摘要
目的 以甲壳素为主要基质制成以重组人角质细胞生长因子-2（rhKGF-2）为主要活性成分的新型制剂流体膜用于治疗烧烫伤促愈合．为该新制剂的质量标准制定可行的活性成分定量测定方法。方法 利用rhKGF-2的特异性抗体性质．采用酶联免疫法（间接ELISA法）测定其在该制剂中的含量．并进行了方法学验证。结果 制剂中其它成分不干扰rhKGF-2的测定；线性范围为0～9μg·mL^-1，回归系数为0．97．检测限度为0．56μg·mL^-1；批内和批间精密度均较高．CV％分别为2．0％，1．01％；回收率为99．1％。测定了3批试制品．平均含量为1．62μg·mL^-1。结论 本方法简便．准确．可用于该制剂中rhKGF-2的含量测定。
：Objective To establish a method for the determination of active ingredient in recombinant human keratinocyte growth factor 2 （rhKGF-2） in the liniment which matrix was mainly constituted by chitin, and to provide a feasible mensuration for quality control. Methods Based on the differential nature of antibody of rhKGF-2 , ELISA was established to determine the content of rhKGF-2 in the liniment, and was confirmed by methodology. Results It was proved that other ingredients in the preparation did not disturb the mensuration of rhKGF-2; the calibration curve was linear over the range of0～9μg· mL^-1, the regressioncoefficient was 0. 97, the limit of detection was 0. 56μg· mL^-1; the repeat experimentation CV% was 2.0%4, and the intermediate precision CV% was 1.01% ; the average recovery was 99.1%. Mensurating three batches of trial manufactures, average content for 1. 62μg· mL^-1. Conclusion This method was simple, accurate and could be used in determination of the rhKGF-2 content in this preparation.
出处
《中国海洋药物》
CAS
CSCD
2006年第4期43-45,共3页
Chinese Journal of Marine Drugs
基金
科技部国家重大专项(863)"创新药物和中药现代化"专项基金资助(No.2004AA2Z3141)
