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Phenoxybenzylamine hydrochloride tablets and preparation method thereof

A phenoxybenzamine hydrochloride tablet and a technology for phenoxybenzamine hydrochloride, which are applied in the field of phenoxybenzamine hydrochloride tablets and their preparation, can solve the problems of low dissolution rate, large inter-batch and intra-batch differences, etc. Good compressibility, improved dissolution and stability

Active Publication Date: 2020-10-09
TOPFOND PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, most of the commercially available products are phenoxybenzamine hydrochloride tablets. Through practice, it is found that the existing phenoxybenzamine hydrochloride tablet products have the problems of low dissolution rate and large inter-batch and intra-batch differences.

Method used

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  • Phenoxybenzylamine hydrochloride tablets and preparation method thereof
  • Phenoxybenzylamine hydrochloride tablets and preparation method thereof
  • Phenoxybenzylamine hydrochloride tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] A kind of phenoxybenzamine hydrochloride tablet, it comprises following component:

[0036]

[0037]

[0038] Among them, the viscosity of the dextrin used is 6.2MPa.s, and the specific surface area of ​​the pregelatinized starch is 160.3m 2 / kg.

[0039]The steps of the preparation method of the above-mentioned phenoxybenzamine hydrochloride tablet include: (1) phenoxybenzamine hydrochloride is pulverized through a 100-mesh sieve, and other components are directly weighed for subsequent use; ) in a small amount of cold water, then add boiling water and continuously stir to make a dextrin slurry with a mass percentage concentration of 20% for subsequent use; (2) mix phenoxybenzamine hydrochloride, microcrystalline cellulose, dextrin, and pregelatinized starch evenly Then spray dextrin slurry with a mass percentage concentration of 20% for one-step granulation, and dry the wet granules in a fluidized bed drying granulator to 55°C before sizing, wherein the sieve f...

Embodiment 2

[0041] A kind of phenoxybenzamine hydrochloride tablet, it comprises following component:

[0042] Material name Dosage (weight ratio%) Features Phenoxybenzamine Hydrochloride 10 active ingredient microcrystalline cellulose 16 filler dextrin 8 filler 20% dextrin paste 5 (dextrin amount) Adhesive pregelatinized starch 35 fillers, disintegrants Magnesium stearate 1 lubricant silica 3 Glidant Carboxymethyl Starch Sodium 3 disintegrant

[0043] Among them, the viscosity of the dextrin used is 7.0MPa.s, and the specific surface area of ​​the pregelatinized starch is 180m 2 / kg.

[0044] The steps of the preparation method of the above-mentioned phenoxybenzamine hydrochloride tablet include: (1) phenoxybenzamine hydrochloride is pulverized through a 100-mesh sieve, and other components are directly weighed for subsequent use; ) in a small amount of cold water, then add boiling water and continuously s...

Embodiment 3

[0046] A kind of phenoxybenzamine hydrochloride tablet, it comprises following component:

[0047] Material name Dosage (weight ratio%) Features Phenoxybenzamine Hydrochloride 20 active ingredient microcrystalline cellulose 28 filler dextrin 10 filler 20% dextrin paste 15 (dextrin amount) Adhesive pregelatinized starch 50 fillers, disintegrants Magnesium stearate 2 lubricant silica 3 Glidant Carboxymethyl Starch Sodium 6 disintegrant

[0048] Among them, the viscosity of the dextrin used is 5.5MPa.s, and the specific surface area of ​​the pregelatinized starch is 130m 2 / kg.

[0049] The steps of the preparation method of the above-mentioned phenoxybenzamine hydrochloride tablet include: (1) phenoxybenzamine hydrochloride is pulverized through a 100-mesh sieve, and other components are directly weighed for subsequent use; ) in a small amount of cold water, then add boiling water and continuously...

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Abstract

The invention discloses a phenoxybenzylamine hydrochloride tablet which comprises the following components: phenoxybenzylamine hydrochloride, dextrin, pregelatinized starch, a disintegrating agent, afilling agent, an adhesive, a lubricating agent and a flow aid. The viscosity of the dextrin ranges from 4.5 mpa.s to 8.5 mpa.s; the specific surface area of the pregelatinized starch is less than orequal to 350m < 2 > / kg; the disintegrating agent is carboxymethyl starch sodium. A disintegrating agent such as carboxymethyl starch sodium, dextrin with viscosity of 4.5-8.5 mpa.s and pregelatinizedstarch with specific surface area of less than or equal to 350m < 2 > / kg are added into the components, so that the obtained phenoxybenzamine hydrochloride tablet has improved dissolution rate and dissolution rate uniformity, and is small in intra-group difference and good in stability.

Description

technical field [0001] The invention relates to the technical field of preparation of pharmaceutical preparations, in particular to a phenoxybenzamine hydrochloride tablet and a preparation method thereof. Background technique [0002] The chemical name of phenoxybenzamine hydrochloride is: N-(1-methyl-2-phenoxyethyl)-N-(2-chloroethyl)benzylamine hydrochloride, and its structural formula is as follows: [0003] [0004] Phenoxybenzamine hydrochloride can change the vasoconstriction response due to the excitation of α-receptors, reduce the resistance of peripheral blood vessels and relieve the capacity of blood vessels in a contracted state, thereby increasing the volume of blood vessels by 20%-30%; it can increase myocardial contraction The ability to increase heart rate and lower blood pressure, reduce peripheral vascular resistance, increase cardiac output and reduce oxygen consumption; it also has the effect of antihistamine, which can increase urine output and make sk...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/138A61K47/36A61P9/02A61P9/06A61P9/12A61P13/08A61P35/00
CPCA61K9/2059A61K9/2095A61K31/138A61P9/12A61P9/06A61P9/02A61P13/08A61P35/00
Inventor 吴严毛新付陈琦黄鸳鸯徐文斌李青霞樊静王凌志高威古东霞冯荣彬刘继方
Owner TOPFOND PHARMA CO LTD
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