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目的:考察安神益心液的稳定性。方法:用HPLC法测定有效成分含量,并考察性状、鉴别、相对密度、pH、微生物限度等其他指标。结果:影响因素试验结果表明本品可受高温及强光影响;加速试验和长期试验结果表明各项考察指标无明显变化。结论:本品在贮存及运输过程中应避免高温及强光照射;本品的工艺及包装等设计合理,符合制剂稳定的要求。
Objective: To investigate the stability of Anshen Yi heart fluid. Methods: HPLC method was used to determine the content of active ingredients, and other properties such as traits, identification, relative density, pH and microbial limit were investigated. Results: The influencing factors test results show that the product can be affected by high temperature and light; accelerated test and long-term test results showed no significant changes in the various indicators. Conclusion: This product should avoid high temperature and strong light irradiation during storage and transportation. This product has reasonable design and packaging, which meets the requirement of stable formulation.