Quality Control Of Longjiatongluo Capsule Based On QbD

The LongjiaTongluo Capsule is a processed traditional Chinese medicine(TCM) which contains Acanthopanax senticosus and Dioscorea nipponica Makino. It helps promote blood circulation and free the network vessels. This research established a novel method to control the preparations` quality. A HPLC-MS method was used for qualitative analysis. A multi-component assay method based on the concept of Quality by Design(QbD) was studied for monitoring the transition of various effective components, which can realize the Total Quality Control(TQC) through the whole manufacturing process. The main work in this dissertation was focused on the following aspects.This thesis measured the content of Dioscin in LongjiaTongluo Capsule with HPLC-ELSD method. Experimental results showed that the linear range of Dioscin was 60~320?g/mL(r=0.9994), the average recovery was 100.0%(RSD=1.40%, n=9).This thesis established the qualitative analysis method of HPLC-MS. 18 peaks were identified on the basis of MS2 data and some interrelated literature, and 7 of them have not been found in any references before.This thesis built multi-component assay method based on the concept of QbD. Drylab software was used to validate the robustness of the HPLC method while two variable parameters were changed at the same time. Then, the critical parameters were found by Plackett—Burman design, and the operating space was established by model fitting and dynamic factor profiling figure. At last, according to the operating space and control space provided by pharmacopoeia, a quality control strategy was set up.This thesis measured the six active ingredients of Dioscin, Protogracellin, Protodioscin, Chlorogenic acid, Isofraxidin and Syringin, with HPLC-DAD/ELSD method. Experimental results showed that the linearities of six compounds were good and the average recoveries were 99.7~100.6%( RSD =0.94% ~1.35%). Finally, we got a robust, rapid and accurate HPLC method to control the multiple compounds, which improved the quality standard of this preparation.