秋水仙碱醇质体凝胶的制备及质量控制

Preparation and Quality Control of Colchicines Ethosomes Gel

目的:制备秋水仙碱醇质体凝胶并建立其质量控制方法。方法:以秋水仙碱为主药,采用注入法制备醇质体,研和法制备醇质体凝胶;采用紫外分光光度法测定其中秋水仙碱的含量,并测定包封率。结果:所制制剂为淡黄色透明凝胶,鉴别项符合2005年版《中国药典》中的相关规定;秋水仙碱检测浓度的线性范围为7.224～18.06μg·mL-1,平均回收率为102.63%(RSD=0.687%,n=3);包封率为(56.99±1.35)%。结论:本制剂制备工艺简便可行,质量稳定可控。

OBJECTIVE： To prepare colchicines ethosomes gel and to establish its quality control method. METHODS： Colchicine ethosomes were prepared by injection method with colchicines as chief agent, and the ehosome gel was prepared using mixing method. The content of colchicine was determined by UV- spectrometry and its encapsulation efficiency was determined. RESULTS： The preparation was yellowish transparent gel, with its property identification in line with the standard specified in Chinese Pharmacopeia （2005 Edition） . The linear range of colchicine was 7.224-18.06μg · mL ^-1 the average recovery was 102.63% （RSD = 0.687%, n = 3）, and the encapsulation efficiency was （56.99± 1.35）%. CONCLUSION： This gel is feasible in preparation technique, stable and controllable in quality.