A kind of matrine osmotic pump controlled-release tablet and preparation method thereof

Abstract

The invention belongs to the technical field of medicine controlled release preparations, particularly discloses kurarinone osmotic pump controlled release tablets, and further discloses a preparation method of the kurarinone osmotic pump controlled release tablets. The kurarinone osmotic pump controlled release tablets are prepared from kurarinone tablets and protective films outside the tablets, wherein the tablets are prepared from core tablets and semipermeable films outside the core tablets; a medicine release hole is formed in each semipermeable film; the core tablets are prepared from the following raw materials in percentage by weight: 40.00%-60.00% of kurarinone, 15.00%-25.00% of sodium chloride, 20.00%-30.00% of lactose, 2.00%-5.00% of hydroxypropyl methylcellulose, 1.00%-3.50% of polyvinylpyrrolidone and 0.50%-2.00% of magnesium stearate. The kurarinone osmotic pump controlled release tablets provided by the invention can keep favorable zero-order medicine release within 20 hours, the final total release amount exceeds 70%, and part of the final total release amount exceeds 80%, so that the kurarinone osmotic pump controlled release tablets can be clinically used for treating Chronic Hepatitis B.

Description

technical field [0001] The invention relates to the technical field of drug controlled-release preparations, in particular to a matrine osmotic pump controlled-release tablet, and also relates to a preparation method thereof. Background technique [0002] Matrine, also known as oxymatrine and Fickgant, comes from Sophora sophora. Sophora sophora is a plant of the genus Sophora genus Fabaceae that grows in Northwest my country. According to "Shen Nong's Materia Medica", Sophora sophora has the functions of clearing away heat, dampness, expelling wind, killing insects, and detoxifying. The active ingredients of matrine are oxymatrine and a small amount of oxysophocarpine. In recent years, the pharmacological and clinical studies of matrine have found that it has various pharmacological effects such as antiviral, antihypertensive, antiarrhythmic, etc., and has achieved good curative effect in the treatment of chronic hepatitis, with less adverse reactions . [0003] For the ...

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Problems solved by technology

[0004] The patent application with the publication number CN 1480137A discloses a matrine osmotic pump type controlled release preparation and its preparation method. The preparation has a 24-hour controlled release. Composed of agents, lubricants, adhesives, etc., the weight of each tablet of the matrine controlled-release tablets is 580mg. Since the raw material of matrine is a highly soluble and highly permeable ingredient, no stabilizer is added in its prescription. Burst release is easy to occur in the in vitro release test; at the same time, the punching method used on the semipermeable membrane is mechanical punching, and the pore size difference between sheets is large, which makes it difficult to achieve large-scale production

[0005] The patent application with publication number CN 101584676A discloses a matrine sustained-release tablet and its preparation method. The sustained-release tablet has a sustained release effect of 16 hours, and is mainly composed of matrine, lactose, microcrystalline cellulose, polyvinyl Composed of ketone K-30 ethanol solution, hydroxypropylmethylcellulose, magnesium stearate, and stomach-soluble film-coating powder, the sustained-release tablet releases about 30% in 0-2 hours, and releases about 60% in 6 hours. About 80% is released in 12 hours, and about 90% is released in 16 hours. It has a certain slow-release characteristic, but the release is relatively fast in the early stage, and the stable and constant release of the drug cannot be achieved, that is, the zero-order release feature. Patients still need to take the drug for 2 days a day. Second-rate

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