Study On Preparation Proceduce And Quality Of Kangtang Mistura

Objective:Diabetes is a common disease, there are many complications of Diabetes, they pose a great threat to human health. Kangtang Decoction is a famous prescription in the treatment of diabetes from the famous doctor Zhang Xichun in Cangzhou.It’s effect on diabetes was confirmed in the experimental study in recent years. Kangtang Decoction has achieved remarkable curative effect for clinical application. According to the need of the clinical diabetes medication, it will put into mixture. The mixture is a liquid preparation which can quickly be absorbed.After extraction and concentration, it will be convenient to carry, save and take, the dose of patient can be reduced.So the mixture can meet the demand of the patient and ensure the preparation of comprehensive efficacy.Methods:(l)Study on process technology:Extracting time, quantity of volume and Extracting times was studied using multi-factor orthogonal design experiment with the rate of dry extract and the content of Puerarin as index, and then we determined the extraction process. Using the method of single factor investigation, with the filtration, centrifugation.50%alcohol,60%alcohol,70%alcohol as factors and the rate of dry extract. the content of Puerarin as index, the purification technology was studied and determined. To optimize the processing conditions, determine the species and amount of additives and preservatives.(2) The study on quality specification and initial stability:Thin layer chromatography (TLC) was used to identify Astragali radix,Schisandre chinensis reuctus, puerariae thomsonii radix,dioscoreae rhizome of Kangtang mixture and the TLC methods were determined. Using high performance liquid chromatography (HPLC) for quantitative determination of Puerarin, established the HPLC method for determination of Puerarin. In accordance with the Provisions of the draft quality standards and methods of the Project, the initial stability has been done.Result:(1)Through the experiment, the optimum process of Kangtang mixture was: extracted3times with10times the amount of water,1.5hours each time, then filtered and merged the filtrate.The filtrate was concentrated to a relative density of1.02-1.10(70-80℃), and got the clear paste, then centrifuged and got the supernatant to concentrate to about950ml, and then2g sorbic acid was added and mixed in the supernatant. Finally we adjusted the pH to4.5to5.0and added water to1000ml.(2) Astragali radix,Schisandre chinensis reuctus, puerariae thomsonii radix of Kangtang mixture were identified by TLC and Using HPLC for quantitative determination of Puerarin. The established quality standard has strong specificity, good reproducibility, strong operability and provides a guarantee for the quality control of Kangtang mixture, make the quality of Kangtang mixture is stable and controllable.Conclusion:The effective ingredients in the chinese empirical prescription were extracted and developed into mixture and the quality standard of the mixture was studied.Experimental results show that the preparation process of Kangtang mixture is reasonable and feasible, the quality standard is controllable on drug quality.