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An etoposide solid pharmaceutical composition

A technology of etoposide and poside solid, applied in the field of medicine

Inactive Publication Date: 2019-01-15
天津双硕医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Easy to degrade and produce impurities

Method used

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  • An etoposide solid pharmaceutical composition
  • An etoposide solid pharmaceutical composition
  • An etoposide solid pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 125

[0108] Embodiment 125mg specification etoposide tablet preparation (unit: g)

[0109] prescription:

[0110] Raw materials

Dosage

Etoposide

25g

sodium cholate

25g

Highly substituted hydroxypropyl cellulose

50g

microcrystalline cellulose

11.6g

Crospovidone

6g

colloidal silica

1.2g

Magnesium stearate

1.2g

N-Methylpyrrolidone

Appropriate amount

unit element tablet weight

120mg

Opadry

5% weight gain for plain tablets

Co-made

1000 pieces

[0111] The preparation process is as follows;

[0112] 1) Take the etoposide bulk drug, pulverize it, pass through an 80-mesh sieve, and set aside;

[0113] 2) Take the prescription quantity step 1) obtained etoposide bulk drug, sodium cholate, highly substituted hydroxypropyl cellulose in sequence, dissolve in an appropriate amount of N-methylpyrrolidone, stir, and set aside;

[0114] 3) Take the solution obtained...

Embodiment 250

[0119] Embodiment 250mg specification etoposide tablet preparation (unit: g)

[0120] prescription:

[0121] Raw materials

Dosage

Etoposide

50g

sodium cholate

50g

Highly substituted hydroxypropyl cellulose

100g

microcrystalline cellulose

23.2g

Crospovidone

12g

colloidal silica

2.4g

Magnesium stearate

2.4g

N-Methylpyrrolidone

Appropriate amount

unit element tablet weight

240mg

Opadry

5% weight gain for plain tablets

Co-made

1000 pieces

[0122] The preparation process is as follows;

[0123] 1) Take the etoposide bulk drug, pulverize it, pass through an 80-mesh sieve, and set aside;

[0124] 2) Take the prescription quantity step 1) obtained etoposide bulk drug, sodium cholate, highly substituted hydroxypropyl cellulose in sequence, dissolve in an appropriate amount of N-methylpyrrolidone, stir, and set aside;

[0125] 3) Take the solution obtain...

Embodiment 3100

[0130] Embodiment 3100mg specification etoposide tablet preparation (unit: g)

[0131] prescription:

[0132]

[0133]

[0134] The preparation process is as follows;

[0135] 1) Take the etoposide bulk drug, pulverize it, pass through an 80-mesh sieve, and set aside;

[0136] 2) Take the prescription quantity step 1) obtained etoposide bulk drug, sodium cholate, highly substituted hydroxypropyl cellulose in sequence, dissolve in an appropriate amount of N-methylpyrrolidone, stir, and set aside;

[0137] 3) Take the solution obtained in step 2), and dry it in a vacuum oven to obtain an improved etoposide solid dispersion;

[0138] 4) Take the improved etoposide solid dispersion obtained in step 3), pulverize, pass through a 40-mesh sieve, and set aside;

[0139] 5) Take the pulverized improved etoposide solid dispersion obtained in step 4), add filler microcrystalline cellulose, disintegrating agent crospovidone, glidant colloidal silicon dioxide, lubricant stearin M...

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PUM

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Abstract

The present application relates to an etoposide solid pharmaceutical composition, and the inventors have finally obtained an improved etoposide solid dispersion preparation process through a series ofexperiments, and obtained an improved etoposide solid dispersion with good water solubility. Furthermore, by choosing crosslinked polyvidone with low water content (no more than 5%) as disintegratingagent of solid preparation, the water content of the preparation is effectively reduced while the disintegrating effect is exerted, and the degradation caused by absorbing the water in the preparation is inhibited. Finally, etoposide is prepared into common oral solid preparation. The results showed that the dissolution behavior and bioavailability of etoposide oral solid preparation prepared bythis technique are significantly improved. At the same time, because of choosing the auxiliary material with low water content, the degradation impurity is restrained and the stability is improved. The preparation process is simple and the quality is controllable, which is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an oral solid pharmaceutical composition of etoposide, a preparation method and application thereof. Background technique [0002] Cancer involves more than one hundred clinically distinct disease forms. Almost every tissue of the body can give rise to cancer, and some can even produce several types of cancer. Cancer is characterized by abnormal growth of cells that can invade the tissue of origin or spread to other sites. In fact, the severity or degree of malignancy of a particular cancer is based on the cancer cells' propensity to invade and ability to spread. That is, different human cancers (eg, carcinomas) differ markedly with respect to their ability to spread from a primary site or tumor and metastasize throughout the body. Indeed, the process of tumor metastasis is detrimental to the survival of cancer patients. Surgeons can remove the primary tumor, but...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/7048A61K47/38A61K9/36A61K9/48A61P35/00A61P35/02
CPCA61K9/146A61K9/2866A61K9/4808A61K31/7048A61P35/00A61P35/02
Inventor 不公告发明人
Owner 天津双硕医药科技有限公司
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