摘要
目的:以三七总皂苷白蛋白微球注射液(PNS-BSA-MS-inj)为研究对象,考察其稳定性。方法:通过影响因素试验(高温、冷藏、冷冻试验)和加速稳定性试验对PNS-BSA-MS-inj的稳定性进行研究,考察PNS-BSA-MS-inj的外观性状、pH值、树脂、有关物质、可见异物、微球形态、三七总皂苷含量等检测项的变化。结果:PNS-BSA-MS-inj在冷藏条件下的稳定性良好,但在高温条件下性状及含量变化较大,冷冻条件下微球有所粘结;在6个月的加速稳定性试验过程中,PNS-BSA-MS-inj中主要有效成分三七皂苷R1在试验期间含量变化相对稳定,但人参皂苷Rg1和人参皂苷Rb1含量整体呈减小趋势,而pH值、微球形态、可见异物及有关物质等考察指标与0月相比均无明显变化。1个月内注射剂基本都是混悬状态或者不需要很用力震摇就能恢复混悬状态,但1个月以后微球粘附在安瓿瓶壁上很严重,且时间越长需越用力震摇才能让其恢复稳定状态。结论:PNS-BSA-MS-inj在高温及冷冻条件下的稳定性较差,低温冷藏条件下的稳定性较好,且PNS-BSA-MS-inj不适合常温长时间存放,故建议将PNS-BSA-MS-inj保存在低温条件下,且不要长时间放置。
The stability of panax notoginseng saponin albumin microsphere injection(PNS-BSA-MS-inj)was investigated.The influencing factors test(high temperature,cold storage and freezing)and accelerated stability test were adopted to investigate the external properties,pH value,resin,related substances,visible particles,microsphere morphology,and panax notoginseng saponin content of PNS-BSA-MS-inj.The results showed that the stability of PNS-BSA-MS-inj was good under cold storage conditions,while its properties and content changed greatly under high temperature conditions,and the microspheres were bound together under freezing conditions.During the 6-month accelerated stability test,the content of the main active ingredient in PNS-BSA-MS-inj,notoginsenoside R1,was relatively stable,while the content of ginsenoside Rg1 and ginsenoside Rb1 decreased;the pH value,microsphere morphology,visible particles and related substances showed no significant change.Within 1 month,the injection was basically in suspended state or could be restored to suspended state without shaking very hard;after 1 month,the microspheres seriously adhered to the wall of the ampoule,and needed hard shaking to restore to suspended state.In conclusion,PNS-BSA-MS-inj has poor stability under high temperature and freezing conditions,while its stability is good under cold storage conditions.Meanwhile,PNS-BSA-MS-inj is not suitable for long-term storage at room temperature.Therefore,it is recommended that PNS-BSA-MS-inj be stored under low temperature conditions,and not for a long time.
作者
杨姗
陈汝玲
吴静澜
代政敏
YANG Shan;CHEN Ruling;WU Jinglan;DAI Zhengmin(Guizhou University of Traditional Chinese Medicine,Guiyang 550025,China)
出处
《贵州科学》
2021年第2期9-13,共5页
Guizhou Science
基金
贵州科技合作计划项目(黔科合LH〔2015〕7280号)
贵州省普通高等学校中药民族药(苗药)新剂型新制剂工程研究中心(No.黔教合KY字〔2014〕22号)
贵州省国内一流建设学科项目(GNYL〔2017〕008号)
贵州省一流专业(中药学)建设项目(黔高教发〔2017〕158号)。
关键词
白蛋白微球
三七总皂苷
注射液
稳定性
albumin microsphere,panax notoginseng saponin,injection
stability
