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Clonidine hydrochloride freeze-dried orally disintegrating tablet and preparation method thereof

A technology for cola hydrochloride and dry mouth, applied in the field of medicine, can solve the problems of easy thrombosis, ischemic cerebral apoplexy and the like, and achieve the effects of accelerating drug absorption, facilitating drug dissolution and good stability

Active Publication Date: 2017-11-21
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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  • Clonidine hydrochloride freeze-dried orally disintegrating tablet and preparation method thereof
  • Clonidine hydrochloride freeze-dried orally disintegrating tablet and preparation method thereof
  • Clonidine hydrochloride freeze-dried orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] A clonidine hydrochloride freeze-dried orally disintegrating tablet, comprising: 5 g of clonidine hydrochloride, 90 g of xylitol, and 2 g of gelatin.

[0029] Dissolve the prescribed amount of gelatin in 750mL of purified water and heat until completely dissolved; add the prescribed amount of clonidine hydrochloride and xylitol, stir to dissolve, then add 250mL of purified water to make up the volume; The filling amount is transferred to the mold, and placed in a freeze-drying box, and the liquid medicine is freeze-dried to control the moisture content of not more than 1.0%, sealed, and packaged as a finished product. The specific steps of freeze-vacuum drying are: freeze at -20°C for 4 hours, slowly heat up to 5°C and dry for 12 hours, continue to heat up to 25°C and dry for 10 hours, cool down to 20°C and keep for 4 hours, and the vacuum degree is controlled at 12 Pa.

Embodiment 2

[0031] A clonidine hydrochloride freeze-dried orally disintegrating tablet, the components of which are: 2 g of clonidine hydrochloride, 80 g of sorbitol, 1 g of dextran, an appropriate amount of hydrochloric acid, 1 g of aspartame, and 1 g of methylparaben.

[0032] Dissolve the prescribed amount of dextran in 500mL distilled water and heat until completely dissolved; dissolve the prescribed amount of clonidine hydrochloride and sorbitol in the above solution, add the prescribed amount of aspartame and methyl paraben, and stir uniform; use hydrochloric acid to adjust the pH value to 3, and use 500mL distilled water to fix the volume; after determining the filling amount according to the specifications, transfer the liquid medicine to the mold according to the filling volume, and place it in a freeze-drying box to freeze and vacuum-dry the liquid medicine to control The water content does not exceed 1.0%, and it is sealed and packaged as a finished product. The specific steps ...

Embodiment 3

[0034] A clonidine hydrochloride freeze-dried orally disintegrating tablet, the components of which are: 10 g of clonidine hydrochloride, 98 g of mannitol, 5 g of sodium alginate, an appropriate amount of hydrochloric acid, 1 g of sucralose, and 0.5 g of sodium benzoate.

[0035] Dissolve the prescribed amount of sodium alginate in 600mL deionized water, and heat until completely dissolved; dissolve the prescribed amount of clonidine hydrochloride and mannitol in the above solution, add the prescribed amount of sucralose and sodium benzoate, and stir well; Adjust the pH value to 2.5 with hydrochloric acid, and use 400mL deionized water to make up the volume; after determining the filling volume according to the specifications, transfer the medicine liquid to the mold according to the filling volume, and place it in a freeze-drying box to freeze and vacuum-dry the medicine liquid to control the moisture content. The content is not more than 1.0%; it is sealed and packaged as a f...

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Abstract

The invention belongs to the field of medicines, and particularly relates to a clonidine hydrochloride freeze-dried orally disintegrating tablet and a preparation method thereof. According to the technical scheme of the invention, the clonidine hydrochloride freeze-dried orally disintegrating tablet is characterized by comprising the following components in parts by weight: 2-10 parts of clonidine hydrochloride, 80-98 parts of a filling agent, 1-5 parts of an adhesive, 0-3 parts of a pH value adjusting agent, 0-3 parts of a corrigent and 0-2 parts of a preservative. The clonidine hydrochloride freeze-dried orally disintegrating tablet provided by the invention is convenient to take, good in taste, beneficial to improvement of compliance of patients taking the medicine, rapid in disintegration in mouths, beneficial to medicine dissolution, rapid in medicinal absorption and treatment effect taking, uniform in content and good in stability. The clonidine hydrochloride freeze-dried orally disintegrating tablet provided by the invention is simple in production process, easy to control and applicable to industrial production, and technical effects beyond expectation are achieved.

Description

Technical field [0001] The invention belongs to the field of medicine, and specifically relates to a clonidine hydrochloride freeze-dried orally disintegrating tablet and a preparation method thereof. Background technique [0002] Clonidine hydrochloride directly stimulates the central postsynaptic membrane α2 receptors in the hypothalamus and oblongata, excitating inhibitory neurons, reducing the outgoing of central sympathetic nerve impulses, thereby inhibiting peripheral sympathetic nerve activity. Clonidine hydrochloride tablets, prescription drugs, taken orally. It is mainly used to treat high blood pressure, hypertensive emergencies, migraines, menopausal hot flashes, dysmenorrhea, and symptoms of opioid addiction. [0003] Clonidine hydrochloride sustained-release tablets were developed by Addrenex Pharmaceuticals of the United States and were approved by the U.S. FDA for the treatment of hypertension on September 29, 2009. Specifications: 0.1mg, 0.2mg. On September...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4168A61P9/12A61P25/06A61P15/12A61P29/00A61P25/36
CPCA61K9/0056A61K9/205A61K9/2063A61K9/2095A61K31/4168
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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