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目的:优化天舒滴丸的制备成型工艺,并建立体外溶出度的测定方法。方法:以滴丸光滑圆整率、丸重差异、溶散时限为指标,采用正交设计试验对影响因素进行考察;以阿魏酸为溶出指标,采用小杯法和高效液相色谱法进行溶出度测定。结果:滴丸成型最佳工艺-药物基质1∶2,PEG6000-S40 3∶1,冷却剂管口温度(25～30)℃,滴速60～65 d.min-1;滴丸在10 min内阿魏酸累积溶出率超过85%,15 min内基本溶出完全。结论:制备工艺合理,对工业化生产有帮助,所得滴丸溶出度好。
Objective: To optimize the preparation process of Tianshu dropping pills and to establish a method for the determination of in vitro dissolution. Methods: Taking the slippery pills’ roundness, difference of pills and dissolving time as indexes, orthogonal design test was used to investigate the influential factors. Ferulic acid was used as dissolution index and small cup method and high performance liquid chromatography Dissolution determination. Results: The optimum conditions of dropping pills were as follows: drug matrix 1: 2, PEG6000-S40 3:1, coolant nozzle temperature (25-30) ℃, dropping speed 60-65 d.min- The cumulative dissolution rate of ferulic acid within 85%, 15 min basic complete dissolution. Conclusion: The preparation process is reasonable, which is helpful for industrial production. The dropping pills obtained have good dissolution rate.