The Study On The Compound Pseudoephedrine Hydrochloride Double Layer Sustained Release Tablets

Cetirizine hydrochloride (CET) is an antihistamine with selective H₁-receptor antagonist activity. Pseudoephedrine hydrochloride (PSE) is an adrenergic (vasoconstrictor) agent for the relief of nasal congestion due to allergic rhinitis. The Combination of these two agents was used to relieve symptoms of seasonal allergic rhinitis in clinic. The fixed dose combination of the double-layer tablets with the immediately release layer of CET (USL) and sustained release layer of PSE (SRL) was prepared.Firstly, basic physicochemical properties of CET and PSE were investigated, and then the related material examination of CET and PSE were developed.High performance liquid chromatographic method and Ultraviolet (UV) spectro photometry method were developed for the measurements of drug physicochemical properties, cumulative released(%) from tablets and the content of CET and PSE in tablets.Similarity factors (f₂) between drug release profile of self-preparing tablets and imported product (Hyrtec-D 12 Hour, UCB) were used as the evaluation standard to optimize the formulation. The results indicated that...