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Freeze-dried composition contg. nicergoline and its prepn. method

A technology of nicergoline and composition, applied in the field of medicine, can solve problems such as side effects, sensitivity to light and temperature, poor stability and the like

Inactive Publication Date: 2006-11-15
范敏华
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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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Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0042] Experimental Example 1: Stability of Nicergoline freeze-dried powder injection.

[0043] The Nicergoline freeze-dried powder injection that embodiment 1 makes carries out stability investigation.

[0044] Method: According to the requirements of the stability test, take this product, simulate the market package, place it at 40°C and 75% relative humidity, and measure it once in 0, 1, 2, 3, and 6 months. Investigate properties, acidity, clarity, content, total impurities. The results are shown in Table 1.

[0045] time

[0046] Conclusion: After 6 months of accelerated test, all indicators have no obvious changes compared with 0 months, and the sample is stable.

experiment example 2

[0047] Experimental Example 2: General Safety of Nicergoline Lyophilized Powder Injection

[0048] The Nicergoline freeze-dried powder injection that embodiment 1 makes is done general safety test, and experimental result shows no irritation, no anaphylaxis, and no hemolysis phenomenon.

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PUM

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Abstract

A freeze-dried powder injection is prepared from nicergoline, the acid as pH value regulator and the excipient for freeze-drying. Its preparing process is also disclosed.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a nicergoline freeze-dried composition. The invention also provides a preparation method of the nicergoline freeze-dried composition. technical background [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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/48A61K9/19A61P25/28
Inventor 范敏华朱小平汪卫军楼金芳
Owner 范敏华
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