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Tablets containing erlotinib hydrochloride and preparation method thereof

A technology of erlotinib hydrochloride tablets and erlotinib hydrochloride, which is applied in the field of medicine, can solve the problems that the dissolution rate is easily affected by temperature and humidity, inhomogeneity, and incomplete dissolution of active ingredients, etc., and achieves fast dissolution rate and Stability, improved dissolution rate, and simple preparation process

Inactive Publication Date: 2014-04-09
SHANDONG BOMAIKANG PHARMA RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The erlotinib hydrochloride tablet prepared by the method provided by the present invention is compared with the commercially available preparation (reference example 2), and the stability investigation results of 6 months at 40°C and 12 months at room temperature for a long time show that this Compared with commercially available preparations (reference example 2), the invention shows faster dissolution rate and stability, and at the same time solves the problem that the dissolution rate of conventional commercially available preparations is easily affected by temperature and humidity after acceleration, resulting in incomplete dissolution of active ingredients and uneven problem

Method used

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  • Tablets containing erlotinib hydrochloride and preparation method thereof
  • Tablets containing erlotinib hydrochloride and preparation method thereof
  • Tablets containing erlotinib hydrochloride and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 2

[0038] According to the prescription and process in the patent CN103110597A reference example 6, preparation sample preparation is carried out;

[0039] Preparation Process:

[0040] A, mixing materials except magnesium stearate (erlotinib hydrochloride micronized treatment, D90 is 5.7 μ m);

[0041] B, carry out dry granulation to the material obtained in step A;

[0042] C, add magnesium stearate and mix, and compress into tablet;

[0043] D, adopt the coating powder of trade name Opadry to carry out coating tablet.

Embodiment 1

[0044] Embodiment 1 (1000 pieces)

[0045]

[0046] A, prescription amount Erlotinib hydrochloride (crossing 80 mesh sieves) and silicon dioxide (crossing 100 mesh sieves), mix;

[0047] B. In the mixture of step A, add lactose, microcrystalline cellulose, sodium carboxymethyl starch, and a small amount of magnesium stearate respectively passing through a 100-mesh sieve of the prescription amount, and mix well;

[0048] C. Carry out dry granulation of the mixture obtained in the above step B, and granulate into 12 meshes;

[0049] D, the granule obtained in step C is mixed with the magnesium stearate of the remaining prescription amount, and compressed into tablets;

[0050] E, adopt the coating powder of trade name Opadry to coat tablet.

[0051] Embodiment 2 (1000 pieces)

[0052]

[0053] A, the erlotinib hydrochloride (crossing 200 mesh sieves) and silicon dioxide (crossing 100 mesh sieves) of prescription quantity micronized, mix;

[0054]B. In the mixture of st...

Embodiment 3

[0058] Embodiment 3 (1000 pieces)

[0059]

[0060] A, prescription amount Erlotinib hydrochloride and silicon dioxide are crossed 100 mesh sieves respectively, mix;

[0061] B. In the mixture of step A, add lactose, microcrystalline cellulose, sodium carboxymethyl starch, and a small amount of magnesium stearate respectively passing through a 100-mesh sieve of the prescription amount, and mix well;

[0062] C. The mixture obtained in the above step B is subjected to dry granulation, and granulated at 30 mesh;

[0063] D, the granule obtained in step C is mixed with the magnesium stearate of the remaining prescription amount, and compressed into tablets;

[0064] E, adopt the coating powder of trade name Opadry to coat tablet.

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Abstract

The invention discloses erlotinib hydrochloride tablets which contain silica which accounts for 2-12 percent of the total weight of the erlotinib hydrochloride tablets. The dissolution can be promoted. The invention also relates to a method for preparing the tablets. The process flow is simple, special requirements on the granularity of the raw materials are avoided, and the dissolution property of the product is good.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a tablet containing erlotinib hydrochloride and a preparation method thereof. Background technique [0002] The chemical name of erlotinib hydrochloride: N-(3-ethynylphenyl)-[6,7-bis(2-methoxyethoxy)]quinazolin-4-amine hydrochloride, English name: Erlotinib Hydrochloride, molecular formula: C 22 h 23 N 3 o 4 · HCl, molecular weight: 429.90, CAS number: 183319-69-9. Its structural formula is as follows: [0003] [0004] Erlotinib hydrochloride belongs to the EGFR tyrosine kinase inhibitor class of anti-tumor drugs. Its mechanism of action is to block the phosphorylation of the EGFR tyrosine kinase structure inside the cell membrane, block the information transmission of cancer cells, and then cause the growth stagnation of cancer cells And / or cell death to achieve anti-tumor effect. Erlotinib was first developed by Astellas in Japan and authorized by Hoffma...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K31/517A61K47/04A61P35/00
Inventor 姜斌谢晓涛李宝玉庞茂平李清霞
Owner SHANDONG BOMAIKANG PHARMA RES
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