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目的:制备乙酰半胱氨酸活性炭微囊(ACNAC),并优化工艺条件。方法:以生物可降解材料明胶为囊材,采用乳化交联法制备ACNAC。以载药量、包封率和粒径分布百分数(粒径为80~140μm者所占百分数)的综合评价指标为指标,以药载比、明胶用量、搅拌速度、乳化剂用量为因素,采用单因素试验和正交试验优化处方工艺,验证并测定所制ACNAC的粒径分布。结果:最优处方工艺为药载比1∶1、明胶15%、乳化剂2.0%、搅拌速度1 000 r/min。所制6批ACNAC的平均载药量为15.9%(RSD=1.21%),平均包封率为78.1%(RSD=1.11%),平均粒径分布百分数为81.9%。结论:成功制得ACNAC,且处方工艺合理、可行。
Objective: To prepare acetylcysteine activated carbon microcapsules (ACNAC) and optimize the process conditions. Methods: The biodegradable material gelatin was used as the shell material, and ACNAC was prepared by emulsion cross-linking method. The drug loading ratio, entrapment efficiency and the percentage of particle size distribution (the percentage of particle size of 80 ~ 140μm) of the comprehensive evaluation index as an indicator, the drug loading ratio, the amount of gelatin, stirring speed, the amount of emulsifier as a factor, using Single factor test and orthogonal test to optimize the formulation process, to verify and determine the size distribution of ACNAC prepared. Results: The optimal prescription was drug loading ratio 1: 1, gelatin 15%, emulsifier 2.0% and stirring speed 1000 r / min. The average drug loading of the 6 batches of ACNAC was 15.9% (RSD = 1.21%), the average entrapment efficiency was 78.1% (RSD = 1.11%) and the average percentage of particle size distribution was 81.9%. Conclusion: The successful preparation of ACNAC, and the prescription process is reasonable and feasible.