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Blonanserin tablet and preparation method thereof
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A technique for blonanserin, tablet
Active Publication Date: 2011-11-16
LIVZON PHARM GRP INC
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[0004] However, the existing blonanserin specification is 4mg, which belongs to the low-dose specification, and the preparation of blonanserin tablets in the prior art usually adopts a wet granulation process. The preparation has the following disadvantages: 1) the loss of the a
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Embodiment 1
[0020] Compatibility test of raw materials and auxiliary materials: investigate the stability of blonanserin and various direct pressure auxiliary materials after 10 days of accelerated test at 60°C and RH75%.
[0021] Sample treatment: Transfer the sample with the composition shown in Table 1 to a 25ml volumetric flask, dilute to the mark with mobile phase, shake well, and detect with high performance liquid phase.
[0022] Table 1 Compatibility test results
[0023]
[0024] It can be seen from the data in Table 1 that the blonanserin raw material itself is very stable, and when it is compatible with other direct-pressing auxiliary materials, the content does not drop significantly after being inspected under certain temperature and humidity conditions, which proves that they can be mixed and pressed. sliced.
Embodiment 2
[0026] Prescription 1
[0027] Blonanserin 4.0g
[0028] Cellulose-Lactose 110.0g
[0029] Croscarmellose Sodium 4.0g
[0030] Magnesium Stearate 1.0g
[0031]
[0032] 119g, made into 1000 pieces
[0033] Preparation method: Weigh each component according to the prescription amount, pass through a 70-mesh sieve, mix well, granulate, and tablet with a single-punch tablet machine.
Embodiment 3
[0035] Prescription 2
[0036] Blonanserin 4.0g
[0037] Spray dried lactose 90.0g
[0038] Microcrystalline Cellulose 102 30.0g
[0039] Croscarmellose Sodium 4.0g
[0040] Magnesium Stearate 1.0g
[0041]
[0042] 129g, made into 1000 pieces
[0043] Preparation method: Weigh each component according to the prescription amount, pass through a 60-mesh sieve, mix well, granulate, and tablet with a single-punch tablet machine.
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Abstract
The invention provides a Blonanserin tablet and a preparation method thereof. The tablet contains Blonanserin, lactose and microcrystalline cellulose. Compared with present products and their preparation technologies, as the loss of active components during the direct compression process is very small, the Blonanserin tablet of the invention has a higher active component content and improved hardness, thus meeting the demands of commercial production and clinical medication.
Description
technical field [0001] The invention belongs to the field of medicine, and in particular relates to a blonanserin tablet and a preparation method thereof. Background technique [0002] The incidence of schizophrenia has shown an upward trend in the past ten years. Taking my country as an example, the incidence of schizophrenia has risen from 5.69% in 1982 to 6.55% in recent years. According to the Ministry of Health report in 2002, there are about 8 million schizophrenic patients in my country, and 150,000 new patients are added every year, and the number has increased to 8.6 million in 2006. [0003] Blonanserin is an atypical antipsychotic drug developed by Sumitomo Pharmaceutical Co., Ltd. and launched in Japan in April 2008. It belongs to the serotonin and dopamine antagonists and has the effect of blocking dopamine D2 receptors and 5-HT2A receptors. It has fewer extrapyramidal side effects than other antipsychotic drugs currently on the market. [0004] However, the...
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Application Information
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