摘要
目的 优化吸入用布地奈德混悬液的处方与制备工艺。方法 以沉降体积比与再分散性的综合评分为指标,采用正交试验法对处方进行优化;采用高压均质技术制备布地奈德混悬液,以单因素试验法优化制备工艺。结果 优选的助悬剂为羧甲基纤维素钠,润湿剂为吐温80,絮凝剂为枸橼酸钠,其用量分别为0.10%、0.05%、0.05%;优化的工艺条件为低压、均质2-3次;按优化后的处方和工艺所制备的布地奈德混悬液的平均粒径为1.70±0.15μm,平均Zeta电位为-24.1±0.4 m V,布地奈德的含量为标示量的99.3%。结论 按优化后的处方和工艺所制备的混悬液的理化稳定性良好,达到了吸入用混悬液的质量要求。
OBJECTIVE To optimize the formulation and preparation process of Budesonide (Bud) suspensions for inhalation. METHODS Bud suspensions was prepared by high - pressure homogeneous technique. Formulation optimization was carried out by orthogonal test with composite score of sedimentation ratio and re - dispersibility as index. Single factor experiment was applied to optimize the preparation process. RESULTS The optimized suspending agent, wetting agent and flocculant were sodium carboxymethylcel- lulose,tween 80 and sodium citrate. Their formula dosage were 0.10% ,0.05% and 0.05% respectively in optimum formulation. The suspension was prepared by high - pressure homogeneous technique with a relatively low pressure repeated to 2 - 3 times. The mean diameter and Zeta potential of the prepared suspension were 1.70 ± 0. 15 μm and - 24.1 ± 0.4 mV respectively, and the average content of Bud was 99.3% of the labeled amount. CONCLUSION The physicochemical stabilities of the prepared suspension with optimized formulation and preparation process are good, and meets the quality requirements of the suspensions for inhalation.
出处
《华西药学杂志》
CAS
CSCD
2016年第5期453-455,共3页
West China Journal of Pharmaceutical Sciences
基金
国家重大新药创制科技重大专项(2009ZX09310-002)
关键词
布地奈德
混悬液
吸入制剂
处方优化
单因素试验
正交试验
制备工艺
稳定性
Budesonide
Suspensions
Inhalation preparation
Formulation optimization
Single factor experiment
Orthogonal tests
Preparation process
Stability