CAJ | 학술논문

目的：建立化生平合剂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RP-HPLC法测定化生平合剂中黄芪甲苷的含量。通过影响因素试验、加速稳定性试验和长期稳定性试验考察化生平合剂的稳定性。结果：RP-HPLC法测定化生平合剂中黄芪甲苷的含量有良好的精密度和重现性。影响因素试验、加速稳定性试验和长期稳定性试验表明，黄芪甲苷含量在上述条件下无明显改变，稳定性较好。结论：RP-HPLC法能简单、准确的应用于化生平合剂的质量控制中，且本品稳定性良好。
목적：건립화생평합제적질량공제방법병고찰기재가속화실온조건하적은정성。방법：채용RP-HPLC법측정화생평합제중황기갑감적함량。통과영향인소시험、가속은정성시험화장기은정성시험고찰화생평합제적은정성。결과：RP-HPLC법측정화생평합제중황기갑감적함량유량호적정밀도화중현성。영향인소시험、가속은정성시험화장기은정성시험표명，황기갑감함량재상술조건하무명현개변，은정성교호。결론：RP-HPLC법능간단、준학적응용우화생평합제적질량공제중，차본품은정성량호。
Objective: To establish the quality control method and study the stability of Hua Sheng Ping mixture at accelerated testing and room temperature. Method: To determine the contents of astragaloside in Hua Sheng Ping mixture by RP-HPLC method. Study on the stability of Hua Sheng Ping mixture by influence factor test, accelerated stability test and long-term stability test method. Results: A RP-HPLC method for the determination of astragaloside in Hua Sheng Ping mixture has good precision and reproducibility. Influence factor test, accelerated stability test and long-term stability test showed that the content of astragaloside had no obvious change in the above condition, better stability. Conclusion: The RP-HPLC method for quality control of Hua Sheng Ping mixture was simple and accurate, and Hua Sheng Ping mixture had excellent stability.