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枸橼酸钾泡腾片的处方、表征及理化性质评价

Formulation, characterization and physicochemical evaluation of potassium citrate effervescent tablets.

作者信息

Aslani Abolfazl, Fattahi Fatemeh

机构信息

Department of Pharmaceutics, School of Pharmacy and Novel Drug Delivery Systems Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

Adv Pharm Bull. 2013;3(1):217-25. doi: 10.5681/apb.2013.036. Epub 2013 Feb 7.

Abstract

PURPOSE

The aim of this study was to design and formulation of potassium citrate effervescent tablet for reduction of calcium oxalate and urate kidney stones in patients suffering from kidney stones.

METHODS

In this study, 13 formulations were prepared from potassium citrate and effervescent base in different concentration. The flowability of powders and granules was studied. Then effervescent tablets were prepared by direct compression, fusion and wet granulation methods. The prepared tablets were evaluated for hardness, friability, effervescent time, pH, content uniformity. To amend taste of formulations, different flavoring agents were used and then panel test was done by using Latin Square method by 30 volunteers.

RESULTS

Formulations obtained from direct compression and fusion methods had good flow but low hardness. Wet granulation improves flowability and other physicochemical properties such as acceptable hardness, effervescence time ≤3 minutes, pH<6, friability < 1%, water percentage < 0.5% and accurate content uniformity. In panel test, both of combination flavors; (orange - lemon) and (strawberry - raspberry) had good acceptability.

CONCLUSION

The prepared tablets by wet granulation method using PVP solution had more tablet hardness. It is a reproducible process and suitable to produce granules that are compressed into effervescent tablets due to larger agglomerates.

摘要

目的

本研究旨在设计并制备柠檬酸钾泡腾片,以减少肾结石患者的草酸钙和尿酸肾结石。

方法

在本研究中,用不同浓度的柠檬酸钾和泡腾基质制备了13种制剂。研究了粉末和颗粒的流动性。然后通过直接压片、熔融和湿法制粒方法制备泡腾片。对制备的片剂进行硬度、脆碎度、泡腾时间、pH值、含量均匀度评估。为改善制剂的口感,使用了不同的调味剂,然后由30名志愿者采用拉丁方方法进行小组测试。

结果

直接压片和熔融法获得的制剂流动性良好,但硬度较低。湿法制粒改善了流动性和其他物理化学性质,如具有可接受的硬度、泡腾时间≤3分钟、pH<6、脆碎度<1%、水分含量<0.5%以及准确的含量均匀度。在小组测试中,(橙子 - 柠檬)和(草莓 - 树莓)这两种组合口味都具有良好的可接受性。

结论

使用聚维酮溶液通过湿法制粒方法制备的片剂具有更高的片剂硬度。这是一个可重复的过程,适合生产由于结块较大而可压制成泡腾片的颗粒。

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