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Tandospirone pharmaceutical composition as well as preparation method and application thereof

A technology of tandospirone and its composition, which is applied in the field of tandospirone pharmaceutical composition and its preparation and application, can solve the problems of large blood drug concentration fluctuations, poor drug compliance, and large drug side effects, and achieve blood drug concentration Small fluctuations, few side effects, and high bioavailability

Active Publication Date: 2021-06-25
SICHUAN CREDIT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention aims to provide a tandospirone pharmaceutical composition to solve the problems of frequent medication, poor drug compliance of patients, large fluctuation of blood drug concentration, large drug side effects, low bioavailability, etc.

Method used

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  • Tandospirone pharmaceutical composition as well as preparation method and application thereof
  • Tandospirone pharmaceutical composition as well as preparation method and application thereof
  • Tandospirone pharmaceutical composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-20

[0070] The tandospirone pharmaceutical composition is prepared according to the components and proportions shown in Tables 1-3.

[0071] Table 1. Tandospirone Pharmaceutical Compositions—Examples 1-8

[0072]

[0073] Table 2. Tandospirone Pharmaceutical Compositions—Examples 9-14

[0074]

[0075] Table 3. Tandospirone Pharmaceutical Compositions—Examples 15-20

[0076]

[0077]

Embodiment 1-7

[0078] For embodiment 1-7, 9-12 and 15-18, its preparation process is as follows:

[0079] a. Pass magnesium stearate through a 60-mesh sieve, and each component except magnesium stearate pass through a 20-mesh sieve respectively, take tandospirone citrate, skeleton material, binder and filler, and mix for 15 minutes ;

[0080] b. Add bleaching aid and mix for 10 minutes; then add magnesium stearate and mix for 3 minutes to obtain mixed powder;

[0081] c. Using a punch of 16.4 mm×7.9 mm to directly compress the mixed powder prepared in step b to obtain a tablet.

Embodiment 8

[0082] For embodiment 8, 13-14 and 19-20, its preparation process is as follows:

[0083] a. Pass tandospirone citrate, skeleton material, binder and filler through a 20-mesh sieve respectively, and mix for 10 minutes; add water to prepare a soft material, dry the wet granules at 50°C and 35cfm for 15 minutes, and dry The granules are passed through a 20-mesh sieve to obtain dry granules;

[0084] B, the bleaching aid is passed through a 20-mesh sieve, mixed with the dry granules prepared in step a for 5 minutes; then adding magnesium stearate (passed through a 60-mesh sieve) and mixed for 3 minutes to obtain mixed granules;

[0085] c. Using a punch of 16.4 mm×7.9 mm to compress the mixed granules prepared in step b to obtain a tablet.

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PUM

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Abstract

The invention discloses a tandospirone pharmaceutical composition as well as a preparation method and an application thereof. The tandospirone pharmaceutical composition comprises an active pharmaceutical ingredient, a framework material, a filler, a bleaching aid, a lubricant and an optional adhesive, and the active pharmaceutical ingredient is tandospirone, pharmaceutically acceptable salt thereof or a solvate of the tandospirone or the pharmaceutically acceptable salt thereof. The framework material comprises one or a combination of a plurality of materials selected from polyoxyethylene WSR 303, polyoxyethylene WSR 1105, polyoxyethylene WSR 301, polyoxyethylene WSR 205 and polyoxyethylene N-80, and the bleaching aid is selected from one or a combination of more of sodium carbonate, sodium bicarbonate, potassium bicarbonate, magnesium carbonate and calcium carbonate. According to the tandospirone pharmaceutical composition disclosed by the invention, the residence time of the medicine in the stomach is prolonged, so that the medicine can be fully released and absorbed, and the bioavailability of the medicine is greatly improved.

Description

Background technique [0001] Tandospirone is a new type of anti-anxiety drug developed by Sumitomo Pharmaceutical Co., Ltd. of Japan. It was approved for marketing in Japan in 1996 and entered the Chinese market in 2004. It is widely used in the field of anti-anxiety in China. Tandospirone can selectively act on 5-HT in the brain 1A Receptors, the action sites are concentrated in the hippocampus, amygdala and other limbic systems of the emotional center and project to the raphe nucleus of the 5-HT nerve, through the activation of presynaptic 5-HT 1A Receptors, inhibit neuron firing, reduce the synthesis of 5-HT, and at the same time inhibit the post-synaptic 5-HT 1A The receptor has a partial agonistic effect, so as to comprehensively regulate the 5-HT function of the synapse and exert an anti-anxiety effect. Long-term use can also play an antidepressant effect. Compared with traditional sedative-hypnotics, tandospirone has specific anti-anxiety effect, fewer side effects, w...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K47/32A61K47/02A61K47/10A61K31/506A61P25/22
CPCA61K9/2054A61K9/2027A61K9/2031A61K9/2009A61K9/0065A61K31/506A61P25/22A61K9/20A61K47/32A61K47/10A61K47/02A61K47/38A61K9/00A61K47/34A61P25/24A61P27/02A61P25/28A61P27/06
Inventor 刘康石凯荣孙样宗太丽谢鹏陈功政陈刚
Owner SICHUAN CREDIT PHARMA
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