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Co-ground materials of benzimidazoles proton pump inhibitors and hydrophilic polymer auxiliary materials

A technology of proton pump inhibitor and hydrophilic polymer, which is applied in the field of co-grinding of active pharmaceutical ingredients and excipients and their preparation, can solve problems such as affecting drug dissolution, and achieve good repeatability, controllability and stability. , the effect of simple operation

Active Publication Date: 2011-08-03
南京百思福医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the drug is ground and pulverized separately, the dissolution rate of the drug will increase to a certain extent as the particle size decreases and the specific surface area increases; however, if the particle size is too small and the particles are too fine, the surface Gibbs free energy will be too high. Large, small drug particles are easy to re-aggregate into larger particles, which prevents the further reduction of the particles and affects the dissolution of the drug.

Method used

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  • Co-ground materials of benzimidazoles proton pump inhibitors and hydrophilic polymer auxiliary materials
  • Co-ground materials of benzimidazoles proton pump inhibitors and hydrophilic polymer auxiliary materials
  • Co-ground materials of benzimidazoles proton pump inhibitors and hydrophilic polymer auxiliary materials

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] 5.01g of lansoprazole and 5.21g of β-CD were preliminarily mixed, placed in a WL-1 ball mill and ground for 2 hours, then taken out, sieved, and stored in a silica gel desiccator in the dark. Carry out dissolution test to this co-grinding thing, the result is:

[0067]

Embodiment 2

[0076] With Lansoprazole 5.23g, L-HPC 5.11g, preliminarily mix, place WL-1 type ball mill and grind for 2 hours, take out, sieve, put in silica gel desiccator and keep away from light. Carry out dissolution test to this co-grinding thing, the result is:

[0077]

[0078]

[0079] Comparative example 1

[0080] Lansoprazole 5.09g, L-HPC 5.41g, put respectively in the WL-1 type ball mill and grind for 2 hours and then take out, sieve, then the two are fully mixed, put in a silica gel desiccator and keep away from light, to obtain Lansoprazole A sample of the physical mixture of Soprazole and HPMC. A dissolution test was performed on a sample of the physical mixture and the results were:

[0081]

[0082] Comparative example 2

[0083] Lansoprazole crude drug 10.38g is independently ground and taken out after 2 hours, sieved, and put in a silica gel desiccator for dark preservation. Carry out dissolution test to bulk drug, the result is:

[0084]

[0085] As can ...

Embodiment 3

[0087] With lansoprazole 5.14g, HPMC 5.11g, preliminarily mix, place WL-1 type ball mill and grind after 2 hours, take out, sieve, put in silica gel desiccator and keep away from light. Carry out dissolution test to this co-grinding thing, the result is:

[0088]

[0089] Comparative example 1

[0090] Lansoprazole 5.25g and HPMC 5.22g were placed in a WL-1 type ball mill and ground for 2 hours, then taken out, sieved, and then the two were fully mixed, and stored in a silica gel desiccator in the dark to obtain Lansoprazole A physical mixture sample of azole and HPMC. A dissolution test was performed on a sample of the physical mixture and the results were:

[0091]

[0092] Comparative example 2

[0093] Lansoprazole bulk drug 10.34g is independently ground for 2 hours and then taken out, sieved, and stored in a silica gel desiccator in the dark. Carry out dissolution test to bulk drug, the result is:

[0094]

[0095] As can be seen from the examples, the diss...

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Abstract

The invention relates to the field of medicinal preparations, in particular to co-ground materials of pharmaceutically active components and auxiliary materials and a preparation method thereof. Particularly, the co-ground materials are prepared by co-grinding benzimidazoles proton pump inhibitors and hydrophilic auxiliary materials so as to achieve the purpose of improving the dissolution rate of the benzimidazoles proton pump inhibitors.

Description

technical field [0001] The present invention relates to the field of pharmaceutical preparations, in particular to a co-grind of pharmaceutical active ingredients and auxiliary materials and a preparation method thereof, in particular, co-grinding is prepared by co-grinding benzimidazole proton pump inhibitors and hydrophilic auxiliary materials substances to achieve the purpose of improving the dissolution rate of benzimidazole proton pump inhibitors. technical background [0002] Peptic ulcer, including gastric ulcer and duodenal ulcer, is a common digestive system disease. The incidence of gastrointestinal diseases accounts for about 10-12% of the population. According to statistics, the incidence of gastrointestinal diseases in the United States is 10% for men and 5% for women; 5-10% for Japan; and 12.3% for Germany. The average incidence rate of gastrointestinal diseases in my country is 11.43%, and the incidence rate of Shanghai residents is as high as 30.23%, accoun...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/00A61P1/04A61K47/36A61K47/38A61K47/48A61K47/32A61K47/40
Inventor 李学明毛利娟王永禄徐元龙
Owner 南京百思福医药科技有限公司