Diclofenac sodium sustained release tablet composition and preparation method thereof

Abstract

The invention relates to the field of drugs, in particular to diclofenac sodium sustained release tablets and a preparation method thereof. The unerodible matrix sustained release tablets which are produced by taking a wax material as an adhesive, taking ion exchange resin as a matrix material and adopting a hot melting wrapping technology are more reasonable in drug releasing mechanism, are basically not released in the stomach and can obviously reduce stimulation of diclofenac sodium to the human stomach and avoid the side effects such as stomachache, burning sensation, sour regurgitation, poor appetite, nausea of a patient. In addition, the stimulating diclofenac sodium ingredient can be wrapped into spherical-like particles by the wax material adhesive at a time through the hot melting wrapping technology, the adverse effects such as strong stimulation on the respiratory tracts and the eyes which are generated by diclofenac sodium dust on production personnel in the pelletizing, mixing, tabletting and packaging process are avoided, and physical and psychological health of the operation personnel and environmental protection are facilitated.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a diclofenac sodium sustained-release tablet and a preparation method thereof. Background technique [0002] Diclofenac sodium is a non-steroidal anti-inflammatory analgesic derived from phenylacetic acid. Its mechanism of action is to inhibit the activity of cyclooxygenase, thereby blocking the conversion of arachidonic acid to prostaglandins. At the same time, it can also promote the combination of arachidonic acid and triglyceride, reduce the concentration of free arachidonic acid in cells, and indirectly inhibit the synthesis of leukotrienes. Diclofenac Sodium Sustained-release Tablets have been on the market for many years at home and abroad, with remarkable curative effect and suitable dosage form. [0003] Diclofenac sodium, the chemical name is [o-(2,6-dichloroaniline)] sodium phenylacetate, and the molecular formula is C1 4 h 10 Cl 2 NNaO 2 , the molecular weight is 318.13,...

AI Technical Summary

Problems solved by technology

[0009] 1. Wet granulation of diclofenac sodium sustained-release tablets uses water as the solvent binder for granulation, and cellulose as the sustained-release material. Common wet granulation process granulation is very easy to form a glue that is not easy to disperse when it encounters water. Agglomerates, and the obtained particles are not uniform, making wet granules very difficult; one-step granulation particles are like snowflakes, loose and fluttering, which is not conducive to production operations

[0010] 2. When wet granulation of Diclofenac Sodium Sustained-release Tablets is granulated with an organic solvent (such as ethanol), the granulation process generates a lot of heat, and the dried granules are very hard and difficult to granulate. Recycling, resulting in even lower yields; large differences in the content of granules and fine powders, large differences in pressure between tablets and tablets, large differences in release between batches, and unstable product quality; at the same time, Organic solvents are flammable and explosive, and there are potential safety hazards in production

[0011] 3. Diclofenac Sodium Sustained Release Tablets Diclofenac Sodium Sustained-release Tablets During the direct tableting process, the uniformly mixed powder is separated during the descent process due to the difference in density and compressibility of the main drug, sustained-release materials and other materials. In this way, there is an uneven distribution of the main drug, sustained-release materials and other materials between the particles, and the release of the pressed tablets is large. Unstable quality

[0012] 4. There is dust flying in the production process, and the dust of diclofenac sodium is difficult to tolerate the strong stimulation of the respiratory tract and eyes of the granulating, mixing, tableting and packaging personnel, which is not conducive to the physical and mental health of the operators

[0013] 5. Diclofenac sodium sustained-release tablets on the domestic market are basically gel-type and eroded-type matrix sustained-release tablets, which are released and dissolved in the stomach. Diclofenac sodium is irritating to the stomach, causing patients to have stomach pain, burning sensation, acid regurgitation, and nausea. Poor, nausea and other side effects

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