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Orally disintegrating tablet of sedative-hypnotic medicine and preparation method for same

A technology for oral disintegrating tablets and sedative hypnotics, applied in the field of sedative and hypnotic oral disintegrating tablets and their preparation, can solve the problems of gritty feeling, affecting patient's taste and compliance, slow disintegration of preparations, etc.

Inactive Publication Date: 2012-07-11
QUANTUM HI TECH BEIJING RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In China, the preparation technology of orally disintegrating tablets started relatively late. At present, most of them adopt the direct compression method to prepare orally disintegrating tablets. Most disintegrants are insoluble in water, so the orally disintegrating tablets prepared by this method often have a gritty feeling after tasting, which affects the taste and compliance of patients when taking it; and the disintegration of the preparation will be very slow

Method used

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  • Orally disintegrating tablet of sedative-hypnotic medicine and preparation method for same
  • Orally disintegrating tablet of sedative-hypnotic medicine and preparation method for same
  • Orally disintegrating tablet of sedative-hypnotic medicine and preparation method for same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0167] Preparation formula of the present invention is made up of following components:

[0168] Zolpidem Tartrate 5.00g

[0169] Glycine 6.00g

[0170] Pullulan 7.00g

[0171] Xanthan gum 0.10g

[0172] Sodium bicarbonate 1.00g

[0173] Acesulfame K 0.10g

[0174] Purified water 180.80g

[0175] A total of 1000 pieces were made.

[0176] The specific preparation method is as follows: Zolpidem tartrate, glycine, pullulan, sodium bicarbonate, and acesulfame-K are added to the fully dissolved xanthan gum solution, and mixed to form a uniform solution; After inflating, pour it into the mold accurately; pre-freeze at -40°C to -170°C for 1 to 60 minutes, then transfer to a freeze dryer, and freeze at a pressure of 0.01mbar to 10mbar and at a temperature of -30°C to 30°C After drying for 1-10 hours, the zolpidem tartrate orally disintegrating tablet of the present invention can be obtained; in the above method, after the pre-freezing step, before transferring to the freeze dr...

Embodiment 2

[0178] The preparation formula of the present invention is made up of following components:

[0179] Zolpidem Tartrate 5.00g

[0180] Mannitol 6.00g

[0181] Pullulan 7.00g

[0182] Xanthan gum 0.10g

[0183] Sodium bicarbonate 1.00g

[0184] Acesulfame K 0.10g

[0185] Purified water 180.80g

[0186] A total of 1000 pieces were made.

[0187] The specific preparation method is as follows: Zolpidem tartrate, mannitol, pullulan, sodium bicarbonate, and acesulfame potassium are added to the fully dissolved xanthan gum solution, and mixed to become a homogeneous solution; the following preparation Method is with embodiment 1.

Embodiment 3

[0189] The preparation formula of the present invention is made up of following components:

[0190] Zolpidem Tartrate 5.00g

[0191] Glycine 3.40g

[0192] Mannitol 3.00g

[0193] Pullulan 5.00g

[0194] Sodium alginate 2.20g

[0195] Konjac Gum 0.50g

[0196] Potassium bicarbonate 1.50g

[0197] Sucralose 0.04g

[0198] Purified water 179.36g

[0199] A total of 1000 pieces were made.

[0200] The specific preparation method is as follows: Zolpidem tartrate, glycine, mannitol, pullulan, sodium alginate, potassium bicarbonate, and sucralose are added to the fully dissolved konjac gum solution, and mixed to make a uniform Solution; The following preparation method is the same as in Example 1.

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Abstract

An orally disintegrating tablet of sedative-hypnotic medicine and a preparation method for the same are disclosed. The invention relates to an orally disintegrating tablet of sedative-hypnotic medicine as well as a prescription and a process for preparing the orally disintegrating tablet of sedative-hypnotic medicine by a freeze-drying method. The orally disintegrating tablet of sedative-hypnotic medicine disclosed by the invention is prepared from main medicines and pharmaceutical excipients, without the need of water while being taken, capable of being rapidly disintegrated in mouth, and suitable for the medication of the patients with difficulty in swallowing, such as the old and children; simultaneously, the orally disintegrating tablet of sedative-hypnotic medicine is suitable for the medication in a condition that water source is not easy to obtain during travelling; moreover, the orally disintegrating tablet of sedative-hypnotic medicine can avoid the influence on sleep due to micturition desire because of no need of water while being taken, thus exerting curative effect better; and the orally disintegrating tablet of sedative-hypnotic medicine disclosed by the invention has better compliance and therapeutic effect in the case that the patients with neurological disease are passive or incoordinate and for the old patients with insomnia compared with other forms, and can obviously reduce the side effects of the sedative-hypnotic medicine. Additionally, the invention further relates to a preparation method for an orally disintegrating tablet of sedative-hypnotic medicine.

Description

Technical field: [0001] The invention relates to a sedative-hypnotic orally disintegrating tablet and a preparation method thereof, in particular to an orally-disintegrating sedative-hypnotic tablet prepared by a freeze-drying method. Background technique: [0002] Insomnia is one of the manifestations of sleep disorders. The clinical manifestations of insomnia are: the time to fall asleep exceeds 30 minutes; the number of night awakenings exceeds 2 times or wakes up early in the morning; many nightmares; the total sleep time is less than 6 hours; there is a daytime residual effect , such as feeling dizzy, lack of energy, drowsiness, fatigue, etc. the next morning. When sleep is seriously lacking, it will lead to low immune function of the human body and various diseases. Nearly half of the severe insomniacs are associated with different mental illnesses. Sleep disturbance may be the early manifestation or even the cause of some psychiatric diseases, and early treatment ma...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/437A61K31/4985A61K31/5517A61K31/519A61P25/20A61J3/00
Inventor 王丛威王洪飞王丽滨赵淑欣周立运
Owner QUANTUM HI TECH BEIJING RES INST
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