The Study And Preparation Of Qilisan 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 Qili San 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 Qilisan Soft Capsules with more safty, healing efficacy, controllability and high technology. Methods: The formula of Qili Pulvis was mainly made up of resinoid,mineral, and expensive medical materials and so on. The ultrafine vibration technique with wet processing could not only increase the traditional Chinese medicinal materials'surface area and cell breaking rate, but also accelerate active ingredients'releasing and dissolving out process.Consequently, the BA was improved remarkably and dramatically. 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. Appropriate identification of five Herbs were made by TLC. Dracorhodin and Mercuric Sulfide were measured respectively by HPLC and titrimetric method, and 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 Pharmacodynatics and Toxicology. Results: Through detailed and complete researches,the optimized ultrafine vibration process was:by 1.4 times of PEG 400 including 10% propylene glycol, vibrating frequently 35 minutes below 40℃,and continuing to pulverize 5 minutes with cinnabar. The thickness of soft capsule was 0.6mm,the rate of gel, glycerine and water was 1∶0.4∶1, and the best indexes of drying process was drying 15h below the temperature of 40℃.The method of TLC and HPLC were reasonable and controllable, the content range of Dracorhodin and Mercuric Sulfide were respectively 12.72～15.55mg per pill and no less than 1.4mg per pill. The pharmacodynamics experiment indicated that compared with Qili San, the new preparation had significant effect under 1/2 drug dose, and the toxicological test showed that it was safe with long term usage. Conclusion: Qilisan 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.