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A kind of clonidine hydrochloride oral film and preparation method thereof

A technology of clonidine hydrochloride and oral film, which can be applied in the directions of anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc. Faster drug absorption, easy-to-control effects

Active Publication Date: 2021-02-26
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, at dawn, the human body is prone to thrombosis and ischemic stroke, especially in hypertensive patients.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Clonidine hydrochloride oral film, comprising the following components:

[0043] Clonidine Hydrochloride 20g

[0044] Poloxamer 70g

[0045] Polyethylene glycol 10g.

[0046] The preparation method comprises the following steps:

[0047] (1) Weigh the prescribed amount of poloxamer, add 60°C water to swell, and cool to 50°C when the solution is completely clear;

[0048] (2) Add the polyethylene glycol of recipe quantity, stir constantly to mix, cool to room temperature;

[0049] (3) add the clonidine hydrochloride of recipe quantity, fully stir and make dissolving, and mix homogeneously;

[0050] (4) Stand still for 2 hours, ultrasonic degassing, ultrasonic 10s each time, interval 3s, control temperature at 20-30°C to prepare film material;

[0051] (5) Pour the film material onto the lower edge of the glass plate, push the film material forward with a push rod to coat the film, dry it, remove the film and cut it into required specifications, seal it and pack it, ...

Embodiment 2

[0054] Clonidine hydrochloride oral film, comprising the following components:

[0055] Clonidine Hydrochloride 10g

[0056] Polyvinyl alcohol 80g

[0057] Sodium carboxymethyl starch 5g

[0058] Glycerin 5g.

[0059] The preparation method comprises the following steps:

[0060] (1) Weigh the polyvinyl alcohol of the prescribed amount, add 70°C water to swell, and cool to 50°C when the solution is completely clear;

[0061] (2) Add the sodium carboxymethyl starch and glycerin of recipe quantity, constantly stir to mix, be cooled to room temperature;

[0062] (3) add the clonidine hydrochloride of recipe quantity, fully stir and make dissolving, and mix homogeneously;

[0063] (4) Stand still for 4 hours, ultrasonic degassing, ultrasonic 10s each time, interval 3s, control the temperature and keep it at 20-30°C to prepare the film material;

[0064] (5) Pour the film material onto the lower edge of the glass plate, push the film material forward with a push rod to coat t...

Embodiment 3

[0067] Clonidine hydrochloride oral film, comprising the following components:

[0068] Clonidine Hydrochloride 15g

[0069] Sodium Alginate 60g

[0070] Crosslinked PVP 5g

[0071] Polypropylene glycol 10g

[0072] Sucralose 8g

[0073] Indigo 2g.

[0074] The preparation method comprises the following steps:

[0075] (1) Weigh the sodium alginate of the prescribed amount, add 50°C water to swell, and cool to 30°C when the solution is completely clear;

[0076] (2) Add the cross-linked PVP, polypropylene glycol, sucralose and indigo of the prescription amount, stir continuously until evenly mixed, and cool to room temperature;

[0077] (3) add the clonidine hydrochloride of recipe quantity, fully stir and make dissolving, and mix homogeneously;

[0078] (4) Stand still for 3 hours, ultrasonic degassing, ultrasonic 10s each time, interval 3s, control the temperature and keep it at 20-30°C to prepare the film material;

[0079] (5) Pour the film material onto the lower ...

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Abstract

The invention belongs to the field of pharmaceutical preparations, in particular to a clonidine hydrochloride oral film and a preparation method thereof. The technical solution adopted by the present invention is a clonidine hydrochloride oral film, which is characterized in that it comprises the following components: clonidine hydrochloride, film-forming material, disintegrant, plasticizer, flavoring agent and coloring agent. The clonidine hydrochloride oral film prepared by the invention is convenient to take, has a good taste, and is beneficial to improve the safety and compliance of patients taking medicine; it dissolves quickly in the oral cavity, has high bioavailability, and accelerates drug absorption and curative effect; the content is uniform, Good stability. The preparation process of the clonidine hydrochloride oral film of the invention is simple, easy to control, suitable for industrial production, and has achieved unexpected technical effects.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a clonidine hydrochloride oral film and a preparation method thereof. Background technique [0002] Clonidine hydrochloride directly excites the central post-synaptic membrane α2 receptors in the hypothalamus and medulla oblongata, excites the inhibitory neurons, reduces the central sympathetic nerve impulse transmission, and thus inhibits the peripheral sympathetic nerve activity. Clonidine hydrochloride tablets, prescription drugs, oral. It is mainly used for the treatment of high blood pressure, hypertensive emergencies, migraine, menopausal hot flashes, dysmenorrhea and symptoms of opioid addiction withdrawal. [0003] Clonidine Hydrochloride Sustained-release Tablets were developed by Addrenex Pharmaceuticals of the United States, and were approved by the FDA for the treatment of hypertension on September 29, 2009. Specifications: 0.1mg, 0.2mg. On September 30, 2...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K47/10A61K47/32A61K47/38A61K31/4168A61P9/12A61P25/06A61P15/00A61P29/00A61P25/36
CPCA61K9/006A61K31/4168A61K47/10A61K47/32A61K47/38
Inventor 陈阳生王明刚刘晓霞孙桂玉臧云龙
Owner CP PHARMA QINGDAO CO LTD
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