摘要
目的:确定力达霉素的效价单位,并建立力达霉素效价测定方法。方法:采用DNA断裂法确定力达霉素标准品引起DNA断裂的最低浓度,并据此浓度确定力达霉素标准品的效价;采用HPLC法分析力达霉素效价与其发色团峰面积的相关性,用力达霉素发色团的峰面积表征力达霉素的效价,用HPLC法测定力达霉素的效价。结果:将首批力达霉素标准品引起pBR322 DNA断裂成Ⅲ型的最低剂量规定为10-4力达霉素单位(u),即每1 mg首批力达霉素标准品的效价为896 u;力达霉素效价与其发色团峰面积呈线性关系(r=0.9995),根据力达霉素发色团的峰面积可以确定力达霉素的效价。结论:本文采用的效价单位确定方法"溯源性"明确;采用HPLC法测定力达霉素的效价可以大大提高传统生物检定的精度。
Objective:To define potency unit of lidamycin and establish the potency determination method. Methods : The potency of primary reference standard for lidamycin were defined in terms of the minimum valid concentration which could break DNA strands in DNA strand - scission test. The correlation between lidamycin potency and peak area of lidamycin chromophore were analyzed by HPLC. Thus,the potency of lidamycin could be represented by the peak area of chromophore and assayed by HPLC. Results:The minimum valid quantity of the primary reference substance for lidamycin which could break pBR322 DNA strands to form Ⅲ was defined as 10 -4 Lidamycin -unit (u) ,namely the potency of the primary reference substance for lidamycin is 896 units per milligram. The correlation between lidamycin potency and the peak area of lidamycin chromophore is linearity (r =0. 9995) . The potency of lidamycin could be assayed by peak area of the chromophore in HPLC. Conclusion: The traceability of the method used to define potency unit in this paper is definite and the accuracy of using HPLC to assay the potency of lidamycin is improved greatly than that of using traditional bioassay.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2004年第5期543-546,共4页
Chinese Journal of Pharmaceutical Analysis
