Abstract:Objective To study the optimization of the technological parameters in preparation process of Yinshen Capsules and 3 batches of samples were produced. Methods Single factor method was used to screen suitable filler, lubricant and adhesive. The mixing uniformity and water content were used as the investigation indexes, the mixing time, baking temperature, baking time and other factors were optimized, and the optimal preparation technology of Yinshen Capsules was obtained, which was verified by three batches of pilot scale production. Results When 32% microcrystalline cellulose was selected as the filler, 0.9% magnesium stearate as the lubricant, and 95% ethanol as the binder, the particles had good fluidity. The total mixing time was 15 min, the baking index was 55℃ and 1.5 h, the particle flow performance of the prepared particles met the requirements of the pilot production, and the three batches of the prepared products all met the requirements. Conclusion The preparation process is simple, suitable for industrialization, the appearance of Yinshen Capsules is bright, clean and beautiful, and the quality meets the requirements.
刘玉明 蒋定文 李珂娴 陈伟 侯登勇. 银参胶囊制备工艺参数优化及其中试生产[J]. 中国医药导报, 2020, 17(9): 107-110.
LIU Yuming JIANG Dingwen LI Kexian CHEN Wei HOU Dengyong. Optimization of preparation process parameters and pilot production of Yinshen Capsules. 中国医药导报, 2020, 17(9): 107-110.