龙心素胶囊质量标准提高研究

目的研究提高龙心素胶囊的质量标准。方法用蚓激酶活性测定替代原标准第1项化学显色鉴别。引入蚓激酶标准品,采用生物统计的量反应平行线法统计计算效价,并对效价测定的琼脂糖纤维蛋白平板法进行了方法学研究。结果新的鉴别方法能反应蚓激酶的活性特征。效价测定的线性范围为8 250～33 000 U/mL(r=0.998 6),精密度RSD为4.71%;重复性RSD为6.54%;平均回收率(n=9)94.63%,RSD为7.69%;不同的溶剂对效价测定影响较小,阴性对照无干扰;供试品溶液在4℃下72 h内稳定。结论提高后的质量标准专属性强,准确性高,可控制测定方法的误差,能更有效地控制龙心素胶囊的质量。

Studies on quality of Longxinsu Capsules

Purpose To study the quality standard for Longxinsu Capsules.Methods Modifying the first chemical identification for Lumbrukinase activity determination.Using reference substance,the method of parallel line assay based on quantitative responses in statistical methods for biological assays was used in the statistics of potency assay.The agar-fibrin plate assay method for determination of Lumbrukinase potency in Longinsu Capsules was studied.Results The new identification method can reflect the activity characteristics of lumbrukinase.The linearity range was 8 250-33 000 U/mL(r=0.998 6),the RSD of accuracy tests was 4.71%,the RSD of repetitiveness tests was 6.54%,the average recovery rate was 94.63%(n=9) and the RSD of average recovery assays was 7.69%.The durability and specificity of assay accord with the requirement the solution of stable at 4 ℃ for 72 hours.Conclusion The improved quality standard is specific and accurate.It can control the error of the potency determination and can be used to effectively control the quality of Longxinsu Capsules.