正交实验法优选注射用单磷酸阿糖腺苷的配伍条件

Optimize the Compatibility Condition of Vidarabine Monophosphate for lnjection by Orthogonal Test

关键词:  注射用单磷酸阿糖腺苷  配伍条件  配伍稳定性

Key words:  Vidarabine Monophosphate for Injection  compatibility conditions  compatible stability

摘要:

目的 考察多因素对注射用单磷酸阿糖腺苷与不同溶媒配伍后稳定性的影响。方法 选择温度、光照、放置时间、溶媒、溶媒用量5个影响因素，采用L₁₈(3⁵)正交试验表，以单磷酸阿糖腺苷含量、配伍液的pH值变化及不溶性微粒数为检测指标，采用高效液相色谱法测定配伍液中单磷酸阿糖腺苷的含量，pHs-2C型精密酸度计测定配伍前后pH值的变化，GWJ-4型智能微粒检测仪测定溶液中微粒数。结果 配伍液的外观、性状在考察时间内均无明显变化。温度、放置时间对配伍液中单磷酸阿糖腺苷的含量有显著性影响；光照对溶液中微粒的含量有显著性影响；溶媒及溶媒用量对所有考察指标均无显著性影响。结论 注射用单磷酸阿糖腺苷合理配伍条件为25 ℃、白炽灯光照下与100 mL 0.9%氯化钠注射配伍放置4 h。

Abstract:

OBJECTIVE To investigate multiple factors on the compatibility stability of Vidarabine Monophosphate for Injection mixed with different solvents. METHODS L₁₈(3⁵) of orthogonal design was used with five factors: temperature, illumination, storage time, solvent and amount of solvent. With the content of vidarabine monophosphate, pH value changes of the compatibility solution and the insoluble particles as indexes, the content of vidarabine monophosphate in the mixture was determined by HPLC, the change of pH value before and after compatibility determined by pHs-2C type precision acidity meter, the insoluble particles were observed by GWJ-4 type particle analyzer. RESULTS There were no significant changes in appearance and character of the mixture in the inspection time. The temperature and time showed significant effects on the contents of vidarabine monophosphate in the mixture, and illumination could influence the number of insoluble particles. The solvent and amount of solvent had no significant influence on all indexes. CONCLUSION The optimal compatibility conditions as follows: temperature of 25 ℃, under the incandescent lights, compatibility time of 4 h, and 100 mL 0.9% sodium chloride injections as the solvent.