Process Design And Quality Control Of Danjin Shugan Granules

Objective: The traditional DanJin Shugan decoction was developed into granules,which were convenient for patients to take and carry.The quality control of the granules was also studied,and the preliminary stability tests of the three batches of granules were made.Provide experimental data for follow-up research and industrial production.Method: The Salvia miltiorrhiza was first extracted using alcohol,and then the residue of Salvia miltiorrhiza was extracted with the other medicinal materials in the prescription.The single factor was first investigated in the two process,and the orthogonal test was used to determine the optimal process.After preparing extracts,sugar,lactose,mannitol,dextrin and starch of five kinds of materials were tested to optimize the forming process.The ingredients of the granules were qualitatively tested by TLC method,and the content of tanshinone II A and salvianolic acid B in the two main components of Salvia miltiorrhiza in the granules was determined by HPLC method.Results:The extraction process and granulation process of DanJin Shugan granules were determined,and TLC qualitative method and HPLC quantitative method were established.The stability test showed that DanJin Shugan granules were stable.Conclusion: The traditional DanJin Shugan decoction can be improved into the DanJin Shugan granules which have the adventages such as convenient for patients to use,easy to storage and quality assurance.The quality study on DanJin Shugan granules can control the quality of the granules effectively.