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Kurarinone osmotic pump controlled release tablets and preparation method thereof

An osmotic pump controlled release and matrine technology, which is applied in osmotic transportation, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of failure to achieve stable and constant release of drugs, difficulty in large-scale production, and differences in pore size Larger problems, to achieve the effect of inhibiting collagen activity, avoiding peak and valley phenomena, and preventing liver fibrosis

Active Publication Date: 2016-07-20
CHANGZHOU ORFAMA PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The patent application with the publication number CN1480137A discloses a matrine osmotic pump type controlled release preparation and its preparation method. The preparation has a 24-hour controlled release. , 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 component, no stabilizer is added in its prescription. Burst release is easy to occur in the release test; at the same time, the punching method used on the semi-permeable 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 the publication number CN101584676A 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, povidone Composed of K-30 ethanol solution, hydroxypropylmethylcellulose, magnesium stearate, and gastric-soluble film-coating powder, the sustained-release tablet releases about 30% in 0-2 hours, releases about 60% in 6 hours, and releases about 60% in 12 hours. The release is about 80% in one hour, and about 90% 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 twice a day.

Method used

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  • Kurarinone osmotic pump controlled release tablets and preparation method thereof
  • Kurarinone osmotic pump controlled release tablets and preparation method thereof
  • Kurarinone osmotic pump controlled release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] See figure 1 As shown, a matrine osmotic pump controlled-release tablet is composed of a plain tablet and a moisture-proof protective film 4 wrapped outside the plain tablet. The plain tablet is composed of a tablet core 2 and a semipermeable membrane 3 wrapped outside the tablet core 2. A drug release hole 1 is provided on the semipermeable membrane 3; the drug release hole 1 is formed by laser drilling, and the size of the hole is 0.5mm.

[0067] Tablet core 2 is made up of the raw material of following weight percentage content:

[0068] 40.00% matrine, 21.00% sodium chloride, 30.00% lactose, 5.00% hydroxypropyl methylcellulose, 3.50% polyvinylpyrrolidone, 0.50% magnesium stearate; the weight of the tablet core is 450.00 mg.

[0069] The semipermeable membrane coating liquid that prepares semipermeable membrane 3 is made up of the raw material of following weight percent content:

[0070] Cellulose acetate 3.50%, polyethylene glycol-40000.25%, diethyl phthalate 0.3...

Embodiment 2

[0083] See figure 1 As shown, a matrine osmotic pump controlled-release tablet is composed of a plain tablet and a moisture-proof protective film 4 wrapped outside the plain tablet. The plain tablet is composed of a tablet core 2 and a semipermeable membrane 3 wrapped outside the tablet core 2. A drug release hole 1 is provided on the semipermeable membrane 3; the drug release hole 1 is formed by laser drilling, and the size of the hole is 0.5mm.

[0084] Tablet core 2 is made up of the raw material of following weight percentage content:

[0085] 40.00% matrine, 25.00% sodium chloride, 26.00% lactose, 4.75% hydroxypropyl methylcellulose, 2.75% polyvinylpyrrolidone, 1.50% magnesium stearate; the weight of the tablet core is 450.00mg.

[0086] The semipermeable membrane coating liquid that prepares semipermeable membrane 3 is made up of the raw material of following weight percent content:

[0087] Cellulose acetate 3.50%, polyethylene glycol-40000.25%, diethyl phthalate 0.35...

Embodiment 3

[0091] See figure 1 As shown, a matrine osmotic pump controlled-release tablet is composed of a plain tablet and a moisture-proof protective film 4 wrapped outside the plain tablet. The plain tablet is composed of a tablet core 2 and a semipermeable membrane 3 wrapped outside the tablet core 2. A drug release hole 1 is provided on the semipermeable membrane 3; the drug release hole 1 is formed by laser drilling, and the size of the hole is 0.5mm.

[0092] Tablet core 2 is made up of the raw material of following weight percentage content:

[0093] 60.00% matrine, 15.00% sodium chloride, 20.00% lactose, 2.75% hydroxypropyl methylcellulose, 1.25% polyvinylpyrrolidone, 1.00% magnesium stearate; the weight of the tablet core is 350.00mg.

[0094] The semipermeable membrane coating liquid that prepares semipermeable membrane 3 is made up of the raw material of following weight percent content:

[0095] Cellulose acetate 3.80%, polyethylene glycol-40000.27%, diethyl phthalate 0.38...

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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 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/28A61K31/4375A61K47/38A61P1/16A61P31/14A61P31/20
CPCA61K9/0004A61K9/2054A61K9/2866A61K31/4375A61K36/489
Inventor 马建国朱华明杨娟赵昱
Owner CHANGZHOU ORFAMA PHARM TECH CO LTD
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