Long-acting injectable preparation, preparation method and application thereof

A technology for long-acting injection preparations and injection preparations, which is applied to medical preparations containing no active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. and adverse effects on the stability of preparations, reducing the shelf life of drugs and drug safety, etc., to achieve the effects of fast administration, reducing economic burden, and improving compliance

Active Publication Date: 2013-09-18
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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  • Long-acting injectable preparation, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1 prepares aripiprazole injection (100mg / ml)

[0035] Mix 100 g of aripiprazole with 100 ml of absolute ethanol and 50 ml of benzyl alcohol and stir until completely dissolved. Add 200ml of benzyl benzoate, mix thoroughly, then slowly add 650ml of peanut oil under stirring to make the final solution. During preparation, attention should be paid to the order and speed of addition of each component, otherwise drug crystals will be precipitated. The solution needs to be blanketed with nitrogen, and then filtered through one or two 0.2 μm pore size filters to sterilize. The sterile filtrate is maintained under a nitrogen blanket while the solution is aseptically filled into cleansed and depyrogenated sterile primary containers such as vials or prefilled syringes. Appropriately add excess solution in the primary packaging container for easy access to the administered dose. Primary packaging containers are blanketed with sterile nitrogen and then aseptically sea...

Embodiment 2

[0036] Embodiment 2 prepares aripiprazole injection (100mg / ml)

[0037] Mix 100 g of aripiprazole with 100 ml of absolute ethanol and 100 ml of benzyl alcohol and stir until completely dissolved. Add 300ml of benzyl benzoate, mix well, then slowly add 500ml of a pre-mixed mixture of sesame oil and castor oil (250ml sesame oil and 250ml castor oil) under stirring to make the final solution. During preparation, attention should be paid to the order and speed of addition of each component, otherwise drug crystals will be precipitated. The solution needs to be blanketed with nitrogen, and then filtered through one or two 0.2 μm pore size filters to sterilize. The sterile filtrate is maintained under a nitrogen blanket while the solution is aseptically filled into cleansed and depyrogenated sterile primary containers such as vials or prefilled syringes. Appropriately add excess solution in the primary packaging container for easy access to the administered dose. Primary packagin...

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PUM

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Abstract

The invention relates to a long-acting injectable preparation, a preparation method and an application thereof. The long-acting injectable preparation comprises psychotropic drugs and a pharmaceutically acceptable non-aqueous carrier, and the preparation can be continuously released for 2 weeks and thus is a novel slow-release pharmaceutical preparation suitable for injectable administration. The preparation is relatively long-acting and stable in slow release effect, and beneficial for improving patient medication compliance.

Description

technical field [0001] The invention relates to a long-acting injection preparation, in particular to a sustained-release injection preparation for psychotropic drugs, which can be released continuously within at least 2 weeks. The present invention also relates to the preparation method and application of the long-acting injection preparation. Background technique [0002] The pace of life in modern society is getting faster and faster. Psychological pressures and unexpected stimuli such as entering a higher school, getting a job, falling in love, losing a loved one, etc. , anxiety, palpitation, stomach discomfort and other mental symptoms and physical symptoms, the formation of mental illness. When the body is affected by internal and external harmful factors to cause brain dysfunction, various mental diseases will occur. When the entire mental activity is obviously abnormal or disordered, and the integrity and unity of mental activity are destroyed, it manifests as ment...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/00A61K9/08A61K9/10A61K47/44A61K47/14A61K47/10A61P25/18
Inventor 吕爱锋李丁陈林陈陆
Owner JIANGSU HANSOH PHARMA CO LTD
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