Study on Quality Control of Silybin Powder for Injection

To identify different quality control of Silybin powder for injection, some indexes such as loss on drying, insoluble particle, ignition dregs, content determining were analyzed.The results indicated that regression curve of Silybin powder for injection was Y = 47741X + 531.19, r = 0.999 9. Precision: average peak area was 11182.42, RSD was 0.4796% (n = 6) ; Stability: RSD was 1.030 9%, which indicated its good stability in 14 hours. The average recovery rate was 99.84%, RSD was 0.5935%. Sample content determination: Content of all samples was as much as 95%-105% of claimed values. The average sample content was 40.7499 mg/bottle. All indexes fit in with pharmacopoeia, which indicate the quality of this Silybin powder for injection can be efficiently controlled.