| Gout is a metabolic disease caused by increased uric acid production in the body and/or decreased uric acid excretion in the blood,which is deposited in the joints and surrounding tissues and kidneys,thereby causing inflammation of the body and morphological changes of the joints.At present,clinical drugs are effective in treating gout,but they have obvious side effects.Though traditional Chinese medicine has more effect and less side effects on gout,it needs to be treated dialectically and lacks scientific and systematic research.Phyllanthi Emblica has a long history in application in the treatment of hyperuricemia(HUA),and has been developed into a variety of proprietary Chinese medicines as a component of the compound.However,there are few researches on the treatment of hyperuricemia and gout with Phyllanthi Emblica,and the modern preparation developed from it has not been producted yet.In the early stage,the project team has carried out many years of research on the anti-hua effect of Phyllanthi Emblica,conducted preliminary pharmacodynamic screening and acute toxicity safety evaluation of the extracts of the medicinal materials,and preliminarily confirmed that the extracts have good uric acid lowering effect and good safety.Objective This study intended to use the single medicinal material of Phyllanthi Emblica as medicine,on the basis of previous studies,according to the relevant requirements of the Provision for Drug Registration,to more than the basic formulation development into a stable process,quality control,curative effect and mechanism of action is relatively clear,conform to the requirements of the traditional Chinese medicine modernization of traditional Chinese medicine effective parts of new drugs as the goal,to carry out the preparation technology,quality control and main pharmacodynamics research,exploration to determine its medicinal properties,laying a foundation for further new drug registration for this product.Methods We took more than the basic medicine to join 8 times 70% ethanol,65 ℃ decoction 2 times,2 hours and 1 hour,respectively,extract filtering,merging,stress concentration to the relative density of 1.02 ～ 1.03,centrifugal,the supernatant was extracted,at a rate of 1 BV/h on D101 macroporous resin column,using a four-fold column of water,according to the 1.5 BV/h speed of elution,collection of 1.5-4 BV eluent,vacuum concentration,dry and grind into powder,namely the gallic acid and glucose times nucleoside total content is more than 50% of total phenol API of Phyllanthi Emblica.After the study of preparation technology,the preparation prescription of this product was preliminarily determined as follows: 200 g of total phenol extract of Phyllanthi Emblica,180 g of MCC,16 g of CMS,4g of Mgst,1000 tablets(0.4g/ tablet).With allopurinol and febuxostat as positive control drugs,the main pharmacodynamics studies of six animal models including the effect of Phyllanthi Emblica preparation on serum uric acid of hyperuricemia model mice were carried out.Results At present,the research on the preparation process of Phyllanthi Emblica has been completed,and the preparation process and process parameters have been determined.The multi-batch pilot test shows that the preparation process is stable and can meet the industrialization requirements.The quality standards of raw medicinal materials,total phenolic raw materials and tablet of Phyllanthi Emblica were studied,and the corresponding quality standards were drawn up,which could be used as the quality control standards for the materials and finished products of this product;The main pharmacodynamics studies of Phyllanthi Emblica tablet on six animal models including mouse and rat hyperuricemia animal models were completed,and the results showed that Phyllanthi Emblica tablet had the effects of reducing blood uric acid level,inhibiting gout inflammation and analgesic effect,and the effects were dose-dependent.At the same time,the mechanism of uric acid lowering is related to the inhibition of xanthine oxidase.Conclusion This study refers to the requirements of the relevant registration management of new drug of TCM,the research work of preparation process,quality standard and the main pharmacodynamics carried out in a Scientific and systematic way and a good medicinal properties is determined.It lays a foundation for the development of a modern effective part of traditional Chinese medicine with stable process,controllable quality,definite curative effect and relatively clear mechanism of action. |
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