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Tandospirone dispersible tablets or coating dispersible tablets, and preparation method thereof

A technology of tandospirone and tandospirone hydrochloride, which is applied in the field of tandospirone dispersible tablets or coated dispersible tablets and its preparation, can solve the problem of difficulty in increasing blood drug concentration, increasing adverse reactions, affecting drug absorption, etc. problem, achieve excellent disintegration effect, prevent the influence of moisture on the tablet core, and achieve high disintegration effect

Active Publication Date: 2015-10-28
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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  • Tandospirone dispersible tablets or coating dispersible tablets, and preparation method thereof
  • Tandospirone dispersible tablets or coating dispersible tablets, and preparation method thereof
  • Tandospirone dispersible tablets or coating dispersible tablets, 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 respectively through a 100-mesh sieve, and mix uniformly; 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 age...

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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PUM

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Abstract

The present invention provides tandospirone dispersible tablets, which is prepared from the following raw materials and auxiliary materials: 1-8% by weight of tandospirone or a pharmaceutically acceptable salt, 65-90% by weight of a filler, and 4-30% of a disintegrant. According to the present invention, the prepared tandospirone dispersible tablets have characteristics of rapid disintegration rate and high dissolution rate compared with the conventional tablets, can be efficiently absorbed in the digestive tract so as to obtain high bioavailability, can be taken after being dispersing in water, has fragrant and sweet taste, and is more suitable for people with poor absorption of oral formulations, people with swallowing difficulty, and old people or children with low medication 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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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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