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Sodium bisulfate andrographolide aseptic powder for injection and its preparation method

A technology of sodium bisulfite and andrographolide, applied in powder delivery, antibacterial drugs, respiratory diseases and other directions, can solve the problems of inconvenient drug preparation and storage, thermal instability of aqueous solution, and impact on clinical drug quality, etc. Accurate dosage, plump appearance and good stability

Inactive Publication Date: 2004-11-03
湖北省医药工业研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because sodium bisulfite andrographolide has a diterpene lactone structure, its aqueous solution is unstable to heat and easy to degrade by ring opening, which affects the quality of clinical medication and brings inconvenience to the preparation and storage of drugs.
It is also inconvenient to transport the aqueous solution in

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Embodiment 1: 50g sodium bisulfite andrographolide is placed in a container, add 1000ml of distilled water for injection to dissolve, the solution is filtered with 0.44 μm and 0.22 μm microporous membranes respectively, and the filtrate is divided into 10ml vials , 2.0ml per bottle; freeze-drying after sub-packaging to obtain the finished sterile powder of sodium bisulfite andrographolide.

[0073] The finished product can be dissolved in an appropriate amount of water for injection for intravenous injection or intramuscular injection, and can also be dissolved in large-capacity glucose injection or sodium chloride injection for intravenous drip.

Embodiment 2

[0074] Embodiment 2: by the method for embodiment 1, 20g sodium bisulfite andrographolide and 50g mannitol are placed in container, add 1000ml distilled water for injection and dissolve, filter; ml; subpackaged and freeze-dried by conventional methods to obtain the finished sterile powder of sodium bisulfite andrographolide.

[0075] The finished product can be dissolved in an appropriate amount of water for injection for intravenous injection or intramuscular injection, and can also be dissolved in large-capacity glucose injection or sodium chloride injection for intravenous drip.

Embodiment 3

[0076] Embodiment 3: according to the method for embodiment 1, 250g sodium bisulfite andrographolide and 100g mannitol are placed in the container, add 1000ml distilled water for injection to dissolve, filter; ml; subpackaged and freeze-dried by conventional methods to obtain the finished sterile powder of sodium bisulfite andrographolide.

[0077] The finished product can be dissolved in an appropriate amount of water for injection for intravenous injection or intramuscular injection, and can also be dissolved in large-capacity glucose injection or sodium chloride injection for intravenous drip.

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PUM

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Abstract

The bacteria-free sodium bisulfate-andrographolide powder for injection is prepared with sodium bisulfate-andrographolide powder and through compounding aqua of 0.01-0.5 g / ml concentration and freeze drying. The preparation process of the bacteria-free sodium bisulfate-andrographolide powder for injection is also provided, and the preparation process includes compounding sodium bisulfate-andrographolide aqua of 0.01-0.5 g / ml concentration, filtering with microporous membrane and final freeze drying. The preparation process is simple and suitable for industrial production, and the preparation is stable and favorable to storing and transportation.

Description

technical field [0001] The invention relates to sodium bisulfite andrographolide (lianbizhi) sterile powder for injection and a preparation method thereof; in particular to a freeze-dried powder injection of sodium bisulfite andrographolide and a preparation method thereof. Background technique [0002] Sodium bisulfite andrographolide is a medicinal active ingredient extracted from Chinese herbal medicine andrographolide, which is obtained by adding sodium bisulfite. It has been proved by pharmacological tests to have strong antibacterial activity. It is mainly used in clinical Treat pneumonia, tonsillitis, bacillary dysentery, etc., because of its small side effects, it is especially suitable for children. [0003] Sodium bisulfite andrographolide is currently only produced as an injection (small needle). Because sodium bisulfite andrographolide has a diterpene lactone structure, its aqueous solution is unstable to heat and easy to degrade by ring opening, which affects t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/365A61P11/00A61P11/04A61P31/04
Inventor 余修祥刘红王登美兰芳艾鸣哲
Owner 湖北省医药工业研究院有限公司
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