赤芍配方颗粒与饮片对急性血瘀大鼠抗凝功能药理等效性研究  

Pharmacological Equivalence Research on Anti-coagulation Function between Dispensing-granule and Decoction Piece of Chishao(Paeoniae Radix Rubra)in Rats with Acute Blood Stasis

作　　者：黄雪君 赵新新 黄晓丹[3] 甘海宁 赵自明 黄奕霖 HUANG Xuejun;ZHAO Xinxin;HUANG Xiaodan;GAN Haining;ZHAO Ziming;HUANG Yilin(Guangdong Provincial Engineering Technology Research Institute of Traditional Chinese Medicine,Guangzhou 510095,Guangdong,China;Guangdong Provincial Key Laboratory of Traditional Chinese Medicine Research and Development,Guangzhou 510095,Guangdong,China;Guangzhou University of Chinese Medicine,Guangzhou 510405,Guangdong,China;Xinhua University of Guangzhou,Guangzhou 510520,Guangdong,China)

机构地区：[1]广东省中医药工程技术研究院,广东广州510095 [2]广东省中医药研究开发重点实验室,广东广州510095 [3]广州中医药大学,广东广州510405 [4]广州新华学院,广东广州510520

出　　处：《辽宁中医药大学学报》2024年第1期5-9,共5页Journal of Liaoning University of Traditional Chinese Medicine

基　　金：国家卫生计生委“重大新药创制”科技重大专项(2018ZX09301011-002)。

摘　　要：目的 探讨赤芍配方颗粒与赤芍饮片对急性血瘀大鼠抗凝功能的药理等效性。方法 大鼠灌胃给药不同剂量赤芍配方颗粒及同批次饮片煎液,复制急性血瘀模型后检测APTT、PT、TT,计算其抑制率并进行主成分分析。根据抑制率主成分建立曲线回归模型,确定合适的量效回归方程。比较两药等效应剂量及等剂量效应,分析两药的药理等效性。结果 模型组大鼠APTT、PT及TT均较空白组显著下降(P<0.01或P<0.05)。赤芍配方颗粒各剂量组APTT均较模型组显著升高(P<0.01或P<0.05);赤芍饮片2~8倍剂量组APTT较模型组显著升高(P<0.01或P<0.05)。赤芍配方颗粒及饮片8倍剂量组PT较模型组显著升高(P<0.05)。赤芍配方颗粒8倍剂量组TT较模型组显著升高(P<0.01)。根据剂量-效应进行曲线拟合后选择最合适的量效曲线方程,根据方程计算等效应剂量及等剂量效应,回归方程分别为:赤芍配方颗粒(g生药·kg^(-1))=0.382 1×DEE赤芍饮片(g生药·kg^(-1))+0.160 1及EED赤芍配方颗粒(%)=-0.029 8×EED赤芍饮片2(%)+3.894 5×EED赤芍饮片(%)-52.38。结论 在对应的效应范围内,1 g生药·kg^(-1)赤芍饮片对急性血瘀大鼠抗凝主成分抑制率效价约相当于0.382 1 g生药·kg^(-1)的赤芍配方颗粒,同剂量赤芍配方颗粒对急性血瘀大鼠抗凝主成分抑制率大于赤芍饮片。Objective To investigate the pharmacological equivalence on anti-coagulation function between dispensing-granule and decoction piece of Chishao(Paeoniae Radix Rubra).Methods Rats were given different doses of dispensing-granule and decoction piece of Chishao(Paeoniae Radix Rubra).After acute blood stasis model was made,APTT,PT and TT were detected,inhibition rate was calculated and principal component analysis was performed.According to the principal component of inhibition rate,a curvilinear regression model was established to determine the appropriate dose-effect regression equation.The pharmacological equivalence of the two drugs was analyzed by comparing the dose and effect.Results Compared with blank group,APTT,PT and TT in model group were significantly decreased(P<0.01 or P<0.05).Compared with model group,APTT was significantly increased in each dose groups of dispensing-granule(P<0.01 or P<0.05).APTT was significantly increased in 2 to 8 times dose groups of decoction piece(P<0.01 or P<0.05).The PT was significantly increased in the 8 times dosage group of dispensing-granule and decoction piece(P<0.05).TT was increased significantly in 8 times dosage group of dispensing-granule(P<0.01).After fitting the dose-effect curve,the most appropriate dose-effect curve equation was selected,and the equal-effect dose and equal-dose effect were calculated according to the equation.The regression equations were as follows:Formula granule of dispensing-granule(g·kg^(-1))=0.3821×DEE decoction piece(g·kg^(-1))+0.1601 and formula granule of dispensing-granule(%)=-0.0298×EED decoction piece 2(%)+3.8945×EED decoction piece(%)-52.38.Conclusion Within the corresponding effect range,the titer of 1 g·kg^(-1) decoction piece on inhibition rate in acute blood stasis rats is about equal to 0.3821 g·kg^(-1) dispensing-granule,and the inhibition rate of dispensing-granule in acute blood stasis rats is greater than that of decoction piece.

关 键 词：药理等效性 赤芍配方颗粒 赤芍饮片 抗凝 血瘀 

分 类 号：R285.5[医药卫生—中药学]