高速剪切制粒中吡拉西坦含量均匀性的控制

Content uniformity control of piracetam by high-speed shear granulation

目的研究高速剪切制粒过程中搅拌桨转速、黏合剂用量及黏度等变量与药物含量均匀性之间的关系,为制剂质量控制提供依据。方法考察于不同的处方参数和操作参数条件下制备得到颗粒中的吡拉西坦的含量均匀性。结果吡拉西坦在粒径小于300μm的颗粒群中吡拉西坦含量较高,粒径大于1 250μm颗粒群中药物含量较低,随着制粒过程的进行,药物含量逐渐趋于一致。减少黏合剂用量,增加黏合剂黏度,提高搅拌桨转速均有利于增加颗粒中的药物含量均匀性。结论在高速剪切制粒中,通过对处方中黏合剂的用量、性质以及操作参数的控制,可以有效地促进药物在不同大小颗粒中的均匀分布,从而得到药物含量均匀的制剂。

Objective To study the relationship between impeller speed,amount and viscosity of binder and drug content uniformity in order to provide a principle for the quality control during high-shear granulation process.Methods The content uniformity of piracetam in the prepared particles was investigated under different prescriptions and operating parameters.Results The content of piracetam was high in the granules which were smaller than 300 μm.In contrast,the content of piracetam was low in the granules which were lower than 1 250 μm.The drug distribution would become more uniform during the granulating process.The uniformity of drug content would increase with reduced amount of binder,increased viscosity of binder or increased impeller speed.Conclusions We can effectively enhance uniform distribution of drug in different sized particles through reasonable control on the amount and viscosity of binder and operating parameters.