甘菊滴丸的质量控制及稳定性考察

Quality Control and Stability of Ganju Dropping Pills

摘要:

目的: 建立甘菊滴丸的质量控制方法并考察其在加速和室温条件下的稳定性。 方法: 采用薄层色谱法鉴别甘菊滴丸中的主要药材甘草和羊耳菊;采用高效液相色谱法测定甘草酸的含量。 结果: 3批甘菊滴丸中试样品经3个月加速试验和24个月长期试验考察,各项指标均符合质量标准要求。 结论: 甘菊滴丸质量可控,稳定性好。

Abstract:

Objective:To establish the quality control method and study the stability of Ganju dropping pills at accelerated testing and room temperature. Method: Radix Glycyrrhizae and Inula cappa in the pills were identified by TLC. The content of glycyrrhizic acid was determined by HPLC. Result: After the accelerated testing and the long-term testing, various indexes of 3 pilot test samples accorded with the quality standard of Ganju dropping pills. Conclusion: Ganju dropping pills are stable and controllable in quality, excellent in stability.