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目的以莲心碱PVP-K30固体分散体的溶出度为指标,采用强化试验(高温、高湿、光照)对莲心碱PVP-K30固体分散体的稳定性进行考察。方法在高湿、高温及强光的条件下,考察各个因素对莲心碱PVP-K30固体分散体质量及稳定性的影响,以溶出度为指标,采用紫外分光光度法进行含量测量,检测波长为282 nm。结果高湿及强光对莲心碱的溶出及含量有较大的影响,在高湿的环境中,固体分散体具有很强的吸湿性能,不但增加了其自身的重量,而且对其自身的颜色也有影响,高温的环境对莲心碱的含量及溶出度的影响不大。结论莲心碱-PVP-30固体分散体应保存在干燥、避光的环境中。
OBJECTIVE To evaluate the stability of PVP-K30 solid dispersions by using the dissolution test of the PVP-K30 solid dispersions of liensinine as an indicator, using intensified test (high temperature, high humidity, light). Methods The effects of various factors on the quality and stability of PVP-K30 solid dispersions were investigated under the conditions of high humidity, high temperature and high light. The dissolution was taken as the index and the content was measured by UV spectrophotometry. The detection wavelength was 282 nm. The results of high humidity and light on the dissolution and content of Liensin have a greater impact in high humidity environment, the solid dispersion has a strong moisture absorption, not only to increase its own weight, but also its own color There are also effects, high temperature environment, the content and dissolution of Liensin little effect. Conclusion The lotus root-PVP-30 solid dispersion should be stored in a dry, dark environment.