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Clonidine hydrochloride sustained release micropill preparation

A technology of clonidine hydrochloride and sustained-release pellets, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, cardiovascular system diseases, etc., and can solve obstacles affecting curative effect, missed doses, and medication compliance To achieve the effect of reducing the number of medications, keeping the blood concentration high and stable, and reducing the incidence of adverse reactions

Active Publication Date: 2011-08-03
HEFEI COSOURCE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Patients with high blood pressure need long-term medication, taking too many times a day will cause great obstacles to medication compliance, and there may be missed doses, which will affect the curative effect

Method used

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  • Clonidine hydrochloride sustained release micropill preparation
  • Clonidine hydrochloride sustained release micropill preparation
  • Clonidine hydrochloride sustained release micropill preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] (1) Preparation of drug-containing pellet core (A)

[0047] Clonidine Hydrochloride

4.0g

Blank ball core (sucrose type)

1600g

[0048] Opadry (CLEAN)

40.0g

purified water

760.0g

[0049] Preparation Process:

[0050]Weigh Opadry (CLEAN), add to purified water and stir to dissolve, pass through a 100-mesh sieve before use, then add the prescribed amount of clonidine hydrochloride raw material, stir and dissolve to obtain a coating solution for the drug layer. Weigh blank ball cores and add them to a fluidized bed coating machine (WBF-5G, Chongqing Yingge Granulation Coating Technology Co., Ltd.), and use a low-spray coating system (Wurster system) for coating. The coating parameters of the equipment are : Air intake 250m 3 / hr, air inlet temperature 50℃, atomization pressure 2kg / cm 2 , coating liquid flow rate 7rpm. After the spraying of the coating solution is finished, the material is discharged aft...

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Abstract

The invention relates to the field of medicinal preparations, in particular to a clonidine hydrochloride sustained release preparation and a preparation method thereof. The clonidine hydrochloride sustained release preparation is characterized in that: a sustained release coating membrane is divided into two layers, wherein a sustained release coating membrane of an inner layer contains a pore-forming agent, and a sustained release coating membrane on an outer layer does not contain the pore-forming agent; and a weight ratio of a sustained release coating on the inner layer to a sustained release coating of the outer layer is (1:1)-(2:5), and the weight of sustained release coatings on inner and outer layers are increased by 7 to 8 percent. In the sustained release preparation, two sustained release layers are coated, so that medicaments are released slowly, safely and effectively.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a slow-release preparation of clonidine hydrochloride and a preparation method thereof. Background technique [0002] Clonidine hydrochloride, its chemical name is: 2-[(2,6-dichlorophenyl) imino] imidazolidine hydrochloride. It is an antihypertensive drug, which is well absorbed in the gastrointestinal tract. After oral administration, 70% to 80% of it is absorbed, and it is quickly distributed to various organs. brain tissue. The protein binding rate is 20% to 40%. Half an hour to 1 hour after oral administration, it exerts its antihypertensive effect, and the blood concentration reaches a peak value in 3 to 5 hours, generally 1.35 ng / ml, and the duration of action is 6 to 8 hours. The elimination half-life is 12.7 (6-23) hours, and it is prolonged when renal insufficiency occurs. The apparent volume of distribution is 2.1±0.4L / kg. The creatinine clearance rate wa...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/4168A61K47/38A61P9/12
Inventor 高署
Owner HEFEI COSOURCE PHARMA CO LTD
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