文章摘要
梁美美,朴晋华,连云岚,董培智,党爱华,王婷婷.基于生物活性方法对不同基原地龙质量评价研究[J].中国药品标准,2019,(4):319-324
基于生物活性方法对不同基原地龙质量评价研究
ComparativeSStudySonSfibrinolyticSactivitySofSLumbricusSfromSDifferentSOrigins
投稿时间:2019-04-02  修订日期:2019-06-27
DOI:
中文关键词: 地龙  纤维蛋白原  蚓激酶  生物效价  基原
英文关键词: lumbricum  Fibrinogen  Earthworm Kinase  Biovalence  origin
基金项目:活血化瘀类中药生物活性测定方法建立协作试验(药典标准提高任务)
作者单位E-mail
梁美美 山西中医药大学 榆次 marypiao@126.com 
朴晋华 山西省食品药品检验所 marypiao@126.com 
连云岚 山西省食品药品检验所 太原  
董培智 山西省食品药品检验所 太原  
党爱华 山西中远威药业有限公司 太谷  
王婷婷 山西省食品药品检验所 太原  
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中文摘要:
      目的:对不同来源不同炮制方法地龙药材进行生物活性质量评价。方法:对纤维蛋白平板法进行方法学考察,并以蚓激酶作为对照,分别测定不同来源不同炮制方法的地龙的纤溶活性。结果:不同批号的凝血酶测定药材效价RSD值为1.71%,不同纤维蛋白原测定药材效价RSD值为1.53%。线性:点样量在12.5~400U范围内,回归方程Y=0.9824X+97.651,R2=0.9531。回收率为86.16%,RSD为9.65%,精密度试验RSD为0.98%,地龙药材的纤溶酶在低于60度时稳定。结论:该方法快速准确,具有高通量,操作简便,精密度好,可作为地龙药材的纤溶活性评价方法。不同来源,不同炮制方法的地龙效价差异很大。随着温度的升高,地龙的活性呈下降趋势,提示在炮制和储运过程中应注意温度对活性的影响。炮制方式中以冻干处理效价最高。
英文摘要:
      Abstract Objective: to evaluate the biological activity quality of Lumbricus from different bases and processed products. Methods: The method of fibrin plate method was studied, also,Lumbrokinase as control ,the titer of the different sources and different processing was determined. Results: The RSD value of thrombin in different batches was 1.71%, and that of fibrinogen in different batches was 1.53%. Linearity: The sample size ranged from 12.5 to 400U, the regression equation Y = 0.9824X + 97.651, R2 = 0.9531. The recovery rate was 86.16%, RSD was 9.65% and RSD was 0.98% in precision test. The sample was stable at lower than 60 degrees, and the fibrinolytic activity of several batches of earthworm medicinal materials was obtained. Conclusion: The method is rapid, accurate, high throughput, simple and accurate, and can be used as a biological quality evaluation method for earthworm. The titer of earthworms from different sources and processing methods varies greatly. With the increase of temperature, the activity of earthworm decreased, suggesting that attention should be paid to the effect of temperature on the activity during processing and storage. The freeze-drying treatment had the highest potency among the processing methods.
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