Development And Application Of Coptis Ointment,a Classic Formula

Objective:Our purpose is to improve the preparation technology of Coptis ointment,and to develop new external medicine for the treatment of burns.The extract process is optimized based on the extract rate of main effective components and the results of antibacterial test in vitro.The drug efficacy is evaluated and the mechanism of drug action is studied by animal efficacy test.Finally,we want to develop the external medicine for treating burns and scalds,and study its quality standard.Methods:1.Study on the improvement of extract technology of Coptis ointmentWe studied the prescription and preparation technology of Coptis ointment through the database literature retrieval and analysis.The original prescription herbs were decocted with water,refluxed with organic solvent,or soaked with water and then refluxed with organic solvent,and the required solvent was recovered to the specified capacity.The extract rate of effective components,such as berberine,catalpol,verbascoside and the antibacterial activity in vitro were as evaluation index to optimize the extract process.2.Study on the pharmacodynamics and mechanism of Coptis ointment extract in scald animal modelsWe replicated the superficial second degree scald model in rats to study the pharmacodynamics and mechanism of action.The therapeutic effect of extract required from improved technology on scalded rats was investigated by observing and evaluating the general condition of scalded wound,the wound healing rate and pathological changes of scalded wound.And The content of vascular endothelial growth factor(VEGF),the level of serum tumor necrosis factor-α(TNF-α)and the activity of xanthine oxidase(XOD)in scald wound were used as evaluation indexes to explore the mechanism of Coptis ointment extract.3.Study on preparation technology and quality standard of Coptis ointment tinctureThe preparation form of Coptis ointment extract was selected according to the above experimental optimization method,the literature and pharmaceutics teaching materials.Also,we studied the ethanol concentration,the amount of glycerol and laurocapram.Referring to the Chinese pharmacopoeia for quality standard research,we added HPLC content test items,and formulated quality standards.Results:1.Study on the improvement of extract technology of Coptis ointmentWe certified the formula and preparation technology of Coptis ointment.The effective components were extracted by soaking in water for 3 hours,refluxing with70% methanol for 2 hours and soaking in water for 3 hours,refluxing with 70%ethanol for 2 hours.Compared with the original process,the extract rate of the above two methods is obviously higher.The results showed that the water extract of Coptis ointment had no antibacterial effect on Staphylococcus aureus,Escherichia coli and Candida albicans.The methanol reflux extract and ethanol reflux extract of Coptis ointment had certain antibacterial effect on Staphylococcus aureus and Escherichia coli.Among them,the extract of soaking in water for 3 hours,heating and refluxing with70% methanol for 2 hours and that of soaking in water for 3 hours,heating and refluxing with 70% ethanol for 2 hours had better antibacterial effect,but all the extracts had no antibacterial effect on Candida albicans.Combined with the production practice,the extract process of modified Coptis ointment was determined as soaking in water for 3 hours,heating and refluxing with 70% ethanol for 2 hours.2.Study on pharmacodynamics and mechanism of improved technology extract of Coptis ointment on scald animal modelIn pharmacodynamic study,each group can accelerate the speed of wound healing,reduce local exudation and relieve the redness around the wound.According to the dosage of the original medicinal materials,the efficacy of the improved technology of Coptis extract is better than that of the original technology.The content of vascular endothelial growth factor(VEGF)in scalded rats could be increased by the improved technology extract of Coptis ointment,which indicated that the improved technology extract of Coptis ointment might promote the synthesis and release of VEGF.The improved extract of Coptis ointment can significantly reduce the content of serum tumor necrosis factor-α and inhibit the activity of serum xanthine oxidase in scalded rats,which proves that the improved extract of Coptis ointment can inhibit the release of local inflammatory factors in scalded rats,reduce the oxidative damage of peri wound cells and organs,and play a protective role in scalded repair.3.Study on preparation technology and quality standard of Coptis ointment tinctureWe use the same amount of medicine as the prescription.The medicinal materials are extracted according to the improved process which included adding 65% ethanol to dissolve it completely,adding 1% glycerin and 0.1% laurocarpone in turn,stirring to dissolve it,and fixing the volume with 65% ethanol to obtain Coptis ointment tincture.According to the tincture requirements of 2020 edition of Chinese Pharmacopoeia,the appearance properties of Coptis ointment tincture meet the requirements.Meanwhile,a method for simultaneous determination of four components(berberine,ferulic acid,berberine hydrochloride,curcumin)in Coptis ointment Tincture by HPLC was established,and the quality standard of Coptis ointment tincture was initially established.Conclusion:To sum up,in this paper,the classic formula of Coptis ointment was developed and studied.After the improvement of extract process,the extract rate of main effective components,such as berberine,catalpol,verbascoside,was significantly higher than that of the original process.The antibacterial effect of the extract on Staphylococcus aureus and Escherichia coli was obvious.And the therapeutic effect on scald animals was better than that of the original process.We also preliminarily elucidated the mechanism of action in the treatment of burns.After that,we developed new drugs to treat burns and initially established the quality standard.