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Anti-cancer drug erlotinib hydrochloride tablet and preparation method thereof

A technology of erlotinib hydrochloride tablets and anticancer drugs, which is applied in the field of pharmaceutical preparations, can solve the problems of erlotinib hydrochloride solubilization, slow disintegration of tablets, and drug stability, and achieve rapid dissolution, Less toxic and side effects, avoiding gastrointestinal side effects

Active Publication Date: 2015-11-11
QINGDAO TUMOR HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] For this reason, the inventor needs to solve the following three problems: 1. the stability problem of medicine in the wet granulation process; melting problem

Method used

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  • Anti-cancer drug erlotinib hydrochloride tablet and preparation method thereof
  • Anti-cancer drug erlotinib hydrochloride tablet and preparation method thereof
  • Anti-cancer drug erlotinib hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032]

[0033]

[0034] Preparation:

[0035] (1) Add hydroxypropyl cellulose to pH2 hydrochloric acid solution, stir until completely dissolved, add erlotinib hydrochloride and stir evenly, grind through a colloid mill, and control the particle size to D 90 ≤30 microns, spare;

[0036] (2) Weigh Polacrilin Potassium IRP-88, mesoporous silica, lactose, and starch into the fluidized bed, and mix evenly; spray the mixed solution prepared in step (1) to granulate, and the air inlet temperature is 60°C. The speed of the injection pump is 10rpm, the atomization pressure is 0.5Mpa, after the liquid injection is completed, continue to dry for 30min, and pass the dry particles through a 20-mesh sieve for granulation;

[0037] (3) Mix the dry granules prepared in step (2) with magnesium stearate evenly, punch the tablets with a shallow arc with a diameter of 9 mm, and control the average hardness to 8-10 kg / m 2 , that is.

Embodiment 2

[0039]

[0040] Preparation:

[0041](1) Add hydroxypropyl cellulose to pH2 hydrochloric acid solution, stir until completely dissolved, add erlotinib hydrochloride and stir evenly, grind through a colloid mill, and control the particle size to D 90 ≤30 microns, spare;

[0042] (2) Weigh Polacrilin Potassium IRP-88, mesoporous silica and microcrystalline cellulose into the fluidized bed, mix evenly; spray the mixed liquid prepared in step (1) to granulate, and the air inlet temperature is 60°C , the speed of the injection pump is 10rpm, the atomization pressure is 0.5Mpa, after the liquid injection is completed, continue to dry for 30min, and pass the dry particles through a 20-mesh sieve for granulation;

[0043] (3) Mix the dry granules prepared in step (2) with sodium stearate fumarate evenly, punch the tablets with a shallow arc with a diameter of 10 mm, and control the average hardness to 8-10 kg / m 2 , that is.

Embodiment 3

[0045]

[0046]

[0047] Preparation:

[0048] (1) Add hydroxypropyl cellulose to pH2 hydrochloric acid solution, stir until completely dissolved, add erlotinib hydrochloride and stir evenly, grind through a colloid mill, and control the particle size to D 90 ≤30 microns, spare;

[0049] (2) Weigh Polacrilin Potassium IRP-88, mesoporous silica and mannitol into the fluidized bed and mix evenly; spray the mixed solution prepared in step (1) to granulate, the inlet air temperature is 60°C, and The rotation speed of the sample pump is 10rpm, the atomization pressure is 0.5Mpa, after the liquid feeding is completed, continue to dry for 30min, and the dry particles pass through a 20-mesh sieve for granulation;

[0050] (3) Mix the dry granules prepared in step (2) with magnesium stearate evenly, punch the tablets with a shallow arc with a diameter of 10mm, and control the average hardness to 8-10kg / m 2 , that is.

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Abstract

The invention discloses an anti-cancer drug erlotinib hydrochloride tablet and a preparation method thereof. A preparation of the drug is prepared from raw materials and auxiliary materials. The auxiliary materials contain polacrilin potassium and mesoporous silicon dioxide. The preparation method comprises the following steps: (1) dissolving a binder in an acidic solution, adding erlotinib hydrochloride into the acidic solution, stirring and grinding for standby application; (2) measuring the polacrilin potassium, mesoporous silicon dioxide and a diluting agent, uniformly mixing in a fluidized bed, then spraying a mixed solution obtained in the step (1), granulating, drying, and size stabilizing; (3) uniformly mixing dry particles and a lubricating agent, and tabletting. The preparation has the advantages of fast dissolution, good dissolution stability and simple preparation process.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an anticancer pharmaceutical preparation, in particular to a tablet containing erlotinib hydrochloride and a preparation method thereof. Background technique [0002] Erlotinib Hydrochloride (Erlotinib Hydrochloride) is a new type of small molecule targeted anti-tumor drug jointly developed by OSI Pharmaceuticals, Genentech and Swiss Roche. Erlotinib hydrochloride is a tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) / human epidermal growth factor receptor I (also known as HER1), which can effectively inhibit the phosphorylation of EGFR in cells, which is usually expressed in The surface of normal cells and tumor cells, which has been approved by the United States and the European Union for the second- and third-line treatment of locally advanced or metastatic non-small cell lung cancer and the first-line treatment of pancreatic ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/517A61K47/04A61K47/32A61P35/00
Inventor 孙丽华
Owner QINGDAO TUMOR HOSPITAL
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