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Icotinib hydrochloride dispersible tablet and preparation method thereof

A technology of icotinib hydrochloride and dispersible tablets, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problems of irritation to the body and low bioavailability, and achieve Reduce body irritation, improve bioavailability, and fast absorption

Inactive Publication Date: 2014-05-14
QINGDAO TUMOR HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The present invention provides a new icotinib hydrochloride dispersible tablet, which is based on the existing problems of icotinib hydrochloride ordinary tablets that the addition of surfactants can stimulate the body and the bioavailability is not high.

Method used

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  • Icotinib hydrochloride dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Icotinib Hydrochloride 250g

[0035] Lactose 120g

[0036] Cross-linked polyvinylpyrrolidone 25g

[0037] Carboxymethyl Starch Sodium 50g

[0038] Hypromellose 4g

[0039] Micronized silica gel 15g

[0040] Magnesium Stearate 10g

[0041] water 60g

[0042] 95% ethanol 122g

[0043] Made in 1000 pieces.

[0044] Preparation:

[0045] Step 1: Pass the pulverized icotinib hydrochloride and pharmaceutical excipients through a 120-mesh sieve, swell the hypromellose with hot water first, stir until dissolved, and then add ethanol to make the ethanol concentration reach 70%.

[0046] Step 2: Mix icotinib hydrochloride, lactose, crospovidone, and micropowdered silica gel evenly according to the prescription amount, and add the hypromellose solution described in step 1 to make a soft material.

[0047] Step 3: Pass the soft material prepared in step 2 through an 18-mesh sieve to granulate, dry at 50°C, and have a moisture content of 2.7%, and granulate through an 18-me...

Embodiment 2

[0052] Icotinib Hydrochloride 250g

[0053] Lactose 80g

[0054] Cross-linked polyvinylpyrrolidone 14g

[0055] Carboxymethyl Starch Sodium 20g

[0056] Hypromellose 4g

[0057] Citric acid 100g

[0058] Micronized silica gel 15g

[0059] Magnesium Stearate 7.5g

[0060] water 250

[0061] 95% ethanol 125g

[0062] Made in 1000 pieces.

[0063] Preparation:

[0064] Step 1: Pass the pulverized icotinib hydrochloride and pharmaceutical excipients through a 120-mesh sieve, swell the hypromellose with hot water first, stir until dissolved, and then add ethanol to make the ethanol concentration reach 70%. Separately take 50 g of the above-mentioned hydroxypropyl methylcellulose solution, add 170 g of water, add citric acid and mix well.

[0065] Step 2: The prescribed amount of icotinib hydrochloride and the citric acid solution in step 1 are embedded in the fluidized bed acid solution, and then mixed with the prescribed amount of lactose, cross-linked polyvinylpyrrolido...

Embodiment 3

[0071] Icotinib Hydrochloride 250g

[0072] Cross-linked polyvinylpyrrolidone 40g

[0073] Carboxymethyl Starch Sodium 40g

[0074] Hypromellose 3.5g

[0075] Citric acid 100g

[0076] Micronized silica gel 15g

[0077] Magnesium Stearate 7.5g

[0078] water 250

[0079] 95% ethanol 125g

[0080] Made in 1000 pieces.

[0081] The preparation method is the same as in Example 2.

[0082] Implementation 3 increased the content of cross-linked polyvinylpyrrolidone and sodium starch glycolate, and the dispersibility of the dispersible tablets met the requirements of the 2010 edition of the Pharmacopoeia, and the dissolution rate was better.

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Abstract

The invention discloses an icotinib hydrochloride dispersible tablet and a preparation method and applications thereof. The icotinib hydrochloride dispersible tablet disclosed by the invention is composed of the components in percentage by weight: 5-50% of icotinib hydrochloride, 10-40% of a filling agent, 10-55% of a disintegrating agent, 10-50% of an acidifying agent, 0.1-15% of an adhesive, and 0.1-20% of a lubricant and a flow aid. Compared with common tablets, the icotinib hydrochloride dispersible tablet disclosed by the invention does not contain a surfactant, is good in solubility, dispersibility and disintegrative property, and can be completely disintegrated within 1 minute. The icotinib hydrochloride dispersible tablet prepared by using the method disclosed by the invention is high in dissolution rate, high in bioavailability, rapid in in-vivo distribution, stable in quality, good in taste, simple and practicable in preparation method, and suitable for industrial production.

Description

field of invention [0001] The invention relates to the field of chemical pharmacy, in particular to a icotinib hydrochloride dispersible tablet and a preparation method thereof. Background of the invention [0002] According to the third national cause of death survey in my country released by the Ministry of Health in April 2008, malignant tumors accounted for the first cause of death in cities, and lung cancer was the first cause of cancer death, accounting for 22.7% of the total number of deaths from malignant tumors. An upward trend, up 46.5% over the past 30 years. R.Peto, a famous British oncologist, predicted that if it is not controlled in time, the annual number of lung cancer patients in my country will exceed 1 million by 2025, becoming the world's largest lung cancer country. [0003] Molecular targeted therapy of tumors uses specific molecules in tumor cells as targets, and the use of molecular targeted drugs can specifically block the biological functions of th...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/519A61K47/12A61K47/22A61K47/04A61P35/00
Inventor 彭宗玉李然郑飞波
Owner QINGDAO TUMOR HOSPITAL