盐酸多柔比星脂质体注射液与葡萄糖和氯化钠注射液的配伍稳定性研究

Disquisition on Stability of Mixture of Doxorubicin Hydrochloride Liposome Injection and Sodium Chloride Injection or Glucose Injection

关键词:  盐酸多柔比星脂质体注射液  葡萄糖注射液  氯化钠注射液  配伍稳定性  粒径  高效液相色谱法  含量  包封率

Key words:  Doxorubicin Hydrochloride Liposome Injection  Sodium Chloride Injection  Glucose Injection  compatibility stability  particle diameter  HPLC  content  encapsulation efficiency

摘要:

目的 研究盐酸多柔比星脂质体注射液与5%葡萄糖注射液和0.9%氯化钠注射液的配伍稳定性。方法 盐酸多柔比星脂质体注射液分别与5%葡萄糖注射液和0.9%氯化钠注射液配伍后，考察配伍溶液的外观、pH值、脂质体的粒径、含量和包封率，采用HPLC测定含量，色谱柱为Lichrospher C₁₈柱(250 mm×4.6 mm，5 μm)，以含0.01 mol·L^-1十二烷基硫酸钠的0.02 mol·L^-1磷酸溶液-乙腈-甲醇(500∶500∶60)为流动相，流速1.0 mL·min^-1，柱温30 ℃，检测波长254 nm，进样量20 μL；离子树脂交换法测定包封率。结果 盐酸多柔比星脂质体注射液与0.9%氯化钠注射液配伍后，6 h内溶液的外观、pH值、脂质体的粒径和含量均无变化，包封率下降约5%；与5%葡萄糖注射液配伍后，6 h内溶液外观、pH值、脂质体的粒径、含量和包封率均无变化。结论 临床中盐酸多柔比星脂质体注射液不宜与0.9%氯化钠注射液配伍，宜与5%葡萄糖注射液配伍。

Abstract:

OBJECTIVE To discuss the compatibility stability of Doxorubicin Hydrochloride Liposome Injection with Sodium Chloride Injection or Glucose Injection. METHODS After Doxorubicin Hydrochloride Liposome Injection mixed with Sodium Chloride Injection or Glucose Injection, the appearance, pH, particle diameter, content and encapsulation efficiency of the mixture was studied. A HPLC method with Lichrospher C₁₈(250 mm×4.6 mm, 5 μm) was applied to determine the concentration of doxorubicin hydrochloride and the mobile phase was 0.02 mol·L^-1 phosphoric acid solution (0.01 mol·L^-1 sodium dodecyl sulfate)-acetonitrile-methanol(500∶500∶60) at the flow rate of 1.0 mL·min^-1. The column temperature was 30 ℃ and the detective wavelength was 254 nm. Ion-exchange resin method was used to determine the encapsulation efficiency. RESULTS In 6 hours, there was no obvious change in the appearance, pH, particle diameter and content in the mixture of Sodium Chloride Injection. But the encapsulation efficiency decreased 5%. However, there was no obvious change in the mixture of Glucose Injection. CONCLUSION The mixture of Doxorubicin Hydrochloride Liposome Injection and Sodium Chloride Injection was unstability. Doxorubicin Hydrochloride Liposome Injection is compatible with Glucose Injection in clinic.