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Medicine preparation for treating malignant tumors and preparation method thereof

A technology of granules and fillers, which is applied in the field of recaprabib phosphate granules and its preparation, can solve the problems of difficult control of microbial limit indicators, poor content uniformity during storage, and easy generation of degraded impurities in products, so as to fill the gap in the market , Easy to carry and take, quick effect

Active Publication Date: 2018-11-23
SHANGHAI ZHAOHUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the conventional oral solid preparation of Recaparib Phosphate suffers from slow absorption and slow onset of action. Larger tablets or capsules are difficult to swallow. However, granules can be swallowed directly or washed into warm water for drinking. , it is more convenient to apply and carry, but after it is made into granules, the solubility of the granules is poor, it is easy to absorb moisture and agglomerate during the placement process, the product is prone to degraded impurities, the product stability is poor, the content uniformity during the placement process is poor, and the shelf life is short. Moreover, technical problems such as microbial limit indicators are not easy to control need to be solved urgently

Method used

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  • Medicine preparation for treating malignant tumors and preparation method thereof
  • Medicine preparation for treating malignant tumors and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A granule of recaprabib phosphate:

[0025] Prescription: 1 part of recaprabib phosphate, 1.0 part of lactose, 1.4 parts of microcrystalline cellulose, 0.9 part of sodium carboxymethyl starch, 0.7 part of mannitol, 0.05 part of aspartame, and polyvinylpyrrolidone with a mass fraction of 7% 1.6 parts of ethanol solution, 0.04 parts of magnesium stearate, 0.5 parts of Tween 20, 0.7 parts of Span 80, 0.05 parts of vitamin C, and 0.14 parts of methionine;

[0026] Preparation:

[0027] 1. Pretreatment of raw and auxiliary materials: Take the prescribed amount of recaprabib phosphate, lactose, microcrystalline cellulose, sodium carboxymethyl starch, mannitol, aspartame, vitamin C, and methionine; In the pulverizer, pulverize respectively through a 100-mesh sieve, and set aside;

[0028] 2. Premixing: Put the pulverized recaparib phosphate, lactose, microcrystalline cellulose, sodium carboxymethyl starch, mannitol, aspartame, vitamin C, and methionine in the three-dimension...

Embodiment 2

[0054] A granule of recaprabib phosphate:

[0055] Prescription: 1 part of recaprabib phosphate, 0.9 parts of lactose, 1.3 parts of microcrystalline cellulose, 0.8 parts of carboxymethyl starch sodium, 0.6 parts of mannitol, 0.04 parts of aspartame, and polyvinylpyrrolidone with a mass fraction of 7% 1.5 parts of ethanol solution, 0.03 parts of magnesium stearate, 0.4 parts of Tween 20, 0.6 parts of Span 80, 0.04 parts of vitamin C, and 0.13 parts of methionine;

[0056] Preparation:

[0057] 1. Pretreatment of raw and auxiliary materials: Take the prescribed amount of recaprabib phosphate, lactose, microcrystalline cellulose, sodium carboxymethyl starch, mannitol, aspartame, vitamin C, and methionine; In the pulverizer, pulverize respectively through a 100-mesh sieve, and set aside;

[0058] 2. Premixing: Put the pulverized recaparib phosphate, lactose, microcrystalline cellulose, sodium carboxymethyl starch, mannitol, aspartame, vitamin C, and methionine in the three-dimen...

Embodiment 3

[0066] A granule of recaprabib phosphate:

[0067] Prescription: 1 part of recaprabib phosphate, 1.1 parts of lactose, 1.5 parts of microcrystalline cellulose, 1.0 parts of sodium carboxymethyl starch, 0.8 parts of mannitol, 0.06 parts of aspartame, and polyvinylpyrrolidone with a mass fraction of 8% 1.7 parts of ethanol solution, 0.05 parts of magnesium stearate, 0.6 parts of Tween 20, 0.8 parts of Span 80, 0.06 parts of vitamin C, and 0.15 parts of methionine;

[0068] Preparation:

[0069] 1. Pretreatment of raw and auxiliary materials: Take the prescribed amount of recaprabib phosphate, lactose, microcrystalline cellulose, sodium carboxymethyl starch, mannitol, aspartame, vitamin C, and methionine; In the pulverizer, pulverize respectively through a 100-mesh sieve, and set aside;

[0070] 2. Premixing: Put the pulverized recaparib phosphate, lactose, microcrystalline cellulose, sodium carboxymethyl starch, mannitol, aspartame, vitamin C, and methionine in the three-dimen...

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Abstract

The invention relates to a medicine preparation for treating malignant tumors. The medicine preparation is prepared by the following steps of using ricarpa phosphate as the raw material, and adding acertain amount of filling agent, flavoring agent, adhesive, lubricant, cosolvent, antioxidant and the like; pretreating, pre-mixing, forming particles, drying, arranging particles, totally mixing, packaging and the like. The medicine preparation has the advantages that the ricarpa phosphate particle can be quickly absorbed, the effect is quickly taken, the bioavailability is high, and the carryingand taking are convenient; by adopting the special formula and special technology preparation method, the dissolving property is good, the medicine preparation can be completely dissolved within 10s,the defect of moisture absorbing and caking is overcome in the placing process, the stability is good, and the increment of impurities in the storage process is small, and is only 0.09%; the medicinepreparation is qualified in microorganism check, the shelf life is long and can reach 24 months, and the industrialized production effect is realized; after the medicine preparation is sold on market, the market blank can be filled, and the medicine preparation is suitable for being popularized and applied.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a recaprabib phosphate granule and a preparation method thereof. Background technique [0002] Ovarian cancer is one of the common malignant tumors of female reproductive organs, and its incidence ranks third after cervical cancer and uterine body cancer. In recent years, due to the prevention and treatment of cervical cancer and uterine body cancer, certain results have been achieved, while the effect of prevention and treatment of ovarian cancer is relatively small. Therefore, ovarian cancer is the tumor with the highest cause of death among women's reproductive system cancers. Rucaparib is an oral, small-molecule ADP-ribose polymerase 1 (PARP1) inhibitor that inhibits PARP1, the enzyme responsible for repairing DNA damage in cancer cells. By inhibiting the action of PARP1, DNA damage in cancer cells is not easily repaired, eventually leading to cancer cell death. Ru...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/36A61K31/55A61P35/00
CPCA61K9/1652A61K9/1682A61K31/55A61P35/00
Inventor 李敏黄河
Owner SHANGHAI ZHAOHUI PHARMA
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