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Injection used nicergoline freeze-dried powder injection and preparation method thereof

A technology of freeze-dried powder injection and nicergoline, applied in the field of freeze-dried powder injection of nicergoline for injection and its preparation, can solve the problems of sensitivity to light and temperature, side effects, poor stability, etc., achieve stable drug properties, improve Stability, smooth surface effect

Inactive Publication Date: 2018-02-09
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Nicergoline is sensitive to light and temperature, and is easy to degrade under light and high temperature. If it exists directly in the form of injection, the stability is poor, and clinical use has side effects

Method used

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  • Injection used nicergoline freeze-dried powder injection and preparation method thereof
  • Injection used nicergoline freeze-dried powder injection and preparation method thereof
  • Injection used nicergoline freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] 1. Prescription

[0025]

[0026] 2. Production process

[0027] 2.1 Control the cleaning and sterilization of antibiotic glass bottles

[0028] Controlled antibiotic glass bottles are removed from the outer packaging, passed into the bottle washing and drying room, cleaned by a bottle washing machine, dried with compressed air, dried and sterilized in a hot air tunnel oven at 350°C for 5 minutes, and cooled.

[0029] 2.2 Cleaning and sterilization of butyl rubber

[0030] The butyl rubber stoppers are removed from the outer packaging and sent to the stopper washing room, cleaned by a stopper washing machine, sterilized at 121°C for 30 minutes, and cooled for later use.

[0031] 2.3 Sterilization of aluminum-plastic combination caps

[0032] The aluminum-plastic cover is removed from the outer packaging, and then transferred to the aluminum cover sterilization room, sterilized in a dry box at 121°C for 30 minutes, cooled, and set aside.

[0033] 2.4 Dosing

[00...

Embodiment 2

[0044] The difference between the present embodiment and embodiment 1 is that the prescription is different, and the prescription of the present embodiment is as follows:

[0045]

Embodiment 3

[0047] The difference between the present embodiment and embodiment 1 is that the prescription is different, and the prescription of the present embodiment is as follows:

[0048]

[0049]

[0050] Stability study

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Abstract

The invention provides an injection used nicergoline freeze-dried powder injection which is prepared by freeze-drying a nicergoline medicine solution with the pH value being 3.2-3.5. Every 2000 ml ofthe nicergoline medicine solution contains 80-120 g of nicergoline, 12-18 g of mannitol, 18-22 g of acetylcysteine, 2-3 g of monopotassium phosphate, 3-5 g of Tween 80, a proper amount of a pH regulating agent, and the balance of water. In the formula of the nicergoline freeze-dried powder injection, the proper amounts of ingredients, such as mannitol, acetylcysteine, Tween 80 and monopotassium phosphate, are added, all components play a synergistic effect, the appearance shape and porosity of the freeze-dried product can be improved, and the surface of the product is smoother; meanwhile, medicine properties are more stable, and storage and transportation of the medicine are facilitated.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to a nicergoline freeze-dried powder for injection and a preparation method thereof. Background technique [0002] With the continuous improvement of people's living standards, the number and proportion of the elderly population continue to increase, the incidence of senile dementia patients is increasing day by day, and the brain health problems of the elderly are also concerned by the society. According to incomplete statistics, the rate of severe senile dementia among people over the age of 65 reaches more than 5%, and by the age of 80, this rate will rise to 15-20%. The average survival period of senile dementia patients is 5.5 years, making this disease one of the main fatal diseases of the elderly in modern society. Among the various diseases of the elderly, Alzheimer's disease (Alzheimer's disease, AD) has attracted the most attention from patients and their fam...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/48A61K47/18A61K47/26A61K47/02A61P25/28
CPCA61K9/0019A61K9/19A61K31/48A61K47/02A61K47/183A61K47/26
Inventor 符永红符成龙杨杰史秋萍陈玉珠
Owner HAINAN GENERAL & KANGLI PHARMA
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