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Loratadine tablet and preparation technology thereof

A technology of loratadine and tablets, which is applied in the field of loratadine tablets and its preparation, can solve the problems of slow dissolution rate and incomplete dissolution, and achieve low friability, no solvent residue, and low energy consumption. Effect

Active Publication Date: 2018-02-02
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention aims to provide a stable loratadine tablet with significantly improved dissolution rate and bioavailability and a preparation process thereof to solve the incomplete dissolution and slow dissolution rate caused by the low solubility of loratadine. problems, and effectively inhibit the formation of loratadine impurities to improve the safety of medication

Method used

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  • Loratadine tablet and preparation technology thereof
  • Loratadine tablet and preparation technology thereof
  • Loratadine tablet and preparation technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3 and comparative example 1-4

[0037] The preparation of embodiment 1-3 and comparative example 1-4 loratadine sheet

[0038] The composition of embodiment 1-3 loratadine tablet is shown in the table below:

[0039]

[0040]

[0041] The composition of comparative example 1-4 loratadine tablet is shown in the table below:

[0042]

Embodiment 1

[0043] The preparation of embodiment 1 loratadine tablet:

[0044](1) Loratadine is dissolved in absolute ethanol to make a solution with a concentration of 15% (m / v) to obtain solution A; sorbitol is dissolved in water to make a concentration of 25% (m / v) solution to obtain solution B;

[0045] (2) Add solution B to solution A under stirring conditions, stir for 10 minutes, heat the suspension, and evaporate to dryness to obtain material C;

[0046] (3) Mix material C and lactose according to the isovolumic incremental method, add starch, microcrystalline cellulose, and stabilizer to the wet granulator in turn, stir and mix evenly, add an appropriate amount of 10% starch slurry, stir for 90 seconds, cut Crushed for 60 seconds, made into soft materials and then granulated;

[0047] (4) Dry after making wet granules, set the air inlet temperature range ≤ 80°C, control the air inlet temperature range ≤ 87°C, control the material temperature ≤ 60°C, and the outlet air temperatu...

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PUM

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Abstract

The invention discloses a loratadine tablet and a preparation technology thereof. The loratadine tablet comprises, by weight, 4-8% of loratadine, 30-40% of a first filler, 15-25% of a second filler, 20-40% of a third filler, 2-10% of a stabilizer, 5-10%of sorbitol, 0.5-1.5% of a disintegrating agent, 0.5-1.5% of a lubricant, and a proper amount of an adhesive. The stabilizer is composed of alginicacid and L-methionine according to a mass ratio of 1:(0.1-0.3). The loratadine tablet prepared in the invention has the advantages of smooth and clean appearance, good hardness, low friability, little weight difference among tablets, uniform content and good in-vitro dissolution behavior, and the dissolution rate reaches 95% or more. The single impurity content is 0.12% and the total content of impurities is 0.47% after the loratadine tablet is stored for 12 months, so the loratadine tablet has a good stability.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a loratadine tablet and a preparation process thereof. Background technique [0002] Loratadine, chemical name 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1 - Ethyl piperidine carboxylate, as an oral long-acting tricyclic antihistamine, it has a fast onset and strong effect, and is effective for peripheral histamine H 1 Receptors are highly selective for central nervous system H 1 Receptor affinity is weak, and it has little effect on acetylcholine receptors or α1 adrenoceptors. Clinically, it is mainly used to relieve symptoms related to allergic rhinitis, such as sneezing, runny nose and nasal itching, nasal congestion, eye itching and burning sensation, and is also suitable for relieving chronic urticaria, itchy skin diseases and other allergic skin diseases Symptoms and signs of antihistamines are the most comm...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/26A61K47/36A61K47/18A61K31/4545A61P37/08
CPCA61K9/2013A61K9/2018A61K9/205A61K9/2095A61K31/4545
Inventor 郑璐朱华荣潘新丛海建高苇
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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