复方红黄口含片成型工艺优化及其耐缺氧作用研究  

Molding process optimization and hypoxia resistance effect of Compound Honghuang Buccal Tablets

作　　者：李婉玉 李琳 马慧萍[3] 鲁艳梅 石晓峰 张朋朋[1,3] 张家旭 董学凤 叶倩女 LI Wan-yu;LI Lin;MA Hui-ping;LU Yan-mei;SHI Xiao-feng;ZHANG Peng-peng;ZHANG Jia-xu;DONG Xue-feng;YE Qian-nu(College of Pharmacy,Gansu University of Chinese Medicine,Lanzhou 730000,China;Gansu Provincial Academy of Medical Sciences,Lanzhou 730050,China;Key Laboratory for Prevention and Treatment of Plateau Injury,Department of Pharmacy,The Ninety-fourth Hospital of Chinese People’s Liberation Army,Lanzhou 730050,China)

机构地区：[1]甘肃中医药大学药学院,甘肃兰州730000 [2]甘肃省医学科学研究院,甘肃兰州730050 [3]中国人民解放军联勤保障部队第九四○医院药剂科全军高原损伤防治重点实验室,甘肃兰州730050

出　　处：《中成药》2022年第6期1731-1737,共7页Chinese Traditional Patent Medicine

基　　金：2017年度甘肃省兰州市人才创新创业项目(2017-RC-28)。

摘　　要：目的 优化复方红黄口含片成型工艺,并评价其耐缺氧作用。方法 以浸膏粉用量、填充剂比例、甜味剂用量、润湿剂体积分数、润滑剂用量为影响因素,外观、口感、硬度、崩解时间为评价指标,正交试验优化成型工艺。采用常压耐缺氧实验、亚硝酸钠中毒存活实验、急性脑缺血缺氧实验考察耐缺氧作用,检测小鼠脑组织氧化应激指标(T-SOD、GSH、CAT、T-AOC、MDA、H_(2)O_(2)、NO)。结果 最优条件为浸膏粉用量40%,填充剂(乳糖-微晶纤维素)比例3∶1,甜味剂(阿斯巴甜)用量1.0%,润湿剂(乙醇)体积分数80%,润滑剂(硬脂酸镁)用量0.5%,所得口含片色泽均匀,表面光滑,口感良好,硬度为62.81 N,崩解时间为18.5 min。与空白组比较,复方红黄口含片中、高剂量组常压耐缺氧存活时间延长(P<0.05,P<0.01),T-SOD活性升高(P<0.05);低剂量组T-AOC活性升高(P<0.05);高剂量组H_(2)O_(2)水平降低(P<0.05);各剂量组张口喘气次数增加(P<0.05,P<0.01),CAT活性升高(P<0.01),而亚硝酸钠中毒存活时间、GSH活性、MDA和NO水平比较,差异无统计学意义(P>0.05)。结论 该方法稳定可行,可用于制备耐缺氧作用较强的复方红黄口含片。AIM To optimize the molding process for Compound Honghuang Buccal Tablets and to evaluate the hypoxia resistance effect.METHODS With extract powder consumption,filler ratio,sweetener consumption,wetting agent concentration and lubricant consumption as influencing factors,appearance,taste,hardness and disintegration time as evaluation indices,the molding process was optimized by orthogonal test.The hypoxia resistance effect was investigated by atmospheric pressure hypoxia resistance test,sodium nitrite poisoning survival test and acute cerebral ischemia hypoxia test,after which oxidative stress indices(T-SOD,GSH,CAT,T-AOC,MDA,H_(2)O_(2),NO) in mouse brain tissues were detected.RESULTS The optimal conditions were determined to be 40% for extract powder consumption,3∶1 for filler(lactose-microcrystalline cellulose) ratio,1.0% for sweetener(aspartame) consumption,80% for wetting agent(ethanol) concentration,and 0.5% for lubricant(magnesium stearate) consumption,the obtained buccal tablets demonstrated uniform color,smooth surface and good taste,along with the hardness of 62.81 N and disintegration time of 18.5 min.Compared with the blank group,Compound Honghuang Buccal Tablets medium-dose and high-dose groups displayed prolonged survival time under normal pressure and hypoxia resistance(P<0.05,P<0.01) and increased T-SOD activity(P<0.05);the low-dose group displayed increased T-AOC activity(P<0.05);the high-dose group displayed decreased H_(2)O_(2) level(P<0.05);the various dose groups displayed elevated mouth opening and wheezing frequency(P<0.05,P<0.01) and increased CAT activity(P<0.01),while no significant differences were found in survival time poisoned by sodium nitrite,GSH activity and MDA,NO levels(P>0.05).CONCLUSION This stable and reliable method can be used for the preparation of Compound Honghuang Buccal Tablets with strong hypoxia resistance effect.

关 键 词：复方红黄口含片 成型工艺 耐缺氧作用 正交试验 

分 类 号：R944[医药卫生—药剂学]