喷昔洛韦中空栓的制备及质量控制

Preparation and Quality Control of Penciclovir Hollow Suppository

目的:制备喷昔洛韦中空栓并建立其质量控制方法。方法:用热溶法制备中空栓剂;采用高效液相色谱法测定其中喷昔洛韦的含量,并考察其稳定性。结果:所制制剂为乳白色中空栓,检查符合2005年版《中国药房》中的相关规定;喷昔洛韦检测浓度的线性范围为5.00～100.00μg.mL-1(r=0.9997);平均回收率为98.69%(RSD=0.81%);室温、避光保存1a,其各项检测指标均无明显变化。结论:该制备工艺简便、可行,质量控制方法操作快速,结果准确可靠。

OBJECTIVE： To prepare penciclovir hollow suppository and establish its quality control method. METHODS： Penciclovir hollow suppository was prepared by heat- melting method. The content of penciclovir was determined by HPLC and the stability of the suppository was investigated as well. RESULTS： The preparation was ivory yellow hollow suppository and its property fitted the description of Chinese Pharmacopeia （2005 edition） . The linear range of penciclovir was 5.00-- 100.00 μg·mL^-1（ r = 0.999 7）, and its average recovery was 98.69% （RSD =0. 81% ）. No obvious change was noted for the property of the suppository within 1 year storage under temperature away from light. CONCLUSION： The preparation tech nique of the penciclovir hollow suppository is simple and feasible, its quality control method is rapid in operation and its de- termination result is accurate and reliable.