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目的:探索以热敏性成分作为指标监控制剂浓缩工艺稳定性的可行性研究。方法:以三七益肾颗粒作为模型药物,选择羟基红花黄色素A和丹酚酸B这2个热敏性成分作为检测指标,系统考察其热稳定性规律,用于浓缩步骤中的工艺参数确定。结果:羟基红花黄色素A和丹酚酸B在温度超过70℃后稳定性明显下降,在浓缩过程中温度须控制在不超过70℃。结论:以羟基红花黄色素A和丹酚酸B为指标对制剂浓缩工艺控制,进而对制剂工艺进行控制,是可行的。
Objective: To explore the feasibility of using heat-sensitive components as indicators to monitor the stability of preparation concentration process. Methods: With the use of “Sanqi Yishen Granule” as model drug, two thermosensitive components of hydroxysafflor yellow A and salvianolic acid B were selected as the detection indexes, and their thermal stability was systematically investigated and used to determine the process parameters in the concentration step . Results: The stability of hydroxysafflor yellow A and salvianolic acid B decreased obviously when the temperature was above 70 ℃. The temperature should be controlled to not more than 70 ℃ during the concentration process. Conclusion: It is feasible to control the concentration process of the preparation by using hydroxysafflor yellow A and salvianolic acid B as the index, and then control the preparation process.