摘要
目的:制备伊曲康唑混悬滴眼液,并对其质量进行评价。方法:以沉降体积比为考察指标,采用正交试验对羧甲基纤维素钠、吐温80、枸橼酸钠的质量分数进行优化,采用紫外分光光度法测定伊曲康唑的含量;对优化处方后制备的样品进行质量检查和稳定性考察,取健康新西兰白色家兔10只进行眼刺激性实验。结果:羧甲基纤维素钠、吐温80、枸橼酸钠的质量分数分别为2.5%、0.1%、2.5%。伊曲康唑检测质量浓度在4.48～38.08μg/ml范围内与峰面积积分值线性关系良好(r=0.9999),平均回收率为99.98%,RSD=0.11%(n=3)。按优化处方制备的伊曲康唑混悬滴眼液的性状、pH值、含量、粒度及沉降体积比均符合2010年版《中国药典》规定;伊曲康唑含量在第0、1、2、3个月分别为100.5%、99.6%、99.8%、99.9%,其他各项指标无明显变化;眼刺激性实验结果符合要求。结论:该滴眼液制备工艺简单、质量稳定,紫外分光光度法测定其含量简便、准确。
OBJECTIVE：To prepare Itraconazole suspension eyedrops and to evaluate the quality.METHODS：The mass fraction of carboxymethylcellulose sodium,tween-80 and sodium citrate were optimized by orthogonal experiment with sedimentation volume ratio as index.The content of itraconazole was determined by UV spectrophotometry.The quality and stability of samples prepared by optimal technology were detected,and 10 healthy New Zealand white rabbits were selected for eye irritation test.RESULTS：The mass fraction of carboxymethylcellulose sodium,tween-80 and sodium citrate were 2.5%,0.1% and 2.5%.The linear range of itraconazole was 4.48-38.08 μg/ml（r=0.999 9）with an average recovery of 99.98%（RSD=0.11%,n=3）.The property,pH value,content determination,particle size and sedimentation volume ratio of Itraconazole suspension eyedrops by the optimal formula were in line with the standards stated in Chinese Pharmacopeia（2010 edition）;the content of itraconazole were 100.5%,99.6%,99.8% and 99.9% within 0,1,2 and 3 months,and other index had no significant change;results of eye irritation test were in line with the requirements.CONCLUSIONS：The preparation technology of eyedrops is simple in technology and stable in quality.UV spectrophotometry is simple and accurate for content determination.
出处
《中国药房》
CAS
CSCD
2013年第9期811-813,共3页
China Pharmacy
关键词
伊曲康唑
混悬液
滴眼液
制备
含量测定
沉降体积比
稳定性
刺激性
Itraconazole
Suspension
Eyedrops
Preparation
Content determination
Sedimentation volume ratio
Stability
Irritation
