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A kind of tandospirone pharmaceutical composition and its preparation method and use

A technology for tandospirenone and composition, applied in the field of tandospirenone pharmaceutical composition and its preparation and use, can solve the problems of large fluctuation of blood drug concentration, poor drug compliance, large drug side effects and the like, and achieves blood drug concentration The effect of less fluctuation, less side effects and high bioavailability

Active Publication Date: 2022-08-09
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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  • A kind of tandospirone pharmaceutical composition and its preparation method and use
  • A kind of tandospirone pharmaceutical composition and its preparation method and use
  • A kind of tandospirone pharmaceutical composition and its preparation method and use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-20

[0070] The tandospirone pharmaceutical composition was 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, magnesium stearate is crossed 60 mesh sieves, each component except magnesium stearate is crossed 20 mesh sieves respectively, get Tandospirone citrate, skeleton material, adhesive and filler, mix 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. Use a punch of 16.4 mm×7.9 mm to directly compress the mixed powder obtained 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 the tandospirone citrate, the framework material, the binder and the filler through a 20-mesh sieve, respectively, and mix for 10 minutes; add water to prepare a soft material, and dry the wet granules at 50 ° C and 35 cfm for 15 minutes, and the whole The granules are passed through a 20-mesh sieve to obtain dry granules;

[0084] b, the bleaching aid is crossed through a 20-mesh sieve, and mixed with the dry granules obtained in step a for 5 minutes; then add magnesium stearate (cross a 60-mesh sieve) and mix for 3 minutes to obtain mixed granules;

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

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Abstract

Tandospirone pharmaceutical composition and preparation method and use thereof. The tandospirone pharmaceutical composition comprises a pharmaceutical active ingredient, a matrix material, a filler, a bleaching aid, a lubricant and an optional binder, and the pharmaceutical active ingredient is tandospirone, which is pharmaceutically acceptable. The salt or the solvate of tandospirenone or a pharmaceutically acceptable salt thereof, the framework material includes selected from polyethylene oxide WSR 303, polyethylene oxide WSR 1105, polyethylene oxide WSR 301, polyethylene oxide WSR 205 , the combination of one or more in polyoxyethylene N-80; Described bleaching aid is selected from the combination of one or more in sodium carbonate, sodium bicarbonate, potassium bicarbonate, magnesium carbonate, calcium carbonate. The tandospirone pharmaceutical composition of the present invention prolongs the retention time of the drug in the stomach, so that the drug can be fully released and absorbed, and its bioavailability is greatly improved.

Description

Background technique [0001] Tandospirenone is a new type of anti-anxiety drug developed by Japan's Sumitomo Pharmaceutical Co., Ltd. It was approved for listing in Japan in 1996, and began to enter the Chinese market in 2004. It is increasingly used in the domestic anti-anxiety field. Tandospirone can selectively act on 5-HT in the brain 1A Receptors, the action sites are concentrated in the limbic system of the brain such as the hippocampus and amygdala in the emotional center and project to the raphe nucleus of the 5-HT nerve, by activating the presynaptic 5-HT 1A Receptor, inhibits neuronal firing, reduces 5-HT synthesis, and simultaneously inhibits postsynaptic 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 anxiolytic effect. Long-term use can also exert antidepressant effects. Compared with traditional sedative-hypnotics, tandospirone has specific anti-anxiety effects, fewer side effe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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