Research on Tongfeng Granules Preparation Technology and its Physical Fingerprint Map Establishment
Objective:To optimize the molding process of Tongfeng Granules and establish its physical fingerprint.Methods:On the basis of single-factor test,the ratio of thick paste and excipients,the ratio of soluble starch and micro-crystalline cellulose(MCC),the ratio of thick paste and colloidal silica,the comprehensive score of molding rate,resting Angle,hygroscopic rate and soft material properties are taken as the evaluation index,and the best molding process is selected by the response surface method.Physical fingerprint mapping was used to comprehensively characterize the physical properties of uniformity,fluidity and stability of Tongfeng Granules to evaluate the quality consistency of dif-ferent batches of particles.Results:The optimal molding process is that the ratio of thick paste and excipients is 1∶0.99,the ratio of soluble starch to microcrystalline cellulose(MCC)is 7∶2,the ratio of thick paste to colloidal sili-ca is 1∶0.09,and the similarity of physical fingerprint of 12 batches of particles is higher than 0.9.Conclusion:The process is stable and feasible,and the particles produced are stable,which meets the actual large production require-ments of Tongfeng Granules.
万方数据
维普
