Stability of salvianolic acid B in Danshen freeze-dried product injection / 中成药

ABSTRACT

AIM:The different factors on stability of salvianolic acid B in Danshen freeze-dried powder injection was investigated to provide the experimental data for clinical application and storage of the preparation. METHODS: The stability of salvianolic acid B for lamplight,temperature,sodium chloride injection and glucose injection in Danshen freeze-dried powder injection were studied and the content of salvianolic acid B was determined by HPLC. RESULTS: The content of salvianolic acid B in Danshen freeze-dried powder injection didn't almost change under the condition of lamplight(3000lx) in 60 d.Its expiry date estimated by Q_(10) method was(2.39) a.The preparation was matched respectively with(0.9%) sodium chloride injection and 5% glucose injection,the content of salvianolic acid B was invariable and insoluble particles were qualified under the condition of 25 and 37 ℃ in 24 h. CONCLUSION: Danshen freeze-dried powder injection is stable for lamplight and clinical injection and the expiry data of the preparation is(2.39) a.