中成药片剂由于受到生药原料、制剂工艺等各方面的影响,某些产品存在着在产品负责期内开裂的现象,而现有的常规质检指标无法预测产品的有效期,本实验旨在通过产品的稳定性加速试验,以片子的开裂为检测指标,同留样进行跟踪对比,摸索出该产品的可能的有效期,从而保证药物制剂的质量。 Due to raw materials, preparation process and other aspects of the Chinese herbal medicines, some products have the phenomenon of cracking within the product liability period. However, the existing routine quality inspection indicators cannot predict the validity period of the products. This experiment aims to pass The stability of the product was accelerated, and the cracking of the film was used as a detection index. The follow-up comparison with the retained sample was performed to find out the possible effective period of the product, thereby ensuring the quality of the pharmaceutical preparation.