Preparation method of tablet with improved performance

A technology for improving performance and tablet, applied in the field of pharmaceutical preparations to prevent sticking and punching problems

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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method can not only ensure the stability of the raw material drug during the preparation and storage process, but also solve the problem of sticking and punching during the tableting process, improve production efficiency, and has the characteristics of simple process, short production cycle, and low cost.

Method used

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  • Preparation method of tablet with improved performance
  • Preparation method of tablet with improved performance
  • Preparation method of tablet with improved performance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Adopt the prescription of following table 3, prepare tablet according to the preparation method of the present invention.

[0092] Table 3: tablet prescription of the present invention

[0093]

[0094] (1) The materials clopidogrel hydrogen sulfate, mannitol M100, polyethylene glycol 6000 and low-substituted hydroxypropyl cellulose LH-21 are passed through a 1.0mm sieve with a pulverizer; the sieved materials Place in a mixing hopper, set the rotation speed at 10 rpm, and mix for 15 minutes to obtain a mixed material.

[0095] (2) Place the above mixed material in the feed bin of the fluidized bed. Set the temperature of the material at 65°C, start the fluidized bed, and start granulation. When the material is observed to be wet without dry powder, the granules have been formed, and the granulation end point has been reached. Turn off the heating, lower the temperature of the granules to below 30°C, take out the granules, and pass through a 1.0mm sieve with a gran...

Embodiment 2

[0108] Tablets were prepared according to the preparation method of the present invention by adopting the prescription in the following Table 5.

[0109] Table 5: tablet prescription of the present invention

[0110]

[0111] (1) Pass the materials clopidogrel hydrogen sulfate, sorbitol CP40 / 200, polyethylene glycol 6000, and low-substituted hydroxypropyl cellulose LH-21 through a 1.0mm sieve with a pulverizer; The material is placed in the mixing hopper and the rotating speed is set at 10 rpm, and mixed for 15 minutes to obtain the mixed material.

[0112](2) Place the above mixed material in the feed bin of the fluidized bed. Set the temperature of the material to 60°C, start the fluidized bed, and start granulation. When the material is observed to be wet without dry powder, the granules have been formed, and the end point of granulation is reached. Turn off the heating, lower the temperature of the granules to below 30°C, take out the granules, and pass through a 1.0m...

Embodiment 3

[0131] Tablets were prepared according to the preparation method of the present invention by adopting the prescription in the following Table 7.

[0132] Table 7: tablet prescription of the present invention

[0133]

[0134] Tablets were prepared by the same process as in Example 1.

[0135] Results and discussion:

[0136] image 3 Dissolution curves of the tablets prepared for Example 1, Example 3 and Comparative Example 3 and the original drug of the reference preparation in pH2.0 hydrochloric acid. Depend on image 3 It can be seen that after the disintegrants of Example 1 and Example 3 of the present invention adopt the mode of internal and external addition, the dissolution curve is similar to that of the reference preparation (Example 1: f 2 =78; Embodiment 3: f 2 =60. when f 2 When ≥50, it shows that the two preparations are similar, otherwise they are not similar), and the dissolution curve is slower than the reference preparation after the disintegrant is ...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and discloses a preparation method of a tablet with improved performance. The preparation method comprises the following steps: uniformly mixing a bulk drug, a melting material, a diluent 1 and a disintegrating agent 1, conducting melting and granulating, uniformly mixing a granulation product with a diluent 2, a disintegrating agent 2 and a lubricant, and conducting tabletting to obtain the tablet. The preparation method not only can ensure that the bulk drug is kept stable in the processes of preparation and storage, but also solves the problem of sticking in a tabletting process, improves production efficiency, and has the characteristics of simple process, short production period, low cost and the like.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, and relates to a method for preparing tablets with improved properties. Specifically, it relates to a method for preparing tablets with improved formability and anti-sticking ability. Background technique [0002] Some large-scale drugs have good clinical efficacy by themselves, however, APIs have poor compressibility and are particularly prone to sticking problems. In terms of production cost and patient acceptability, the weight of the tablet should not be too large, and making a suitable tablet has always been a recognized research difficulty in the industry. The drug clopidogrel with these properties is a classic case. [0003] Clopidogrel bisulfate is used to prevent and treat heart, brain and other arterial circulation disorders caused by high platelet aggregation. Sanofi Clir SNC (Sanofi) was developed and approved for marketing in the United States in November 1997. The chemi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/26A61K47/44A61K31/4365A61P7/02
CPCA61K9/2054A61K9/2095A61K9/2018A61K9/2013A61K31/4365A61P7/02
Inventor 徐国杰赵兰敏谭海松诸弘刚
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