目的 建立首批HPLC含量測定用縮宮素國家標(biāo)準(zhǔn)品。方法 第3批縮宮素國家標(biāo)準(zhǔn)品采用凍干制備。使用核磁共振和HPLC法對縮宮素進(jìn)行結(jié)構(gòu)確證；采用HPLC法測定待標(biāo)品的質(zhì)量分?jǐn)?shù)，并測定待標(biāo)品水分及氨基酸比值；以縮宮素USP對照品為標(biāo)準(zhǔn)，采用HPLC外標(biāo)法和大鼠子宮法分別測定待標(biāo)品的生物效價。結(jié)果 經(jīng)核磁共振和HPLC法確證縮宮素的結(jié)構(gòu)；待標(biāo)品水分含量為4.8%，各氨基酸比值均在限度范圍內(nèi)，經(jīng)HPLC檢測質(zhì)量分?jǐn)?shù)為99.69%；待標(biāo)品經(jīng)HPLC法測定每支含量為274 IU，經(jīng)大鼠子宮法測定每支含量為275 IU。結(jié)論 建立的待標(biāo)品可作為第3批縮宮素國家標(biāo)準(zhǔn)品，供縮宮素效價測定及鑒別使用。

Objective To establish the first batch of national standard of oxytocin for high performance liquid chromatography (HPLC). Methods This batch of standard is prepared by freeze-drying. The structure of oxytocin was confirmed by NMR and HPLC. HPLC was used to determine the purity of the standard, moreover the water and amino acid ratio of the standard were determinated. The biological potency of oxytocin was determined by HPLC external standard method and rat uterus method against the oxytocin USP reference standard. Results The structure of oxytocin was confirmed by NMR and HPLC. The water content of the standard sample was 4.8%, the ratio of each amino acid was within the limit, and the mass fraction is 99.69% by HPLC. The content of oxytocin national standard was 274 IU per ampoule by HPLC and 275 IU per ampoule by rat uterus method. Conclusion This batch of standard substance can be used as the first batch of oxytocin national standard for HPLC content determination for oxytocin potency determination and HPLC identification.

R921.2