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Clonidine hydrochloride sustained release tablets and preparation method thereof

A technology of clonidine hydrochloride and sustained-release tablets, which is applied in the direction of medical formulas, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problems affecting the reproductive ability of female mice, and achieve effective treatment. Blood pressure, drug stability, and convenient storage

Inactive Publication Date: 2015-02-18
HARBIN SHENGJI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007]4. Clinical studies have confirmed that clonidine hydrochloride reduces plasma renin activity, aldosterone and catecholamine secretion, but the exact relationship between these pharmacological effects and antihypertensive effects is not complete clear
[0009]6. Clonidine hydrochloride can treat migraine, dysmenorrhea and menopausal hot flashes, but its therapeutic mechanism is unknown, and it may play a role by stabilizing peripheral blood vessels
Clonidine hydrochloride at 150mcg / kg or about 3 times the maximum recommended human dose does not affect the reproductive ability of male or female mice; but at 500-2000mcg / kg or 10-40 times the maximum recommended human dose, it affects the reproductive ability of female mice

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] A clonidine hydrochloride sustained-release tablet and a preparation method thereof, which are made of clonidine hydrochloride, a sustained-release framework material, and a lubricant, wherein, in parts by weight, 0.2 parts of clonidine hydrochloride, 70-90 parts of a sustained-release framework material, 10-20 parts of lubricant.

[0033] According to the optimal parts by weight, 0.2 parts of clonidine hydrochloride, 70 parts of slow-release matrix material and 10 parts of lubricant.

[0034] The sustained-release matrix material is hypromellose.

[0035] The hypromellose is one or a mixture of 75hd100cr hypromellose, 75hd4000cr hypromellose, 75hd15000cr hypromellose, 100000cr hypromellose.

[0036] Described lubricant is magnesium stearate, talcum powder, silicon dioxide or a mixture of both.

Embodiment 2

[0038] A kind of clonidine hydrochloride slow-release tablet and preparation method thereof, the concrete steps of its preparation method are:

[0039] Step 1, material preparation: pulverize clonidine hydrochloride with a pulverizer, pass through a 100-mesh sieve, and set aside;

[0040] Step 2: Total mixing: weigh clonidine hydrochloride and hypromellose in parts by weight, put them into a three-dimensional mixer and mix for 30 minutes, take them out for later use;

[0041] Step 3: Granulation: Put the mixed fine powder of raw and auxiliary materials into the wet granulator, use pure water as the binder, put the binder into the liquid supply tank, turn on the machine, adjust the parameters, and start adding the moistening Wet agent, open the shear flying knife at the same time, 2-5 minutes, discharge, use a swing granulator, granulate with a 18-mesh nylon screen, use a fluidized bed dryer to dry, first dry with cool wind, wait After the skin is completely dry, turn ...

Embodiment 3

[0047] Interactions with other medicines

[0048] 1. Combining with central nervous system depressants such as ethanol, barbiturates or sedatives can strengthen the central depressive effect.

[0049] 2. Combining with other antihypertensive drugs can enhance the antihypertensive effect.

[0050] 3. Stopping the drug after combined use with β-receptor blockers can increase the withdrawal syndrome crisis of clonidine hydrochloride, so it is advisable to stop using β-receptor blockers first, and then stop clonidine hydrochloride.

[0051] 4. Combined use with tricyclic antidepressants can weaken the antihypertensive effect of clonidine hydrochloride, and the dose of clonidine hydrochloride must be increased.

[0052] 5. When used in combination with non-steroidal anti-inflammatory drugs, it can weaken the antihypertensive effect of clonidine hydrochloride.

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Abstract

The invention provides clonidine hydrochloride sustained release tablets. The clonidine hydrochloride sustained release tablets are prepared from 0.2 part of clonidine hydrochloride, 70-90 parts of sustained release skeleton material and 10-20 parts of lubricating agent by weight. A preparation method of the clonidine hydrochloride sustained release tablets comprises the steps of material preparing, blending, granulating, blending, tabletting and aluminium-plastic packaging. The clonidine hydrochloride sustained release tablets and the preparation method have the beneficial effects that the clonidine hydrochloride sustained release tablets have good stability and definite curative effects and can be used for effectively treating hypertension; the novel sustained release preparations are adopted; sustained release refers to reducing the medicine release rates of medicines from the dosage forms and reducing the absorption rates of the medicines into bodies, thus achieving more stable treatment effects; compared with oral liquids, the clonidine hydrochloride sustained release tablets have the advantages of good medicine stability, convenience in packaging, transportation and storage, and the like; the preparation method is simple and practicable and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of chemical drug sustained-release preparations, in particular to a clonidine hydrochloride sustained-release tablet 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] Pharmacological effects: [0004] 1. Clonidine hydrochloride is an alpha receptor agonist. [0005] 2. Clonidine hydrochloride directly excites the central post-synaptic membrane α2 receptors in the hypothalamus and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/4168A61K47/38A61P9/12A61J3/10
Inventor 马玉国
Owner HARBIN SHENGJI PHARMA
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