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速释双氯芬酸钠栓剂的研制与评价

Development and evaluation of immediate release diclofenac sodium suppositories.

作者信息

Sultan Tariq, Hamid Shaista, Hassan Sohail, Hussain Kanwal, Ahmed Ateka, Bashir Lubna, Naz Shazia, Maqbool Tahmina

机构信息

Department of Pharmaceutics, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.

Department of Pharmaceutical Chemistry, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.

出版信息

Pak J Pharm Sci. 2018 Sep;31(5):1791-1795.

Abstract

The objective of present study was to develop and evaluate polyethylene glycol (PEG) based diclofenac sodium suppositories. This study used water soluble PEG bases (1000, 4000 and 6000) in different combinations to formulate suppositories, which were further subjected for their physicochemical properties evaluation such as weight variation, average melting point, content uniformity and disintegration. Dissolution test was used to perform the in vitro release rate studies of the suppositories. The suppository (P3) containing PEG-6000 (50%) and PEG-4000 (50%) exhibited rapid in vitro release rate of diclofenac sodium. Moreover, homogeneous distribution of diclofenac sodium is found in all six formulations. The in vitro release patterns of diclofenac sodium from the marketed Voltral suppository (100mg) and formulated suppositories were also compared and found in standard limits.

摘要

本研究的目的是开发并评估基于聚乙二醇(PEG)的双氯芬酸钠栓剂。本研究使用不同组合的水溶性PEG基质(1000、4000和6000)来制备栓剂,并进一步对其进行物理化学性质评估,如重量差异、平均熔点、含量均匀度和崩解情况。采用溶出度试验进行栓剂的体外释放速率研究。含有PEG - 6000(50%)和PEG - 4000(50%)的栓剂(P3)表现出双氯芬酸钠快速的体外释放速率。此外,在所有六种制剂中均发现双氯芬酸钠分布均匀。还比较了市售扶他林栓剂(100mg)和所制备栓剂中双氯芬酸钠的体外释放模式,结果发现均在标准限度内。

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