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Coculine osmosis pump type release-controlled preparation and preparation process thereof

A controlled-release preparation, the technology of sinomenine, is applied in the directions of anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc., which can solve the problems of difficulty in controlling the release rate, difficulty in industrialized mass production, and large differences in product batches, etc. , to achieve stable release, reduce peak-to-valley phenomenon, and reduce the number of doses

Inactive Publication Date: 2002-10-02
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the preparations of sinomenine mainly include enteric-coated film-coated tablets and sinomenine gel matrix tablets twice a day. The existing dosage forms are far from meeting the clinical needs. clinical development needs
[0003] Sinomenine, especially sinomenine hydrochloride, has good water solubility, and it is not easy to control the drug release rate. Controlling the long-term stable release of the drug is the main difficulty. On the other hand, there are large differences between product batches, poor production stability, and difficult to carry out industrialized production

Method used

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  • Coculine osmosis pump type release-controlled preparation and preparation process thereof
  • Coculine osmosis pump type release-controlled preparation and preparation process thereof
  • Coculine osmosis pump type release-controlled preparation and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Tablet prescription:

[0022] Sinomenine Hydrochloride 120.0g

[0023] Sodium chloride 110.2g

[0024] Sucrose 50.8g

[0025] 2% hydroxypropyl methylcellulose aqueous solution 60g

[0026] Magnesium Stearate 5.8g Film Coated Prescription:

[0027] Cellulose acetate 80g

[0028] Polyethylene Glycol-4000 23g

[0029] Preparation: Grind the prescription amount of medicine, sodium chloride and sucrose separately, and then sieve, mix evenly, add binder to make soft material, granulate with 20 mesh sieve, dry at 40±5°C, granulate with 16 mesh sieve, dry Granules plus lubricant magnesium stearate are pressed into tablet cores, cellulose acetate and plasticizer polyethylene glycol-4000 are dissolved in a mixed solvent of acetone and chloroform, the tablet cores are placed in a coating pan, and Coating, after the coating is completed, the coated tablet is dried in a drying oven to solidify the coating film. Then a dr...

Embodiment 2

[0031] Tablet prescription:

[0032] Sinomenine Hydrochloride 1200g

[0033] Sodium chloride 1100g

[0034] Sucrose 501g

[0035] 5% polyvinylpyrrolidone aqueous solution 400g

[0036] Magnesium Stearate 58g

[0037] Coating film prescription:

[0038] Cellulose acetate 800g

[0039] Polyethylene Glycol-6000 200g

[0040] Preparation: Grind the prescribed amount of medicine, potassium chloride and sucrose separately, then sieve, mix evenly, add binder to make soft material, granulate with 20-mesh sieve, dry at 40±5°C, granulate with 16-mesh sieve, Dry granules plus lubricant magnesium stearate are pressed into tablet cores, cellulose acetate and plasticizer polyethylene glycol-6000 are dissolved in a mixed solvent of acetone and chloroform, and the tablet cores are placed in a coating pan. Coating is carried out, and after the coating is completed, the coated tablet is dried in a drying oven to solidify the coating...

Embodiment 3

[0042] Tablet prescription:

[0043] Sinomenine Hydrochloride 360g

[0044]Sodium chloride 330g

[0045] Sucrose 150g

[0046] 2% sodium carboxymethyl cellulose aqueous solution 150g

[0047] Magnesium Stearate 17g

[0048] Coating film prescription:

[0049] Cellulose acetate 240g

[0050] Polyethylene Glycol-1500 90g

[0051] Preparation: Grind the prescribed amount of medicine, potassium chloride and sucrose separately, then sieve, mix evenly, add binder to make soft material, granulate with 20-mesh sieve, dry at 40±5°C, granulate with 16-mesh sieve, Dry granules plus lubricant magnesium stearate are pressed into tablet cores, cellulose acetate and plasticizer polyethylene glycol-1500 are dissolved in a mixed solvent of acetone and chloroform, and the tablet cores are placed in a coating pan. Coating is carried out, and after the coating is completed, the coated tablet is dried in a drying oven to solidify the coating f...

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Abstract

The sinomenine osmotic pump type control-released preparation capable of releasing a certain quantity of medicine at a constant releasing speed mainly is formed from main core, coating membrane and medicine-releasing hole, and its tablet core is composed of sinomenine hydrochloride, osmosis agent, filling agent and other medicinal auxiliary material, and the coating membrane is a cellulose acetate semi-permeable membrane, and is made up through the processes of pulverizing, sieving, coating and drying. The obtained control-release preparation uses the osmotic pressure difference between interior and exterior of the membrane as medicine-releasing power, and possesses the advantages of blood concentration equilibration, small side effect and long duration of drug effect, etc.

Description

Technical field: [0001] The invention relates to a new drug dosage form of sinomenine, specifically, it relates to a sinomenine osmotic pump type controlled-release preparation and a preparation method thereof. Background technique: [0002] Sinomenine (sinomenine) is an effective alkaloid monomer extracted from the traditional Chinese medicine Qingfengteng, and its hydrochloride is mostly used in medicine. Qingfengteng is the cane of Sinomenium scutumRehd. et Wils. Sinomenine has anti-inflammatory, immunosuppressive, analgesic, antihypertensive, antiarrhythmic and other pharmacological effects. It has been clinically used for thousands of years to treat rheumatism and rheumatoid diseases, and its curative effect is definite. In 1996, it was officially approved as a national protected variety of traditional Chinese medicine, and it was included in the eighteenth volume of the Ministry of Health's drug standards (preparations of traditional Chinese medicine). Due to the re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/30A61K31/407A61P29/00A61P37/06
Inventor 何仲贵魏树辉赵春顺
Owner SHENYANG PHARMA UNIVERSITY
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