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美他沙酮和双氯芬酸钾局部用凝胶的处方、验证及评价研究

Formulation, validation and evaluation studies on metaxalone and diclofenac potassium topical gel.

作者信息

Tiwari Ashutosh, Bag Puja, Sarkar Mrinmoy, Chawla Viney, Chawla Pooja A

机构信息

Gyani Inder Singh Institute of Professional Studies, Dehradun, Uttarakhand, India.

Department of Pharmaceutical Analysis, ISF College of Pharmacy, Moga, Punjab, India.

出版信息

Environ Anal Health Toxicol. 2021 Mar;36(1):e2021001-0. doi: 10.5620/eaht.2021001. Epub 2021 Jan 11.

Abstract

Twenty different batches of gels containing metaxalone and diclofenac potassium were prepared for topical application. These drugs act synergistically in the management of pain and inflammation. Gels were prepared by varying the type of gelling agent (ten batches each of hydroxyl propyl methyl cellulose and carbopol 934). The prepared gels were characterized and evaluated. Batch F7 emerged as the best batch on the basis of favourable pH, high drug content, homogeneity and drug release. HPLC (High-performance liquid chromatography) method validation of gel formulation was also carried out and the developed and validated method was found to be robust and accurate.

摘要

制备了二十批含美他沙酮和双氯芬酸钾的凝胶用于局部给药。这些药物在疼痛和炎症管理中具有协同作用。通过改变凝胶剂类型(羟丙基甲基纤维素和卡波姆934各十批)来制备凝胶。对制备的凝胶进行了表征和评价。基于适宜的pH值、高药物含量、均匀性和药物释放情况,F7批次成为最佳批次。还对凝胶制剂进行了高效液相色谱(HPLC)方法验证,发现所开发和验证的方法稳健且准确。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da4e/8207004/41b2801b64a9/eaht-36-1-e2021001f1.jpg

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