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目的:考察几种从动物脏器中提取制备的注射剂与输液配伍稳定性。方法:按《中国药典》2005年版不溶性微粒检查显微计数法测定不溶性微粒,用细菌内毒素检查法凝胶限量实验测定细菌内毒素,用分光光度法测定配伍前后吸收光谱变化;用酸度计测定pH变化。结果:各注射剂与0.9%氯化钠注射液和5%葡萄糖注射液配伍后,不溶性微粒略有增加,未发现提取成分的特别析出物,鹿瓜多肽、胸腺肽、脑蛋白水解物与5%葡萄糖注射液配伍24 h后Amax下降2%~6%,本类注射剂若被污染极易细菌繁殖、细菌内毒素大量增加。结论:各注射剂与输液配伍后较为稳定,使用时注意消毒和无菌操作。
OBJECTIVE: To investigate the stability of several injection and infusion solutions prepared from animal organs. Methods: Insoluble microparticles were determined according to the Chinese Pharmacopoeia (2005). The bacterial endotoxin was determined by bacterial endotoxin test. The changes of absorption spectra before and after compatibility were determined by spectrophotometry. pH change. Results: The results showed that the insoluble particulates increased slightly after injection of 0.9% sodium chloride injection and 5% dextrose injection. No special extract of extracted components, deer melon peptide, thymosin, brain protein hydrolyzate and 5% glucose Amax decreased by 2% ~ 6% 24 h after injection compatibility. If this kind of injection is easily contaminated by bacteria, bacterial endotoxin will increase greatly. Conclusion: All injection and infusion compatibility is more stable, the use of attention to disinfection and aseptic operation.