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复方人参健体方的处方优化及其抗疲劳活性和急性毒性研究
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| 篇名： | 复方人参健体方的处方优化及其抗疲劳活性和急性毒性研究 |
| TITLE： | Formulation Optimization of Compound Renshen Jianti Formulation and Study on Its Anti-fatigue Activity and Acute Toxicity |
| 摘要： | 目的：优化复方人参健体方4种组方药材（人参、山药、枸杞子、益智仁）的配比，并考察其抗疲劳活性及急性毒性。方法：通过水提取、浓缩、减压干燥制备复方人参健体方水提物。采用单因素试验，以小鼠负重游泳时间为指标，考察人参、山药、枸杞子、益智仁的处方量等4个因素的影响。在单因素试验的基础上，以小鼠负重游泳时间和运动后血清尿素氮含量、肝糖原含量和血乳酸曲线下面积的综合评分为评价指标，采用Box-Behnken响应面法优化处方配比。将小鼠分为空白对照组（水）、阳性对照组（人参红景天胶囊，0.135g/kg）和复方低、中、高剂量组[最优配比复方人参健体方提取物（以下简称“优化复方”）4.08、8.16、12.24g/kg，以生药量计]，灌胃给药或水20mL/kg，每日1次，连续30d。以给药后小鼠的负重游泳时间和运动后血清尿素氮含量、肝糖原含量和血乳酸曲线下面积的综合评分验证优化复方的抗疲劳活性；同时，以复方中剂量组小鼠的测定数据计算综合评分，比较其与理论预测值的差距。对小鼠灌胃优化复方（总剂量为16.00g/kg，以提取物计），连续14d观察并记录小鼠的一般状态、体质量变化、中毒特征以及死亡情况等，并测定半数致死量（LD50）和最大耐受剂量（MTD）。结果：复方人参健体方的最优处方配比为人参1.5g、山药10g、枸杞子10g、益智仁3g。抗疲劳活性验证试验显示，优化复方较空白对照组可显著延长小鼠负重游泳时间，降低血清尿素氮含量和血乳酸含量及曲线下面积（低剂量组除外），提高肝糖原含量（P＜0.05或P＜0.01）；且复方中剂量组的综合评分平均值为96.95分，与理论预测值97.01分仅相差0.06％。急性毒性实验显示，小鼠均未见死亡现象发生，优化复方的经口MTD均大于15g/kg，属无毒级。结论：优化的复方人参健体方对小鼠具有显著的抗疲劳活性，且未见明显毒副作用。 |
| ABSTRACT： | OBJECTIVE：To optimi ze the ratio of four comp onents of Compound renshen jianti formulation （Panax ginseng ， Dioscorea oppositifolia ，Lycium barbarum fruit，Alpinia oxyphylla ），and to investigate its anti-fatigue activity and acute toxicity. METHODS：The water extract of Compound renshen jianti formulation was prepared by water extraction ，concentration and decompression drying. By single factor tests ，using weight-bearing swimming time as index ，the effects of four factors were investigated，such as the amount of P. ginseng ，D. oppositifolia ，L. barbarum fruit，A. oxyphylla . On the basis of single factor tests，using comprehensive score of weight-bearing swimming time ，serum urea nitrogen content ，liver glycogen content and AUC of blood lactate after exercise as index ，the formulation was optimized by Box-Behnken response surface method. The mice was divided into blank control group （water），positive control group （Renshen hongjingtian capsules ，0.135 g/kg）and compound low-dose，medium-dose and high-dose groups [the optimal ratio of Compound renshen jianti formulation extract （called“optimal compound formulation ”for short ）4.08，8.16，12.24 g/kg，by crude drug] ，intragastric administration of drug or distilled water 20 mL/kg，once a day ，for consecutive 30 d. The weight-bearing swimming time ，the contents of serum urea nitrogen ，liver glycogen and blood lactate AUC after exercise were used to optimize its anti-fatigue activity of optimal compound formulation. The comprehensive score was calculated based on the measured data of mice in the compound formulation middle-dose group ， and the difference between it and the theoretical prediction value was compared. The mice were given optimal compound formulation intragastrically （total dose 16.00 g/kg， by extract）. The general state ， body mass change ， toxic characteristics and death of mice were observed and recorded for 14 days. Median lethal dose （LD50）and maximum tolerated dose （MTD）were measured. RESULTS ：The optimal formulation ratio of Compound renshen jianti formulation included that P. ginseng 1.5 g，D. oppositifolia 10 g，L. barbarum fruit 10 g，A. oxyphylla 3 g. Results of anti-fatigue activity validation test showed that the optimal compound formulation could significantly prolonged weight-bearing swimming time ，reduced serum content of urea nitrogen ，blood lactate content and its AUC （except for low-dose group ），while significantly increased the content of liver glycogen （P＜0.05 or P＜0.01）. Average comprehensive score of medium-dose group was 96.95，which was only 0.06％ different from the theoretical prediction value of 97.01. The results of acute toxicity test showed that there was no death in mice. The oral MTD of the optimal compound formulation was more than 15 g/kg，which was non-toxic. CONCLUSIONS ：The optimal Compound renshen jianti formulation has effective anti-fatigue activity of mice ，and has no significant toxic effect. |
| 期刊： | 2020年第31卷第08期 |
| 作者： | 睢博文，马翠霞，苗磊，王苗，张荣榕，马馨桐，赵大庆，邵帅，严铭铭 |
| AUTHORS： | SUI Bowen，MA Cuixia， MIAO Lei，WANG Miao，ZHANG Rongrong，MA Xintong，ZHAO Daqing，SHAO Shuai，YAN Mingming |
| 关键字： | 复方人参健体方；Box-Behnken响应面法；处方筛选；抗疲劳；安全性；小鼠 |
| KEYWORDS： | Compound renshen jianti formulation ； Box-Behnken response surface method ； Formulation screening ； |
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