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秋水仙碱与萘普生钠复方缓释片的制备及其体外评价用于痛风治疗

Formulation and in vitro evaluation of colchicines and naproxen sodium sustain release tablets in combination for treatment of gout.

作者信息

Mehmood Yasir, Riaz Humayun, Yousaf Hammad, Raza Syed Atif, Mahmood Rana Khalid, Khan Zia Mohy-Ud-Din, Saleem Noviara

机构信息

Faculty of Pharmacy, University of Central Punjab, Lahore Pakistan.

Rashid Latif College of Pharmacy Lahore, Pakistan.

出版信息

Pak J Pharm Sci. 2016 Sep;29(5):1579-1586.

PMID:27731815
Abstract

Present investigation concern with combination of two drugs for the treatment of gout. One of these drug (naproxen sodium) is pain killer which is sustain their action within the body for 12 hours and the other drug (colchicine) is anti-gout, which release as conventional dosage. After oral administration naproxen will act as sustain release dosage and increase patient compliance about six batches of tablet were developed and evaluate .For the sustain release action polymers Methocel K4M and HPMCK15were used. These polymers were used in combination used with other inactive ingredients. Two methods were used for proration of final tablets. In 1st method only naproxen sodium granules were prepared which are sustained released. In second method these granules were mixed with colchicines powder and other all inactive ingredients. This method is easy and cost effective characterization of pallets and final tablets were performed. Final tablets were evaluated for all tests like appearance, friability, dissolution, hardness, assay, weight variation and in-vitro release study performed. The results obtained were satisfactory and complies with USP specification. Formulation containing combination of Methocel K4M and HPMC K15 showed good sustain release profile for 12 hours.

摘要

目前的研究关注两种药物联合用于治疗痛风。其中一种药物(萘普生钠)是止痛药,在体内可持续作用12小时,另一种药物(秋水仙碱)是抗痛风药,按常规剂量释放。口服后,萘普生将作为缓释剂型,提高患者的顺应性。研发并评估了约六批片剂。为实现缓释作用,使用了甲基纤维素K4M和羟丙基甲基纤维素K15聚合物。这些聚合物与其他惰性成分联合使用。最终片剂采用两种方法制备。第一种方法仅制备了萘普生钠缓释颗粒。第二种方法是将这些颗粒与秋水仙碱粉末及其他所有惰性成分混合。该方法简便且成本效益高。对片托和最终片剂进行了表征。对最终片剂进行了外观、脆碎度、溶出度、硬度、含量测定、重量差异等所有测试,并进行了体外释放研究。所得结果令人满意,符合美国药典标准。含有甲基纤维素K4M和羟丙基甲基纤维素K15组合的制剂显示出良好的12小时缓释特性。

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