Doxofylline sustained release tablet and preparation method thereof

Abstract

The invention relates to a doxofylline sustained release tablet. The doxofylline sustained release tablet is characterized in that each unit preparation is prepared from the components by weight: 0.1g-0.3g of doxofylline, 0.05g-0.15g of a compound ODT direct pressure filler, 0.05g-0.15g of lactose, 0.05g-0.2g of cholestyramine resin, 0.05g-0.15g of sodium carboxymethylcellulose, 0.05g-0.10g of polacrilin potassium and 0.005g-0.02g of magnesium stearate. The invention further provides a preparation method of the doxofylline sustained release tablet. According to the doxofylline sustained release tablet and the preparation method thereof, components synergistically work, the finally prepared composition is good in the sustained release effect, and the property is stable.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a doxofylline sustained-release tablet and a preparation method thereof. Background technique [0002] Bronchial asthma (bronchial asthma) is a chronic airway inflammation involving a variety of cells, especially mast cells, eosinophils, and T lymphocytes. In susceptible individuals, this inflammation can cause recurrent wheezing, shortness of breath, and chest tightness. Symptoms such as cough and (or) cough mostly occur at night and (or) in the early morning, and the airway is more responsive to various stimuli. But the symptoms can be relieved by themselves or by treatment. In the past ten years, the prevalence and mortality of asthma in the United States, the United Kingdom, Australia, New Zealand and other countries have been on the rise. There are about 100 million asthma patients in the world, and it has become a major chronic disease that seriously ...

AI Technical Summary

Problems solved by technology

This patent uses hypromellose as a sustained-release material and coordinates the enteric coating to achieve a sustained-release effect, but the preparation process is too complicated and there are many key control parameters, which will easily lead to an increase in product failure rate, which is not conducive to commercialization Production

[0005] Chinese patent CN 101028254 discloses a sustained-release preparation of doxofylline and its preparation method. The patent is composed of two parts: quick-release and sustained-release, and 10-60% of doxofylline and quick-release auxiliary materials in the two parts Mix to prepare the immediate-release part, and mix 40%-90% of doxofylline with sustained-release excipients to prepare the sustained-release part. Although this patent can solve the problem of quickly reaching blood concentration after taking it, it can also maintain a certain blood concentration. , but in this prescription process, the amount of doxofylline is relatively large, and the types of excipients are as high as more than a dozen, which will inevitably lead to higher product costs and increase the economic burden of patients on re-medication

[0006] CN 200310119144.0 discloses an osmotic pump type control preparation of doxofylline to achieve the purpose of stable release of doxofylline. The size of the drug has an impact on the release of the drug. If it is not properly controlled during production, the effect of steady release will not be achieved. These controlled or sustained release preparations release the drug at a constant rate to maintain the blood concentration of the drug, but it is unfavorable. Yes, due to its constant release rate, the patient's blood concentration is too low at the beginning of taking it, and cannot quickly relieve asthma symptoms

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