星点设计-响应面法优选水合氯醛口服溶液制备工艺  

Optimization of Preparation Process of Chloral Hydrate Oral Solution by CCD-RSM

作　　者：饶俊珍 杨全伟[1] 胡松[1] RAO Junzhen;YANG Quanwei;HU Song(Department of Pharmacy,Wuhan No.1 Hospital,Wuhan,Hubei,China 430022)

机构地区：[1]湖北省武汉市第一医院药学部,湖北武汉430022

出　　处：《中国药业》2023年第3期63-66,共4页China Pharmaceuticals

摘　　要：目的优选水合氯醛口服溶液的最佳制备工艺。方法采用星点设计-响应面法,以水合氯醛口服溶液含量的相对标准偏差(RSD,即含量均匀度)为考察指标,选择溶解水量、搅拌转速、搅拌时间3个考察因素,分别设置3个水平,优选水合氯醛口服溶液的最佳制备工艺。按优选工艺进行3次平行试验验证。结果优选的水合氯醛口服溶液制备工艺为加水79.8 mL,以298 r/min的转速搅拌29.8 min;结合实际生产进行验证试验,计算得3批样品含量分别为100.72%,100.50%,100.82%(n=3)。结论所建立的方法结果准确,批间差异较小,受主观因素干扰小,稳定可行。Objective To optimize the preparation process of Chloral Hydrate Oral Solution.Methods With the relative standard deviation(RSD)of chloral hydrate content(that was content uniformity)as the investigation index,and with the dissolved water amount,stirring speed and stirring time as the investigation factors(with three levels,respectively),the preparation process of Chloral Hydrate Oral Solution was optimized by the central composite design-response surface methodology(CCD-RSM).Three parallel tests by the optimal process were carried out for verification.Results The optimal preparation process of Chloral Hydrate Oral Solution was as follows:adding 79.8 mL of water,and stirring at the speed of 298 r/min for 29.8 min.The verification test was carried out based on the actual production,and the contents of chloral hydrate in the three batches of samples were 100.72%,100.50% and 100.82%(n=3)respectively.Conclusion The established method is accurate,stable and feasible,with the small difference between batches and the small interference from subjective factors.

关 键 词：星点设计-响应面法 水合氯醛口服溶液 制备工艺 含量均匀度 

分 类 号：R971.3[医药卫生—药品] TQ460.6[医药卫生—药学]