CAJ | 학술논문

目的：研究绵羊血浆法检测肝素钠效价的影响因素和改进方法。方法参照羊血浆法，研究测定过程产生气泡、样品中的固形物、样品pH值、NaCl浓度对肝素钠效价测定的影响。结果气泡对效价测定的影响较小，固形物是影响效价测定主要因素，含固形物酶解液的效价为（2.87±0.01） U／mL，除去固形物后的效价为24.60 U／mL，提升了约8.5倍。去除固形物的样品，pH为7.5～9.5时对效价测定影响不大，pH在6.5与7.0时，对效价的测定影响较小；而样品中存在固形物时，表现出随着样品pH的上升，效价也上升，样品在pH 9.0时的效价是样品在pH 6.5时的3.4倍。酶解液固形物主要为：蛋白47.86％、NaCl 39.16％、脂肪4.12％，其中蛋白主要为小分子多肽占91.34％。 NaCl浓度对样品测定没有影响，小分子多肽是影响效价测定主要因素。该改进方法回收率在98.92％～101.53％之间。结论改进方法可靠，通过测定值计算出的肝素钠产值与实际生产过程中的肝素产值一致。该方法可用于肝素钠生产过程每个环节中肝素效价的测定。
목적：연구면양혈장법검측간소납효개적영향인소화개진방법。방법삼조양혈장법，연구측정과정산생기포、양품중적고형물、양품pH치、NaCl농도대간소납효개측정적영향。결과기포대효개측정적영향교소，고형물시영향효개측정주요인소，함고형물매해액적효개위（2.87±0.01） U／mL，제거고형물후적효개위24.60 U／mL，제승료약8.5배。거제고형물적양품，pH위7.5～9.5시대효개측정영향불대，pH재6.5여7.0시，대효개적측정영향교소；이양품중존재고형물시，표현출수착양품pH적상승，효개야상승，양품재pH 9.0시적효개시양품재pH 6.5시적3.4배。매해액고형물주요위：단백47.86％、NaCl 39.16％、지방4.12％，기중단백주요위소분자다태점91.34％。 NaCl농도대양품측정몰유영향，소분자다태시영향효개측정주요인소。해개진방법회수솔재98.92％～101.53％지간。결론개진방법가고，통과측정치계산출적간소납산치여실제생산과정중적간소산치일치。해방법가용우간소납생산과정매개배절중간소효개적측정。
Objective To study on the factors of sheep plasma method detect heparin potency and improved methods.Methods Acorrding to sheep plasma method, to study the bubbles, solids, pH and NaCl concentration on the heparin potency determination.Results The bubbles impact on the heparin potency determination was less.Solids were the main factors on heparin potency determination, containing solids protein hydrolysates heparin potency determination was (2.87 ± 0.01 ) U/mL, after removing solids potency was 24.60 U/mL, raised about 8.5 times.In the removed solids sample, when pH 7.5 to 9.5 had little effect on heparin potency determination, and pH 6.5 and 7.0 had smaller effect on the heparin potency determination.The presence of solids in the sample, as the sample pH rised, heparin potency determination also rised, at potency of sample at pH 9.0 was 3.4 times than that at pH 6.5.Enzymatic hydrolyzate mainly contain: 47.86% protein, 39.16% NaCl, 4.12% fat, wherein the protein was 91.34% of small peptides.NaCl concentration had no effect on the heparin potency determination.The improved method of recovery assay value was 98.92%~101.53%.Conclusion The method is reliable, the heparin output value calculated by measuring value in accordance with the process of practical production output.This method can be used for the determination the production process of each link in heparin potency of heparin.