尿囊素乳膏处方改进及稳定性考察

目的：改进尿囊素乳膏处方，建立质量控制标准，并对稳定性进行初步考察。方法：采用高效液相色谱法测定尿囊素含量；对尿囊素乳膏处方进行调整，提高乳膏稳定性。结果：尿囊素在0．005～0．100mg·ml^-1浓度范围内呈良好的线性关系（r=0．9999），高、中、低浓度平均回收率分别为101．22％、100．89％、103．10％，RSD分别为1．62％、1．96％、2．08％。处方调整后，常温贮存6个月尿囊素乳膏含量基本不变，稳定性显著增强。结论：调整所得尿囊素乳膏处方合理稳定，生产工艺简便，含量测定方法准确，适于质控。

Study on Formulation Improvement and Stability of Allantoin Cream

Objective： To improve formulation of allantoin cream, establish the quality control method and study the stability as well. Method ： The formulation of allantoin cream was adjusted to increase the stability, and the content of which was determined by HPLC. Result： The calibration curve was linear within the range of 0. 005-0. 100 mg· ml^-1 for allantoin （r = 0. 999 9 ）. The average recovery of high,medium and low concentration was 101.22%, 100. 89% and 103. 10% with RSD of 1.62%, 1.96% and 2. 08%, respectively. The stability of adjusted allantoin cream was enhanced significantly with little content change after stored at 25℃ for six months. Conclusion ： The adjusted formulation of allantoin cream is reasonable and stable, while the preparation process is simple. The determination method is accurate and reliable for the quality control of the preparation.