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CN-122005470-A - Preparation method of rosuvastatin calcium tablet

CN122005470ACN 122005470 ACN122005470 ACN 122005470ACN-122005470-A

Abstract

The invention discloses a preparation method of rosuvastatin calcium tablet, belonging to the field of pharmacy. The rosuvastatin calcium tablet comprises the components of rosuvastatin calcium, and auxiliary materials of lactose, microcrystalline cellulose, hydrophobic colloidal silicon dioxide and magnesium stearate, and the preparation method comprises the operations of prescription weighing, raw material crushing and sieving pretreatment, auxiliary material granule-shaping and sieving pretreatment, premixing, feeding total mixing, tabletting and the like.

Inventors

  • Fu Jindao

Assignees

  • 琼海市人民医院

Dates

Publication Date
20260512
Application Date
20260228

Claims (9)

  1. 1. A preparation method of a rosuvastatin calcium tablet is characterized in that the components of the rosuvastatin calcium tablet comprise crude drugs of rosuvastatin calcium and auxiliary materials of lactose, microcrystalline cellulose, hydrophobic colloidal silicon dioxide and magnesium stearate; the preparation method comprises the following steps of S1, weighing prescription amount of rosuvastatin calcium raw materials, respectively weighing prescription amount of lactose, microcrystalline cellulose, hydrophobic colloidal silicon dioxide and magnesium stearate for later use, S2, preprocessing raw materials, namely sieving rosuvastatin calcium by a 80-mesh sieve, smashing the rosuvastatin calcium without passing through the sieve until the rosuvastatin calcium passes through the 80-mesh sieve, S3, preprocessing auxiliary materials, namely, putting lactose into a dry granulator for granulating, installing a 1.0 mm-aperture sieve, sieving lactose for later use, putting microcrystalline cellulose into an oscillating sieve of a 40-mesh sieve for sieving for later use, S4, premixing, namely, sequentially putting lactose, rosuvastatin calcium and microcrystalline cellulose into a mixer for later use, S5, totally mixing, namely, sieving magnesium stearate with a 40-mesh sieve, directly adding the premixed powder and the hydrophobic colloidal silicon dioxide into the mixer for 5min, taking the premixed powder and mixing with the hydrophobic colloidal silicon dioxide for 1min, and adding the sieved powder into the mixer for totally mixing, S6, tabletting, namely, carrying out tablet compression, hardness testing, and tabletting, namely, carrying out tablet compression, and quality test, after the tablet compression, of rosuvastatin is finished.
  2. 2. The preparation method of rosuvastatin calcium tablet according to claim 1, wherein in the step S1, the bulk drug is rosuvastatin calcium, and the weight part is 7.5% -8.5%.
  3. 3. The method for preparing rosuvastatin calcium tablet according to claim 1, wherein in step S1, the weight part of lactose is 65.5% -66.0%, the weight part of microcrystalline cellulose is 24.0% -25.0%, the weight part of hydrophobic colloidal silica is 0.2% -0.5%, and the weight part of magnesium stearate is 1.0% -1.8%.
  4. 4. The method for preparing rosuvastatin calcium tablet according to claim 1, wherein in step S2, the pulverization treatment is carried out by pulverizing with a multifunctional pulverizer with fineness of 50-300 mesh, pulverizing time of 10 seconds/time and pulverizing times of 3 times.
  5. 5. The method for preparing rosuvastatin calcium tablet according to claim 1, characterized in that in step S4, the premixing rotation speed is set to 15rpm, and premixing is performed for 15min.
  6. 6. The method for preparing rosuvastatin calcium tablet according to claim 1, characterized in that in step S5, the total mixing rotational speed is set to 15rpm, total mixing is performed for 15min.
  7. 7. The method for preparing rosuvastatin calcium tablet according to claim 1, wherein in step S6, the tabletting speed is 6-10 ten thousand tablets/hour.
  8. 8. The preparation method of rosuvastatin calcium tablet according to claim 2, characterized in that the weight part of rosuvastatin calcium is 8.1%.
  9. 9. A process for the preparation of rosuvastatin calcium tablet according to claim 3, characterized in that the weight parts of lactose is 65.6%, microcrystalline cellulose is 25.0%, hydrophobic colloidal silicon dioxide is 0.3% and magnesium stearate is 1.0%.

Description

Preparation method of rosuvastatin calcium tablet Technical Field The invention relates to a preparation method of a medicine, in particular to a preparation method of rosuvastatin calcium tablet, belonging to the field of pharmacy. Background Rosuvastatin calcium tablet is suitable for primary hypercholesterolemia (type IIa, including heterozygote familial hypercholesterolemia) or mixed dyslipidemia (type IIb) which cannot be properly controlled by diet control and other non-drug treatment (such as: exercise treatment, weight loss). It is also suitable for patients with homozygous familial hypercholesterolemia as an adjunct to diet control and other lipid lowering measures (e.g., LDL removal therapy), or when these methods are not applicable. The active ingredient of the rosuvastatin calcium tablet is rosuvastatin calcium, the chemical name is bis- [ (E) -7- [4- (4-fluorophenyl) -6-isopropyl-2- [ methyl (methylsulfonyl) amino ] -pyrimidin-5-yl ] (3R, 5S) -3, 5-hydroxyhept-6-enoic acid ] calcium salt (2:1), the molecular formula is (C 22H27FN3O6S)2 Ca), and the molecular weight is 1001.13. At present, in the process of preparing rosuvastatin calcium tablet, more waste products such as fracture, cracking, splinter and the like can appear, so that the quality of the medicine obtained by production and preparation is poor, and the production quality of the medicine needs to be improved. Disclosure of Invention The invention aims to solve the technical problem of providing a preparation method of rosuvastatin calcium tablet, which solves the problem of more waste products in the production process of preparing rosuvastatin calcium tablet in the prior art. In order to solve the technical problems, the invention adopts the technical scheme that the preparation method of the rosuvastatin calcium tablet comprises the following raw materials of rosuvastatin calcium and auxiliary materials of lactose, microcrystalline cellulose, hydrophobic colloidal silicon dioxide and magnesium stearate; the preparation method comprises the following steps of S1, weighing prescription amounts of rosuvastatin calcium raw materials, respectively weighing prescription amounts of lactose, microcrystalline cellulose, hydrophobic colloidal silicon dioxide and magnesium stearate for later use, S2, preprocessing raw materials, namely sieving rosuvastatin calcium by a 80-mesh sieve, crushing the rosuvastatin calcium without passing through the sieve, until the rosuvastatin calcium is used after passing through the 80-mesh sieve, S3, preprocessing auxiliary materials, namely placing lactose into a dry granulator for granulating, installing a 1.0 mm-aperture sieve, sieving lactose for later use, placing microcrystalline cellulose into an oscillating sieve of a 40-mesh sieve for sieving, S4, premixing, namely sequentially placing lactose, rosuvastatin calcium and microcrystalline cellulose into a mixer for later use, S5, totally mixing, namely sieving magnesium stearate by a 40-mesh sieve, directly adding the magnesium stearate into the mixer for 5min, taking the rosuvastatin calcium pre-mixing with the hydrophobic colloidal silicon dioxide for 1min, adding the rosuvastatin calcium pre-mixing powder into the mixer for totally mixing, S6, tabletting, namely carrying out tablet compression, and tabletting, namely obtaining qualified tablet after the tablet compression, and quality test, the tablet compression is carried out. Further, in the step S1, the bulk drug is rosuvastatin calcium, and the weight part is 7.5% -8.5%. Further, in step S1, the weight part of lactose is 65.5% -66.0%, the weight part of microcrystalline cellulose is 24.0% -25.0%, the weight part of hydrophobic colloidal silicon dioxide is 0.2% -0.5%, and the weight part of magnesium stearate is 1.0% -1.8%. Further, in step S2, the pulverization treatment is carried out by using a multifunctional pulverizer, wherein the fineness is 50-300 meshes, the pulverization time is 10 seconds/time, and the pulverization times are 3 times. Further, in step S4, the premixing speed is set to 15rpm, and the premixing is performed for 15 minutes. Further, in step S5, the total mixing speed was set to 15rpm, and the total mixing was performed for 15 minutes. Further, in step S6, the tabletting speed is 6-10 ten thousand tablets/hour. Further, rosuvastatin calcium was 8.1% by weight. Further, the weight parts of lactose, microcrystalline cellulose, hydrophobic colloidal silicon dioxide and magnesium stearate were 65.6%, 25.0%, 0.3% and 1.0%, respectively. By adopting the technical scheme, the preparation method has the advantages that the quality of the prepared rosuvastatin calcium tablet is better, the stability is high, and the waste is less through the operations of precisely weighing the weight distribution ratio of each material component, crushing and sieving the raw materials, sieving the auxiliary materials, granulating and sieving the auxiliary materials, premixing, adding the material