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目的建立完善的医院制剂质量标准以提高医院制剂血通胶囊的可控性和稳定性。方法从定性、定量两方面进行研究,用薄层色谱法对血通胶囊中何首乌、水蛭、大黄三味中药定性鉴别;用高效液相色谱法对何首乌中二苯乙烯苷进行含量测定。结果三味药材薄层色谱图斑点清晰,具有专属性;二苯乙烯苷标曲线性关系良好,精密度、重复性、稳定性和回收率实验结果较好。结论该方法能准确可靠地进行定性、定量检测,能有效地控制血通胶囊的质量。
Objective To establish a perfect hospital preparation quality standards to improve the controllability and stability of the hospital preparation Xue Tong capsule. Methods Qualitative and quantitative studies were carried out. The contents of stilbene glycosides in Polygonum multiflorum Thunb. Were identified by TLC. The contents of Polygonum multiflorum, Leech and Rhubarb in Huatong Capsules were identified qualitatively by TLC. Results The TLC chromatogram of Sanwei was clear and specific. The calibration curve of stilbene glycoside was good, and the experimental results of precision, repeatability, stability and recovery were good. Conclusion The method can accurately and reliably carry out qualitative and quantitative testing, which can effectively control the quality of Xue Tong Capsule.