Clonidine hydrochloride oral membrane and preparation method thereof

A technology of clonidine hydrochloride and oral film, which is applied in the direction of anti-inflammatory agents, pharmaceutical formulas, non-central analgesics, etc., can solve the problems of prone to thrombosis and ischemic stroke, and achieve faster drug absorption, Accelerated efficacy, easy-to-control effects

Active Publication Date: 2017-12-08
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

Method used

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  • Clonidine hydrochloride oral membrane and preparation method thereof
  • Clonidine hydrochloride oral membrane and preparation method thereof

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 and in particular relates to a clonidine hydrochloride oral membrane and a preparation method thereof. According to the adopted technical scheme, the clonidine hydrochloride oral membrane is characterized by containing the following components: clonidine hydrochloride, a membrane forming material, a disintegrating agent, a plasticizer, a corrective agent and a coloring agent. The prepared clonidine hydrochloride oral membrane is easy to take and good in taste and can beneficially improve safety and compliance of a patient in a process of taking a medicine; the clonidine hydrochloride oral membrane is rapidly dissolved in an oral cavity, bioavailability is high, and medicine absorption and play of curative effect are sped up; and content is uniform, and stability is good. The clonidine hydrochloride oral membrane provided by the invention has the advantages that preparation technique is simple, control is easy, the clonidine hydrochloride oral membrane is applicable to industrial production, and unexpected technical effect is obtained.

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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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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