Medicament composition of a high-load lubricant and preparation method thereof

Abstract

The invention provides a high-load lubricant pharmaceutical composition and a preparation method thereof. The high-load lubricant pharmaceutical composition includes the following ingredients in parts by weight: at least one aryl alkanoic acid non-steroidal anti-inflammatory drug 50 -150, at least one filler 120-350, at least one disintegrant 10-30, at least one binder 4-10, wherein the pharmaceutical composition also includes a lubricant, the lubricant is in the pharmaceutical combination 2.3-4% of the mass percentage in the product; the lubricant is a mixture of pregelatinized starch and sodium stearate with a weight ratio of 1-1.3:1; Sodium fatty acid and pregelatinized starch are used as lubricants, and their dosage is screened, which not only makes the dissolution and disintegration of the pharmaceutical composition meet the regulations, but also significantly improves the tensile strength of the pharmaceutical composition, thereby improving its compression formability .

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations containing organic active ingredients, and in particular relates to a pharmaceutical composition of a high-load lubricant and a preparation method thereof. Background technique [0002] NSAIDs (Nonsteroidal Antiinflammatory Drugs, NSAIDs) are a class of anti-inflammatory drugs that do not contain a steroidal structure. According to different chemical structures, they are divided into salicylic acid, such as aspirin and benolate, and acetanilide, such as Acetaminophen, pyrazolones such as antipyrine, 3,5-pyrazolidinediones such as phenylbutazone, aryl alkanoic acids such as indomethacin, sulindac, diclofenac sodium , ibuprofen and naproxen, anthranilic acids such as clofenamic acid, 1,2-benzothiazines such as piroxicam, meloxicam, etc., and others such as nimesulide . Non-steroidal anti-inflammatory drugs have anti-inflammatory, anti-rheumatic, analgesic, antipyretic and anti-coagulant ...

AI Technical Summary

Problems solved by technology

However, in known formulation systems, the loading ratio of stearate should not exceed 1%. If the loading ratio is too high, it will cause disintegration or slow dissolution

In order to ensure that the disintegration and dissolution of aryl alkanoic acid NSAIDs meet the regulations, it is necessary to strictly limit the amount of stearate lubricants, and then in the aryl alkanoic acid NSAID tablets During the preparation process, since the amount of stearate is too low, good lubricating properties and anti-adhesive properties cannot be guaranteed, so the tensile strength of the prepared aryl alkanoic acid NSAID tablet is low, which affects the quality of the tablet. compression formability

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