CAJ | 학술논문

目的：考察清炎滴丸的稳定性。方法用高效液相色谱（HPLC）法测定清炎滴丸中异嗪皮啶和苦玄参苷ⅠA的含量，并考察性状、鉴别、溶散时限、微生物限度等其他指标。结果清炎滴丸样品在加速实验及长期实验中，考察前后各项检查指标均无明显变化。结论清炎滴丸在室温条件下稳定性较好。本品的工艺及包装等设计合理，符合制剂稳定的要求。
목적：고찰청염적환적은정성。방법용고효액상색보（HPLC）법측정청염적환중이진피정화고현삼감ⅠA적함량，병고찰성상、감별、용산시한、미생물한도등기타지표。결과청염적환양품재가속실험급장기실험중，고찰전후각항검사지표균무명현변화。결론청염적환재실온조건하은정성교호。본품적공예급포장등설계합리，부합제제은정적요구。
Objective To investigate the stability of Qingyan drops. Methods The active ingredients (isofraxi-din and piefeltarraenin ⅠA) in the samples were assayed by using high-performance liquid chromatography (HPLC). Other indices, including character, identification and microbial limit, were also determined. Results No significant changes in individual parameters were found in the acceleration test and long-term test. Conclusion Qingyan drops are stable at room temperatures. The designs, preparation processes and package are in keeping with the standards for maintaining stability.