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Slow release medicinal composition for treating anxiety and its preparing method

A slow-release drug and composition technology, applied in the field of medicine, can solve the problems of poor patient taking compliance and large fluctuation of blood drug concentration, and achieve the effects of avoiding peak-to-valley phenomenon, stabilizing blood drug concentration and improving compliance.

Active Publication Date: 2007-01-24
SICHUAN CREDIT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are no reports of sustained-release preparations at home and abroad
However, the existing commercially available common preparations are taken 3 times a day, each dosage is 10 mg, the blood drug concentration fluctuates greatly, and the patient's compliance is poor.

Method used

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  • Slow release medicinal composition for treating anxiety and its preparing method
  • Slow release medicinal composition for treating anxiety and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Tandospirone Citrate 16.2g

[0042] Hydroxypropylmethylcellulose (HPMC K4M) 64.8g

[0043] 75% ethanol 12ml

[0044] Lactose 110g

[0045] Magnesium stearate 3g

[0046] Talc powder 6g

[0047] Preparation process: Mix tandospirone citrate raw material with hydroxypropyl methylcellulose and lactose evenly, sieve, add 75% alcohol solution to make soft material, pass through 20-mesh sieve to make wet granules, and store at 50°C Dry left and right, sieve with 20 meshes, add magnesium stearate and talcum powder, mix evenly and press into tablets. The weight of the tablet is 0.2g, and a total of 1000 tablets are made.

[0048] Animal experiment: Take 12 New Zealand rabbits, half male and half female, weighing (4.5-5) kg, and randomly divide them into 2 groups, fast for 18 hours before administration, and administer with 10 mg tandospirone citrate / kg. Blood was taken from rabbit ear vein, and the pharmacokinetic parameters were measured. The results showed that compared...

Embodiment 2

[0053] Tandospirone Citrate 30g

[0054] Hydroxypropylmethylcellulose (HPMC K15M) 50g

[0055] Methylcellulose 50g

[0056] 75% ethanol 13ml

[0057] Lactose 70g

[0058] Magnesium Stearate 5g

[0059] Talc powder 7g

[0060] Preparation process: Mix tandospirone citrate raw material with hydroxypropyl methylcellulose, methylcellulose, lactose, and evenly, sieve, add 75% ethanol solution to make soft material, pass through 20-mesh sieve to make wet Granules, dried at about 50°C, sieved with 20 meshes, added magnesium stearate and talcum powder, mixed evenly and pressed into tablets. The weight of the tablet is 0.2g, and a total of 1000 tablets are made.

[0061] The animal experiment method is as example 1, and the results are shown in Table 2

[0062] t peak (h)

C max (ng / ml)

AUC(ng.h / ml)

Sustained Release Tablets

Ordinary film

3.4±3.1 *

0.8±0.5

1.7±0.8 *

3.5±1.3

44.7±12.3 *

13.1±3.5

[0063] ...

Embodiment 3

[0066] Tandospirone Citrate 10g

[0067] Sodium Alginate 25g

[0068] Methylcellulose 50g

[0069] Carboxymethylcellulose 25g

[0070] 75% ethanol solution 10ml

[0071] Cornstarch 100g

[0072] Preparation process: Mix tandospirone citrate raw material with sodium alginate, methyl cellulose, carboxymethyl cellulose, and corn starch evenly, sieve, add 75% ethanol solution to make soft material, and pass through a 20-mesh sieve Prepare wet granules and compress into tablets. The weight of the tablet is 0.2g, and a total of 1000 tablets are made.

[0073] The animal experiment method is as example 1, and the results are shown in Table 3

[0074] t peak (h)

C max (ng / ml)

AUC(ng.h / ml)

Sustained Release Tablets

Ordinary film

3.9±1.4 *

1.1±1.2

1.4±0.3 *

3.4±2.1

43.2±10.3 *

11.4±6.5

[0075] * Compared with ordinary tablets, P<0.05

[0076] Side effects: No side effects occurred.

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PUM

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Abstract

The present invention provides a kind of slow released medicinal composition for treating anxiety, and features that the slow released medicinal composition is slow released medicinal preparation with tadosporin citrate in effective quantity as the active component and pharmaceutically acceptable supplementary material. By means of the action of the slow releasing material, tadosporin citrate is released slowly to generate slow and smooth blood medicine level without peak valley phenomenon and with raised patient compliance. The present invention has reduced medicine taking times and convenient taking.

Description

technical field [0001] The invention relates to a slow-release preparation and a preparation method of tandospirone citrate, belonging to the field of medicine. Background technique [0002] Tandospirone citrate is a 5-HT receptor agonist used in the treatment of generalized anxiety disorder and mixed anxiety and depression. There are no reports of sustained-release preparations at home and abroad. However, the existing commercially available common preparations are taken 3 times a day, each dosage is 10 mg, the blood drug concentration fluctuates greatly, and the patient's taking compliance is poor. Therefore, it is necessary to prepare a sustained-release preparation that can maintain the blood concentration for 12 hours. Tandospirone citrate is well absorbed after oral administration, and the peak time is 0.5-2 hours. It is metabolized into 1-pyrimidinyl piperazine (1-Pyrimidiny1-piperazine, 1-PP) in the body, and the concentration of the metabolite is about 2 to 8 tim...

Claims

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Application Information

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IPC IPC(8): A61K31/506A61K47/38A61K9/20A61K9/08A61K9/48A61K9/16A61K9/02A61K9/10A61P25/22
Inventor 陈刚刁健代竹青
Owner SICHUAN CREDIT PHARMA
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