Study On Preparation Technology And Quality Standard Of Traditional Prescription Sichong Capsule

Objective: To study the preparation technology,quality standard and preliminary stability of sichong capsule,a traditional prescription for thromboembolic diseases,based on the experience of Professor Shang Dejun,a master of traditional Chinese medicine in the Affiliated Hospital of Shandong University of traditional Chinese medicine,At the same time,it can provide reference for further research and development of sichong capsule.Methods: 1.The extract yield,protein content and antithrombin activity were used as in vitro evaluation indexes,and the coagulation function(prothrombin time(PT),thrombin time(TT)and fibrinogen(FIB)were used as in vivo evaluation indexes in the preparation of acute blood stasis rat model.The in vivo and in vitro indexes were comprehensively scored by the method of total evaluation and normalization,so as to evaluate the coagulation function in raw powder,water extraction,alcohol extraction and homogenate Finally,box Behnken response surface methodology was used to optimize the parameters of the optimal extraction process.2.With anticoagulant activity,protein content and wall hanging as evaluation indexes,the optimal concentration and drying process was determined.3.Taking angle of repose,hygroscopic rate and molding rate as evaluation indexes,the types of excipients,the proportion of excipients and mixed powder,the concentration and dosage of wetting agent were studied to optimize the molding process.4.TLC was used to identify the flavor of the finished granules;Scorpion venom protein in scorpion and uracil in tuyuan were selected as index components,and their contents were determined by UV spectrophotometry and HPLC respectively,The quality standard draft of sichong capsule was established and its stability was investigated.Result: 1.Extraction process: the results in vivo and in vitro showed that the homogenization method was superior to the other four extraction processes;the best extraction process parameters of homogenization were adding 6 times phosphate buffer(PBS),extracting for 30 min each time,and the concentration of Na Cl was 0.5%.2.Concentration and drying process: reduce the pressure until the ratio of medicinal materials to paste is 1:1,the drying temperature is 50 ℃,and the vacuum pressure is 0.09 MPa.3.Molding process: dextrin was selected as the excipient,the ratio of excipient and mixed powder was 4:5,95% ethanol was used as wetting agent,the dosage was 20% of the auxiliary dosage,soft material was made,24 mesh sieve was used to granulation,dry,whole,and finally filled the capsule.4.4.TLC identification: the scorpion and centipede in Sizhong capsule were identified by TLC.The results showed that they showed the same color spots on the corresponding position with their reference substance,and negative without interference;Content determination: the content of scorpion protein in sichong capsule was determined by UV spectrophotometry at 260 nm and 280 nm;HPLC was used to determine uracil,a nucleoside component.Chromatographic conditions:The filler is octadecylsilane bonded silica gel,The mobile phase was methanol water(1:99),the flow rate was 1 ml / min,the column temperature was 30 ℃,the detection wavelength was 254 nm,injection volume: 10 μ L.according to the protein content of main components and HPLC content determination results,the content of scorpion venom protein and uracil in the formula should not be less than 27.8mg / g and 2mg / g respectively.The quality of the preparation is stable.Conclusion: 1.Through the screening of experimental conditions,the optimal preparation process of sichong capsule was established.2.Established TLC identification and content determination method of effective components in sichong capsule.3.The quality standard draft of sichong capsule was formulated.