Azithromycin dispersible tablets with bitterness covering function and preparation method of azithromycin dispersible tablets

Abstract

The invention discloses azithromycin dispersible tablets with a bitterness covering function and a preparation method of the azithromycin dispersible tablets. According to the preparation method, azithromycin and an ethanol solution of polyacrylate resin are stirred, sieved and dried to prepare soft, fine and wet particles, then the soft, fine and wet particles are mixed with other taste covering components and parts of pharmaceutically accepted pharmaceutical excipients, the mixture is sieved and granulated, wet azithromycin particles are obtained, dried and mixed with tableting auxiliary materials for tableting, and the azithromycin dispersible tablets are obtained. In the process, azithromycin is coated with a compact membrane formed by the solution of the polyacrylate resin at a drying rate determined by specific drying temperature, the bitterness of the azithromycin can be covered well, the taste of the preparation can be improved, the compliance of patients can be improved, sticking phenomena are avoided in the granulating and tableting processes, the problem of anaphylaxis of production staff during production of azithromycin products is solved, and industrial production is facilitated.

Description

technical field [0001] The invention relates to a solid oral preparation of azithromycin, in particular to an azithromycin dispersible tablet for masking bitter taste and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Azithromycin is suitable for acute pharyngitis and acute tonsillitis caused by Streptococcus pyogenes; sinusitis, acute otitis media, acute bronchitis, acute exacerbation of chronic bronchitis caused by sensitive bacteria; Pneumonia; urethritis and cervicitis caused by Chlamydia trachomatis and non-multidrug-resistant Neisseria gonorrhoeae; skin and soft tissue infections caused by sensitive bacteria. It has good curative effect, low toxicity and side effects, and its excellent pharmacokinetic characteristics. Therefore, it has been widely used clinically in recent years, and the dosage is increasing year by year. [0003] However, azithromycin tastes extremely bitter, and the bitter...

AI Technical Summary

Problems solved by technology

The current conventional method is to use sweeteners and food flavors to cover the taste, such as the preparation method of azithromycin orally disintegrating tablets described in Chinese patent 200410030577.3 and the azithromycin dispersible tablets mainly used in clinical practice. Although it can mask slightly bitter drugs, it often does not have a very good effect on azithromycin with a strong bitter taste

Other methods are to micropowder or microencapsulate bitter medicaments by macromolecular compounds to achieve taste-masking effects, such as a dry suspension of azithromycin and its preparation method described in Chinese patent 200510061861.1, but the production process is complex and cumbersome , there are many process steps, which is not convenient for the wide application of actual industrialization. In addition, for the active agent azithromycin with strong bitter taste, it is often not enough to completely cover up its bitter taste

Azithromycin-coated tablets developed subsequently, such as azithromycin enteric-coated preparations, can directly isolate the bitter taste of the drug from the taste buds of the user, and solve the discomfort brought by the bitter taste of azithromycin to the patient. After being coated with enteric-coated layer and enteric-coated layer, one of its disadvantages is the same as that of ordinary tablets or capsules. The disintegration time is too long, so the drug bioavailability is low and the drug effect is slow. It is suitable for children, the elderly and patients with dysphagia, so it cannot meet the current clinical requirements