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Alfuzosin Hydrochloride permeating pump type controlled-release preparation and method for preparing the same

A controlled-release technology of alfuzosin hydrochloride and osmotic pump, which is applied in the field of medicine, can solve the problems of good water solubility of alfuzosin hydrochloride, difficulty in controlling the drug release rate, and large batch-to-batch differences to achieve drug efficacy Long maintenance time, convenient administration and taking, and long-lasting effect

Inactive Publication Date: 2011-04-20
KANGYA OF NINGXIA PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent 200410042295.5 discloses a controlled-release tablet of alfuzosin hydrochloride, which is a double-layer tablet or a three-layer tablet, and its process is relatively complicated
[0004] Alfuzosin 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.

Method used

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  • Alfuzosin Hydrochloride permeating pump type controlled-release preparation and method for preparing the same
  • Alfuzosin Hydrochloride permeating pump type controlled-release preparation and method for preparing the same
  • Alfuzosin Hydrochloride permeating pump type controlled-release preparation and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Tablet prescription:

[0029] Alfuzosin Hydrochloride 10.0g

[0030] Lactose 40.0g

[0031] Microcrystalline Cellulose 40.0g

[0032] Magnesium stearate 0.25g

[0033] Tablet core preparation: mix the excipients and main ingredients through a 100-mesh sieve, make a soft material with 95% ethanol, granulate through a 18-mesh sieve, ventilate and dry in an oven at 40-45°C, add magnesium stearate, pass through a 16-mesh sieve, mix and prepare Granules, compressed tablets.

[0034] Coating Solution Prescription:

[0035] Cellulose acetate 100g

[0036] Macrogol 400 4g

[0037]Dibutyl phthalate 4g

[0038] Acetone 5L

[0039] Coating process: Put the tablet core in the coating pan, blow in hot air, and coat the tablet core when the temperature is about 45°C. The flow rate of the coating solution is 5-7mL / min, and the temperature in the coating pan is about 45°C until the thickness of the outer coating film of the tablet core reaches a weight gain of 4.0-4.5%, contin...

Embodiment 2

[0041] Tablet prescription:

[0042] Alfuzosin Hydrochloride 10.0g

[0043] Sucrose 35.0g

[0044] Lactose 45.0g

[0045] Magnesium stearate 0.25g

[0046] Tablet core preparation, with embodiment 1;

[0047] Coating Solution Prescription:

[0048] Cellulose acetate 100g

[0049] Macrogol 1500 5g

[0050] Dibutyl phthalate 5g

[0051] Acetone 5L

[0052] Coating process, with embodiment 1.

Embodiment 3

[0054] Tablet prescription:

[0055] Alfuzosin Hydrochloride 10.0g

[0056] Sodium chloride 40.0g

[0057] Pregelatinized starch 40.0g

[0058] Magnesium stearate 0.25g

[0059] Tablet core preparation: same as Example 1.

[0060] Coating Solution Prescription:

[0061] Cellulose acetate 100g

[0062] Macrogol 400 4.5g

[0063] Dibutyl phthalate 4g

[0064] Acetone 5L

[0065] Coating process: with embodiment 1.

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Abstract

The invention belongs to medical technique field, and relates to osmotic pump controlled-release tablets of alfuzosin hydrochloride and the preparation method, which comprises tablet core, clothing sheet membrane and controlled-release pore. The solid medicine and osmotic active substance and shaping agent forms the tablet core; the coating membrane is insoluble controlled-release clothing sheet that is water permeable but not medical permeable. Said pore is on the clothing sheeting membrane. The comprised raw material of tablet core and clothing sheet membrane and proportion by weight are asfollows: table core: alfuzosin hydrochloride 0.5-50%, packing agent 5-80%, penetration -promoting agent 5-80%, lubricating agent 0.2-3%, adhesive agent 0.01-10%; clothing sheet membrane: semi-permeable membrane clothing sheet high polymer material 70-99%, plasticizing agent 1-30%. The invention is characterized by stable and continuous release, long retention time for effective blood concentration and reduced peak-to-valley of blood concentration phenomena.

Description

Technical field: [0001] The invention belongs to the technical field of medicine, and relates to a new pharmaceutical dosage form of alfuzosin hydrochloride, in particular to an alfuzosin hydrochloride osmotic pump type controlled-release preparation and a preparation method thereof. Background technique: [0002] Alfuzosin hydrochloride (Alfuzosin), also known as Santaqianlietai, is a selective α1-receptor blocker. Pharmacological studies in vitro have confirmed that alfuzosin hydrochloride is specific to the α1-receptors of the trigone of the bladder, urethra and prostate, and can reduce urethral pressure, thereby reducing urination resistance and treating benign prostatic hyperplasia. A 12-month prospective study of 5,849 patients with benign prostatic hyperplasia showed that those who received alfuzosin 3 times a day, 2.5 mg each time, improved symptoms and improved quality of life. A short-term study showed that taking alfuzosin hydrochloride twice a day, 5 mg each tim...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/517A61K9/36A61K47/26A61K47/36A61K47/38A61P13/08
Inventor 何仲贵翟国松王永军
Owner KANGYA OF NINGXIA PHARMA
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