas chromatography-mass spectrometry(GC-MS)method was used to detect the content of short-chain fatty acids in fecal bacterial fluid.The results indicated that the TSC and TEC especially M-TSC group,could positively regulate and restore the metabolism of SCFAs in intestinal tract.In summary,using the 28 batches of Codonopsis pilosula,we developed Codonopsis pilosula dispensing granules showing stable,feasible and controllable quality.The studies on the quality standard and stability provide a scientific basis for the translation and application of Codonopsis pilosula dispensing granules.In addition,this study for the first time revealed the effects of Codonopsis pilosula extract to reduce uric acid in hyperuricemia-rats induced by high-fructose and yeast.Our results suggested that the mechanisms might be the down-regulation of Glut9 in the livers of the treated rats. |
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