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Blonanserin pharmaceutical composition and preparation method thereof

A technology of blonanserin and its composition, which is applied in the field of medicine, can solve the problems of large-scale production that is difficult to realize industrialization, low dissolution rate of blonanserin, and high production cost, so as to improve bioavailability, accelerate drug dissolution, and improve quality. reliable effect

Inactive Publication Date: 2016-04-13
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The existing Chinese patent application CN201010618820.9 discloses a pharmaceutical composition containing blonanserin and its preparation method. The composition consists of the following ingredients and weight percentages: 3.3-20% blonanserin, 60-85% Filling agent, 5~25% disintegrant, 2~6% binder, 0.25~5% lubricant and 0.5~2% glidant, the preparation process adopts wet granulation, the purpose is to solve the problem of blonanserin For the problem of drug dissolution, oral preparations prepared by referring to this method are not only complicated in process, high in production cost, and difficult to realize large-scale industrial production, but also have low dissolution rate of blonanserin

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  • Blonanserin pharmaceutical composition and preparation method thereof

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Effect test

Embodiment 1

[0032] The described blonanserin pharmaceutical composition of every 1000, its formula consists of:

[0033] Blonanserin 4g

[0034] Mannitol 60g

[0035] Microcrystalline cellulose 30g

[0036] Croscarmellose Sodium 21.6g

[0037] Magnesium stearate 2g

[0038] Micropowder silica gel 2.4

[0039] Preparation process: Take blonanserin, mannitol, and microcrystalline cellulose to pass through an 80-mesh sieve for later use, weigh the formula amount of mannitol, microcrystalline cellulose, cross-linked carmellose sodium, magnesium stearate and micropowder Silica gel to obtain the excipient mixture, weigh the blonanserin in the formula amount, and mix it with the excipient mixture uniformly by equal volume addition method, measure the drug content of the mixture, calculate the tablet weight, and directly compress the tablet.

Embodiment 2

[0041] The described blonanserin pharmaceutical composition of every 1000, its formula consists of:

[0042] Blonanserin 4g

[0043] Mannitol 48g

[0044] Microcrystalline cellulose 36g

[0045] Crospovidone 30g

[0046] Magnesium stearate 1.2g

[0047] Differential silica gel 0.8g

[0048] Preparation process: take blonanserin, mannitol, and microcrystalline cellulose to pass through an 80-mesh sieve for later use, and weigh the formula amount of mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, and micropowdered silica gel to obtain auxiliary materials For the mixture, weigh the blonanserin in the prescribed amount, mix it uniformly with the auxiliary material mixture by the equal-volume incremental method, measure the drug content of the mixture, calculate the tablet weight, and directly compress the tablet to obtain the product.

Embodiment 3

[0050] The described blonanserin pharmaceutical composition of every 1000, its formula consists of:

[0051] Blonanserin 4g

[0052] Mannitol 66g

[0053] Microcrystalline cellulose 24g

[0054] Low-substituted hydroxypropyl cellulose 21.6g

[0055] Magnesium stearate 2g

[0056] Differential silica gel 2.4g

[0057] Preparation process: take blonanserin, mannitol, and microcrystalline cellulose and pass through an 80-mesh sieve for later use; For the auxiliary material mixture, weigh the blonanserin in the prescribed amount, mix it uniformly with the auxiliary material mixture by the equal-volume incremental method, measure the drug content of the mixture, calculate the tablet weight, and directly compress the tablet to obtain the product.

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Abstract

The invention discloses a blonanserin pharmaceutical composition. Mannitol and microcrystalline cellulose are used as filling agents, wherein the weight percentage of the mannitol is 40%-55%, and the weight percentage of the microcrystalline cellulose is 20%-30%. The blonanserin pharmaceutical composition is high in stability and has evident advantages of product yield increase, cost reduction, industrialization realization and clinical application, dissolubility can be effectively improved, and bioavailability is improved evidently.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a blonanserin pharmaceutical composition and a preparation method thereof. Background technique [0002] Blonanserin, its chemical name is: 2-(4-ethyl-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydroaromatic Octa[b]pyridine, molecular formula: C23H30FN3, molecular weight: 367.5. It was first disclosed by EP0385237 and was developed by Sumitomo Corporation of Japan. It was launched in Japan in January 2008. It is a drug that specifically acts on 5-HT2 receptors and D2 receptors. It is the closest atypical antipsychotic drug in the market. Drugs that act selectively. Significantly improve the positive symptoms (such as hallucinations, delusions, etc.) and negative symptoms (such as depression, hypokinesia, etc.) etc.) and other adverse reactions, and its safety and tolerance are significantly better than traditional antipsychotic drugs. [0003] Orally disi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/496A61K47/38A61K47/26A61P25/18
Inventor 严洁
Owner TIANJIN HANKANG PHARMA BIOTECH
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