伊曲康唑凝胶剂的制备及稳定性考察
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文章编号：(2004)06-0134-05,伊曲康唑凝胶剂的制备及稳定性考察
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李 飞1, 齐晓飞2，李乐道1，马明欣1，王思玲1，苏德森1
(1.沈阳药科大学 药学院，辽宁 沈阳 110016； 2.辽宁省药品检验所，辽宁 沈阳 110023 )
摘要：目的 制备伊曲康唑凝胶剂并考察其稳定性。方法 以卡波姆-940为凝胶剂基质制备伊曲康唑凝胶剂，采用HPLC法测定伊曲康唑含量，通过初步稳定性实验考察伊曲康唑凝胶剂的稳定性。结果 制得制剂均匀，分散性好；在2.40～24.00 mg·L-1 内线性
关系良好，线性回归方程为A=77 017ρ+1 227.9，r=0.999 9，平均回收率为100.70 %；在光照、高温和离心条件下，制剂无沉积、合并、分层，药物含量也无明显变化。结论 该制剂制备工艺简单，质量可控，物理化学性质稳定。
关键词：药剂学；凝胶剂；高效液相色谱法；伊曲康唑；稳定性
中图分类号：R94 文献标识码：A
Study on the preparation and stability of itraconazole gels
LI Fei1, QI Xiao-fei2, LI Le-dao1, MA Ming-xin1, WANG Si-ling1, SU De-sen1
(1. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China; 2. Liaoning Institute for Drug Control, Shenyang 110023, China)
Abstract: Objective To study the formulation and stability of itraconazole gels. Method Carbopol 940 was used as gel matrix to prepare itraconazole gels. A HPLC method was established to determine itraconazole concentration in the preparation. The preliminary stability experiments were carried out. Result A uniform preparation was obtained. The calibration curve were linear in the range 2.40～24.00 mg·L-1 . The regression equation was A=77 017ρ+1 227.9 (r=0.999 9). The average recovery for itraconazole was 100.70%. The result of stability experiments showed that no flocculation, coalescence or breaking was found under high temperature, light, or centrifugation. In the meanwhile, the drug content of the gels was not obviously changed. Conclusion The preparation process is simple and quality controllable. Physical and chemistry properties of the itraconazole gels are stable.
Key words: pharmaceutics; gel; HPLC; itraconazole; stability
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