辐照对盐酸利多卡因注射液含量的影响考察

目的:建立测定盐酸利多卡因注射液中盐酸利多卡因含量的方法,并考察盐酸利多卡因注射液吸收不同强度的γ射线辐照后含量的变化。方法:采用高效液相色谱法测定含量。色谱柱为Diamonsil-C18,流动相为1%磷酸缓冲液(三乙胺调pH至3.0)-乙腈=80:20,流速为1.0mL.min-1,检测波长为254nm。将同一批号的盐酸利多卡因注射液置于60Co-γ射线放射源中,一次性吸收1、2、4、8、16、25kGy的辐照剂量后检测药物含量。结果:盐酸利多卡因检测浓度线性范围为80～200μg.mL-1(r=0.9998);低、中、高浓度的平均回收率分别为99.55%、99.13%、99.90%;日间及日内RSD(n=3)均小于2%;当吸收辐照剂量在2kGy以上时样品含量变化较大,2、4、8、16、25kGy辐照后含量分别约为152、149、148、138、121μg.mL-1(基础值160μg.mL-1),辐照强度增加与含量下降呈线性关系(r=0.9862)。结论:所建立的高效液相色谱法可用于盐酸利多卡因注射液的含量测定;辐照对盐酸利多卡因注射液的稳定性具有显著影响。

Influence of Radiation on the Content of Lidocaine Hydrochloride Injection

OBJECTIVE： To develop a method for the content determination of lidocaine hydrochloride in Lidocaine hydrochlo- ride injection, and to investigate the content changes of Lidocaine hydrochloride injection after absorbing γ-ray radiation in different intensity levels. METHODS： HPLC method was adopted. The determination was performed on Diamonsil-C18 column with mobile phase consisted of 1% phosphoric acid buffer solution （pH adjusted to 3.0 by using triethylamine）-acetonitrile （80：20） at the flow rate of 1.0 mL .min-1. The detection wavelength was set at 254 nm. Same batch of Lidocaine hydrochloride injection was put into 60Co-γ ray, absorbing the radiation dose of 1, 2, 4, 8, 16, 25 kGy for once. Then drug concentration was determined. RESULTS： The linear range of lidocaine hydrochloride was 80-200 μg.mL-1 （r=0.999 8） ; average recoveries of the low, medium and high concentrations were 99.55% ,99.13% and 99.90% ; and the RSD of inter-day and intra-day were less than 2% （n=3） ; after absorb- ing dose of more than 2 kGy, the content of sample had great changes. After absorbing dose of 2, 4, 8, 16 and 25 kGy, drug con- centrations were 152, 149, 148, 138 and 121 μg.mL-1 （baseline was 160 μg-mL-~）. Linear relationship was between content de- crease and the radiation intensity increase （r=0.986 2）. CONCLUSION： The developed HPLC method can be used for the content determination of Lidocaine hydrochloride injection; radiation has a significant impact on the content of Lidocaine hydrochloride injection.