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目的:建立苦豆子总碱温度敏感型凝胶的质量控制以及其稳定性研究。方法:采用TLC鉴别苦豆子总碱,HPLC测定槐定碱含量,以性状、颜色、pH值、胶凝温度和槐定碱含量为指标,通过离心试验、耐热耐寒试验和长期稳定性试验考察凝胶的稳定性。结果:HPLC法测定槐定碱在9.06~580μg·mL~(-1)的质量浓度范围内线性关系良好;凝胶剂在常温下为均匀、淡黄色澄明液体,在33℃左右变为凝胶状;贮存6个月后性状、颜色、pH值、胶凝温度和槐定碱含量均未发生明显变化。结论:该制剂在室温储存质量稳定,建立的质量标准可用于控制凝胶的质量。
OBJECTIVE: To establish the quality control and stability study of temperature-sensitive gel of Sophora alopecuroides. Methods: The total alkaloids of Sophora alopecuroides were identified by TLC. The sophoridine content was determined by HPLC. The properties of the sophoridine were determined by the methods of centrifugation, heat-endurance, cold-resistance and long-term stability with the properties, color, pH value, gelation temperature and sophoridine content as indexes Gel stability. Results: The sophoridine was linear in the concentration range of 9.06-580μg · mL -1 by HPLC. The gel was uniform and light yellow liquid at room temperature and became gel at about 33 ℃ The shape, color, pH value, gelling temperature and sophoridine content did not change significantly after 6 months of storage. Conclusion: The preparation is stable at room temperature and the established quality standards can be used to control the quality of the gel.