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Sustained release preparation of doxepin

A sustained-release preparation and preparation technology, which is applied in the field of doxepin sustained-release preparations and its preparation, can solve the problems of affecting drug efficacy, inconvenient use of patients, and affecting the steady-state blood drug concentration of the drug, so as to reduce the number of medications and effectively Sexual or fitness-enhancing effects

Inactive Publication Date: 2007-08-15
刘凤鸣
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The half-life (t1 / 2) is 8 to 12 hours, and the daily dosage is 50 to 200 mg, which is divided into three doses, which brings inconvenience to patients and affects the steady state blood drug concentration of the drug due to sleep time and other factors. , thus affecting the efficacy of the

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] The preparation of embodiment 1-doxepine sustained release tablet (1)

[0050] Method: Take 25 grams of doxepin, 50 grams of hydroxypropyl cellulose, 15 grams of hypromellose, 10 grams of lactose, 10 grams of microcrystalline cellulose, 1 gram of carbomer, and 30 grams of polyethylene glycol 4000 , mixed evenly, dry granulated, mixed with magnesium stearate, and tableted to obtain a finished product, with a drug content of 25mg / tablet. Then, the dissolution rate of the doxepin sustained-release tablet (1) in 900 ml of water at 37° C. was measured. After release measurement, the results are shown in Table 1, which meets the requirements.

[0051] The dissolution rate of table 1 doxepin sustained-release tablet (1)

[0052] Sampling time (hours)

Embodiment 2

[0053] The preparation of embodiment 2-doxepin sustained release tablet (2)

[0054] Method: Take 25 grams of doxepin, 10 grams of hydroxypropyl cellulose, 20 grams of stearyl alcohol, 15 grams of hypromellose, 1 gram of carbomer, and 10 grams of lactose, respectively, pass through 80 mesh sieves, grind and mix Evenly, add a 95% ethanol solution of 10% polyvinylpyrrolidone as a binder and stir to make a soft material, granulate through a 16-mesh sieve, dry the granules at room temperature for 2 hours, granulate with a 16-mesh sieve, and then add stearin Magnesium acid 4.5 grams, micropowder silica gel 2 grams, mix evenly, and tabletting obtains finished product, and drug-containing amount is 25mg / sheet. Then the dissolution rate of the doxepin sustained-release tablet (2) in 900 ml of water at 37° C. was measured. After release measurement, the results are shown in Table 2, which meets the requirements.

[0055] The dissolution rate of table 2 doxepin sustained-release table...

Embodiment 3

[0057] The preparation of embodiment 3-doxepine sustained release tablet (3)

[0058] Method: Take 25g of doxepin, 35g of hypromellose, 5g of microcrystalline cellulose, and 1g of carbomer, pass through 80-mesh sieve respectively, mix well, add 95% ethanol solution of polyvinylpyrrolidone with a concentration of 10% Used as a binder and stirred to make a soft material, granulated through a 16-mesh sieve, dried at 60°C for 1 hour, granulated with a 16-mesh sieve, then added with 2.5 grams of magnesium stearate, mixed evenly, and pressed into tablets to obtain a finished product, containing medicine The dosage is 25mg / tablet. Then, the dissolution rate of the doxepin sustained-release tablet (3) in 900 ml of water at 37° C. was measured. After release measurement, the results are shown in Table 3, meeting the requirements.

[0059] The dissolution rate of table 3 doxepin sustained-release tablet (3)

[0060] Sampling time (hours)

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PUM

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Abstract

The invention discloses a slow release preparation of Doxepin and its preparing process, wherein the raw materials of the preparation include Doxepin of a predetermined proportion, slow release matrix material and medicinal material, the preparation can be prepared into solid dispersing agent, wherein the medicament can be released slowly and continuously after being administrated, the effective concentration in blood can be maintained, and long action can be achieved. The advantages of the invention include decreased frequency of medicinal administration, improved patient's adaptability, lowered blood concentration peak-valley, increased medicinal effect and safety, and reduced total medicinal dose, thereby optimum curative effect can be achieved through minimum dose, thus the preparation is more suitable for patients.

Description

[0001] [Technical Field] The present invention relates to a sustained-release preparation of doxepin and a preparation method thereof. [Background technique] [0002] The research and development of sustained-release preparations has a history of more than 40 years. It releases slowly and at a non-constant rate as required in a prescribed environment. Prolonged formulation. This kind of preparation can make the human body maintain this kind of blood drug concentration for a long time, instead of dropping rapidly like ordinary preparations, so as to avoid the "peak and valley" phenomenon that occurs when common preparations are frequently administered, and ensure the safety of the drug. Sexuality, effectiveness or adaptability have been improved, thereby reducing the number of medications, which greatly facilitates patients, especially patients who have been taking medication for a long time. Commonly used oral dosage forms include matrix tablets, microporous coated surface fi...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/48A61K47/02A61K47/12A61K47/34A61K47/38A61K47/42A61K47/44A61K31/55A61P25/24A61K47/10A61K47/14A61K47/32
Inventor 刘凤鸣
Owner 刘凤鸣
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