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目的:通过正交试验筛选出癌痛消颗粒的最佳成型工艺。方法:以颗粒的成型率、抗湿性及颗粒色泽均匀度为筛选指标,对影响颗粒制剂工艺的主要因素:混合辅料的组成比例、羧甲基纤维素钠(CMC-Na)用量及湿润剂乙醇体积分数等进行优化试验,采取正交设计L9(34)方法筛选出最佳成型工艺。结果:干浸膏粉中加入按糊精:可溶性淀粉(2∶1)比例组成的混合辅料,并加入2%CMC-Na,以85%乙醇做为湿润剂混合制粒为最佳工艺。结论:该处方制剂的成型率、抗湿性及颗粒色泽均匀度均较好,可为其生产提供科学的实验依据。
OBJECTIVE: To screen out the best forming process of Jiaotongxiao granules by orthogonal test. Methods: The main factors influencing the granulation process were the forming rate of the granule, the moisture resistance and the color uniformity of the granule. The main factors of the granule preparation process were the composition ratio of the mixture, the content of CMC-Na and the wetting agent ethanol Volume fraction and so on. The orthogonal design L9 (34) was used to select the best forming process. Results: The optimum conditions were as follows: the mixture of dextrin and soluble starch (2: 1) was added into the dry extract powder, and 2% CMC-Na was added. The optimal process was granulation with 85% ethanol as wetting agent. Conclusion: The formulation of the formulation rate, moisture resistance and particle color uniformity are good, for its production to provide a scientific experimental basis.