Study On Preparation Process Of SH Capsules

Objective:As a late complication of diabetes mellitus,diabetic nephropathy（DN）has become the main cause of death and one of the most serious chronic complications of diabetes mellitus.It not only brings great pain to the patients and their families,but also has a heavy economic burden to the health care system and the whole society.There is still no effective and reliable treatment for this disease.The formulation of SH capsule based on a traditional Chinese medicine empirical prescription,has been added Salvia miltiorrhiza and Kudzu root in it.Previous studies showed that the formulation can reduce the serum advanced glycation end products,inhibit aldose reductase pathway of the kidney and improve insulin resistance,which has been proved to be effect on diabetic nephropathy.In this paper,we combined modern science and technology to optimize the preparation process of SH capsules. Methods:We studied the extraction and purification as well as molding process of SH capsule.1.The extraction and purification process:according to the distinct characteristics of different traditional Chinese medicine and effective components of SH capsule prescription,we used different extraction methods.Salvia miltiorrhiza was extracted with alcohol and then water.In alcohol extraction,the orthogonal test was used,the extraction rate and the paste rate of tanshinoneⅡA as indicator,to explore Salvia particle size,extraction time,ethanol volume fraction,ethanol volume on the extraction rate of tanshinoneⅡA and extract rate influence,thus selecting the optimal alcohol extraction process.We use single factor analysis and salvianolic acid B as the indicator to explore the effects of different kinds of macroporous resins and the factors affecting the separation of salvianolic acid B,thus selecting the best purification process;With infiltration extraction of rhubarb,Kudzu root.we explore the rhubarb,Radix Puerariae inquiry particle size,infiltration velocity,ethanol concentration,ethanol concentration on the extraction rate and paste rate of rhein,thus selecting the optimal percolation extraction process.2.Study on the molding process:based on tending the viscosity and hygroscopicity properties of extractions,using fluidity and hygroscopicity of the drugs as the indicators,we explored the impact of type and proportion of excipients and concentration of ethanol on molding process,to determine the process parameters and select the optimal process.Results:1.the best ethanol extraction process of Salvia miltiorrhiza Bunge:Salvia miltiorrhiza coarse particles added 8 times amount of 85%ethanol to heat reflux 1h,concentration at 60 degrees Celsius.2.The best purification process of salvianolic acid B:macroporous resin HPD-300 packed column,8BV extraction loading at 3BV/h,followed by distilled water of 4 BV,45%ethanol 5BV eluting at a rate of 3BV/h,and the eluent collected and concentrated at 70 degrees Celsius.3.The optimum extraction process of Rhubarb and Radix puerariae:the coarse particles of Radix Puerariae and Rhubarb were added with 12BV 60% ethanol,and the leachate was collected at the infiltration rate of 1ml.min^-1.4.Molding process results:30% dextrin was used as filler,and 95% ethanol as wetting agent.Conclusions:1.In this paper,the extraction process of SH capsule was studied,and a stable and feasible extraction process was established.2.The best molding process was selected by screening the excipients and humectant.