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Solid preparation of doxycycline ambroxol medicine compound

A technology of doxycycline and ambroxol, applied in the field of doxycycline ambroxol pharmaceutical composition vesicular phospholipid gel solid preparation, doxycycline ambroxol composition compound preparation, can solve biological problems Problems such as low utilization, low bioavailability of sustained-release preparations, complicated preparation process, etc., to improve the dissolution of preparations, improve product quality and therapeutic effect, and reduce toxic and side effects

Inactive Publication Date: 2012-08-08
HAINAN YONGTIAN PHARMA INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It mainly achieves sustained release by coating the drug-containing layer on the sustained-release tablet core, but the sustained-release preparations produced by conventional preparation methods have low bioavailability and the preparation process is too complicated
Patent CN1850090A discloses a compound sustained-release tablet of ambroxol hydrochloride and its preparation method, which mainly includes ambroxol hydrochloride, doxycycline hydrochloride and pharmaceutically acceptable carriers or adjuvants prepared by the preparation method of compound sustained-release tablet In the past, the compounding process was mainly achieved by pressing double-layer tablets. This method is complicated for industrial production, and the product is not easy to preserve and has low bioavailability.
Patent CN101084912A discloses a kind of compound ambroxol hydrochloride slow-release tablet and preparation method thereof, and it is prepared by skeleton material and pharmaceutically commonly used adjuvant by ambroxol hydrochloride and roxithromycin of recipe quantity, and its preparation process is too cumbersome, limited by matrix agent, low bioavailability

Method used

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  • Solid preparation of doxycycline ambroxol medicine compound
  • Solid preparation of doxycycline ambroxol medicine compound
  • Solid preparation of doxycycline ambroxol medicine compound

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preparation example Construction

[0067] On the other hand, the present invention provides the preparation method of doxycycline ambroxol pharmaceutical composition vesicular phospholipid gel, the method comprises the following steps:

[0068] (1) Dissolve distearoylphosphatidylethanolamine, cholesterol succinate and ambroxol hydrochloride in an appropriate amount of organic solvent under nitrogen protection, and stir magnetically for 1-2 hours at about 50° C. to obtain a phospholipid solution;

[0069] (2) Filter the above-mentioned phospholipid solution with a 0.45 μm microporous membrane, freeze the filtrate at -50°C for 4 hours, then raise the temperature to 10°C at a rate of 3°C / hour for 2 hours, and then repeatedly freeze Melt three times, and finally dry at 25°C for 1-3 hours until it is completely dry to obtain a dry solid in the form of a loose sponge;

[0070] (3) Disperse the above solid and doxycycline hydrochloride in a phosphate buffer solution of pH 6.8 under the protection of nitrogen, stir it ...

Embodiment 1

[0109] The preparation of embodiment 1 doxycycline ambroxol pharmaceutical composition vesicular phospholipid gel tablet

[0110] The raw and auxiliary materials used in the prescription (1000 tablets) are as follows:

[0111]

[0112] Preparation Process

[0113] (1) under nitrogen protection, 120g distearoyl phosphatidylethanolamine and 40g cholesterol succinate and 7g ambroxol hydrochloride are dissolved in the mixed solvent of n-butanol and tert-butyl alcohol that the volume ratio of 250ml is 2: 3, Stir magnetically for 2 hours at about 50°C to obtain a phospholipid solution;

[0114] (2) Filter the above-mentioned phospholipid solution with a 0.45 μm microporous membrane, freeze the filtrate at -50°C for 4 hours, then raise the temperature to 10°C at a rate of 3°C / hour for 2 hours, and then repeatedly freeze Melt three times, and finally dry at 25°C for 1 hour until it is completely dry to obtain a dry solid in the form of a loose sponge;

[0115] (3) Disperse the a...

Embodiment 2

[0119] The preparation of embodiment 2 doxycycline ambroxol pharmaceutical composition vesicular phospholipid gel tablet

[0120] The raw and auxiliary materials used in the prescription (1000 tablets) are as follows:

[0121]

[0122]

[0123] Preparation Process

[0124] (1) under nitrogen protection, 180g distearoylphosphatidylethanolamine and 60g cholesteryl succinate and 7g ambroxol hydrochloride are dissolved in the mixed solvent of n-butanol and tert-butyl alcohol that the volume ratio of 200ml is 2:3, Stir with magnetic force for 1 hour at about 50°C to obtain a phospholipid solution;

[0125] (2) Filter the above-mentioned phospholipid solution with a 0.45 μm microporous membrane, freeze the filtrate at -50°C for 4 hours, then raise the temperature to 10°C at a rate of 3°C / hour for 2 hours, and then repeatedly freeze Melt three times, and finally dry at 25°C for 3 hours until completely dry to obtain a dry solid in the form of a loose sponge;

[0126] (3) Dis...

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Abstract

The invention discloses a slow-release solid preparation of a doxycycline ambroxol medicine compound and a preparation method thereof. The preparation method comprises the following steps: preparing a vesica type phospholipid gel by adopting the following materials in parts by weight: 10 parts of doxycycline hydrochloride (count by doxycycline), 7 parts of ambroxol hydrochloride, 30-300 parts of distearoyl phosphatidylcholine ethanolamine and 10-100 parts of cholesterol succinate, and then adding frequently-used other medicinal excipients to the vesica type phospholipid gel of the doxycyclineambroxol medicine compound, thereby obtaining the slow-release solid preparation. According to the preparation method provided by the invention, the quality of preparation product is increased, the toxic side effect is reduced, the stability and dissolution rate as well as bioavailability of the medicine are greatly increased, the effect is stable and long-lasting, and the curative effect is obvious.

Description

technical field [0001] The invention relates to a compound preparation of a doxycycline-ambroxol composition, in particular to a vesicle-type phospholipid gel solid preparation of a doxycycline-ambroxol pharmaceutical composition and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Respiratory tract infection is a common and frequently-occurring disease that mainly occurs in the throat, trachea, bronchi, and lungs of the human body. The main manifestations of the disease are cough, phlegm, wheezing, and inflammation. Relevant survey data from the Ministry of Health of my country show that the current incidence of respiratory diseases in my country is about 6.9%, which shows that there are nearly 90 million patients with respiratory diseases in the country every year. From the perspective of susceptible population, the elderly are the population with the highest incidence of respiratory diseases. Therefore, under the i...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/20A61K9/06A61K31/65A61K47/28A61K47/24A61P31/04A61P11/10A61P11/14A61P29/00A61K31/137
Inventor 王明曹丽梅
Owner HAINAN YONGTIAN PHARMA INST
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