更昔洛韦凝胶剂的制备及基本性质考察
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文章编号:(2004)06-0124-05,更昔洛韦凝胶剂的制备及基本性质考察
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耿海明1, 关佩沛2, 李乐道2,苏德森2, 王思玲2
(1. 武汉武药科技有限公司,湖北 武汉 430000 ;2. 沈阳药科大学 药学院,辽宁 沈阳 110016)
摘要:目的 研究更昔洛韦凝胶剂的制备及其基本性质。方法 以卡波姆940为凝胶基质,采用增溶与助溶手段,紫外分析法与高效液相色谱法。结果 紫外扫描显示,更昔洛韦原料在254.2 nm处有最大吸收; HPLC测定显示,在3.842~15.296 mg·L-1 内药物质量浓度与峰面积线性关系良好(ρ=1×10-5A+0.455 6,r2=0.999 9 );所制备的更昔洛韦凝胶剂在高热、低温及离心条件下稳定性
良好。结论 更昔洛韦凝胶剂制备工艺简单,性质稳定,质量控制方法可行。
关键词:药剂学;凝胶剂;增溶;更昔洛韦;卡波姆;基本性质;制备
Preparation and properties of ganciclovir (GCV) gel
Geng Hai-ming1, Guan Pei-pei2, Li Le-dao2, Su De-sen2, Wang Si-ling2
(1. Wuhan Wuyao Science & Technology CO.,Ltd., Wuhan Hubei 430000;2. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang Liaoning 110016)
Abstract: Objective To study the preparation and basic properties of GCV gel. Methods Carbopol 940 was used as the gel matrix, and the GCV gel was prepared by means of solubilization and cosolvent. UV spectrometry and HPLC methods were applied to study the basic properties of GCV gel. Results UV scanning indicated that GCV’s max absorption was at 254.2 nm. HPLC method, used to detect GCV concentration, had a great linearity between drug concentration and the area of peak (ρ=1×10-5A+0.455 6,r2=0.999 9). The GCV gel was stable at high or low temperature, and stable under centrifugation. Conclusions The preparation of GCV gel is simple, and prepared preparation is stable and quality controllable.
Key words: pharmaceutics; gel; solubilization; ganciclovir; carbopol; properties; preparation
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