摘要
通过添加稳定剂聚乙烯醇(Polyvinyl alcohol,PVA),有效解决银黄注射液的稳定性问题。通过影响因素试验和加速试验对银黄注射液的性状、pH、鉴别及含量进行稳定性考察。结果表明:在高温(60℃)、低温(4℃)和强光照射(4500±500 lx)的影响因素试验和6个月的加速试验(温度40±2℃、湿度75%±5%)条件下,按药典标准制备银黄注射液(对照组)的黄芩苷含量虽变化不显著,性状和鉴别也符合要求,但pH值和绿原酸含量均不稳定,呈显著性变化;而银黄聚乙烯醇注射液(试验组)的pH值、绿原酸、黄芩苷含量稳定,变化均不显著,性状和鉴别也符合要求。这说明在银黄注射液配方中加入质量比为2%的PVA,再调整注射液pH值至5.5~7.0,所制备得到的银黄聚乙烯醇注射液,比药典标准银黄注射液更加稳定有效。
The stability of yinhuang injection was effectively solved by adding the stabilizer polyvinyl alcohol.The stability of yinhuang injection was investigated through the influencing factor test and accelerated test.The results showed that under the conditions of influence factor test with high temperature(60℃),low temperature(4℃)and strong light exposure(4500±500 lx),and accelerated test of 6 months(with temperature of 40±2℃and humidity of 75%±5%),the change of baicalin content in yinhuang injection prepared according to pharmacopeia standards(control group)was not significant,and the traits and identification also met the requirements,while the pH value and chlorogenic acid content were not stable with significant changes.However,the pH value,chlorogenic acid and baicalin content of yinhuang-polyvinyl alcohol injection(treatment group)were stable with no significant changes,and the traits and identification were also in line with the requirements.This indicated that the yinhuang-polyvinyl alcohol injection by adding 2% PVA in the formula and adjusting the pH value of the injection to 5.5-7.0 was more stable and effective than the yinhuang injection prepared according to pharmacopoeia standard.
作者
伍涛
李茂婷
邓余
曹政
闫志强
朱买勋
WU Tao;LI Mao-ting;DENG Yu;CAO Zheng;YAN Zhi-qiang;ZHU Mai-xun(Chongqing Academy of Animal Husbandry Sciences,Chongqing 402460,China;Rongchang Campus,Southwest University,Chongqing 402460,China)
出处
《福建农业科技》
2019年第11期55-59,共5页
Fujian Agricultural Science and Technology
基金
重庆市畜牧科技研究与推广项目(19532)
关键词
银黄注射液
聚乙烯醇
绿原酸
稳定性
Yinhuang injection
Polyvinyl alcohol
Chlorogenic acid
Stability
