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目的:研究益脑康宁滴丸的最佳成型工艺。方法:以丸重变异系数和外观作为评价指标,对冷却剂、滴速、滴距采用单因素考察,对药物与基质的比例、两种水溶性基质的比例及滴制液温度三因素进行正交试验。结果:优选的最佳成型工艺是甲基硅油与液体石蜡以2:1比例混合作为冷却液,药物与基质比例1∶1.5,基质聚乙二醇4000(PEG4000)与聚乙二醇6000(PEG6000)比例1.5∶1,滴制液温度70℃,滴速20 d.min-1,滴距8 cm,滴丸成型率最高。结论:以筛选出的成型工艺条件制成的滴丸,成品得率高,符合《中国药典》中滴丸剂的质量标准。
Objective: To study the best molding process of Yibai Corning Drop Pills. Methods: Taking the coefficient of variation of pellet weight and appearance as the evaluation index, single factor test was conducted on the coolants, drip rate and dripping distance. The ratio of drug to matrix, the ratio of two water-soluble matrix and the temperature of dropping liquid Pay the test. Results: The optimal forming process was as follows: methyl silicone oil and liquid paraffin were mixed in a ratio of 2: 1 as a cooling solution, the ratio of drug to matrix was 1: 1.5, the ratio of PEG 4000 to PEG 6000 ) Ratio 1.5: 1, dropping temperature 70 ℃, dropping speed 20 d.min-1, dripping distance 8 cm, dripping rate was the highest. Conclusion: The dropping pills made by the selected molding process have high yield and meet the quality standard of pills in “Chinese Pharmacopoeia”.