辐照对尼可刹米注射液含量的影响

目的：建立测定尼可刹米注射液中主药含量的方法，并考察其吸收不同强度的γ射线辐照后含量的变化。方法：采用高效液相色谱法。色谱柱为Diamonsil Technology C18柱，流动相为甲醇-水（50：50，V/V），流速为1ml／min，检测波长为263nm，柱温为30℃．进样量为20μl。将同一批号的尼可刹米注射液放置于^60Co-γ射线放射源中，一次性吸收2、4、8、16、26、34kGy的辐照剂量后检测药物含量，并与辐照前比较。结果：尼可刹米检测质量浓度在12-36μg／ml范围内与峰面积积分值呈良好的线性关系（r=0.9998）；日间（n=5）及日内精密度（n=3）均小于2％；低、中、高质量浓度的平均加样回收率分别为100．64％、98．69％、101．15％。辐照8、16、26、34kGy时其含主药的量显著低于辐照前，与辐照前比较差异有统计学意义（P〈0．05）。结论：该方法可用于尼可刹米注射液中主药的含量测定；辐照对尼可刹米注射液的含量及稳定性有一定影响。

Effects of Irradiation on the Content of Nikethamide Injection

OBJECTIVE： To develop a method for the content determination of nikethamide in Nikethamide injection, and to study the changes of Nikethamide injection after 3,-ray irradiation in different intensity levels. METHODS： HPLC method was adopted. The determination was performed on Diamonsil Technology C18 with mobile phase consisted of methanol-water （50：50, V/V） at the flow rate of 1 ml/min. The detection wavelength was set at 263 nm, and the column temperature was 30 ℃. The injection volume was 20 μl. The same batch of Nikethamide injection put in the ^60Co-γ, ray with radiation dose of 2, 4, 8, 16, 26, 34 kGy by one-time, compared with before radiation. RESULTS： The linear range of nikethamide was 12-36 μg/ml （r= 0.999 8）; RSD of intra-day （n=5） and inter-day （n=3） were lower than 2%. The average recoveries of low, medium and high concentrations were 100.64%, 98.69% and 101.15%, respectively. The amounts of main components after 8, 16, 26 and 34 kGy irradiation were significantly lower than before; there was statistical significance （P〈0.05）. CONCLUSIONS： The develop method can be used for the content determination of nikethamide in Nikethamide injection; and the irradiation has impact on the stability of Nikethamide injection to some extent.