复方左氧卡波普缓释眼凝胶的制备工艺及其含量测定  

Preparation technology and determination of Compound levofloxacin carbopol sustained-release ocular fixation gelata

作　　者：黄克峰[1] 俞平[2] 

机构地区：[1]张掖医学高等专科学校,甘肃张掖734000 [2]张掖市人民医院药剂科,甘肃张掖734000

出　　处：《华西药学杂志》2010年第1期92-94,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的优选复方左氧卡波普缓释眼凝胶的制备工艺及其质量控制的方法。方法采用正交试验法,考察活性炭、中间品pH、卡波普对成品质量及工艺的影响;采用UV法测定主药左氧氟沙星的含量;采用系散倍法测定地塞米松的含量。结果各因素对乳酸左氧氟沙星含量的影响程度最大者为活性炭量;乳酸左氧氟沙星的紫外测定在293.5nm的线性范围为2.0～8.0μg·mL-1;地塞米松磷酸钠的波长测定为242.0nm、参比波长为326.5nm,线性范围4.0～10.0μg·mL-1;制备工艺为:半成品调pH5.5,加0.05%活性炭和0.3%的卡波普940进行生产;其回归方程分别为:Y乳酸左氧氟沙星=10.349X-0.069(r=0.9996,n=5)、Y地塞米松磷酸钠=312.739X-0.124(r=0.9998,n=5)。结论所制制剂的处方设计合理,制备方法可行,测定结果准确,精密度良好。OBJECTIVE To optimize the preparation technology and establish the quality control method for compound levofloxacin earbopol sustained - release ocular fixation gelata. METHODS To apply orthogonal experiment and use L9 （ 3^4 ） orthogonal table to investigate the effects that actiearbon, pH value of intennedia product, carbopol have on the quality and technic of the agent. To employ ultraviolet spectrophotometry to measure the content of Levofloxacin and multiple coefficient to measure the content of dexamethasone. RESULTS Actiearbon was the most important factor. The linear range of the ultra - mesuration of levofloxacin at 293.5 nm was 2.0 - 8.0 μg·mL^-1, the measurement of dexamethasone was measured as follows ： the measuring wavelength 242.0 nm, the comparison wavelength 326.5 nm, the linear range 4.0 - 10.0μg·mL^-1. Then the gelata was prepared by adding 0.05% actiearbon and 0. 30% earbopol 940 and adjusted to pH5.5. The ultra - mesuration of levofloxacin was Y = 10. 349X - 0. 069 （ r = 0.9996, n = 5 ）, and dexamethasone was Y = 312. 739AX - 0. 124 （ r = 0. 9998, n = 5 ）. CONCLUSION The design of the formula is reasonable and the technic is feasible. The results are accurate and the precision is fine.

关 键 词：左氧氟沙星 缓释眼凝胶 地塞米松磷酸钠 正交试验法 紫外分光光度法 

分 类 号：R917[医药卫生—药物分析学] R94[医药卫生—药学]