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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
硕士研究生。研究方向:药物制剂与天然产物药理作用机制。电话:023-60353049。E-mail:qinchunm@126.com
主任药师,博士生导师。研究方向:天然活性产物、医院药学。电话:023-68766377。E-mail:liusq@hospital.cqmu.edu.cn
纸质出版日期:2024-02-29,
收稿日期:2023-08-21,
修回日期:2024-01-25,
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秦春梦,李文军,李辽平等.圣草酚咀嚼片的制备及质量评价 Δ[J].中国药房,2024,35(04):449-452.
QIN Chunmeng,LI Wenjun,LI Liaoping,et al.Preparation and quality evaluation of Eriodictyol chewable tablet[J].ZHONGGUO YAOFANG,2024,35(04):449-452.
秦春梦,李文军,李辽平等.圣草酚咀嚼片的制备及质量评价 Δ[J].中国药房,2024,35(04):449-452. DOI: 10.6039/j.issn.1001-0408.2024.04.12.
QIN Chunmeng,LI Wenjun,LI Liaoping,et al.Preparation and quality evaluation of Eriodictyol chewable tablet[J].ZHONGGUO YAOFANG,2024,35(04):449-452. DOI: 10.6039/j.issn.1001-0408.2024.04.12.
目的
2
制备圣草酚咀嚼片,并对其进行质量评价。
方法
2
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
2
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
2
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
2
To prepare the Eriodictyol chewable tablet and to evaluate its quality.
METHODS
2
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
2
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
2
Eriodictyol chewable tablet prepared by optimal formulation conforms to the requirements of the 2020 edition of
Chinese Pharmacopoeia
.
圣草酚咀嚼片处方优化正交实验质量评价
chewable tabletformulation optimizationorthogonal testquality evaluation
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LI W J,DU Q,LI X L,et al. Eriodictyol inhibits proliferation,metastasis and induces apoptosis of glioma cells via PI3K/Akt/NF-κB signaling pathway[J]. Front Pharmacol,2020,11:114.
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朱春媚,滕健皓,张梦,等. 咀嚼片质量评价方法研究进展[J]. 中国新药杂志,2022,31(7):645-654.
ZHU C M,TENG J H,ZHANG M,et al. Research pro-gress on quality evaluation methods of chewable tablets[J]. Chin J N Drugs,2022,31(7):645-654.
张璐. 复方党参超微粉咀嚼片的制备[J]. 山西中医药大学学报,2020,21(5):345-348.
ZHANG L. Preparation of compound Dangshen superfine powder chewable tablets[J]. J Shanxi Univ Chin Med,2020,21(5):345-348.
RIBEIRO C B,RAMOS F M,MANTHEY J A,et al. Effectiveness of Eriomin® in managing hyperglycemia and reversal of prediabetes condition:a double-blind,rando-mized,controlled study[J]. Phytother Res,2019,33(7):1921-1933.
李洪建,王祎璠,楚文静,等. 羧甲基壳聚糖的阻垢性能评价及其机理研究[J]. 应用化工,2020,49(5):1101-1104.
LI H J,WANG Y F,CHU W J,et al. Scale inhibition performance evaluation and mechanism of carboxymethyl chitosan[J]. Appl Chem Ind,2020,49(5):1101-1104.
国家药典委员会.中华人民共和国药典:四部[M]. 2020年版.北京:中国医药科技出版社,2020:131-137.
National Pharmacopoeia Commission. Pharmacopoeia of the People’s Republic of China:part Ⅳ[M]. 2020 edition. Beijing:China Medical Science and Technology Press,2020:131-137.
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