Niraparib combination drug and preparation method thereof

A drug and drug powder technology, applied in the field of niraparib combination drug and its preparation, can solve the problems of restricting the promotion and application of niraparib drug, and achieve the effect of strengthening anticancer effect, obvious effect and lower concentration

Inactive Publication Date: 2019-07-23
南京瑄宇医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These adverse reactions limit the popularization and application of niraparib drugs, so it is necessary to develop niraparib anticancer drugs that can alleviate its adverse reactions

Method used

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  • Niraparib combination drug and preparation method thereof
  • Niraparib combination drug and preparation method thereof
  • Niraparib combination drug and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] A kind of niraparib combination medicine, comprises the component of following parts by weight:

[0053] Nirapani 5 parts;

[0054] 5 parts of tea polyphenols;

[0055] 8 parts of glucose;

[0056] 8 parts of hesperidin;

[0057] Vitamin C 2 parts;

[0058] 75 parts of filler;

[0059] Disintegrant 5 parts.

[0060] In this embodiment, the filler is microcrystalline cellulose.

[0061] In this embodiment, the disintegrant is a combination of low-substituted hydroxypropyl cellulose and croscarmellose sodium, and their mass ratio is 1:1.

[0062] The preparation method of the above-mentioned niraparib combination medicine comprises the following steps:

[0063] (i) Get 8 parts of filler and mix niraparib and tea polyphenols, pulverize and pass through an 80-mesh sieve to obtain inner layer medicinal powder; glucose, vitamin C, hesperidin, disintegrant and remaining After the filler is mixed evenly, it is pulverized and passed through an 80-mesh sieve to obtain the...

Embodiment 2

[0077] A kind of niraparib combination medicine, comprises the component of following parts by weight:

[0078] 6 parts nirapani;

[0079] 4.5 parts of tea polyphenols;

[0080] Glucose 8.5 parts;

[0081] 7 parts of hesperidin;

[0082] Vitamin C 2.5 parts;

[0083] 73 parts of filler;

[0084] Disintegrant 5 parts.

[0085] In this embodiment, the tea polyphenols are selected from green tea polyphenols. The anti-tumor effect of tea polyphenols has been recognized by relevant researchers at home and abroad. Studies have shown that catechins (accounting for 70% to 80% of the total amount of tea polyphenols) play the main role. Green tea is rich in vitamin E. Among them, catechin is a kind of polyphenol with more content in plants. Its unique green and astringent taste is a strong antioxidant. At the same time, green tea can prevent harmful acidic toxins. , has a high antioxidant effect and can achieve the effect of preventing ovarian cancer, which is just in line with t...

Embodiment 3

[0093] A kind of niraparib combination medicine, comprises the component of following parts by weight:

[0094] Nirapani 6.5 parts;

[0095] 4 parts of tea polyphenols;

[0096] 9 parts of glucose;

[0097] 7 parts of hesperidin;

[0098] Vitamin C 3 parts;

[0099] 70 parts of filler;

[0100] Disintegrant 5 parts.

[0101] In this embodiment, the tea polyphenols are selected from green tea polyphenols.

[0102] In this embodiment, the filler is a composition of pregelatinized starch and microcrystalline cellulose, and their mass ratio is 1:1.

[0103] In this embodiment, the disintegrating agent is a composition of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose and croscarmellose sodium, and their mass ratio is 2:3:2.

[0104] The preparation method of the above-mentioned niraparib combination medicine comprises the following steps:

[0105] (ⅰ) Get 6.92 parts of filler and mix Niraparib and tea polyphenols, pulverize and pass through 80 mesh si...

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Abstract

The present invention discloses a niraparib combination drug and a preparation method thereof, and belongs to the field of drug production. The niraparib combination drug comprises the following components in parts by weight: 5-8 parts of niraparib, 3-5 parts of tea polyphenols, 8-10 parts of glucose, 5-8 parts of hesperidin, 2-4 parts of vitamin C, 65-75 parts of a filler and 4-5 parts of a disintegrant. The preparation method comprises the following steps: the niraparib, the tea polyphenols and a part of the filler are mixed into inner layer drug powder, other raw materials are mixed into surface layer drug powder, then a direct tableting machine is used to fill the drug powder in a tablet mold cavity according to a sequence of the surface layer drug powder-the inner layer drug powder-the surface layer drug powder, and after the direct tableting, the tablet is obtained. The provided drug is relatively good in an anti-cancer effect and can also weaken adverse reactions; and in the preparation method, the direct tableting machine is used to improve particle size uniformity and material feeding homogeneity of the drug powder, can prevent the drug tablets from sticking to a pressureplate, is optimized in a material discharging effect and relatively high in work efficiency.

Description

technical field [0001] The invention relates to the field of medicine production, in particular to a niraparib combination medicine and a preparation method thereof. Background technique [0002] Niraparib (Niraparib) is an oral poly ADP-ribose polymerase (PARP) inhibitor, mainly targeting cancers with BRCA1 / 2 gene mutations, developed for ovarian cancer and breast cancer. Niraparib inhibits the repair of cells to DNA damage. For cancer cells with BRCA gene mutations, if PARP activity is further inhibited, a large amount of DNA damage will be generated when these cells divide, leading to the death of cancer cells. The chemical name of Nirapa is 2-[4-((3S)-3-piperidinyl)phenyl]-2H-indazole-7-carboxamide, which was developed by Merck and later transferred to American Biotechnology The company Tesaro, which announced the phase III clinical data of niraparib for advanced ovarian cancer, showed extremely good efficacy. [0003] Niraparib capsules were approved for marketing in ...

Claims

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Application Information

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IPC IPC(8): A61K31/454A61K31/353A61K31/7004A61K31/7048A61K31/375A61P35/00A61P3/02A61P7/06A61P1/08A61P25/20
CPCA61K31/353A61K31/375A61K31/454A61K31/7004A61K31/7048A61P1/08A61P3/02A61P7/06A61P25/20A61P35/00A61K2300/00
Inventor 吴飞飞姚伟东
Owner 南京瑄宇医药科技有限公司
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