Studies On Quality And Manufacturing Process Of Nimesulide Tablet

In order to change the Nimesulide tablet prescription obsoletely, the production craft backwardness condition, thus the thorough settlement product outward appearance difference, friability major problem, further enhanced the labor productivity, the promotion product quality, this article has carried on the Nimesulide preparation craft and the quality research. The research choice fluid bed equipment, and so on factor analysis, orthogonal experiment, the screening definite excepients, optimizes the Nimesulide tablet prescription and the production craft; Prepares 6 batch of samples, carries on the contrast with 6 batch of original prescription product quality, has discussed in the manufacture process the tablet quality and the particle intermediate micromeritics nature relations; Carried on dissolution and the degradation compound examination methodology research, carried on the sample stable inspection. Main findings: The prescription for Nimesulide 100 mg, lactose 60 mg, MCC 85 mg, L-HPC 10 mg, the bond: 4%HPMC60RT5, 2%PEG6000, 3% fine powder silica gel water-soluble fluid right amount, sur- ethyloic CMS-Na 20 mg, magnesium stearate 3 mg; Using the Nimesulide tablet new prescription and the manufacture craft production product, had the distinct enhancement compared with the original product quality; Through after the particle characteristic research analysis, obtains the particle quality control target to be as follows: The particle-size distribution standard deviation 1.82-2.04, stops the angle of repose to be smaller than 35°, the particle compressibility is smaller than 18%; Has established the quality control mathematical model which the particle -size distribution standard deviation and between the tablet weight variation, between the particle compressibility and tablet hardness and friability change; Enhanced dissolution standard in the original Nimesulide tablet quality standard foundation, added the degradation compound HPLC test. We obtained the new prescription and the production craft through this topic research, and obtained the quality stable sample, formulated the new product quality standard. The study has provided reliable basis for the digitization production and the enhancement on production process quality controllability.