| 丁丽玉,张丹,许莹,等.3个指标性成分用于监控芪贞降糖颗粒浓缩工艺的研究[J].安徽医药,2016,20(10):1848-1851. |
| 3个指标性成分用于监控芪贞降糖颗粒浓缩工艺的研究 |
| Application of three main components to indicate the reliabilityof Qizhenjiangtang Granules concentration process |
| 投稿时间：2016-05-04 |
| DOI： |
| 中文关键词: 芪贞降糖颗粒 浓缩 稳定性 转移率 枸橼酸 特女贞苷 毛蕊异黄酮葡萄糖苷 |
| 英文关键词: Qizhenjiangtang Granules Concentration Stability Transfer rate Citric acid Specnuezhenide Calycosin-7-glucoside |
| 基金项目:上海市卫计委中医医院中药制剂能力提升项目(ZY3-JSFC-2-2017);上海市卫计委项目资助(ZY3-CCCX-3-5001)；上海市科委平台资助项目(15DZ2292000) |
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| 中文摘要: |
| 目的 探索3个主要成分作为指标监控芪贞降糖颗粒浓缩工艺稳定性的可行性。方法 选择枸橼酸、特女贞苷和毛蕊异黄酮葡萄糖苷3个主要成分作为高效液相色谱法(HPLC)检测指标,分别在常压和减压条件下进行芪贞降糖颗粒提取液的浓缩,测定不同温度下不同时间点样品中指标性成分的含量变化情况,系统考察其热稳定性规律,用于浓缩工艺的参数确定。结果 常压和减压条件下经过8 h浓缩后,枸橼酸在温度60～80 ℃范围内稳定性良好,90 ℃条件下转移率下降约15%。常压条件下经过8 h浓缩,特女贞苷在温度60～80 ℃范围内转移率下降不超过13%,在90 ℃条件下转移率下降25%；减压条件下经过8 h浓缩,特女贞苷在温度60～80 ℃范围内转移率下降不超过11%,在90 ℃条件下转移率下降约20%。常压和减压条件下经过8 h浓缩后,毛蕊异黄酮葡萄糖苷在60～90 ℃范围内稳定性良好。因此,芪贞降糖颗粒的常压和减压浓缩温度均应控制不超过80 ℃。3批中试放大试验均验证了以上规律和工艺参数的可行稳定。结论 以枸橼酸、特女贞苷和毛蕊异黄酮葡萄糖苷的热稳定性作为指标得到的浓缩工艺参数,可用于芪贞降糖颗粒的制剂工艺质量控制。 |
| 英文摘要: |
| Objective To explore the stability of Qizhenjiangtang Granules concentration process by using 3 main components as the index.Methods Citric acid,specnuezhenide and calycosin-7-glucoside were chosen as the detection indicators to display the thermal stability during the concentration process.The concentrated solution were prepared under both the atmospheric and vacuum conditions. The concentration of the 3 components were determined at different time points and at different bath temperature,so as to select the suitable process parameter in this step.Results In both atmospheric and vacuum conditions,citric acid was stable between 60 ℃ and 80 ℃ and the transfer rate decreased by 15% at 90 ℃ in 8 hours.Calycosin-7-glucoside kept stable for 8 hours between 60 ℃ and 90 ℃.In the atmospheric condition,the transfer rate of specnuezhenide decreased by no more than 13% between 60 ℃ and 80 ℃ while it decreased by 25% at 90 ℃.In the vacuum condition,the transfer rate of specnuezhenide decreased by no more than 11% between 60 ℃ and 80 ℃ while it decreased by about 20% at 90 ℃.So the concentration temperature should be controlled no more than 80 ℃.The thermal stability of the 3 components and the optimal concentration parameters were validated by 3 batches of product via pilot magnification.Conclusions The parameters obtained from the stability study of citric acid,specnuezhenide and calycosin-7-glucoside are suitable for the quality control of Qizhenjiangtang Granules concentration process. |
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