提高芪鹿益肾片稳定性的方法研究

目的 筛选适宜的防潮辅料以提高芪鹿益肾片浸膏粉的临界相对湿度，从而提高芪鹿益肾片的稳定性。方法 以浸膏粉的临界相对湿度为评价指标，采用单因素法考察微晶纤维素、微粉硅胶、无水乳糖及甲壳素4种不同的辅料对芪鹿益肾片浸膏粉吸湿性能的影响，并采用长期稳定性试验研究制剂的稳定性。结果 在芪鹿益肾稠浸膏中加入上述辅料后，可使芪鹿益肾浸膏粉临界相对湿度从原工艺的53%分别提高至63%、65%、62%、71%，以0.5%甲壳素改善效果最佳，且长期稳定性研究表明采用该辅料后芪鹿益肾片的质量稳定。结论 在芪鹿益肾稠浸膏中加入适量的甲壳素，能显著提高芪鹿益肾浸膏粉的临界相对湿度，改善芪鹿益肾片的吸潮性，降低制剂工艺中的环境要求，有效地保证芪鹿益肾片的稳定性。

A new method to improve the stability of the Qilu Yishen tablets

Objective To screen a suitable moisture-proof excipient to improve the critical relative humidity（CRH） of the Qilu Yishen extract powder for enhancing the stability of the Qilu Yishen tablets.Methods The single factor method was used to study the effect of four different types of microcrystalline cellulose,silica gel powder,anhydrous lactose,and chitin excipients on the hygroscopicity of Qilu Yishen extract powder by the evaluation of CRH,and a long-term stability test was also used to study the stability of the preparation within the designed period.Results Four different types of excipients could increase the CRH of Qilu Yishen extract powder from 53% to 63%,65%,62%,71% and 0.5%（w） chitin improved the best results after a long-term stability test.Conclusion Chitin is a suitable excipient to improve the CRH of Qilu Yishen extract powder significantly and the stability of Qilu Yishen tablets.