Slow release tablet of rotundine and production process

A technology of sustained-release preparations and sustained-release parts, which is applied in the field of new dosage forms - Rotundine sustained-release tablets, which can solve problems such as unsuitable for taking

Inactive Publication Date: 2006-02-01
INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In addition, because the side effect of this medicine is that it has a strong sedative and h

Method used

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  • Slow release tablet of rotundine and production process

Examples

Experimental program
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Effect test

Embodiment 1

[0016] Embodiment 1: the sustained-release preparation containing 105mg rotundine

[0017] Immediate release part: rotundine 45mg, polyvinylpyrrolidone 6mg, microcrystalline cellulose 40mg, lactose 20mg, magnesium stearate 1mg.

[0018] Mix the above-mentioned amount of rotundine, polyvinylpolypyrrolidone, microcrystalline cellulose, and lactose in equal amounts, add an appropriate amount of 10% povidone aqueous solution, and make a soft material, pass through a 12-20 mesh sieve Granulate, dry in an oven at 50-60°C, granulate, add the above-mentioned amount of magnesium stearate, mix well, analyze the content of the semi-finished product, and prepare the granules for later use.

[0019] Sustained-release part: 60mg of rotundine, 60mg of hydroxypropyl methylcellulose K4000, 30mg of L-tartaric acid, 2mg of magnesium stearate.

[0020] Mix the above amount of rotundine, hydroxypropyl methylcellulose K4000, and L-tartaric acid evenly, add 50% ethanol solution to make a soft mater...

Embodiment 2

[0022] Embodiment 2: the sustained release preparation of 120mg rotundine

[0023] Immediate release part: rotundine 30mg; polyvinylpyrrolidone 7mg, β-cyclodextrin 100mg, magnesium stearate 1mg.

[0024] Production process: Weigh 30 mg of rotundine, add ethanol to dissolve, add dropwise to 100 mg of β-cyclodextrin (β-cyclodextrin: water = 20:80w / v) solution heated to 70-80°C, and stir for 2 hours , filter the precipitate, and dry it in a 50-60°C oven to obtain a mixture of rottondine and β-cyclodextrin. Mix with the above-mentioned amount of polyvinylpolypyrrolidone and process according to the method in Example 1.

[0025] Sustained-release components: rotundine 90mg, hydroxypropyl methylcellulose K 4000 90mg, L-tartaric acid 45mg, magnesium stearate 2mg are processed by the method described in Example 1 to obtain the sustained-release preparation of 120mg rotundine / tablet.

Embodiment 3

[0026] Example 3: Sustained release formulation of rotundine 210 mg.

[0027] Immediate-release components: 90 mg of rotundine, 12 mg of polyvinylpyrrolidone, 80 mg of microcrystalline cellulose, 40 mg of lactose, and 2 mg of magnesium stearate, processed according to the method of Example 1 to obtain immediate-release component granules.

[0028] Sustained release components: rotundine 120mg, hydroxypropyl methylcellulose K 4000 120mg, L-tartaric acid 60mg, magnesium stearate 4mg, according to embodiment 1 sustained-release component processing and tabletting processing method, obtain the sustained-release preparation of 210mg rotundine / tablet.

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Abstract

A slowly-releasing tablet of analgesic rotundine is disclosed.

Description

field of invention [0001] The invention relates to a new dosage form of the analgesic rotundine-rotundine sustained-release tablet. Background technique [0002] Rotundine is an alkaloid extracted from plants by Chinese pharmaceutical workers, and its chemical name is 2,3,9,10-tetramethoxy-5,8,13,13α-tetrahydro-6H -Dibenzo[α,g]quinazine, the structure of which is as follows: [0003] [0004] Molecular formula C 21 h 25 NO 4 Molecular weight 355.43 [0005] The pharmacological effect of rotundine is a medium-strength analgesic, and its effect is equivalent to that of tramadol. It is clinically effective for all kinds of acute and chronic pain analgesia. However, due to the fast metabolism of rotundine in vivo, t 1 / 2 Small, short time to maintain effective concentration, its drug effect can only last about 2 hours, patients take it frequently every day, generally 30mg / tablet, 3-4 times / day. In addition, because the side effect of this medicine ...

Claims

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Application Information

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IPC IPC(8): A61K31/4745A61K9/22A61P25/04A61P29/00
Inventor 高永良曹捷赵巧玲杨征
Owner INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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