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Sustained release preparation of perhexiline

A sustained-release preparation, perhexiline technology, applied in the field of sustained-release preparations and its preparation, can solve the problems of affecting drug efficacy, short biological half-life, inconvenient use of patients, etc., to improve effectiveness or adaptability, and reduce the number of medications Effect

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

Perhexiline is a drug with a short biological half-life, and its dosage is 100 mg once. Generally, it needs to be administered 2-3 times a day, which brings inconvenience to patients. At the same time, due to factors such as sleep time, it affects the stability of the drug. State blood drug concentration, thereby affecting drug efficacy

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0050] Method: Take 100 grams of perhexiline, 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. gram, mixed evenly, dry granulated, mixed with magnesium stearate, compressed into tablets to obtain the finished product, with a drug content of 100mg / tablet. Then the dissolution rate of the perhexiline 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 perhexiline sustained-release tablet (1)

[0052] Sampling time (hours)

Embodiment 2

[0053] The preparation of embodiment 2-perhexiline sustained-release tablets (2)

[0054] Method: Take 100 grams of perhexiline, 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, and grind Mix evenly, add 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 hard Magnesium fatty acid 4.5 grams, micropowder silica gel 2 grams, mix evenly, tabletting obtains finished product, and the drug-containing amount is 100mg / tablet. Then the dissolution rate of the perhexiline 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 perhexiline su...

Embodiment 3

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

[0058] Method: Take 100g of perhexiline, 35g of hypromellose, 5g of microcrystalline cellulose, and 1g of carbomer respectively, pass through 80 mesh sieves, mix well, add 95% ethanol with a concentration of 10% polyvinylpyrrolidone The solution is 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 through a 16-mesh sieve, added with 2.5 grams of magnesium stearate, mixed evenly, and compressed to obtain a finished product, containing Drug dosage is 100mg / tablet. Then the dissolution rate of the perhexiline 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 perhexiline sustained-release tablets (3)

[0060] Sampling time (hours)

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PUM

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Abstract

The invention discloses a slow release preparation of Perhexiline and its preparing process, wherein the raw materials of the preparation include Perhexiline 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 perhexiline 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 surfac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/48A61K47/02A61K47/12A61K47/34A61K47/38A61K47/42A61K47/44A61K31/4458A61P9/06A61K47/10A61K47/32
Inventor 刘凤鸣
Owner 刘凤鸣
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