Objective:The best drug load and process parameters of Taohong Siwu Tang granules are investigated.Methods:Firstly,the properties of the dry paste powder are investigated to determine the feasibility of the preparation of granules.Lactose,microcrystalline cellulose,corn starch,dextrin and maltodextrin are mixed with dry paste powder respectively,and the types and content of excipients are screened by granulation condition,primary molding rate,particle character,solubility,etc.Results:The dry paste powder is used for direct granulation,and the prepared particles are generally compressible,with good fluidity and hygroscopicity,which can be used for dry granulation.The preferred excipient is maltodextrin,the drug loading is in the range of 50%to 90%,the prepared particles are uniform in size and good fluidity;the critical relative humidity of the particles is 66%to 72%,and the relative humidity of the environment should be controlled below 65%in actual production.The results of the three batches of process validation showed that the particle yield is higher by the preferred granulation method.Conclusion:The preferred preparation process of Taohong Siwu Tang granules are stable and reliable,and can be used in the subsequent industrial production of peach soup particles.
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