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Zolpidem tartrate controlled-release pellet and preparation method thereof

A technology for zolpidem tartrate and zolpidem tartrate is applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, medical preparations containing active ingredients, etc., and can solve the problems of high requirements for production equipment and technical personnel and complex preparation methods , complex preparation process and other problems, to avoid excessive peak-to-valley ratio of blood drug concentration, flexible design, and improve the effect of treatment

Inactive Publication Date: 2010-11-17
BEIJING HONGWAN PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method described in the CN1212838C patent is relatively complicated and has high requirements for production equipment and technical personnel; the preparation process in the CN1660086 patent is complicated, and in actual application, the drug loss is often large, and the dosage is inaccurate
In order to maintain the minimum effective concentration, the dosage must be increased, and long-term medication may bring greater side effects

Method used

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  • Zolpidem tartrate controlled-release pellet and preparation method thereof
  • Zolpidem tartrate controlled-release pellet and preparation method thereof
  • Zolpidem tartrate controlled-release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Embodiment 1 drug-containing 10mg zolpidem tartrate sustained-release pellets

[0048] a. Contains pill core ingredients

[0049] zolpidem tartrate

[0050] zolpidem tartrate

[0051] Preparation method: Weigh the raw and auxiliary materials according to the prescription quantity, mix them evenly, add a binder and mix them evenly to make a soft material; use a granulator (or coating pan) to pick up the mother and roll the pellets to the required mesh size of 15-30 mesh, Dry and sieve the best 18-25 mesh pellets for later use.

[0052] b. Sustained release layer ingredients

[0053] with pill core

[0054] Coating process: Weigh 15g of NE30D, 2g of talc powder and 30g of distilled water, mix them evenly under magnetic stirring, and set aside; weigh 100g of pill cores and place them in a fluidized bed, start the machine, adjust the air inlet temperature to 30°C, and use 5ml / min flow rate, sprayed on the outer layer of drug-containing pelle...

Embodiment 2

[0055] Embodiment 2 drug-containing 15mg zolpidem tartrate sustained-release pellets

[0056] a. Contains pill core ingredients

[0057] Blank base pellets (16-20 mesh)

[0058] Preparation method: Dissolve the prescribed amount of zolpidem tartrate, tartaric acid and hypromellose in 100g of distilled water; take 200g of blank base pellets in a fluidized bed, adjust the inlet air temperature to 45°C, and spray at a flow rate of 7ml / min Spray on the outer layer of the base pill until it is completely sprayed, dry for 15 minutes, take out and sieve to remove fine powder for later use.

[0059] b. Sustained release layer ingredients

[0060] with pill core

[0061] Coating process: weigh L30D-5550g, talc powder 5g, triethyl citrate 3g and distilled water 100g, mix evenly under magnetic stirring, and set aside; weigh 180g of pill core and place it in a fluidized bed, start the machine, adjust The air inlet temperature is 30°C, and the coating is carried out a...

Embodiment 3

[0062] Example 3 Drug-containing 10mg zolpidem tartrate sustained-release pellets

[0063] a. Contains pill core ingredients

[0064] Blank base pellets (18-22 mesh)

[0065] Preparation method: Dissolve the prescribed amount of zolpidem tartrate, tartaric acid and hypromellose in a mixed solution of distilled water and ethanol; take 300 g of blank base pills in a fluidized bed, adjust the inlet air temperature to 50°C, and keep the bed temperature At 40-45°C, spray on the outer layer of the base pellet at a flow rate of 8ml / min until it is completely sprayed, dry for 15 minutes, take out and sieve to remove fine powder for later use.

[0066] b. Sustained release layer ingredients

[0067] with pill core

[0068] with pill core

[0069] Coating process: Weigh 80g of ethyl cellulose 25% aqueous dispersion, 60000.5g of polyethylene glycol, 2.0g of hypromellose and 80g of distilled water, mix evenly under magnetic stirring, and set aside; weigh 260...

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PUM

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Abstract

The invention provides an officinal composite containing zolpidem tartrate, and the weight of the active ingredients of the officinal composite is between 1mg and 20mg. The invention is characterized in that the officinal composite is a controlled-release pellet which mainly consists of a pill core and a controlled-release layer with a controlled-release function or consists of a faster-working quick-release outer layer part, a controlled-release layer maintaining slow release and a pill core. The preparation prepared by the invention can prolong drug release time by 6h and play roles in reducing blood concentration fluctuation and prolonging drug action time.

Description

technical field [0001] The invention belongs to the technical field of drug sustained-release preparations, and more specifically relates to a sustained-release pellet containing an active ingredient of zolpidem tartrate and a preparation method thereof. Background technique [0002] Zolpidem tartrate is an imidazopyridine sedative-hypnotics whose chemical structure is different from benzodiazepines, barbiturates or other known hypnotics. This product interacts with the γ-aminobutyric acid-benzodiazepine (GABA-BZ) receptor complex and has some pharmacological properties of the BZ class. In vitro tests have shown that, unlike BZs, which non-selectively bind and activate all ω-receptor subtypes, they produce pharmacological effects by selectively binding to the ω1-receptor subtype of the central nervous system. ω1-receptors are mainly present in layer IV of cortical sensorimotor areas, substantia nigra, molecular layer of cerebellum, olfactory bulb, ventral thalamic complex, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/437A61K47/32A61K47/34A61K47/38A61P25/20A61K47/10
Inventor 李洪起任晓文连潇嫣徐为人张士俊刘巍
Owner BEIJING HONGWAN PHARMA TECH
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