保元咀嚼片的制备及其抗疲劳作用评价  

Preparation of Baoyuan Chewable Tablets and Evaluation of Its Anti-fatigue Effect

作　　者：刘漫 杨颖 嵇晶[1] 刘陶世[1] 程建明 LIU Man;YANG Ying;JI Jing;LIU Taoshi;CHENG Jianming(Jiangsu Province Engineering Research Center of Famous Classical Formulas,School of Pharmacy,Nanjing University of Chinese Medicine,Nanjing 210023,China)

机构地区：[1]南京中医药大学药学院,江苏省经典名方工程研究中心,南京210023

出　　处：《中国实验方剂学杂志》2023年第22期128-135,共8页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：江苏省自然科学基金面上项目(BK20181424)。

摘　　要：目的:筛选保元咀嚼片的制备工艺并初步探究其抗疲劳作用及机制。方法:以挥发油包合率、浸膏得率、人参皂苷和甘草酸等有效成分提取率等为指标,采用单因素和正交试验设计优选保元咀嚼片的挥发油包合工艺、水煎煮工艺和制剂成型工艺。ICR小鼠随机分为空白组、模型组、高山红景天口服液组(6.01 mL·kg^(-1))、保元咀嚼片低、中、高剂量(2.1、4.2、8.4 g·kg^(-1)),每组8只,每日按相应剂量灌胃给药1次,空白组和模型组给予等体积生理盐水,持续15 d,末次给药30 min后在小鼠尾部负重体质量5%的铅负荷,游泳至力竭建立疲劳模型,并记录各组小鼠负重游泳时间,同时对小鼠肌肉组织切片,苏木素-伊红(HE)染色并进行病理观察,测定血清中血尿素氮(BUN)、乳酸(LA)、肝糖原(LG)的水平,乳酸脱氢酶(LDH)和肌酸激酶(CK)的活性。结果:保元咀嚼片中肉桂挥发油的最佳包合工艺为主客比(β-环糊精-挥发油)10∶1,采用饱和水溶液法50℃包合2 h;最佳水提工艺为煎煮2次,首次加10倍水煎煮50 min,再次加9倍水煎煮40 min;保元汤提取物与微晶纤维素、麦芽糊精、蔗糖、甘露醇、柠檬酸、硬脂酸镁比例为63∶13∶8∶17∶17∶1∶1,采用湿法制粒压片,每片1.2 g,硬度为60~80 N。与模型组比较,保元咀嚼片低、中、高剂量组均能明显延长小鼠负重游泳至力竭的时间(P<0.05),提高机体的运动耐力,HE染色结果表明保元咀嚼片各剂量组均能明显改善由运动导致的肌肉组织损伤,显著降低血清BUN、LA的水平(P<0.01),和血清LDH、CK的活性(P<0.01),并明显提高LG含量(P<0.05,P<0.01)。结论:筛选所得保元咀嚼片制备工艺稳定可行,该制剂可通过增加肝组织中LG水平以提高运动耐力、加速清除体内的LA以缓解肌肉酸痛、降低CK和LDH活力以发挥抗疲劳作用。Objective:To screen the preparation technology of Baoyuan chewable tablets and to preliminarily elucidate its anti-fatigue effect and mechanism.Method:Taking encapsulation rate of volatile oil,extract rate and extraction rate of active ingredients as indexes,single factor test and orthogonal test were used to optimize the volatile oil inclusion,aqueous decoction and formulation molding processes of Baoyuan chewable tablets.ICR rats were randomly divided into the blank group,model group,Gaoshan Hongjingtian oral liquids group(6.01 mL·kg^(-1))and and Baoyuan chewable tablets low,medium,and high dose groups(2.1,4.2,8.4 g·kg^(-1)),8 mice in each group,and were administered by gastric gavage at the corresponding dose once a day,the blank and model groups were given equal volume of saline for 15 d.After the last administration for 30 min,the mice were loaded with 5%of the body mass of lead at the tail and swam until exhaustion to establish the fatigue model,and the weighted swimming time of the mice in each group was recorded,meanwhile,the muscle tissues of the mice were sliced,stained by hematoxylin-eosin(HE)and subjected to pathological observation,and the levels of blood urea nitrogen(BUN),lactic acid(LA),liver glycogen(LG),activities of lactate dehydrogenase(LDH)and creatine kinase(CK)in the serum were determined.Result:The optimal inclusion process of cinnamon oil in Baoyuan chewable tablets was 10∶1 forβ-cyclodextrin-volatile oil,and inclusion at 50℃for 2 h with saturated aqueous solution method.The optimal water extraction process was to extract twice,adding 10 times of water to extract for 50 min for the first time,and adding 9 times of water to extract for 40 min for the second time.The ratio of the extract of Baoyuan chewable tablets with microcrystalline cellulose,maltodextrin,mannitol,citric acid,magnesium stearate was 63∶13∶8∶17∶17∶1∶1,the tablets were pressed by wet granulation,the each tablet weight was 1.2 g,and the hardness was 60-80 N.Compared with the model group,Baoyuan chewable t

关 键 词：保元汤 咀嚼片 制备工艺 抗疲劳作用 药效评价 高山红景天口服液 酶活性 

分 类 号：R22[医药卫生—中医基础理论] R28[医药卫生—中医学] R94[理学—分析化学] O657[理学—化学]