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Nicergoline dry emulsion and its preparation method and application

A dry emulsion and emulsifier technology, which is applied in the field of pharmaceutical dosage forms in the field of medical technology, can solve the problems of long dissolution time, low bioavailability, obvious side effects, etc., and achieve improved stability and curative effect, mature production process, and high drug content. controllable effect

Inactive Publication Date: 2007-10-24
陈云生 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the poor water solubility of Nicergoline, most of the oral preparations of Nicergoline currently on the market have problems such as long dissolution time, low dissolution rate, poor absorption and low bioavailability after taking, thus affecting the performance of the drug. , also directly affects the therapeutic effect
[0006] Although ordinary freeze-dried powder injection has the advantages of fast onset of action and high bioavailability, due to the use of acidic solution or a large amount of surfactant to solubilize, the side effects are obvious in clinical application, and the patient's medication compliance is very poor. The product is unstable to water, light and heat, the drug content is easy to change during production, transportation and storage, and the storage validity period is short, which brings a lot of inconvenience to clinical use and promotion

Method used

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  • Nicergoline dry emulsion and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] 1) In the preparation equipment, 100 g of Nicergoline will be dissolved in acetone, and then the acetone solution will be evenly dispersed in 1000 ml of olive oil;

[0046] 2) Mix 5g of poloxamer, 0.1g of natural stevioside with water, and add 50g of ethylparaben;

[0047] 3) Add 2) to 1) under the condition of stirring, and after stirring at 80°C, a uniform solution is obtained. Prepare 5000ml of liquid medicine;

[0048] 4) Add 40% sucrose as protective agent, remove moisture by distillation under reduced pressure, and add silicon dioxide to absorb excess moisture to obtain dry nicergoline dry emulsion;

[0049] 5) Add water to the prepared dry emulsion according to the required amount, revert to emulsion after hydration and shaking.

Embodiment 2

[0051] 1) In the preparation equipment, 40 mg of Nicergoline is dissolved in 15 ml of tea oil for injection;

[0052] 2) Mix 5 g of egg yolk lecithin for injection, 2 g of glycerin and an appropriate amount of water for injection, and add 0.1 g of ethylparaben;

[0053] 3) Add 1) to 2) under the condition of stirring, and after stirring at 20°C, pass through a homogenizer to homogenize the solution repeatedly to obtain a uniform solution. Prepare 2000ml of liquid medicine;

[0054] 4) add 6% glucose and 3% mannitol as protective agent, remove moisture through freeze-drying, get dry nicergoline dry emulsion;

[0055] 5) Add water to the prepared dry emulsion according to the required amount, revert to emulsion after hydration and shaking.

Embodiment 3

[0057] 1) in the preparation equipment, Nicergoline 8g is dissolved in 25ml safflower oil for injection;

[0058] 2) Mix 10g of lecithin with an appropriate amount of water for injection, and add 30gV C ;

[0059] 3) Add 2) into 1) under the condition of stirring, and after stirring at 40° C., pass through a homogenizer to homogenize the solution repeatedly to obtain a uniform solution. Prepare a total of 1000ml of liquid medicine;

[0060] 4) add 1% sucrose as protective agent, remove moisture through freeze-drying, get the dried Nicergoline dry emulsion;

[0061] 5) Add water to the prepared dry emulsion according to the required amount, revert to emulsion after hydration and shaking.

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Abstract

The invention discloses a medicine preparation form, especially discloses a nicergoline dry emulsion and the preparing method and application. It takes nicergoline in the dry emulsion as effective component, and also comprises oil phase, emulsifying agent and other findings. The dry emulsion is characterized by mature preparation process, easy industrialization, good stability, easy transportation and storage, controllable medicine content and good effect. The invention is used for improving cerebral arteriosclerosis and affective disorder caused by cerebral apoplexy after-effect, acute and chronic circulatory disturbance and acute urine retention resulted from blood vessel dementia and prostate gland proliferation.

Description

Technical field: [0001] The invention relates to pharmaceutical dosage forms in the technical field of medicine, in particular to a nicergoline dry emulsion and a preparation method and application thereof. Background technique: [0002] Nicergoline is a semi-synthetic ergot derivative. It has α-receptor blocking effect and vasodilator effect, which can strengthen the energy metabolism of brain cells, increase the utilization of oxygen and glucose; promote the conversion of neurotransmitter dopamine to increase nerve conduction, strengthen the synthesis of brain proteins, and benevolent to the brain. Features. It is mainly used to improve depression and emotional disorders caused by cerebral arteriosclerosis and sequelae of cerebral apoplexy, such as unresponsiveness, inattention, memory loss, lack of ideas, depression, restlessness, etc.; acute and chronic peripheral circulation disorders, such as limb vascular occlusion disease, Raynaud's syndrome, and other symptoms of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/48A61K9/107A61P25/00
Inventor 陈云生贾奕
Owner 陈云生
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