不同温度下注射用丹参稳定性的紫外光谱相似度考察

Study on UV Spectrum of the Stability of Danshen for Injection under Different Temperatures

目的:考察注射用丹参在不同温度下7h内的稳定性。方法:模拟临床用药方法,分别在5、10、20、30、40℃下用0.9%氯化钠溶液配制浓度为0.8mg·mL-1的注射用丹参溶液,分别标记为A、B、C、D、E,测定配伍后7h内配伍液的紫外光谱(UV)吸收值;以层次分析法设定不同波长段的权重系数,根据UV吸收值计算UV相似度及紫外吸收差异值,并就其平均值用单变量双因素方差分析法比较差异。结果:7h内的平均相对和绝对UV相似度按大小排列依次均为C>D>E>B>A;方差分析结果显示温度对相对UV相似度无显著影响(P>0.05),但对绝对UV相似度影响非常显著(P<0.01)。低温时(≤10℃)配伍液的UV相似度在配伍之初即发生较大变化;而温度>30℃时,药物配伍之初并不是UV相似度发生最大变化的时间。结论:温度对注射用丹参配伍液的稳定性有一定影响,20℃时稳定性最好,温度偏低(≤10℃)可能较温度偏高(≥30℃)对注射用丹参的稳定性影响更大。当外界温度低于10℃时,建议临床谨慎使用注射用丹参。

OBJECTWE： To study the stability of Danshen for injection under different temperatures within 7 hours. METHODS： Simulating the clinical application, Danshen for injection was mixed with 0.9% Nacl to confected into 0.8 mg· mL^-1 compatible solution under five temperatures of 5 ℃, 10 ℃ ,20 ℃ ,30℃ and 40℃, which were coded of A,B,C,D,E respectively. The UV absorbance of the five solution were determined in 7 h. Weight coefficient was set by Analytical Hierarchy Process （AHP）. The UV similarity and ＇the value of different wavelength were calculated by UV absorbance. The average value of UV similarity were analyzed by Univarity ANOVA. RESULTS： Both of the descending order of average relative and absolute UV similarity were C, D, E, B,A. The temperature had no significant effect on relative UV similarity of the five solutions （P〉0.05）, but on absolute UV similarity the effect was very significant（P〈0.01）. The UV similarity of compatible solution had great changes in the first time under a low temperature（ ≤10 ℃）, but when the temperature was higher than 30 ℃, the great changes didn＇t happened at the counterpart time. CONCLUSION： Temperature can affect the stability of Danshen for injection compatible solution. It is the most stable when the temperature is 20℃. Low temperature （≤10℃ ） may more greatly effect on the stability of Danshen for injection than relative high temperature（≥30 ℃ ）. It is suggested that when the temperature is lower than 10℃, DanShen for injection should be used carefully.