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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 lysine vasopressin national standards. Methods Based on the WHO first international standards of lysine vasopressin provided by the National Institute for Biological Standards and Control (NIBSC), four laboratories were selected and two Chinese Pharmacopoeia (2010 edition) Appendix ⅫA vasopressin bioassay for the first batch of lysine vasopressin national standard pending test biological titer collaborative calibration and comparison of the two main peak of high performance liquid chromatography (HPLC) retention Time; in accordance with the “Chinese Pharmacopoeia” two (2010 edition) appendix Ⅷ M moisture determination method, the first method (Fei Hus method) B. Coulometric titration method for the first batch of lysine vasopressin national standards pending Moisture content. Results The first batch of lysine vasopressin standard products to be screened by the collaboration, to determine the biological potency of 4.0 IU / support; its main peak HPLC retention time consistent with the first batch of lysine vasopressin international standards ; Its moisture content is 2.9%. Conclusion This batch of standard goods can be used as the first batch of lysine vasopressin national standards for the determination of vasopressin, vasopressin identification and the use of substances.