Sugar-free desloratadine oral solution and preparation process

Abstract

The invention discloses a sugar-free desloratadine oral solution and a preparation process. The sugar-free desloratadine oral solution is prepared from 50mg of desloratadine, 500mg-1000mg of a solubilizer, 500mg-1500mg of sorbitol, an appropriate amount of a buffer pair, 100mg-500mg of aspartame, an appropriate amount of essences and 100ml-200ml of purified water. The preparation process includes:adding purified water accounting for 60%-80% of the formulated quantity into a preparation tank; sequentially adding the solubilizer, the buffer pair and sorbitol, and stirring to dissolve; adding desloratadine, and stirring to dissolve; adding aspartame and essences, and adding the remaining purified water; performing 0.22micron sterile filtration, filling and sealing. Risks caused by adding oforganic solvents in a traditional formula are avoided while the preparation process of the oral solution is simplified; by adding of aspartame as a sweetening agent, the sugar-free desloratadine oralsolution can be applied to patients with diabetes.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a sugar-free desloratadine oral solution and a preparation process. Background technique [0002] Desloratadine is a tricyclic long-acting histamine antagonist (Antagonist), which has potent and selective antagonism of peripheral H1 receptors. [0003] However, the prior art has the following problems: [0004] (1) Desloratadine clinical commonly used dosage forms have tablet, dispersible tablet, syrup, oral liquid etc., because desloratadine water solubility is poor, solid preparation medicines such as tablet, dispersible tablet are difficult to dissolve, thereby make medicine reach less than the desired therapeutic effect. Liquid preparations such as syrups and oral solutions have high bioavailability and are especially suitable for children and patients with dysphagia. In traditional prescriptions, organic solvents such as propylene glycol are added for ...

AI Technical Summary

Problems solved by technology

In traditional prescriptions, organic solvents such as propylene glycol are added for solubilization, but the impurities such as diethylene glycol brought by propylene glycol itself have a new impact on product quality;

[0005] (2) Sucrose, fructose, etc. are used as sweeteners in traditional prescriptions, and sucrose, fructose, etc. are converted into glucose in the body, which affects the use of diabetics

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