枫香片:从传统剂型到现代剂型

Q3 Medicine Journal of Medicinal Plants Pub Date : 2022-05-01 DOI:10.52547/jmp.21.82.56
S. Esmaeili, B. Keramatian, Haniye Kashafroodi, R. Choopani, H. Hajimehdipoor
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引用次数: 0

摘要

背景:刺山柑在波斯医学中被用于治疗各种疾病。为了更容易使用,更好的患者接受度和更稳定,制备合适的剂型是必要的。目的:以刺山柑为原料制备片剂,并对其进行质量评价。方法:采用80%乙醇浸渍法提取果实,冷冻干燥。使用乳糖、avicel PH-102、SiO2和硬脂酸镁制备了八种制剂。最佳配方在稳定性测试中失败;因此,以麦芽糊精和二氧化硅为辅料,采用喷雾干燥法对提取物进行干燥。使用乳糖、avicel PH-102、交联羧甲基纤维素钠、PVP K30和硬脂酸镁制备了八种配方,并选出了最佳配方。对所选配方进行理化和微生物评估,并在40°C、75%湿度和30°C下进行稳定性测试。结果:采用冷冻干燥提取物的Caper片剂发生了变形和变色,而采用喷雾干燥提取物的片剂在30°C下是稳定的。它们是长方形、绿蓝色、双凸、刻痕片剂,尺寸为20.3×9.9×6.7mm。重量、硬度、崩解时间、芦丁含量和溶出度在60min内分别为1115mg±10%、18.33±1.52kp、15±3.5min、0.58±0.02mg/tab和93.03±3.61%。结论:经过体内和临床研究,卡佩尔片有望工业化生产。此外,在长期研究中,片剂的稳定性评估应在合适的包装中进行。
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Capparis spinosa L. tablet: from traditional to modern dosage form
Background: Capparis spinosa is used in Persian medicine for treatment of various diseases. In order to easier use, better patient’s acceptance and more stability, preparing a suitable dosage form is necessary. Objective: The aim of the study was preparing tablet form from caper fruits and quality assessment of the product. Methods: The fruit extraction was performed using ethanol 80% and maceration technique and the extract was dried by freeze dryer. Eight formulations were made using lactose, avicel PH-102, SiO 2 and magnesium stearate. The best formulation was failed during stability tests; therefore, the extract was dried by spray drying method along with maltodextrin and SiO 2 as excipients. Eight formulations were prepared using lactose, avicel PH-102, croscarmellose sodium, PVP K30 and magnesium stearate and the best one was selected. Physicochemical and microbial assessments were performed on the selected formulation and stability tests were done in 40°C and 75% humidity as well as 30°C. Results: Caper tablets with freeze dried extract were deformed and their color changed but tablets with spray dried extract were stable in 30°C. They were oblong, green-blue, biconvex, scored tablets with 20.3×9.9×6.7 mm dimensions. Weight, hardness, disintegration time, rutin assay and dissolution were 1115 mg ± 10%, 18.33 ± 1.52 kp, 15±3.5 min, 0.58 ± 0.02 mg/tab and 93.03 ± 3.61 % in 60 min, respectively. Conclusion: Caper tablets are good candidate for production in industrial scale after in vivo and clinical studies. Moreover stability assessment of the tablets should be performed in suitable packaging in long term study.
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来源期刊
Journal of Medicinal Plants
Journal of Medicinal Plants Medicine-Complementary and Alternative Medicine
CiteScore
1.60
自引率
0.00%
发文量
0
期刊介绍: The Journal of Medicinal Plants is published quarterly. This journal contains articles in the fields of basic and clinical sciences related to medicinal plants including pharmacognosy, basic and clinical pharmacology, basic and clinical toxicology, and pharmacology.
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