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Palbociclib pharmaceutical composition and method for preparing same

A composition and medicine technology, applied in the field of palbociclib pharmaceutical composition and preparation thereof, can solve the problems of poor dissolution stability, poor dissolution, large influence, etc., achieve good stability, solve pH sensitivity without Stable, low volume variance effect

Active Publication Date: 2018-05-25
SHANDONG YUXIN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, its particle size is too large, which has a greater impact on its mixed materials, and its dissolution rate is not good, especially palbociclib is more sensitive to pH. When the pH is greater than 4, its dissolution rate is not good, and it is easy to cause dissolution stability. Difference

Method used

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  • Palbociclib pharmaceutical composition and method for preparing same
  • Palbociclib pharmaceutical composition and method for preparing same
  • Palbociclib pharmaceutical composition and method for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] composition

[0028] The raw materials and excipients of Pabocinil are pulverized separately, and after the particle sizes of the raw materials and excipients are controlled, the raw and auxiliary materials are mixed uniformly and the capsules are directly filled.

Embodiment 2

[0030] composition

[0031] The raw materials and excipients of Pabocinil are pulverized separately, and after the particle sizes of the raw materials and excipients are controlled, the raw and auxiliary materials are mixed uniformly and the capsules are directly filled.

Embodiment 3

[0033] composition

[0034] The raw materials and excipients of Pabocinil are pulverized separately, and after the particle sizes of the raw materials and excipients are controlled, the raw and auxiliary materials are mixed uniformly and the capsules are directly filled.

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PUM

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Abstract

The invention relates to the field of pharmaceutical preparations, and particularly discloses a palbociclib pharmaceutical composition and a method for preparing the same. The palbociclib pharmaceutical composition comprises, by weight, 20%-30% of palbociclib, 30%-40% of pregelatinized starch, 20%-30% of lactitol, 3%-5% of starch sodium glycollate, 4%-6% of hydroxyethyl methyl celluloses, 3%-5% ofhydroxyethyl celluloses and 1%-3% of citric acid fatty glyceride. The palbociclib pharmaceutical composition and the method have the advantages that excellent dissolution effects can be realized by the palbociclib pharmaceutical composition, the contents of related substances can be obviously reduced, the stability can be obviously enhanced, and clinical medicines can be advantageously safely used and can be advantageously stored for a long term; the particle sizes of raw auxiliary materials are controlled, accordingly, the palbociclib pharmaceutical composition is good in mixing property andflowability as discovered via experiments, and capsules can be directly filled with the palbociclib pharmaceutical composition by means of mixing.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition of Pabocinil and a preparation method thereof. Background technique [0002] Statistics from the World Health Organization show that breast cancer is the second killer cause of cancer deaths in women worldwide. In the past few decades, the incidence of breast cancer has been increasing. It is estimated that by 2020, there will be more than 1.7 million new cases of breast cancer each year. In 2012, there were 1.67 million new cases of breast cancer worldwide, accounting for 25% of all new cases of cancer. Among them, there are 883,000 cases in developed countries; 794,000 cases in developing countries. The growth rate of new cases of breast cancer in developing countries is slightly higher than that in developed countries. The number of deaths from breast cancer was 522,000, ranking fifth among all cancers; the number of female deaths in under...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/519A61P35/00A61P35/04
CPCA61K9/1652A61K31/519
Inventor 刘振腾李晓峰耿强袁雪
Owner SHANDONG YUXIN PHARMA CO LTD
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