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Clonidine hydrochloride sustained-release capsule

A technology of clonidine hydrochloride and sustained-release capsules, which is applied in the field of medicine, can solve the problems of the introduction of sustained-release effect, unknown indicators such as dissolution rate, and uneven content, and achieve uniform release, good patient compliance, and simple preparation process. Effect

Active Publication Date: 2016-03-16
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The currently known preparation method of clonidine hydrochloride sustained-release agent, CN104138362A, adopts the solvent dispersion method to dissolve the clonidine hydrochloride raw material in an appropriate amount of wetting agent, which mainly improves the problem of uneven content in the preparation process of clonidine hydrochloride sustained-release tablets; CN104352473A introduces a method for preparing sustained-release tablets using hypromellose as the sustained-release framework material, but there is no introduction to the slow-release effect of the examples, and the indicators such as dissolution rate are unknown; CN102138906A and CN102138906A respectively introduce a kind of cola hydrochloride The preparation method of fixed-release pellets

Method used

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  • Clonidine hydrochloride sustained-release capsule
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  • Clonidine hydrochloride sustained-release capsule

Examples

Experimental program
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Effect test

preparation example Construction

[0020] A preparation method of clonidine hydrochloride sustained-release capsules, comprising the following steps:

[0021] (1) Take a certain amount of starch and put it in a centrifugal granulator, use water as a binder, and make a blank pellet core with a particle size of 40-60 mesh;

[0022] (2) take clonidine hydrochloride, filler and binder by weight percentage, binder is made into 2~6% aqueous solution, clonidine hydrochloride and filler are put in the powder supply chamber of centrifugal granulator, Take an appropriate amount of the blank pellet core prepared in step (1) and put it in a granulation pot, use the aqueous solution of the binder as the binder to prepare drug-containing pellets, dry the pellets at 50-60°C after they are taken out of the pot, and sieve for 15 ~25 mesh for the next step of coating;

[0023] (3) Dissolve the slow-release material, plasticizer, porogen, and anti-tack agent with 65-85% ethanol solution to make a slow-release coating solution; ...

Embodiment 1～3

[0027] The preparation of embodiment 1~3 clonidine hydrochloride sustained release capsule

[0028] According to the raw and auxiliary materials in the table below, according to the above preparation method, taking the 0.1mg specification as an example, and using the ratio of 40% for the blank core, 40% for the drug-containing layer, and 20% for the coating layer, each example was prepared respectively 2000 clonidine hydrochloride extended-release capsules. The weight ratio of the slow-release material to the porogen in Example 1 is 9:1, the weight ratio of the slow-release material to the porogen in Example 2 is 10:1, and the weight ratio of the slow-release material to the porogen in Example 3 is The ratio is 8:1.

[0029]

[0030] Test Example 1 Determination of Release of Clonidine Hydrochloride Sustained-release Capsules Gained in Examples 1-3

[0031] According to the "Guidelines for Sustained-release, Controlled-release and Delayed-release Preparations" in the 2015...

Embodiment 4～6

[0034] The preparation of embodiment 4~6 clonidine hydrochloride sustained-release capsules

[0035] According to the raw and auxiliary materials in the following table, according to the above-mentioned preparation method, taking 0.1 mg specification as an example, 2000 clonidine hydrochloride sustained-release capsules were prepared in each embodiment. According to the ratio of 35% for the blank core, 40% for the drug-containing layer, and 25% for the coating layer, 2000 clonidine hydrochloride sustained-release capsules were respectively prepared in each embodiment. The weight ratio of the slow-release material and the porogen in Example 4 is 9:1, the weight ratio of the slow-release material in Example 5 and the porogen is 10:1, and the weight of the slow-release material in Example 6 and the porogen The ratio is 8:1.

[0036]

[0037] Test Example 2 Determination of Release of Clonidine Hydrochloride Sustained-release Capsules Gained in Examples 4-6

[0038] The measu...

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Abstract

The invention discloses a clonidine hydrochloride sustained-release capsule, which is formed by filling clonidine hydrochloride sustained-release pellets in a capsule shell; during preparing, drug-containing layers and coating layers cover blank pellet cores, so that the clonidine hydrochloride sustained-release pellets are obtained, and then the clonidine hydrochloride sustained-release pellets are filled into the capsule shell, so that the clonidine hydrochloride sustained-release capsule is prepared. The clonidine hydrochloride, as a major ingredient in the clonidine hydrochloride sustained-release capsule disclosed by the invention, has an effect of relieving muscle spasm as well as accompanied severe pain in skeletal muscle and the like; the sustained-release preparation can develop effects of stopping pain and relieving spasm stably; and the sustained-release capsule is safe and effective, stable in quality, low in cost and low in administration efficiency, and patient compliance is enhanced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a preparation method of clonidine hydrochloride sustained-release capsules. The invention provides a safe, effective, stable quality, low cost, less frequency of administration, enhanced patient compliance, and stable pain relief and spasm relief. sustained-release preparations. 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 ...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K47/38A61K31/4168A61P29/00A61P21/02A61P9/12A61P25/36A61P25/06
CPCA61K9/0002A61K9/5042A61K31/4168
Inventor 王明刚陈阳生任莉孙桂玉刘晓霞牛建兴付全磊
Owner CP PHARMA QINGDAO CO LTD
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