The Study And Preparation Of Huoxue Tongmai Soft Capsules

Subjective:By the innovative technique of ultrafine vibration with wet processing, the purpose of the research is to develop the traditional and classic formula of Huoxue tongmai repeatedly.Improve its original preparing process, change the backword dosage form and establish the perfect quality control system aiming at raising its bioavailability in the last degree, so we can get the morden chinese materia medica preparation named Huoxue tongmai Soft Capsules with more safty, healing efficacy,controllability and high technology. Methods:Using materials particle size(D50,D90) and stability which could denote the vibration effect completely as main indicators, the pulverization progress was studied by orthogonal test and single factor method. In this way, the effects of such conditions as pulverizing time,optimal mediator and so were investigated. The preparation process of soft capsules was carried out in Weihai Tsinghua Ziguang Science and Technology Developing Co. Ltd. Antithrombin activity was measured respectively by enzyme-titration ainsize analyzer and peptide was measured by Lowry.measured materials'particle size with the laser grainsize analyzer.Established reasonable and complete quality control system. Studied preparation's stability. Evaluated the new preparation by indexs of preliminary pharmacodynatics. Results:Through detailed and vibration process was:by 3.8 times of PEG400 including 8% propylene glycol, vibrating frequently 50 minutes below 40℃. The capsule skin rate of gel, glycerine and water was 0.4:1:0.9,also include 8% PEG400 which including 8% propylene glycol. and the best indexes of drying process was drying 15h below the temperature of 40℃.The antithrombin activity should not less than 0.8U per grain, The peptide measured by Lowrythe shoule not less than 3.7mg per grain; The particle size of D50 should less than 15 micron, D90 less than 50 micron.The pharmacodynamics experiment indicated that compared with Hxue tongmai, the new preparation had significant effect under 1/2 drug dose. Conclusion:Huoxue tongmai Soft Capsules has ideal curative effect in comparison with the original preparation. The established quality control system is stable, reasonable and controllable.This study is up to the standards for TCM Modernization and it should have a good future.