0.05%硫酸阿托品滴眼液的研制及临床疗效观察  

Preparation and Clinical Curative Effect of Atropine Sulfate Eye-drops

作　　者：文远大[1] 谭芳[1] 史志华[1] 

机构地区：[1]怀化市第一人民医院,湖南怀化418000

出　　处：《中国药师》2008年第2期194-196,共3页China Pharmacist

摘　　要：目的:建立0.05%硫酸阿托品滴眼液的制备工艺、质量控制方法,并观察其临床疗效。方法:取硫酸阿托品与辅料,制成浓度为0.05%的硫酸阿托品滴眼液,以乙腈-水(55:45)为流动相,采用高效液相色谱法测定其含量,并观察105例患者的临床疗效。结果:硫酸阿托品在10～60μg·ml^(-1)内线性关系良好,回归方程:A=3.390×10~4C+1.481×10~4,r=0.9999,平均回收率为99.92%,RSD为0.91%(n=5)。治疗组有效率81.18%,空白对照组有效率4.35%,两组比较差异显著(P<0.01)。结论:该制剂制备工艺简单,含量测定方法准确,质量可控,临床应用效果满意。Objective： To establish the preparation process and method of quality control and observe the clinical curative effect of atropine sulfate eye-drops. Method： 0.05 % atropine sulfate eye-drops was prepared with atropine and additives in water was prepared. The content of atropine sulfate was determined by HPLC, the system consisted of C18 column and mobile phase of acetonitrile- water （55：45 ）. The clinical curative effect of 105 cases were observed. Result： The production is colorless and cleaning solution. The linear range of atropine sulfate was 10 - 60 μg· ml^-1 （ r = 0.999 9, n = 6 ） and linear regression equation is A = 3. 390 × 10^4 C ＋ 1.481 × 10^4C,the average recovery rate was 99.92% （RSD = 0.91%, n = 5 ） . The effects rate in cases who used atropine eye-drops is 81.18%, the eortrol group was 4.35% （ P 〈 0.01 ）. Conclusion ： The technological process of atropine sulfate eye-drops is simple , the method of quality control is reliable and the clinical curative effects are obvious.

关 键 词：硫酸阿托品 滴眼液 制备 高效液相色谱法 疗效观察 

分 类 号：R944.12[医药卫生—药剂学] R971.92[医药卫生—药学]