圣草酚咀嚼片的制备及质量评价  

Preparation and quality evaluation of Eriodictyol chewable tablet

作　　者：秦春梦 李文军 李辽平 刘杰 刘松青[1,2] QIN Chunmeng;LI Wenjun;LI Liaoping;LIU Jie;LIU Songqing(College of Pharmacy,Chongqing Medical University,Chongqing 400010,China;Dept.of Pharmacy,the Third Affiliated Hospital of Chongqing Medical University,Chongqing 401120,China;Chongqing Liyang Medical Pharmaceutical Development Co.,Ltd.,Chongqing 400050,China)

机构地区：[1]重庆医科大学药学院,重庆400010 [2]重庆医科大学附属第三医院药剂科,重庆401120 [3]重庆市力扬医药开发有限公司,重庆400050

出　　处：《中国药房》2024年第4期449-452,共4页China Pharmacy

基　　金：重庆市技术创新与应用发展专项面上项目(No.cstc2020jscx-msxmX0123)。

摘　　要：目的制备圣草酚咀嚼片,并对其进行质量评价。方法选择微晶纤维素(MCC)和甘露醇为填充剂,聚乙烯吡咯烷酮(PVP)为黏合剂,柠檬酸和三氯蔗糖为矫味剂,硬脂酸镁为润滑剂,以湿法制粒法制备咀嚼片;以各辅料的用量为因素,以外观、口感、风味、质地为指标对圣草酚咀嚼片进行综合评分,利用正交实验方法优选圣草酚咀嚼片的辅料配比,并对采用优选处方制得的圣草酚咀嚼片的外观性状、重量差异、硬度、脆碎度、圣草酚含量、溶出度、含量均匀度进行评价。结果最佳处方为圣草酚26.4%(每片含50 mg)、甘露醇45%、MCC 25%、柠檬酸0.3%、三氯蔗糖0.3%、硬脂酸镁1%、PVP 2%(以纯化水配制成5%的溶液)。处方验证实验中3批圣草酚咀嚼片的综合评分分别为8.76、8.75、8.80(RSD=0.30%,n=3)。制得的圣草酚咀嚼片外观完整,表面光洁;平均片重为192.57 mg,平均硬度为57.36 N,脆碎度为0.09%,平均每片圣草酚含量为50.74 mg,30 min累积溶出度超过80%,含量均匀度为5.51。结论本研究优化处方所制圣草酚咀嚼片符合2020年版《中国药典》的相关要求。OBJECTIVE To prepare the Eriodictyol chewable tablet and to evaluate its quality.METHODS The chewable tablet was prepared by the wetting granulation method by using microcrystalline cellulose(MCC)and mannitol as fillers,polyvinylpyrrolidone(PVP)as adhesive,citric acid and sucralose as flavor correction agents,magnesium stearate as lubricant.The comprehensive evaluation was conducted on Eriodictyol chewable tablets with the dosage of each excipient as a factor using the appearance,taste,flavor and texture as indicators.The ratio of excipients was optimized by orthogonal test,and the quality of Eriodictyol chewable tablets prepared by optimized formulation was evaluated in terms of appearance,weight difference,hardness,fragility,eriodictyol content,dissolution and content uniformity.RESULTS The optimal formulation was as follows:26.4%eriodictyol(50 mg each piece),45%mannitol,25%MCC,0.3%citric acid,0.3%sucralose,1%magnesium stearate,2%PVP(preparing 5%solution using purified water).The scores of 3 batches of Eriodictyol chewable tablets in the validation test were 8.76,8.75 and 8.80(RSD=0.30%,n=3),respectively.The Eriodictyol chewable tablet had a complete appearance and a smooth surface;the average tablet weight was 192.57 mg,the average hardness was 57.36 N,the fragility was 0.09%,the average content of eriodictyol per tablet was 50.74 mg,the cumulative dissolution within 30 min was exceeding 80%,and the content uniformity was 5.51.CONCLUSIONS Eriodictyol chewable tablet prepared by optimal formulation conforms to the requirements of the 2020 edition of Chinese Pharmacopoeia.

关 键 词：圣草酚 咀嚼片 处方优化 正交实验 质量评价 

分 类 号：R944.4[医药卫生—药剂学] R917[医药卫生—药学]