Study On The Compatible Stability Of Ethamsylate Injection And Tween 80

Ethamsylate is a common hemostat. When blood vessels are damaged, in common it is used to prevent and cure hemorrhage caused by operation, platelet dysfunction, and increased fragility of blood vessels. In many times, it is used with other different hemostats of different mechanisms. For example, aminomethylbenzoic acid, ethamsylate and vitamin K, which are the most frequently used combination. Some people guess that ethamsylate can't be used with vitamin K. because vitamin K contains Tween 80, which can set off a chemical reaction.So far, this guess isn't conformed in home and abroad. This research adopts HPLC (High-performance liquid chromatography) for the determination of ethamsylate content to study the stability of ethamsylate injection and Tween 80 at different conditions. The result provides theoretical basis for practical applications.Objective:To study the compatible stability of ethamsylate injection and Tween 80 in different conditions (0-6h).Methods: This experiment was divided into three parts:the stability studies of ethamsylate injection; the compatible stability of ethamsylate injection and Tween80 in different conditions; the compatible stability of ethamsylate injection and vitamin K in different condition.The stability studies of ethamsylate injection:according to the solubility of ethamsylate. chose water as solvent. The maximum absorption wavelength was 301nm after scanning the ultraviolet absorption wavelength, so chose 301 nm as external analysis wavelength. The optimized color spectrum of conditions:A steady bonded silica gel column. Mobile phase:phosphoric acid solution-methanol (90:10). How rate:0.05 mol·L-1. The basis of experiments is mainly choose time(0h,2h.4h,6h). temperature(4℃.20 "C and 37℃)as effect factors,The index items:its appearance, pH value and content of ethamsylate.The study of the compatible stability of ethamsylate and Tween80 was established. First, took the clinical dosage of ethamsylate with different amount Tween80 diluted by deionized distilled water, At different time (0h,2h.4h,6h) and different temperature(4℃.20℃and 37℃) observed the sample appearance characters, the pH value and the content of ethamsylate.This last procedure was to study the compatible stability of ethamsylate and vitamin K:took the clinical dosage of ethamsylate with different amount vitamin K, diluted by deionized distilled water. At different time (0h,2h,4h,6h) and different temperature (4℃.20℃and 37℃) observe the sample appearance characters, the pH value and the content of ethamsylate.Results:A HPLC method for the content of ethamsylate in vitro was established. The result showed that the method was highly specific. The linear regression equation was C-2×10-5 A+0.1419 (r=0.9999). The linear rang is 20-120μg·mL-1.the lower limit of quantitation is 20μg·mL-1,The precision test results of intra-day and inier-day showed RSD below 2%.The average recover was 99.87%, Detection of the recover showed RSD below 2%. For this analysis method was accurate and reliable, high accuracy, reproducibility, specificity, superior and practicability with facilitate promotion. The study of the compatible stability of ethamsylate and Tween80 showed that at different time and different temperature observed the sample appearance characters, the pH value and the content of ethamsylate, were not significantly change. The change range of RSI) of the content below 5%.The results showed that under these conditions of experiment the compatible stability of ethamsylate and Tween80 was good.The study of the compatible stability of ethamsylate and vitamin K, showed that at different time and different temperature observed the sample appearance characters, the pH value and the content of ethamsylate, were not significantly change. The change range of RSD of the content below 5%.The results showed that under these conditions of experiment the compatible stability of ethamsylate and Tween80 was good.Conclusion:The compatible stability of Ethamsylate and Tween 80, or vitamin K, in 6 hours was good, because the appearance, pH value, content, were not significantly changed.