Preparation method of rupatadine fumarate tablet

A technology of rupatadine fumarate and magnesium stearate, which is applied in the field of medicine, can solve problems such as repeated and complicated operations, achieve stable and controllable processes, improve bioavailability, and increase solubility

Inactive Publication Date: 2021-07-09
北京阳光诺和药物研究股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] Chinese patent application (CN 107550874A) discloses a process condition such as screening the types and dosages of fillers, disintegrants, binders, and lubrica...

Method used

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  • Preparation method of rupatadine fumarate tablet
  • Preparation method of rupatadine fumarate tablet
  • Preparation method of rupatadine fumarate tablet

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Embodiment 1

[0088] Embodiment 1, preparation rupatadine fumarate tablet

[0089] This embodiment provides the preparation of preparing 10,000 prescriptions, and the composition of the prescription is shown in Table 16:

[0090] Table 16 Prescription Composition of Rupatadine Fumarate Tablets

[0091]

[0092] Made into 10,000 pieces

[0093] Prepared by wet granulation process, the process steps are as shown in Table 17:

[0094] Table 17 Wet granulation process of rupatadine fumarate tablets

[0095]

[0096] Concrete process conditions are as shown in table 18 and table 19:

[0097] Table 18 Conditions for wet granulation and fluid bed drying

[0098]

[0099] The specific parameters of tableting are shown in Table 19.

[0100] Table 19 Tablet Compression Conditions

[0101]

[0102] Dissolution data are shown in Table 20.

[0103] Table 20 Dissolution Data

[0104]

[0105]

[0106] By scaling up the determined crushing ratio, it was shown that the process had...

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Abstract

The invention discloses a preparation method of a rupatadine fumarate tablet. The preparation method comprises the following steps of: S1, mixing rupatadine fumarate with a part of microcrystalline cellulose, and then performing jet milling to obtain mixed powder; S2, mixing the mixed powder, pregelatinized starch, lactose and the remaining microcrystalline cellulose, performing wet granulation, and drying the mixture in a fluidized bed, adopting water as a wetting agent; and S3, carrying out size stabilization on particles obtained in the step S2, mixing the particles with magnesium stearate and a coloring agent, and tabletting to obtain the rupatadine fumarate tablet. According to the preparation method of the rupatadine fumarate tablet of the invention, the rupatadine fumarate and a part of microcrystalline cellulose are mixed and then are subjected to airflow pulverization, so that the operability in production is improved, the solubility of the raw materials can also be improved, and the absorption speed of the product in vivo is greatly increased; the wet granulation process is adopted, the process is stable and controllable; and the stability of the prepared sample is relatively good, and large-scale production and quality control during large-scale production are facilitated.

Description

technical field [0001] The invention relates to a preparation method of rupatadine fumarate tablets, which belongs to the technical field of medicine. Background technique [0002] Rupatadine fumarate (FR, Rupatadine Fumarate) chemical name is 8-chloro-6,11-dihydro-11-[1-[(5-methyl-3-pyridine)methyl]-4-piper Pyridyl]-5H-benzocyclohepta[1,2-b]pyridine fumarate, successfully developed by Uriach Pharmaceutical Company of Spain, was first listed in Spain in 2003, and is a new generation of tricyclic antihistamines It has the dual effects of antihistamine and antagonism of platelet activating factor (PAF), and it is also the only strong and efficient antiallergic drug currently on the market that has both antihistamine effect and antagonism of PAF activity. The drug can selectively block H1 receptors, and has only weak blocking effects on 5-hydroxytryptamine, acetylcholine, prostaglandin F2, and leukotriene D4. Sensitized cell degranulation has the advantages of no cardiovascul...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K31/4545A61P37/08
CPCA61K9/2054A61K9/2095A61K31/4545A61P37/08
Inventor 刘宇晶郑柏松韩琳琳佟德全童元峰谌宗永
Owner 北京阳光诺和药物研究股份有限公司
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