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Rucaparib phosphate soft capsule and preparation method thereof

A technology of rica phosphate and soft capsules, which is applied in the directions of capsule delivery, pharmaceutical formulations, and medical preparations with inactive ingredients, etc., can solve the problems of less than 30% survival rate, large material increase, and short shelf life, etc. The method is simple and feasible, the bioavailability is high, and the product shelf life is long.

Inactive Publication Date: 2018-11-06
李莉
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the insidious onset of ovarian cancer, the lack of obvious early symptoms and mature diagnostic methods, more than 70% of patients have reached an advanced stage when they are diagnosed, and about 70% of patients relapse within two years. %” makes its clinical treatment work has been facing formidable challenges, the five-year survival rate is usually less than 30%
[0004] At present, Recaprabib Phosphate Tablets has poor stability, is easy to absorb moisture and deteriorate, and has a large increase in related substances during storage; and the capsule shell is prone to lose moisture, making it hard and cracked, and the pH of the contents changes greatly. Technical problems such as large increment of related substances and short shelf life need to be solved urgently

Method used

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  • Rucaparib phosphate soft capsule and preparation method thereof
  • Rucaparib phosphate soft capsule and preparation method thereof
  • Rucaparib phosphate soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A Recaprabib Phosphate Soft Capsule:

[0026]

[0027] A preparation method of Recaprabib phosphate soft capsules, comprising the following steps:

[0028] 1. Preparation of rubber:

[0029] (1) Get the methylparaben and propylparaben of formula quantity, place respectively in the universal pulverizer and pulverize, cross 80 mesh sieves, collect fine powder, for subsequent use;

[0030] (2) Take another amount of glycerin and purified water in a plastic tank, heat to 62°C, add the crushed methylparaben and propylparaben, and stir to make the methylparaben and propylparaben Dissolve, continue to keep warm, standby; Wherein said stirring speed is 50r / min;

[0031] (3) after methylparaben and propylparaben dissolve, stop stirring, add the gelatin of formula quantity in the chemical glue tank, continue to keep warm, gelatin is melted;

[0032] (4) After the gelatin is melted, add curcumin in the prescribed amount, set the stirring speed to 50r / min, and stir for 25 min...

Embodiment 2

[0060] A Recaprabib Phosphate Soft Capsule:

[0061]

[0062]

[0063] A preparation method of Recaprabib phosphate soft capsules, comprising the following steps:

[0064] 1. Preparation of rubber:

[0065] (1) Get the methylparaben and propylparaben of formula quantity, place respectively in the universal pulverizer and pulverize, cross 80 mesh sieves, collect fine powder, for subsequent use;

[0066] (2) Take another amount of glycerin and purified water in a plastic tank, heat to 60°C, add the above-mentioned pulverized methylparaben and propylparaben, and stir to make the methylparaben and propylparaben Dissolve, continue to keep warm, standby; Wherein said stirring speed is 40r / min;

[0067] (3) after methylparaben and propylparaben dissolve, stop stirring, add the gelatin of formula quantity in the chemical glue tank, continue to keep warm, gelatin is melted;

[0068] (4) After the gelatin is melted, add curcumin in the prescribed amount, set the stirring speed ...

Embodiment 6

[0087] Embodiment 6, concrete formula is as follows:

[0088]

[0089] Remarks: "--" means not added

[0090] The experimental results are shown in Table 6:

[0091] Table 6 embodiment and comparative example under different time related substance comparative investigation results

[0092] time (days)

[0093] From the above comparative experiments, it can be known that using sodium thiosulfate combined with disodium edetate as a compound antioxidant can significantly increase the stability of Recaprabib Soft Capsules with a small increase in impurities.

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Abstract

The invention discloses a rucaparib phosphate soft capsule. The rucaparib phosphate soft capsule comprises a capsule shell and content encapsulated in the capsule shell. The capsule shell comprises gelatin, glycerin, purified water, a preservative and a coloring agent. The content comprises rucaparib phosphate, polyethylene glycol 200 and an antioxidant. Through the prescription and process adjustment, the rucaparib phosphate soft capsule produces effects fast and has high bioavailability. Through the stability inspection test, the rucaparib phosphate soft capsule has good stability. In storage, the capsule shell does not lose moisture so that the capsule shell hardens and ruptures. The pH of the content is decreased and there is no obvious change in pH after 24 months of storage. The change of related substances in the long-term storage process is small. The preparation method is simple and feasible, and is worthy of promotion and application in the market.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a recaprabib phosphate soft capsule and a preparation method thereof. Background technique [0002] Ovarian cancer ranks sixth in the incidence of female malignancies. According to the survey, there were about 239,000 newly diagnosed cases worldwide in 2012. Although the incidence of ovarian cancer is not as high as that of breast cancer, its mortality rate ranks first among gynecological malignancies. Due to the insidious onset of ovarian cancer, the lack of obvious early symptoms and mature diagnostic methods, more than 70% of patients have reached an advanced stage when they are diagnosed, and about 70% of patients relapse within two years. %” makes its clinical treatment work has been facing formidable challenges, and the five-year survival rate is usually less than 30%. [0003] Recaparib phosphate, a breakthrough therapy drug for ovarian cancer, is now in phase I...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/14A61K47/02A61K31/55A61P35/00
CPCA61K9/4825A61K9/485A61K31/55A61K47/14A61P35/00
Inventor 李莉于浩刘伟红
Owner 李莉
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