The Study On The Preparation And The Quality Standard Of Compound Danshen Oral Dissolvable Films(ODF)

Objective:Preparation of a Compound Fufang Danshen oral dissolvable films.Study on extraction of Salvia miltiorrhiza、Pseudo-ginseng and Borneol effective components,to prepare a oral dissolvable films（ODF）which can dissolve and absorb in the mouth is prepared with edible polymer materials.All experiment based on modern analytical chemistry theory,through the experiment,to establish the quality control standards and evaluation methods of Compound Danshen OFD,to screen and optimize the prescription and process design of Compound Danshen OFD,and study the stability.Method:In the extraction process,extraction of Salvia miltiorrhiza and pseudo-ginseng in Chinese Pharmacopoeia 2015th was optimizated and the final extraction method was determined.In the preparation process,The ODF film formation time,film appearance,flexibility and thickness,film dissolution time were selected as index,the amount of PVA_17-88,CMC-Na and GL were explored as factor.The best scheme is obtained and verified.In the determination process,the main component of Compound Danshen OFD are Tanshinone II A、salvianolic acid B and saponins,the Tanshinone II A and salvianolic acid B were determinated by external standard method,as the saponins by quantitative analysis of multi-components by single marker（QAMS）.All determination method from High performance liquid chromaography.In TLC identification process,Salvia miltiorrhiza and pseudo-ginseng were identified which from Compound Danshen OFD.In the Stability investigation process,film appearance,the TLC identification,Content of active ingredients were used as index to study the stability and Accelerated test was carried out.Result:Extraction of Compound Danshen OFD can be used to extract Salvia miltiorrhiza and of the main effective components.The optimal formulation of compound Danshen ODF is 15%PVA_17-88,2%CMC-Na,15%GL;The QAMS method of saponins showed a good reproducibility.Content of Tanshinone II A and salvianolic acid B were determinated by RP-HPLC method was accuracy.No significant differences were observed in the quantitative results of saponins between the external standard method and RCFs.Compound Danshen ODF was tested stability experiment for 6 months,The indicators are within the acceptable range.After preliminary study and discussion,the compound Danshen ODF was prepared with good stability and controllable quality.Conclusions:The Compound Danshen ODF showed high quality,Establish the methods of quality control which are simple,accurate and easy to operate,the quality of products can be effectively controlled.This research expand the usage of Compound Danshen,provide the experimental basis and scientific evidence for the development in the field of external preparation of Compound Danshen ODF.