Dexibuprofen enteric-coated and sustained-release tablet and preparation method thereof

Abstract

The invention relates to a dexibuprofen enteric-coated and sustained-release tablet. The dexibuprofen enteric-coated and sustained-release tablet comprises a tablet core with a sustained release effect and a coating for coating the table core, wherein the tablet core is prepared from the following components: 70-90 parts of dexibuprofen, 10-30 parts of sustained-release skeleton stabilizer, 0-10 parts of filler, 0.2-1.5 parts of lubricating agent and 0.2-1.5 parts of flow aid; the effective quantity of active ingredient dexibuprofen takes more than 70% of the weight of table core. The invention has the advantages of excellent formula, reliable preparation process and easiness in industrial production; the prepared enteric-coated and sustained-release tablet in-vitro dissolution experiment shows: the releasing rate of gastric juice in 2 hours is smaller than 10%, which meets the requirements; the releasing rate of intestinal juice in 2 hours is 25-55%, the accumulative releasing rate in 4 hours is 50-80%, the accumulative releasing rate in 8 hours is more than 80%, and therefore, the releasing effect is excellent. The dexibuprofen enteric-coated and sustained-release tablet has effects of undissolving in the stomach and slowly releasing in the intestines so as to prevent irritation to the stomach and prolong the in-vivo releasing time of medicines simultaneously; the dexibuprofen enteric-coated and sustained-release tablet facilitates absorption to human bodies and has lasting effects.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a dextroibuprofen enteric-coated sustained-release tablet and a preparation method thereof. Background technique [0002] Active ingredient: Dexibuprofen [0003] Chemical name: (2S)-2-[4-(2-methylpropyl)phenyl]propanoic acid [0004] English name: Dexibuprofen [0005] English chemical name: S(+)-2(4-isobutylphenyl) propionic acid [0006] Molecular formula: C 13 h 18 o 2 [0007] Molecular weight: 206.28 [0008] Structural formula: [0009] [0010] As a non-steroidal anti-inflammatory drug that has been used clinically for many years, ibuprofen has been fully confirmed in its safety and effectiveness. It produces antipyretic, analgesic and anti-inflammatory effects by inhibiting the synthesis of prostaglandins. For rheumatism and rheumatoid arthritis, it can also be used for general antipyretic and analgesic, and it is the first step drug i...

AI Technical Summary

Problems solved by technology

Chinese patents CN102160855B and CN102293759A both involve dextroibuprofen sustained-release tablets and their preparation methods. The preparation of CN102160855B sustained-release tablets consists of quick-release parts, sustained-release parts and magnesium stearate; the preparation process of CN102293759A involves direct mixing of powders and tableting The preparation method of the process, obviously due to the poor fluidity of dextrobuprofen, the powder direct mixing tablet process is not suitable for industrialized large-scale production

The above two patents involve a large amount of excipients used in the prescription ratio, and the weight ratio of the active ingredient, ibuprofen, in the tablet is low, and the tablet is heavy and difficult to swallow; and they are not acid-resistant

[0014] Although Dexibuprofen is relatively safe, as a non-steroidal anti-inflammatory drug, its irritation to the stomach should not be underestimated

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