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Dripping pills of clemastine fumarate and its preparation method

A technology of clemastine fumarate and clemastine, which is applied in the direction of pill delivery, respiratory diseases, skin diseases, etc., can solve the problem of affecting the therapeutic effect of clemastine fumarate, low dissolution rate and dissolution rate, and large proportion of excipients and other problems, to achieve the effect of convenient carrying and taking, improved dissolution rate and dissolution rate, and reduced dosage of excipients

Inactive Publication Date: 2005-04-06
HONGYI SCI & TECH CO LTD NANCHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Clemastine fumarate has a slightly bitter taste and is very slightly soluble in water. Its tablet disintegration time is long, the dissolution rate and dissolution rate are low, the absorption is poor, the bioavailability is low, and the proportion of excipients is large. Children, the elderly, and bedridden patients It is inconvenient and poor compliance for patients with dysphagia, which affects the therapeutic effect of clemastine fumarate

Method used

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  • Dripping pills of clemastine fumarate and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0052] prescription:

[0053] Clemastine Fumarate 1.34g

[0054] Macrogol 6000 20g

[0055] Makes 1000 capsules

[0056] Preparation method: Take the clemastine fumarate fine powder that has been ultrafinely pulverized and passed through a 200-mesh sieve, add it to the molten polyethylene glycol 6000 matrix, stir well, use simethicone as a coolant, make pellets by drop method, dry, Instantly.

example 2

[0058] prescription:

[0059] Clemastine Fumarate 1.34g

[0060] Macrogol 4000 20g

[0061] Makes 1000 capsules

[0062] Preparation method: Take clemastine fumarate fine powder that has been ultrafinely pulverized and passed through a 200-mesh sieve, add it to the molten polyethylene glycol 4000 matrix, stir well, use simethicone as coolant, make pellets by drop method, dry, Instantly.

example 3

[0064] prescription:

[0065] Clemastine Fumarate 1.34g

[0066] Macrogol 6000 10g

[0067] Macrogol 4000 10g

[0068] Makes 1000 capsules

[0069] Preparation method: Take clemastine fumarate fine powder that has been ultrafinely pulverized and passed through a 200-mesh sieve, add it to the molten polyethylene glycol 4000 and polyethylene glycol 6000 mixed matrix, stir well, use simethicone as the coolant, Drop system into legal pills, dry, and get it.

[0070] 4. Example 4

[0071] prescription:

[0072] Clemastine Fumarate 1.34g

[0073] Glyceryl monostearate 20g

[0074] Makes 1000 capsules

[0075] Preparation method: Take clemastine fumarate fine powder that has been ultrafinely pulverized and passed through a 200-mesh sieve, add it to the molten glyceryl monostearate matrix, mix well, use ice water as a coolant, make pellets by dropping, dry, and have to.

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Abstract

The invention uses super micro shattering and drop pills producing the technology to produce fenfluramine drop pills, reaching the purposes such as increasing speed, and dissolution of disintegration, increasing the medicine stability, reducing the dose of auxiliary materials and decreasing cost, with rapid effect and convenient use. It can be buccal as well as deglutition, has remarkable conformity, and is especially suitable for children, older man, sicker in bed or with difficulty of swallowing.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to clemastine fumarate dropping pills and a preparation method thereof. Background technique [0002] Clemastine fumarate is H 1 Receptor antagonist, can inhibit capillary permeability, can quickly relieve itching, and still has anticholinergic and sedative effects. [0003] Clemastine fumarate is rapidly absorbed through the digestive tract when taken orally. It takes effect 30 minutes after taking the medicine, and the blood concentration reaches its peak in 2 to 5 hours. The effect can last for 12 hours. . t 1 / 2 After 21 hours, it is metabolized into mono- and di-methylated products in the liver, or combined with glucuronic acid, and is mainly excreted in urine and feces in the form of metabolites and a small amount of the original drug, and a small amount can appear in milk. Only tablets are currently on the market, and it is mainly used clinic...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/40A61P11/02A61P17/04A61P37/08
Inventor 钱进许军彭红李平朱丹刘孝乐
Owner HONGYI SCI & TECH CO LTD NANCHANG
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