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A kind of tandospirone dispersible tablet or coated dispersible tablet and preparation method thereof

A technology of tandospirone and tandospirone acid, applied in the field of tandospirone dispersible tablets or coated dispersible tablets and their preparation, can solve the problem of difficulty in increasing blood drug concentration, affecting drug absorption, increasing adverse reactions, etc. problem, to achieve excellent disintegration effect, high disintegration effect, and the effect of preventing the effect of moisture on the tablet core

Active Publication Date: 2017-12-15
SICHUAN CREDIT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The film-coated tablets and ordinary capsules currently on the market have the problems of long disintegration time or large particle size after disintegration, and slow dissolution, which affects the absorption of the drug, so it is difficult to increase the blood concentration after oral administration
If simply increasing the dosage to overcome the problem of low blood concentration will bring about an increased risk of adverse reactions

Method used

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  • A kind of tandospirone dispersible tablet or coated dispersible tablet and preparation method thereof
  • A kind of tandospirone dispersible tablet or coated dispersible tablet and preparation method thereof
  • A kind of tandospirone dispersible tablet or coated dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Tablet composition (1000 tablets):

[0047] Tandospirone Citrate 10g

[0048] Sucrose 240g

[0049] Mannitol 45g

[0050] Pregelatinized starch 50g

[0051] Microcrystalline Cellulose 80g

[0052] Low-substituted hydroxypropyl cellulose 70g

[0053] Sodium Laureth Sulfate 3g

[0054] Micronized silica gel 2g

[0055] Coating liquid composition:

[0056] Hypromellose 12g

[0057] Mannitol 10g

[0058] Glycerin 12ml

[0059] Strawberry essence 2g

[0060] Chili red 3g

[0061]water 600ml

[0062] Evaluation indicators:

[0063]

[0064] Preparation Process:

[0065] Tablet core compression: pass tandospirone or its pharmaceutically acceptable salt, filler, and disintegrant through a 100-mesh sieve, and mix well; According to the content of dospirone, the weight of the tablet is calculated, and the tablet is directly compressed with a tablet machine.

[0066] Preparation of coating liquid: first add sugar alcohol, glycerin, flavoring agent and coloring a...

Embodiment 2

[0070] Tablet composition (1000 tablets):

[0071] Tandospirone Citrate 10g

[0072] Glucose 240g

[0073] Mannitol 45g

[0074] Pregelatinized starch 50g

[0075] Microcrystalline Cellulose 60g

[0076] Croscarmellose Sodium 90g

[0077] Sodium stearyl fumarate 3g

[0078] Micronized silica gel 2g

[0079] Coating liquid composition:

[0080] Hypromellose 12g

[0081] Mannitol 10g

[0082] Glycerin 12ml

[0083] Strawberry essence 2g

[0084] Chili red 3g

[0085] water 600ml

[0086] Evaluation indicators:

[0087]

Embodiment 3

[0089] Tablet composition (1000 tablets):

[0090] Tandospirone Citrate 10g

[0091] Sodium saccharin 240g

[0092] Mannitol 45g

[0093] Pregelatinized starch 50g

[0094] Microcrystalline Cellulose 80g

[0095] Crospovidone 70g

[0096] Sodium Polyoxyethylene Lauryl Sulfate 3g

[0097] Micronized silica gel 2g

[0098] Coating liquid composition:

[0099] Hypromellose 12g

[0100] Mannitol 10g

[0101] Glycerin 12ml

[0102] Apple essence 2g

[0103] Pine leaf orchid 5g

[0104] water 600ml

[0105] Evaluation indicators:

[0106]

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Abstract

The invention provides a tandospirone dispersible tablet, which is prepared by containing the following raw and auxiliary materials in weight percentage: tandospirone or its pharmaceutically acceptable salt 1%-8%, filler 65%-90% , Disintegrant 4% to 30%. The tandospirone dispersible tablet prepared by the invention has a faster disintegration rate and a higher dissolution rate than ordinary tablets, can be efficiently absorbed in the digestive tract, and obtains higher bioavailability. The present invention can also be dispersed in water before taking, and has a sweet taste, and is more suitable for people who have poor absorption of oral preparations, people who have difficulty in swallowing, and the elderly or children with low drug compliance.

Description

technical field [0001] The invention relates to a tandospirone dispersible tablet or a coated dispersible tablet and a preparation method thereof. Background technique [0002] Tandospirone is a new type of anti-anxiety drug successfully 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. [0003] Tandospirone acts selectively 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....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/36A61K31/506A61K47/36A61K47/32A61K47/38
Inventor 傅霖陈刚林科名
Owner SICHUAN CREDIT PHARMA
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