Water-soluble drug sustained-release tablet and preparation method thereof

Abstract

The invention relates to a water-soluble drug sustained-release tablet and a preparation method thereof, the technology is characterized in that: the components and the weight percentages are as follows: 1 to 20 percent of water-soluble drug, 20 to 70 percent of hydrophilic gel, 30 to 50 of percent waxy material and the rest of filler, lubricant and other excipients that are commonly used for ordinary tablets. The method takes the hydrophilic gel sustained-release material and the waxy sustained-release material as a mixed matrix, the water-soluble drug is added to change the features of fast dissolution and short half life of the drug release, thus achieving the purpose of slow and smooth release. The drug of the invention has good stability, the needed equipment is simple, the manufacturing process is simple and easy, the operatability is strong, the in vitro dissolution test shows that the release rate is 25 to 35 percent in 2 hours, 55 to 65 percent in 5 hours and more than 80 percent in 10 hours, thus having good sustained-release effect. In addition, the sustained-release tablet is less affected by the gastrointestinal tract environment, the absorption is stable, and the individual difference is small, thus being the ideal sustained-release tablet.

Description

technical field [0001] The invention relates to a water-soluble drug sustained-release tablet and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Sustained-release preparations refer to a class of preparations that improve the release, absorption, distribution, metabolism, and excretion of drugs in the body through appropriate methods, so as to prolong the drug's effect and reduce adverse drug reactions. Sustained-release preparations are a new type of dosage form that has long-acting effects, can reduce the number of doses, and releases steadily. Sustained-release formulations provide the best therapeutic effect of the drug. In recent years, research on sustained-release preparations has become more active and has become an important direction for the development of the pharmaceutical industry at home and abroad. [0003] Matrix Tablets are an important component of sustained-release preparations. Because of their ...

AI Technical Summary

Problems solved by technology

Because the initial drug release of single hydrophilic gel matrix sustained-release tablets is too fast, it is difficult to block the release of water-soluble drugs, so it is rarely used; while the single wax matrix sustained-release tablets have the problem of incomplete drug release and easy tablet discharge; Exchange resin, sustained-release material plus controlled-release film coating all use organic solvents in the preparation process, so the finished preparation will produce organic solvent residues, which poses hidden concerns in terms of safety for human use, and will cause certain pollution to the environment; and The method of sustained-release drug-containing layer + blank sustained-release layer is complex in process and requires high equipment. It must be produced by a double-layer tablet press. Quality control is difficult and the production cost is relatively high.

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