止血生物效价用于白及品质评价的研究

采用凝血酶时间(TT)将对照物质维生素K1注射液与白及参照物质进行对比检定,对白及参照物质进行标化,建立了白及体外测定凝血酶时间的生物活性测定方法,运用"量反应平行线法"(3.3)对不同产地的白及进行止血生物效价测定。白及参照物质量效之间具有良好的线性关系(Y=66.332-23.913X,R2=0.995 3),测得不同产地白及止血生物效价为821.93~1 187.53 U·g-1,并均能通过可靠性检验(偏离直线P>0.05,偏离平行P>0.05)。该方法仪器精密度(RSD3.8%)、中间精密度(RSD 4.6%)、重复性(RSD 3.2%)、稳定性(RSD 3.7%)较好,所建立的白及止血生物效价检测方法可靠,操作简便,重复性好,可用于白及止血生物效价的测定。

Quality evaluation of Bletillae Rhizoma based on hemostatic biopotency

This dissertation is to determine the biopotency of hemostat which processed in different places by establishing a bioassay method of Bletillae Rhizoma based on the thrombin time. Contrast test is the main methodology. Specifically, the reference substance of Bletillae Rhizoma is determined by comparing with the control substance of vitamin K₁ using thrombin time, which is calibrated the Bletillae Rhizoma. The hemostatic biopotency is calculated by using the method of "parallel line assay method based on quantitative responses"(3.3) from different processed products. It indicates that there is a strong linear correlation between Bletillae Rhizoma and control drugs(Y=66.332-23.913X, R²=0.995 3). The hemostatic biopotency of Bletillae Rhizoma from different processed products ranged between 821.93-1 187.53 U·g^-1 shown in the paper, and all of them can meet the requirements of the test. The methodology has an appropriate instrument precision (RSD 3.8%), intermediate precision (RSD 4.6%), repeatability(RSD 3.2%) and stability (RSD 3.7%). Therefore, it can be turned out that the methodology which established in the dissertation is good at determinating the hemostatic biopotency of Bletillae Rhizoma and it is reliable, simple and repeatable.