Etodolac sustained-release tablet and preparation method thereof

Abstract

The invention relates to an etodolac sustained-release tablet and a preparation method thereof, wherein the etodolac sustained-release tablet is prepared from the following raw materials by weight: etodolac, hydroxypropylmethylcellulose, and a lubricant. According to the present invention, the novel sustained-release preparation and the micro-pill preparation are used, wherein the sustain release is that the absorption rate on the drug by the body is reduced by delaying the release rate of the drug from the dosage form so as to provide the stable treatment effect; the micro-pill can increase the drug distribution area on the gastrointestinal tract surface so as to reduce the irritation and improve the bioavailability, and the drug release is not affected by the gastric emptying factor, such that the absorption on the drug in the body is uniform and the individual difference is low; and with the synchronous application of the two advanced technologies, the technical advantage of the etodolac sustained-release tablet is enhanced.

Description

technical field

[0001] The invention belongs to the field of chemical drug sustained-release preparations, and in particular relates to an etodolac sustained-release tablet and a preparation method thereof. Background technique

[0002] Rheumatoid arthritis is a chronic systemic autoimmune disease mainly characterized by joint disease. The main clinical manifestations are joint swelling and pain caused by the synovial membrane of the facet joints, followed by cartilage destruction and joint space narrowing. In the late stage, severe bone destruction and absorption lead to joint stiffness, deformity, and dysfunction. In my country, the prevalence rate of rheumatoid arthritis is 0.24-0.5%, and women are more than men, about 2-3:1. It can occur at any age, and the most common is 20-50 years old. The disease is mostly a recurrent disease, with a high disability rate and poor prognosis, and there is no good cure at present.

[0003] At present, the existing products on the...

Examples

Embodiment 1

[0026] A kind of etodolac sustained-release tablet is made of the following raw materials: 400mg etodolac, 150-390mg hypromellose , 10-50mg lubricant.

[0027] said The preferred weight ratio in raw materials is: 400mg etodolac, 385mg hypromellose , 15mg lubricant.

[0028] said Hypromellose can be one or both of the following types: 75hd100cr hypromellose 、75hd4000cr hypromellose 、75hd15000cr hypromellose 、100000cr Hypromellose.

[0029] said lubricant is One or both of magnesium stearate, talc, and silicon dioxide 。

[0030] Its production method includes the following steps:

[0031] Step 1: material preparation: according to the above mass ratio, etodolac is pulverized with a pulverizer, and passed through a 100-mesh sieve;

[0032] Step 2: Mixing: Weigh etodolac and hypromellose according to the above mass ratio, put them into a three-dimensional mixer and mix for 30 minutes to make medicine subdivisions, and take them o...

Embodiment 3

[0039] Indications of the present invention: for treating symptoms and signs of rheumatoid arthritis and osteoarthritis.

Embodiment 4

[0041] medicine interactions:

[0042] 1 1. It is not recommended to take this product with aspirin at the same time, so as not to increase the possibility of adverse events;

[0043] 2 1. The combined use of warfarin and non-steroidal anti-inflammatory drugs will increase the risk of gastrointestinal bleeding;

[0044] 3 , Non-steroidal anti-inflammatory drugs will competitively inhibit the accumulation of methotrexate in the kidney, which may increase the toxicity of methotrexate;

[0045] 4 , Non-steroidal anti-inflammatory drugs will weaken the antihypertensive effect of ACE inhibitors;

[0046] 5 1. When diuretics are used in combination with non-steroidal anti-inflammatory drugs, patients should be carefully observed for signs of renal failure;

[0047] 6 2. Lithium: Non-steroidal anti-inflammatory drugs inhibit the synthesis of renal prostaglandins. The use of such drugs will lead to increased lithium ion levels in plasma and decreased renal lithiu...

technical field

[0001] The invention belongs to the field of chemical drug sustained-release preparations, and in particular relates to an etodolac sustained-release tablet and a preparation method thereof. Background technique

[0002] Rheumatoid arthritis is a chronic systemic autoimmune disease mainly characterized by joint disease. The main clinical manifestations are joint swelling and pain caused by the synovial membrane of the facet joints, followed by cartilage destruction and joint space narrowing. In the late stage, severe bone destruction and absorption lead to joint stiffness, deformity, and dysfunction. In my country, the prevalence rate of rheumatoid arthritis is 0.24-0.5%, and women are more than men, about 2-3:1. It can occur at any age, and the most common is 20-50 years old. The disease is mostly a recurrent disease, with a high disability rate and poor prognosis, and there is no good cure at present.

[0003] At present, the existing products on the...

Examples

Embodiment 1

[0026] A kind of etodolac sustained-release tablet is made of the following raw materials: 400mg etodolac, 150-390mg hypromellose , 10-50mg lubricant.

[0027] said The preferred weight ratio in raw materials is: 400mg etodolac, 385mg hypromellose , 15mg lubricant.

[0028] said Hypromellose can be one or both of the following types: 75hd100cr hypromellose 、75hd4000cr hypromellose 、75hd15000cr hypromellose 、100000cr Hypromellose.

[0029] said lubricant is One or both of magnesium stearate, talc, and silicon dioxide 。

[0030] Its production method includes the following steps:

[0031] Step 1: material preparation: according to the above mass ratio, etodolac is pulverized with a pulverizer, and passed through a 100-mesh sieve;

[0032] Step 2: Mixing: Weigh etodolac and hypromellose according to the above mass ratio, put them into a three-dimensional mixer and mix for 30 minutes to make medicine subdivisions, and take them o...

Embodiment 3

[0039] Indications of the present invention: for treating symptoms and signs of rheumatoid arthritis and osteoarthritis.

Embodiment 4

[0041] medicine interactions:

[0042] 1 1. It is not recommended to take this product with aspirin at the same time, so as not to increase the possibility of adverse events;

[0043] 2 1. The combined use of warfarin and non-steroidal anti-inflammatory drugs will increase the risk of gastrointestinal bleeding;

[0044] 3 , Non-steroidal anti-inflammatory drugs will competitively inhibit the accumulation of methotrexate in the kidney, which may increase the toxicity of methotrexate;

[0045] 4 , Non-steroidal anti-inflammatory drugs will weaken the antihypertensive effect of ACE inhibitors;

[0046] 5 1. When diuretics are used in combination with non-steroidal anti-inflammatory drugs, patients should be carefully observed for signs of renal failure;

[0047] 6 2. Lithium: Non-steroidal anti-inflammatory drugs inhibit the synthesis of renal prostaglandins. The use of such drugs will lead to increased lithium ion levels in plasma and decreased renal lithiu...

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