Study On The Preparation Process And Quality Standard Of Yangxue Antai Pills

Objective:The traditional Chinese medicine?TCM?formula Yangxue Antai decotion had been an effective experience prescription established and summarized by Keming Yao who was a national famous docter in the mdical clinical practice during a period of long time,composed by 18 herbs.It had been used for the treatment of habitual abortion with excellent therapeutic effet.However,it had been not convenient to take the original decotion for a long time.In order to better meet the long-term needs of patients better,reduce the dosage,and make it more convenient to carry,we will develop the formulation as a concentrated pills.In this paper,its preparation process and quality evaluation standards are systematically studied,also draft quality satandards finally.Methods:?1?Study on preparation process:The process route will be designed accrording to the nature of the pieces in the prescription and the conventional preparation process of the condensate pills;Review the crushing process with the yield of powder collected;In order to determine the optimal extraction process of water decoction for the pellet,L₉?3⁴?orthogonal experiment was investigated on the extraction times,decoction time and the amount of water with paeoniflorin transfer rate and dry extract yield as the examining index.The content of paeoniflorin will be determined by high performance liquid chromatography?HPLC?.The chromatographic conditions:column:Diamonsil C₁₈?4.6mm×250mm,5?m?,mobile phase:acetonitrile-0.1%phosphoric acid?12:88?,flow rate:1mL/min,columntemperature:30?,detection wavelength:230nm.In order to select the best molding process,roundness,dissolution time,bulk density and friability are used as indicators.?2?Study on quality standard:in order to control the final production quality of Yangxue Antai concentrated pills,Thin-layer Chromatography?TLC?was used to qualitatively identify all herb pieces in the finished preparations;The content of calycosin-7-glucoside in Radix Astragali,ferulic acid in Angelica sinensis and paeoniflorin in Radix Paeoniae Alba will be determined by HPLC.The chromatographicconditionsforcalycosin-7-glucoside:column:Diamonsil C₁₈?4.6mm×250mm,5?m?,mobile phase:acetonitrile-0.1%formic acid?14:86?,flow rate:1mL/min,columntemperature:20?,detection wavelength:260nm.The chromatographic conditions for ferulic acid:column:Diamonsil C₁₈?4.6mm×250mm,5?m?,mobile phase:acetonitrile-0.1%formicacid?82:18?,flow rate:1mL/min,columntemperature:230°C,detection wavelength:320nm.The chromatographic conditions for paeoniflorin:the condition was the same with the determination of paeoniflorin transfer rate.?3?Study on preliminary stability:initial stability for the finished product was investigated using an accelerated test?temperature 40°C±2°C,relative humidity 75%±5%?and long-term test?temperature 25°C±2°C,relative humidity 60%±10%?.Results:?1?The pre-selection treatment process is crushing the group pieces and smashing them with a 100-mesh sieve,and the average yield of powder collection is 97.0%,which is suitable for industrial production.The extraction group pieces are soaked for 10 times the amount of water,extracted for 3 times,1.5h each time,the average yield of the dried extract of the extract was 27.35%,and the average transfer rate of paeoniflorin was 94.67%under this process condition.The filtrate was combined and concentrated to a thick paste?relative density 1.30¹.35,80.0°C?at 70°C⁸0°C,then it was mixed with crude drug powder and dried at 50°C,100mesh sieve spare.?2?The best molding process is beginning with 90%ethanol,growing with70%-80%ethanol,covering,drying at 50°C,polishing.?3?When TLC method is used to identify the Astragali Radix,Angelicae Sinensis Radix,Dipsaci Radix,Polygoni Multiflori Caulis,Cuscutae Semen and Amomi Fructus,the results indicated that six identified herbs could show the same color pot with the control herbs or contrast in the same position,so they can be included in the draft quality standard.When TLC method is used to identify the other twelve pieces,the blank control chromatography was spotted or no proper identification method was found,so they should not be included in the draft quality standard.?4?Under the chromatographic conditions,the content of calycosin-7-glucoside and ferulic acid in the finished product was found to be less than one in 10000,so it woud not be suitable to be included in the draft quality standard.Paeoniflorin had good linearity in the range of 0.12?g¹.50?g,the average recovery rate was 97.84%,RSD was 1.96%,and the average content was 1.189mg/g,so it will can be included in the draft quality standard.?5?Long-term tests and accelerated tests had shown that the preparation has good stability.Conclustion:the preferred preparation process was stable,reasonable and feasible,the quality standard control method was simple and reliable,with strong specificity and good reproducibility,and can effectively control the quality of finished preparations.A draft quality standard can be prepared.