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Bromhexine hydrochloride slow-release capsules and preparation method thereof

A technology of bromhexine hydrochloride and sustained-release capsules, which is applied in the field of bromhexine hydrochloride sustained-release capsules and its preparation, can solve the problems of difficult tablet integrity, fragility, and high production costs, and achieve the effect of narrow particle distribution

Inactive Publication Date: 2018-03-30
HUAYI PHARMA ANHUI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to solve the problem that the traditional cough medicine tablets are too large, the production process is complicated, the prepared tablets are low in hardness and fragile, it is difficult to maintain the integrity of the tablets, and special packaging is required to prevent the tablets from breaking. Due to the disadvantages of high production cost, the bromhexine hydrochloride sustained-release capsules can be taken according to their own body weight to determine the amount of tablets to be taken, realizing personalized drug administration, making the intake of drugs more accurate and safer; at the same time, the active ingredients of the drug are in the form of nanometer Highly soluble and dispersible tablets in grade form, which is conducive to full absorption and high bioavailability

Method used

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  • Bromhexine hydrochloride slow-release capsules and preparation method thereof

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Effect test

Embodiment 1

[0021] A bromhexine hydrochloride sustained-release capsule, the preparation method comprising the following steps:

[0022] The preparation method comprises the following steps:

[0023] 1) Weigh 10 g of bromhexine hydrochloride and 1 g of sweetener, add 800 ml of purified water, stir and make it dissolve completely;

[0024] 2) Add 0.1 lactose and pregelatinized starch, stir well to dissolve completely;

[0025] 3) The dispersant PEG-4000 is prepared into a 1.0g / 100ml solution, and ethylenediamine is added to adjust the pH to 8.2;

[0026] 4) Add purified water to make the volume to 1000ml;

[0027] 5) After filtering with a 0.22 μm filter membrane, use a CIK2000 nano-disperser to stir and disperse to obtain bromhexine hydrochloride nano-dispersant;

[0028] 6) The bromhexine hydrochloride nano-dispersant is distilled under reduced pressure, and poured into a fluidized bed to prepare bromhexine hydrochloride sustained-release capsules.

Embodiment 2

[0030] 1) Weigh 5 g of bromhexine hydrochloride and 1 g of sweetener, add 800 ml of purified water, stir and make it dissolve completely;

[0031] 2) Add 0.1 lactose and pregelatinized starch, stir well to dissolve completely;

[0032] 3) The dispersant PEG-4000 is prepared into a 1.0g / 100ml solution, and ethylenediamine is added to adjust the pH to 8.2;

[0033] 4) Add purified water to make the volume to 1000ml;

[0034] 5) After filtering with a 0.22 μm filter membrane, use a CIK2000 nano-disperser to stir and disperse to obtain bromhexine hydrochloride nano-dispersant;

[0035] 6) The bromhexine hydrochloride nano-dispersant is distilled under reduced pressure, and poured into a fluidized bed to prepare bromhexine hydrochloride sustained-release capsules.

Embodiment 3

[0037] 1) Weigh 10 g of bromhexine hydrochloride and 1 g of sweetener, add 800 ml of purified water, stir and make it dissolve completely;

[0038] 2) Add 0.1 lactose and pregelatinized starch, stir well to dissolve completely;

[0039] 3) The dispersant PEG-4000 is prepared into a 10.0g / 100ml solution, and ethylenediamine is added to adjust the pH to 8.2;

[0040] 4) Add purified water to make the volume to 1000ml;

[0041] 5) After filtering with a 0.22 μm filter membrane, use a CIK2000 nano-disperser to stir and disperse to obtain bromhexine hydrochloride nano-dispersant;

[0042] 6) The bromhexine hydrochloride nano-dispersant is distilled under reduced pressure, and poured into a fluidized bed to prepare bromhexine hydrochloride sustained-release capsules.

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Abstract

The invention discloses a bromhexine hydrochloride slow-release capsule and a preparation method thereof, comprising 40-60 parts of bromhexine hydrochloride, 30-60 parts of filler, 2-8 parts of lactose, 1-5 parts of pregelatinized starch, lubricating 0.5-1 part of sweetener and 1-3 parts of sweetener are stirred, mixed, and poured into a fluidized bed to make capsules. The results of comparing the prepared bromhexine hydrochloride sustained-release capsules with those of the commercially available antitussive tablets show that the present invention has fast disintegration, high dissolution rate and dissolution rate, short time to peak blood drug concentration, rapid release-absorption, complete tablet appearance, It has strong hardness, delicate and refreshing taste, and no gritty feeling; compared with the existing technology of preparing orally disintegrating tablets by freeze-drying, vacuum drying, and spray-drying methods, the present invention does not require special production equipment and conditions, nor does it require special packaging , the preparation process is simple, the cost is low and the benefit is high.

Description

technical field [0001] The invention belongs to the field of drug synthesis, and in particular relates to a bromhexine hydrochloride sustained-release capsule and a preparation method thereof. Background technique [0002] Due to the deteriorating environmental quality, air pollution has become a major public hazard that endangers human life. Smoking and drug abuse are becoming more and more common. At the same time, various new viruses, bacteria, chlamydia and other pathogenic microorganisms are complicated. The incidence of respiratory diseases has greatly increased, seriously affecting the quality of life of the public. As a commonly used drug for respiratory diseases, bromhexine hydrochloride not only requires the standardization and standardization of clinical use, but also needs to be further developed and researched to improve its safety and curative effect, thus contributing to the treatment of diseases . [0003] Bromhexine hydrochloride is an expectorant, which i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/66A61K31/136A61P11/10
CPCA61K9/4866A61K31/136
Inventor 操铖高煜
Owner HUAYI PHARMA ANHUI CO LTD
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