摘要
目的:考察3个不同厂家的银杏叶提取物注射液与两种溶媒(0.9%氯化钠注射液和5%葡萄糖注射液)配伍后不同时间和不同条件(常温、高温和光照)下的稳定性。方法:银杏叶提取物注射液与2种溶媒配伍后,分为常温组、高温组及光照组,考察各组成品输液的外观、不溶性微粒、pH及水解后黄酮类化合物含量变化,其中外观、不溶性微粒按中国药典2015年版四部通则项下特性检查法进行检测,黄酮类化合物含量采用HPLC-UV法测定。结果:各成品输液24 h内无明显浑浊和沉淀,色泽无明显变化,为黄色澄清液,pH和微粒值无明显变化;5%葡萄糖注射液的成品输液pH较0.9%氯化钠注射液偏低,但均符合成品输液的pH要求;各成品输液中的槲皮素、异鼠李素于24 h内含量基本保持不变,神威药业的山奈酚含量较其他两个厂家偏高,但均在标准范围内。结论:3个不同厂家的成品输液在不同条件下的含量均较稳定。
Objective： To determine and investigate the stability of ginkgo biloba extract injection from three different manufacturers respectively in 0. 9% NaCl infusion and 5% glucose infusion under different conditions（ room temperature,high temperature and light）. Methods： Ginkgo biloba extract injection was mixed with the two kinds of infusions,and then divided into the normal temperature group,the high temperature group and the light group. The appearance,insoluble particles,p H and content of flavonoids after the relevant treatment were investigated. The appearance and insoluble particles were tested according to the characteristics of the inspection method described in Chinese Pharmacopoeia（ 2015 edition,volume IV,the general rule）,and the content of flavonoids was detected by HPLC-UV. Results： All the mixed solutions were yellow. No significant changes were found in the appearance,p H value,insoluble particles and contents of quercetin and isorhamnetin in all the mixed solutions in 24 h. The pH value of the mixed solution with 5% glucose infusion was lower than that with 0. 9% NaCl infusion,and all the pH values met the standard in Chinese Pharmacopeias.The kaemphenol content in the injection from Shenwei pharmaceutical company was higher than that from the other manufacturers,while the content of kaemphenol in all the injections was within the standard range. Conclusion： The quality of Ginkgo biloba extract injection from the three different manufacturers is stable under different conditions.
出处
《中国药师》
CAS
2018年第3期504-508,共5页
China Pharmacist
基金
2014年政府资助省级临床医学优秀人才项目
