Composition for risedronate sodium coated tablet and preparation method thereof

Abstract

The invention provides a composition for risedronate sodium coated tablet and a preparation method thereof. The risedronate sodium coated tablet is prepared from chitosan, hydroxypropyl methylcellulose, polyethylene glycol, microcrystalline cellulose and other adjuvants. The risedronate sodium coated tablet has the advantages of low content of related substances, less adverse reaction in the indigestive tract, safe medicine use and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a risedronate sodium coated tablet composition and a preparation method thereof. Background technique [0002] Risedronate Sodium (Risedronate Sodium) chemical name: 2-(3-pyridyl)-1-hydroxyethane-1,1-bisphosphonic acid monosodium salt two sesquihydrate, molecular formula C 7 h 10 NO 7 P 2 Na 2.5H 2 O, the structural formula is as follows: [0003] [0004] Risedronate sodium is a third-generation bisphosphonate compound, belonging to pyridyl bisphosphonate, developed by Proctor and Gamble Pharmaceutical Company of the United States, and launched in the United States and Europe in December 1998. [0005] Risedronate sodium has definite curative and preventive effects on osteoporosis in postmenopausal women. However, the existing studies on risedronate sodium solid preparations are rare and have many defects. For example, although the risedronate sodiu...

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Problems solved by technology

However, the existing studies on risedronate sodium solid preparations are rare, and there are many defects

For example, although the risedronate sodium tablet disclosed in CN101601661A adopts the direct compression method, which has certain advantages in terms of production technology and cost, it still has defects such as high content of related substances and low drug safety; The risedronate sodium tablets currently on the market have strong irritation to the digestive tract and should be taken in an upright position at least 30 minutes before a meal. Although a large amount of water (200ml) is required to be taken, it is necessary to keep standing or standing upright within 30 minutes after taking the medicine. Sitting posture, but it may still cause dysphagia, esophagitis, gastric ulcer, abdominal pain, diarrhea, constipation and other gastrointestinal adverse reactions

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