摘要
目的:制备复方血压安缓释片并建立其质量控制方法。方法:以缓释材料羟丙基甲基纤维素为主要辅料,阿替洛尔、氢氯噻嗪、硝苯地平为主药制备缓释片;采用高效液相色谱法同时测定其中3主药的含量;并考察其体外释放行为。结果:所制制剂为淡黄色片,鉴别、检查均符合2005年版《中国药典》中的相关规定;阿替洛尔、氢氯噻嗪、硝苯地平检测浓度的线性范围分别为10～250(r=0.9994)、6～150(r=0.9996)、5～125μg·mL-1(r=0.9992),平均回收率分别为99.95%、99.68%、99.42%,RSD分别为1.41%、1.55%、1.38%;该制剂体外释放行为符合Higuchi方程,8h累积释放度>80%。结论:该制剂制备工艺简便,缓释效果理想,质量可控。
OBJECTIVE： To prepare Compound Xueyaan sustained-release tablet and establish a method for its quality control. METHODS：Compound Xueyaan sustained-release tablet was prepared with hydroxy propyl methyl cellulose as main adjuvants and atenolo, hydrochlorothiazide and nifedipine as main ingredients. The content of three main ingredients and in vitro dissolution were determined by HPLC. RESULTS： The preparation manifested faint yellow tablet and its identification and test was in line with standards specified in Chinese Pharmacopeia （2005 edition）. The linear ranges of atenolol, hydrochlorothiazide and nifedipine in Compound Xueyaan sustained-release tablet were 10-250 ug.mL^-1（r=0.999 4）, 6-150ug·mL^-1（r=0.999 6） and 5-125ug.mL^-1 （r=0.999 2）, respectively. The mean recovery of all compounds were 99.95%（RSD=1.41%）, 99.68%（RSD=l.55%）、99.42% （RSD= 1.38%）, respectively. CONCLUSION：The preparation technology is simple and convenient. The preparation assumed satisfied sustained-release and controllable in quality.
出处
《中国药房》
CAS
CSCD
北大核心
2010年第1期64-66,共3页
China Pharmacy
