目的 比较血脂宁及其拆方组合对正常小鼠急性毒性影响,探讨组方配伍规律,为临床合理使用该方提供实验依据.方法 参照方剂配伍结构、单味药功效、降脂作用特点3个层面将血脂宁拆分为7个组合,即决明子+山楂(组合1)、决明子+荷叶(组合2)、决明子+制何首乌(组合3)、制何首乌+荷叶(组合4)、决明子+山楂+荷叶(组合5)、决明子+山楂+制何首乌(组合6)、决明子+山楂+荷叶+制何首乌(组合7),运用经典急性毒性实验方法,进行血脂宁及不同拆方组合对正常小鼠急性毒性实验比较研究.结果 7个组合全组分的最大给药量(MFD)为39.60、34.80、42.00、21.60、37.20、38.40、39.60 g·kg-1,分别相当于临床70 kg人每kg体重日用量的19.05、14.87、16.15、11.87、12.49、12.31倍、10.15倍,水提组分MFD为192.00、320.40、192.00、300.00、218.40、177.60、192.00 g·kg-1,分别相当于临床70 kg人每kg体重日用量的92.31、136.92、73.85、164.84、73.36、56.92、49.23倍,各组合全组分毒性大小顺序为:组合4>组合2>组合5>组合6>组合1≈组合7>组合3;水提组分毒性大小顺序为:组合6>组合1≈组3≈组合7>组合5>组合4>组合2.小鼠的急性毒性症状主要有:精神不佳、怠动、俯卧.结论 上述各组合急毒结果小于实验室前期报道的决明子、何首乌的急毒结果,提示按照中医组方结构进行配伍的血脂宁不同拆方组合,均能减轻决明子、何首乌的急毒程度,印证了中医配伍在安全性控制上的科学性与合理性,其配伍减毒机制有待于后续深入研究.%Objective To compare the acute toxicity of Xuezhining and its separated prescriptions in mice and to explore the mechanism of prescription compatibility, so as to provide a foundation for safe and rational drug use in clinic. Methods Xuezhining was divided into seven combinations by referring to the combination of prescription, single flavor and the characteristics of lipid lowering effect, namely Cassiae Semen and Crataegi Fructus (group 1), Cassiae Semen and Nelumbinis Folium (group 2), Cassiae Semen and Polygoni Multiflori Radix Praeparata (group 3), Polygoni Multiflori Radix Praeparata and Nelumbinis Folium (group 4), Cassiae Semen and Crataegi Fructus and Nelumbinis Folium (group 5), Cassiae Semen and Crataegi Fructus and Polygoni Multiflori Radix Praeparata (group 6), Cassiae Semen and Crataegi Fructus and Polygoni Multiflori Radix Praeparata and Nelumbinis Folium (group 7). The classical method of acute toxicity was used to compare the difference of acute toxicity among Xuezhining and its separatedprescriptions. Results The maximum dosage (MFD) of all components of seven groups were respectively 39.60, 34.80, 42.00, 21.60, 37.20, 38.40 and 39.60 g·kg -1, which were respectively equal to 19.05, 14.87, 16.15, 11.87, 12.49, 12.31 and 10.15 times of the clinical daily dosage in 70 kg humans. The MFD of water extracted components of all groups referred were respectively 192.00, 320.40, 192.00, 300.00, 218.40, 177.60 and 192.00 g·kg-1, which were respectively equal to 92.31, 136.92, 73.85, 164.84, 73.36, 56.92 and 49.23 times of the clinical daily dosage in 70 kg humans. The sequence of acute toxicity of all-components of all groups is group 4>group 2>group 5>group 6>group 1≈group 7>group 3; The sequence of acute toxicity of water extracted components of all groups is group 6>group 1≈group 3≈group 7>group 5>group 4>group 2. The main acute toxicity symptoms and signs are poor spirit, negligent action and prostrate. Conclusion The results of the acute toxicity of combinations mentioned above were less than Cassia Semen and Polygoni Multiflori Radix Praeparata which were previously reported in laboratory. It is suggested that the separated prescriptions of Xuezhining which divided according to the prescription structure of traditional Chinese medicine can reduce the degree of acute toxicity of Cassiae Semen and Polygoni Multiflori Radix Praeparata. It also proved that the compatibility of traditional Chinese medicine in safety control is scientific and reasonable. The mechanism of detoxification should be further researched.
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