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作 者:方红英[1] 庄让笑[1] 潘旭旺[1] 孙晶晶[1] 席建军[1] 王福根[1] 史婷婷[1] 刘寿荣[1]
机构地区:[1]浙江中医药大学附属杭州西溪医院,杭州310030
出 处:《中国药房》2016年第7期955-958,共4页China Pharmacy
基 金:杭州市科技发展计划项目(No.20110833B17)
摘 要: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 Activated carbon N-acetylcysteine microcapsule (ACNAC), and to optimize preparation technology. METHODS: ACNAC was prepared by emulsion cross-linked method using biodegradable material gelatin as capsule wall material. Using comprehensive evaluation index of drug-loading amount, entrapment rate and particle size distribution percentage (the percentage of 80-140 μm particle) as index, drug-loading ratio, amount of gelatin, mixing speed and the amount of emulsifier as factors, single factor test and orthogonal test were used to optimize formulation technology. The technology was validated and distribution of particle size of ACNAC was determined. RESULTS: The optimal formulation technology was as follows as drug-loading ratio 1 : 1, gelatin 15%, emulsifier 2.0%, mixing speed 1 000 r/min. Average drug-loading amount of 6 batches of ACNAC was 15.9% (RSD=1.21%), average encapsulation efficiency was 78.1% (RSD=1.11%) and average particle size distribution percentage was 81.9%. CONCLUSIONS: ACNAC is prepared successfully, and formulation technology is reasonable and feasible.
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