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Preparation method of bemegride injection

A technology of injection preparation and Bemag, which is applied in the fields of pharmaceutical formulation, drug delivery, nervous system diseases, etc., can solve problems such as high risk, sterility cannot be effectively guaranteed, and drug safety cannot be effectively guaranteed, reaching Large application value, simple method, and the effect of reducing quality risks

Active Publication Date: 2015-06-10
SHANGHAI ZHAOHUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] However, the products prepared by the above method failed the sterility test. Due to the special route of administration of injection products, the high risk of this type of product is determined. Once the sterility of the product is not effectively guaranteed, it will not be able to Effectively ensure medication safety

Method used

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  • Preparation method of bemegride injection
  • Preparation method of bemegride injection
  • Preparation method of bemegride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1 prepares Bemige injection:

[0041]

ingredients

Per 10,000ml prescription volume

1

Bemeg

27.8g

2

Sodium chloride

90g

3

medicinal charcoal

10g

4

Water for Injection

up to 10,000 ml

[0042] (1) Put 80% of the prepared water for injection (the temperature of water for injection is 70-75°C) into the liquid mixing tank, add the weighed sodium chloride and stir.

[0043] (2) Add the weighed Bemag and stir.

[0044] (3) Add the weighed medicinal charcoal and stir.

[0045] (4) Add water for injection to the full amount and stir.

[0046] (5) The solution is first filtered through a titanium filter, and then through a 0.45 μm and a 0.2 μm microporous membrane cartridge filter.

[0047] (6) Adjust the pH value to the range of 5.0-6.0.

[0048] (7) Determination of intermediate product content and pH value.

[0049] (8) Fill and seal into 20ml ampoules.

[0050] (9) Termina...

Embodiment 2

[0053] Embodiment 2 prepares Bemige injection

[0054] The composition and preparation method are the same as in Example 1, but the water temperature of the water for injection in step (1) is 76-80°C.

Embodiment 3

[0055] Embodiment 3 prepares Bemige injection

[0056] Composition and preparation are the same as in Example 1, but the water temperature of the water for injection in step (1) is 81-85°C

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Abstract

The invention provides a preparation method of a bemegride injection. By virtue of improvement of the preparation method, a terminal sterilization condition is improved to 116 DEG C for 30-45 minutes from 100 DEG C for 45 minutes; and the temperature of liquid-dispensing injection water is improved to 70-85 DEG C from 90 DEG C. By virtue of test detection, the sterile detection of the product reaches the specified requirements; the related substance indexes are reduced. Thus, the quality risk of the product and the medication risk of patients are relatively well reduced. An accelerated test and a long-term stability test prove that the indexes such as sterile detection, related substance and content of the bemegride injection reach the bemegride injection YHB03112012 standard of the Chinese state food and drug administration; and a good effect is achieved. The method disclosed by the invention is simple; new cost is not increased; and the preparation method is suitable for large-scale industrial production, and has relatively great application value.

Description

technical field [0001] The present invention relates to medicinal chemistry. Specifically, it relates to a preparation method of Bemige injection. Background technique [0002] Bemag is a central stimulant drug, which has an exciting effect on the medullary respiratory center and can also directly excite the vascular center. Clinically, it is mostly used to relieve respiratory depression caused by barbiturates and other hypnotics, and can also be used to reduce the depth of thiopental anesthesia to accelerate its recovery. The commonly used clinical formulation of this variety is Bemige Injection. [0003] The composition of Bemige Injection is as follows: [0004] ingredients Per 10,000ml prescription volume 1 Bemeg 27.8g 2 Sodium chloride 90g 3 medicinal charcoal 10g 4 Water for Injection up to 10,000 ml [0005] The preparation method of the existing Bemige injection is: [0006] ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/45A61P25/26
Inventor 王燕
Owner SHANGHAI ZHAOHUI PHARMA
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