Sustained release injection preparation and preparation method and application thereof

A technology for sustained release and injection preparations, which is applied to the sustained release injection preparations of psychotropic drugs. The field of preparation of the sustained release injection preparations can solve the problem of unsatisfactory drug sustained release effects and stability, drug body and preparation stability Adverse effects, reducing the shelf life of drugs, drug safety and other issues, to achieve the effect of improving physical stability, facilitating industrial production, and improving chemical stability

Active Publication Date: 2012-07-04
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] CN1845721A discloses a method for administering aripiprazole in the form of concentrated drug bolus injection, which prolongs the release time of the drug to a certain extent, but the preparation process of the concentrated drug bolus is complicated, the cost is high, and the product is expensive, and The combination of the drug body and the aqueous injection vehicle not only increases the complexity of the preparation process, but also has adverse effects on the stability of the drug body and the preparation, reducing the shelf life of the drug and the safety of the drug.
Although this preparation prolongs the release time of the drug, the active ingredient of the drug is combined with an aqueous solvent, and the preparation process of this type of preparation is complicated, especially the preparation needs to be lyophilized, and the product of this preparation is inconvenient to use, and the delay of the drug The release effect and stability are not ideal

Method used

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  • Sustained release injection preparation and preparation method and application thereof
  • Sustained release injection preparation and preparation method and application thereof
  • Sustained release injection preparation and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1 prepares aripiprazole polyethylene glycol injection (100mg / ml)

[0034] First, add 50 g of aripiprazole and 500 ml of PEG400 into a horizontal grinding machine (SWZX-0.4 horizontal grinding machine, Shanghai Shihe Electromechanical Equipment Co., Ltd.), and first grind at 20 Hz for 3 to 5 minutes to crush large particles. The medicine and the polyethylene glycol are fully mixed, then the grinding speed is increased, and the grinding is continued for 30 minutes at 45 Hz.

[0035] Then it was added to a high-pressure counter-jet homogenizer (Nano DeBEE), and the inlet temperature was kept at about 40° C., and the high-pressure homogenization cycle was performed at 500 bar for 3 times to obtain a primary suspension, which was collected for use. Then the inlet temperature was adjusted to 10°C, the primary suspension was homogenized at 1500 bar, the liquid was circulated 6 times, and the medicinal solution was collected.

[0036] The particle size distribution ...

Embodiment 2

[0037] Example 2 Preparation of Aripiprazole Polyethylene Glycol Injection (200mg / ml)

[0038] First, add 100 g of aripiprazole and 500 ml of PEG400 into a horizontal grinding machine (SWZX-0.4 horizontal grinding machine, Shanghai Shihe Electromechanical Equipment Co., Ltd.), and first grind at 20 Hz for 3 to 5 minutes to crush large particles. , so that the medicine and polyethylene glycol are fully mixed, then the grinding speed is increased, and the grinding is continued for 40 minutes at 45 Hz.

[0039] Then, it was added to a high-pressure counter-jet homogenizer (Nano DeBEE), and the inlet temperature was kept at about 40° C., and the high-pressure homogenization cycle was performed at 500 bar for 3 times to obtain a primary suspension, which was collected for use. Then the inlet temperature was adjusted to 10°C, the primary suspension was homogenized at 1500 bar, the liquid was circulated 6 times, and the medicinal solution was collected.

[0040] The particle size di...

Embodiment 3

[0041] Embodiment 3 prepares aripiprazole soybean oil injection (200mg / ml)

[0042] First, aripiprazole was pulverized to a D4,3 of 3.45 μm using a jet pulverizer (MX-50 supersonic jet pulverizer, Yixing Juneng Superfine Pulverization Equipment Co., Ltd.).

[0043] Then, 100 g of aripiprazole and 500 ml of soybean oil for injection were initially dispersed (20 Hz for 3 minutes) with a horizontal grinding machine (SWZX-0.4 type horizontal grinding machine, Shanghai Shihe Electromechanical Equipment Co., Ltd.), and then 40 Hertz mill for 20 minutes.

[0044]The particle size distribution of the product was evaluated with a MASTERSIZER 2000 laser particle size analyzer. The product has the following characteristics: the volume average particle size D4,3 is 2.13 μm.

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Abstract

The invention relates to a sustained release injection preparation and a preparation method and application of the preparation. Specifically, the invention relates to a sustained release injection preparation, which comprises a psychotropic medication and a nonaqueous carrier and can be released in a sustained manner within at least one week. The sustained release injection preparation of the invention has the advantages of better sustained release effect, longer effect, better stability, simple dosage form, no need of lyophilization, eaier preparation process, lower cost, and more convenience for use.

Description

technical field [0001] The present invention relates to a sustained-release injection preparation, in particular to a sustained-release injection preparation for psychotropic drugs, which can be sustained release within at least one week. The present invention also relates to the preparation method and application of the sustained release injection preparation. Background technique [0002] To produce a pharmacological effect, a drug must reach an appropriate concentration at its site of action in the body. The availability of a drug is influenced by numerous factors, including the amount administered, the extent and rate of absorption from its site of administration, its distribution, binding or localization in tissues, its biotransformation and excretion. A common indicator of drug availability is the concentration of the drug achieved in the patient's blood or plasma or other appropriate body fluid or tissue following administration. [0003] Plasma drug concentrations ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/454A61K31/496A61K31/519A61K47/44A61P25/18
Inventor 徐坚吕爱锋刘任石晓磊涂炎君杨闯宋晓芳赵军军
Owner JIANGSU HANSOH PHARMA CO LTD
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