中国药师
中國藥師
중국약사
China Pharmacist
2015年
11期
1848-1850
,共3页
核糖核酸Ⅰ%核糖核酸Ⅱ%核糖核酸Ⅲ%小鼠白细胞黏附抑制试验%免疫活力
覈糖覈痠Ⅰ%覈糖覈痠Ⅱ%覈糖覈痠Ⅲ%小鼠白細胞黏附抑製試驗%免疫活力
핵당핵산Ⅰ%핵당핵산Ⅱ%핵당핵산Ⅲ%소서백세포점부억제시험%면역활력
Ribonucleic acidⅠ%Ribonucleic acidⅡ%Ribonucleic acidⅢ%Leucocyte adherence inhibition test%Immunological activity
目的：：建立核糖核酸类药物免疫活力测定方法。方法：选用小鼠白细胞黏附抑制试验,对实验重要参数,如小鼠品系、药物作用浓度,黏附时间,缓冲液成分和细胞密度等进行探讨研究,初步建立了该类药物的免疫活力测定方法。并用该方法对核糖核酸Ⅰ、核糖核酸Ⅱ和核糖核酸Ⅲ各2批样品进行了免疫活力测定。结果：确定了适合该类产品免疫活力测定方法的实验参数：小鼠品系对实验结果无影响,药物作用浓度为10 mg·ml-1,黏附时间为2 h,缓冲液中必须含钙镁离子,细胞密度约为4×107个/ml。用该方法对该类产品进行免疫活力测定,3次重复实验,结果均合格,RSD均低于20%。结论：白细胞黏附抑制试验可作为评价核糖核酸类药物免疫活力的方法。
目的：：建立覈糖覈痠類藥物免疫活力測定方法。方法：選用小鼠白細胞黏附抑製試驗,對實驗重要參數,如小鼠品繫、藥物作用濃度,黏附時間,緩遲液成分和細胞密度等進行探討研究,初步建立瞭該類藥物的免疫活力測定方法。併用該方法對覈糖覈痠Ⅰ、覈糖覈痠Ⅱ和覈糖覈痠Ⅲ各2批樣品進行瞭免疫活力測定。結果：確定瞭適閤該類產品免疫活力測定方法的實驗參數：小鼠品繫對實驗結果無影響,藥物作用濃度為10 mg·ml-1,黏附時間為2 h,緩遲液中必鬚含鈣鎂離子,細胞密度約為4×107箇/ml。用該方法對該類產品進行免疫活力測定,3次重複實驗,結果均閤格,RSD均低于20%。結論：白細胞黏附抑製試驗可作為評價覈糖覈痠類藥物免疫活力的方法。
목적：：건립핵당핵산류약물면역활력측정방법。방법：선용소서백세포점부억제시험,대실험중요삼수,여소서품계、약물작용농도,점부시간,완충액성분화세포밀도등진행탐토연구,초보건립료해류약물적면역활력측정방법。병용해방법대핵당핵산Ⅰ、핵당핵산Ⅱ화핵당핵산Ⅲ각2비양품진행료면역활력측정。결과：학정료괄합해류산품면역활력측정방법적실험삼수：소서품계대실험결과무영향,약물작용농도위10 mg·ml-1,점부시간위2 h,완충액중필수함개미리자,세포밀도약위4×107개/ml。용해방법대해류산품진행면역활력측정,3차중복실험,결과균합격,RSD균저우20%。결론：백세포점부억제시험가작위평개핵당핵산류약물면역활력적방법。
Objective:To establish a method for determining the immunological activity of ribonucleic acid. Methods: Leucocyte adherence inhibition test ( LAI) was applied, and the important parameters of LAI including the mouse strain, drug concentration, treatment time, content of buffer solution and cell density were researched. The immunological activity of RNAⅠ, Ⅱand Ⅲ was re-spectively determined by the method. Results:Stable and reliable parameters were obtained: the sample concentration was 10 mg· ml-1 , the treatment time was 2 hours, Ca2+ and Mg2+ were necessary for the buffer solution, and the cell density was about 4 × 107 cell·ml-1 . The strain of mouse showed no effect on the results. As a result, the determination method for immunological activity was established. Using the method, the immunological activity of RNA Ⅰ,Ⅱand Ⅲ was determined 3 times, and the results met the re-quirements with RSD below 20%. Conclusion:The method is suitable for determining the immunological activity of RNA.
