摘要
目的制备第一批赖氨酸升压素国家标准品。方法以英国国家生物制品检定所(National Institute for Biological Standards and Control,NIBSC)提供的WHO第一批赖氨酸升压素国际标准品作为标准,选择4个实验室,采用《中国药典》二部(2010版)附录ⅫA升压素生物测定法对第一批赖氨酸升压素国家标准品待标品的生物效价进行协作标定,并比较二者的高效液相色谱(HPLC)主峰保留时间;按照《中国药典》二部(2010版)附录ⅧM水分测定法,第一法(费休氏法)B.库仑滴定法测定第一批赖氨酸升压素国家标准品待标品的水分含量。结果第一批赖氨酸升压素国家标准品待标品经协作标定,确定其生物效价为4.0 IU/支;其HPLC主峰保留时间与第一批赖氨酸升压素国际标准品一致;其水分含量为2.9%。结论本批待标品可作为第一批赖氨酸升压素国家标准品,以供赖氨酸升压素效价测定、鉴别及升压物质检查使用。
Objective To prepare the first batch of national standard for lysine vasopressin. Methods The biological potency of the first batch of candidate national standard for lysine vasopressin was collaboratively calibrated by four laboratories by the method in Appendix Ⅻ A in Chinese Pharmacopoeia（Volume Ⅱ,2010 edition）using the first batch of WHO international standard provided by National Institute for Biological Standards and Control（NIBSC）as standard.The retention times of main peaks of the two standards on HPLC profile were compared. The moisture content in national standard to be calibrated was determined by coulometric titration in Appendix Ⅷ M in Chinese Pharmacopoeia（VolumeⅡ,2010 edition）. Results The biological potency of the candidate national standard was defined as 4. 0 IU per container by collaborative calibration,while the retention time of main peak on HPLC profile was consistent with that of international standard,and the moisture content was 2. 9%. Conclusion The candidate may be used as the first batch of national standard for lysine vasopressin for determination of potency,identification and test for vasopressor substance.
出处
《中国生物制品学杂志》
CAS
CSCD
2014年第7期923-926,共4页
Chinese Journal of Biologicals
关键词
赖氨酸升压素
标准品
生物效价
高效液相色谱
Lysine vasopressin Standard Biological potency High performance liquid chromatography
