烯丙孕素片的制备及质量研究

Preparation and quality study of Altrenogest tablets

关键词:  烯丙孕素片  崩解时限  溶出度  质量研究

Key words:  Altrenogest tablets  Time limit for disintegration  Dissolution  Quality study

摘要:

对烯丙孕素片的制备及质量进行研究。以药物的崩解时限和溶出度为主要指标，应用正交设计法对其处方进行优化，制备一种延缓崩解开始时间的烯丙孕素片，以适应不同猪场和环境的湿法饲喂需求。考察烯丙孕素片的外观性状、硬度、片重差异、脆碎度、崩解时限、溶出度、含量测定等，重点对烯丙孕素片的溶出度方法进行了研究。结果表明，烯丙孕素片外观性状、硬度、片重差异、脆碎度、崩解时限、溶出度、含量测定等结果符合要求，含量测定为标示量的90.0%～105.0%。崩解时限和溶出度结果表明，烯丙孕素片在遇水后7～15分钟全部崩解完毕，溶出度大于90%。研究所得烯丙孕素片的崩解时限延长了5～10分钟，且溶出度和含量均达标。由此确定研制的烯丙孕素片处方工艺可行，质量可控，符合拟定的质量标准。

Abstract:

The preparation and quality of Altrenogest tablets were studied. Taking the disintegration time and dissolution degree of the drug as the main indexes, the orthogonal design method was used to optimize the prescription, and an Altrenogest tablet with delayed disintegration time was prepared to meet the wet feeding needs of different pig farms and environments. The appearance characteristics, hardness, weight difference, fragility, disintegration time, dissolution and content determination of Altrenogest tablets were investigated, and the dissolution method of Altrenogest tablets was studied. The results showed that the results of appearance traits, hardness, weight differences, fragility, disintegration time, dissolution and content determination of Altrenogest tablets met the requirements, and the content was determined to be 90.0%~105.0% of the labeled amount. The results of disintegration time and dissolution showed that the disintegration of Altrenogest tablets was completed 7~15 minutes after contact with water, and the dissolution was greater than 90%. The disintegration time of the Altrenogest tablets obtained in the study was extended by 5~10 minutes, and the dissolution and content reached the standards. Therefore, it was determined that the prescription process of the developed Altrenogest tablets was feasible, the quality was controllable, and it met the proposed quality standards.