Quick-release medicinal composition and preparation method thereof

A technology of composition and medicine, which is applied in the fields of quick-release carrier and sedative-hypnotic drug composition and its preparation, can solve the problems of complex operation, high cost, long production cycle, etc., achieve rapid onset of effect, reduce gastrointestinal irritation, capture The effect of high bioavailability

Inactive Publication Date: 2009-12-09
ARMY MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The preparation methods of orally disintegrating tablets mainly include freeze-drying method and tablet compression method. Among them, the freeze-drying method is the earliest application and the technology is mature, but the operation is complicated, the production cycle is long, and the cost is high. It is widely used abroad.

Method used

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  • Quick-release medicinal composition and preparation method thereof
  • Quick-release medicinal composition and preparation method thereof
  • Quick-release medicinal composition and preparation method thereof

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preparation example Construction

[0079] The present invention also provides a preparation method of the immediate-release pharmaceutical composition of the present invention, the steps are as follows: after indiplon and auxiliary materials are respectively passed through a 100-mesh sieve, the main drug, CCNa, PVPPXL, MCC , SiO 2 , lactose, vanillin, citric acid, and aspartame in an appropriate amount are mixed by equal addition method, and then magnesium stearate is added to mix evenly. The tablet weight is 200mg and the hardness is 30N-80N. Tablets, instant-release pharmaceutical compositions.

[0080] (2) Quality control

[0081] The present invention also provides a quality control method of the immediate-release pharmaceutical composition of the present invention, the steps are as follows:

[0082] Adopt high performance liquid chromatography (HPLC), UVD detector; Chromatographic column is C8 post; Mobile phase is acetonitrile-phosphate buffer saline (pH is 6.8) (38 / 62); Ultraviolet detection wavelength...

Embodiment 1

[0087] Indiplon 10mg

[0088] Croscarmellose Sodium 25mg

[0089] Crospovidone 40mg

[0090] Silica 3mg

[0091] Magnesium Stearate 1mg

[0092] Microcrystalline Cellulose 20mg

[0093] Lactose 90mg

[0094] Vanillin 1mg

[0095] Citric acid 8mg

[0096] Aspartame 1mg

[0097] After passing the main drug and auxiliary materials through a 100-mesh sieve, the main drug, CCNa, PVPP XL, MCC, SiO2, lactose, vanillin, citric acid, and aspartame were delivered in equal amounts according to the above-mentioned optimized ratio and content of the main drug. Add magnesium stearate and mix evenly, and prepare tablets with a tablet weight of 200 mg and a hardness of 30N to 80N by using the powder direct compression method.

Embodiment 2

[0099] Indiplon 5mg

[0100] Croscarmellose Sodium 30mg

[0101] Crospovidone 30mg

[0102]Silica 3mg

[0103] Magnesium Stearate 1mg

[0104] Pregelatinized starch 50mg

[0105] Lactose 71mg

[0106] Vanillin 2mg

[0107] Citric acid 6mg

[0108] Aspartame 2mg

[0109] The preparation method is the same as in Example 1.

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Abstract

The invention relates to a quick-release medicinal composition, which contains indiplon and pharmaceutically acceptable carrier. The oral quick-release composition prepared from the indiplon and the quick-release carrier can provide a new convenient medicament administration mode and a new dosage form for oral medicaments under the special conditions that the medicaments are difficult to swallow and inconvenient to drink water. Compared with a common oral preparation, because the mucosa of the gastrointestinal tract is widely covered by rapidly-disintegrated medicament, the medicinal composition has quick response. If the medicament can be absorbed through the mucosa of the oral cavity, the medicinal composition has no first-pass effect so as to improve the bioavailability and reduce the stimulation to the stomach and intestine.

Description

technical field [0001] The invention relates to an immediate-release carrier, a sedative-hypnotic pharmaceutical composition and a preparation method thereof. The immediate-release pharmaceutical composition of the invention is composed of indiplon, an active pharmaceutical ingredient, and a pharmaceutically acceptable carrier with an immediate-release function. It is mainly used for sedative hypnosis and sleep disorders caused by various reasons. Background technique [0002] "Insomnia" refers to a patient's lack of sleep or any disturbed state associated with the sensation of sleep. Insomnia is a common disorder. The most direct consequence of insomnia is the disorder of the body's metabolism, reduced productivity, and changes in mood, behavior, and psychomotor functions. In addition, insomnia is associated with other diseases, including depression, anxiety, gastrointestinal tract, and cardiovascular disease. System obstacles, etc. The continuous experiment at the Unive...

Claims

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Application Information

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IPC IPC(8): A61K31/519A61K47/38A61K47/32A61K47/12A61K47/46A61J3/10A61K9/20A61P25/20
Inventor苏敏周向东徐长荣
OwnerARMY MEDICAL UNIV