Study On The Preparation Process And Quality Standards Of Tongbian Capsules

ObjectiveIn recent years,with a gradual increasing of diabetic constipation patients in clinical and the complex of pathogenesis,TCM believes that it is one of the representations of the imbalance of yin and yang of vital energy.At present the market has Laxative health food,but the formula and the specificity for crowd are varied.The recipe consists of the Cassis leaf,Bitter almonds,Panax quinquefolius,with the function of Laxative.It will be a better effect for diabetic constipation patients.In this paper,the extraction technology and molding process are optimized according to the related technology of modern preparation,and the quality standard is studied.MethodsThis study is based on the extraction technology,the forming process and the quality standard of tongbian capsules.1 Extraction process:access to pharmacopoeia and related literature,to determine the three indicative and pharmacological active ingredients in the extraction of solvent and methods.Cassis leaf is after the other drug,It was designed four factors(ethanol concentration,ethanol times,extraction time and extraction times)and three levels of orthogonal test based on the single factor experiment,The optimum process was determined by the content of pharmacological active ingredient sennoside A,B.Bitter almonds was designed three factors(the amount of water,extraction time and extraction times)and three levels of orthogonal test,The optimum process was determined by the content of amygdalin and the yield of dry cream.Panax quinquefolius is for the other drug,the optimal process was determined for Ginseng total saponins based on four factors(ethanol concentration,ethanol times,extraction time and extraction times)three levels of orthogonal test.2 molding process:According to the moisture absorption,mobility of powder and the degree of difficulty in granulatio to determine accessories type,it studied angle of repose and critical relative humidity for semi-finished particles.3 quality standards:In order to ensure the stability of the preparation to facilitate the control of the quality of the preparation,the subject from the qualitative and quantitative aspects of the initial development of its quality standards.The qualitative identification of Cassis leaf,bitter almond and Panax quinquefolius was carried out by thin layer chromatography;The content of sennoside A,B in the capsules were determined by HPLC.Results1 Extraction process results:Cassis leaf Best Alcohol Process:Ei times Gi ethanol concentration,extracted Fi times,each Ti.Concentrated to a relative density of about 1.15,placed at 50℃,-0.10MPa oven drying;Bitter almond the best water extraction process:E2 times the water extraction T2;Panax quinquefolius best alcohol extraction process:E3 times G2 ethanol,extraction times F2 times,each time T3.2 forming process results:powder and auxiliary dextrin by J mixed evenly to K ethanol as wetting agent,the relative humidity controlled below L,N mesh sieve wet granulation,H dry particles T4,P mesh sieve granules,filling capsules,packaging that finished capsules.3 Quality standards:The method for qualitative identification of senescence of Cassis leaf,Bitter almond and Panax quinquefolius was established.A method for the determination of sennoside A and sennoside B in Tongtong capsule was established by high performance liquid chromatography(HPLC).The measurement conditions were:Waters Sunfire Cis(250 mm ×4.6 mm,5 μm)Column:The acetonitrile(A)-0.1%phosphoric acid(B)was used as the mobile phase,The elution conditions were:0 to 50min,(A)20%;50 to 51min,(A)20%to 95%,;52 to 62min,(A)95%;62 to 63min,(A)95%;64 to 74 min,(A)20%.Flow rate of 1.0mL/min,column temperature of 30℃,detection wavelength of 271nm.Sennoside A,sennoside B content of Tongbian capsule not less than 1.575mg each grain.ConclusionThe optimal extraction technology of Tongbian Capsule was established and the quality standard was established.The method was reasonable and feasible,stable and reliable,and could effectively control the quality of the preparation,which laid the foundation for the development of health food.