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'Yanhuning' frozen-dried powder injection and its preparation method

A freeze-dried powder injection, Yanhuning technology, applied in the field of Yanhuning freeze-dried powder injection and its preparation, can solve the problem of content decline, unstable pH environment, fast, and some content will drop to the lower limit after one year, etc. problem, achieving slow oxidation, stable pH environment, and improved shelf life

Active Publication Date: 2009-06-17
HARBIN ZHENBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Store it according to the storage conditions (airtight, in a cool and dry place), because the pH environment is unstable, so the content drops quickly, and some content drops to the lower limit after one year, and cannot reach the 2-year validity period

Method used

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  • 'Yanhuning' frozen-dried powder injection and its preparation method
  • 'Yanhuning' frozen-dried powder injection and its preparation method
  • 'Yanhuning' frozen-dried powder injection and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Example 1 Preparation of Yanhuning freeze-dried powder injection

[0020] Take 800g of Yanhuning, dissolve it with 14000ml of 55℃ water for injection and keep it at 50℃~55℃, and adjust the pH value to 6.7; take 89.6g of disodium hydrogen phosphate and 64.5g of sodium dihydrogen phosphate respectively, and dissolve them in 1000ml of water for injection ; Take 6g of L-cysteine ​​hydrochloride, dissolve it with 1000ml of water for injection, mix the above three solutions evenly, adsorb on activated carbon, remove carbon, adjust the pH value to 6.8, add water for injection to 20000ml, stir well, 30 Fine filtration below ℃, filling, semi-corking, freeze-drying, corking, capping, visual inspection, packaging, and the finished product is obtained.

Embodiment 2

[0021] Example 2 Preparation of Yanhuning freeze-dried powder injection

[0022] Take 720g of Yanhuning, dissolve it with 12000ml of water for injection at 50°C, and adjust the pH to 6.0; take 80.64g of disodium hydrogen phosphate and 50.05g of sodium dihydrogen phosphate, and dissolve it with water for injection; take L-cysteine ​​salt Salt 4.9g, dissolve with water for injection, mix the above three solutions evenly, add activated carbon for adsorption at 0.4% by weight, remove carbon, adjust the pH value to 6.3, add water for injection to 13000ml, stir evenly, and refine at 30°C Filtration, filling, semi-stoppering, freeze-drying, stoppering, capping, visual inspection, packaging, and the finished product is obtained.

Embodiment 3

[0023] Example 3 Preparation of Yanhuning freeze-dried powder injection

[0024] Take 880g of Yanhuning, dissolve it with 13000ml of water for injection at 60°C, and adjust the pH value to 7.0; take 98.56g of disodium hydrogen phosphate and 70.95g of sodium dihydrogen phosphate, and dissolve it with 1000ml of water for injection; take L-cysteine Hydrochloride 7.6g, dissolved with 1000ml of water for injection, mixed the above three solutions evenly, added activated carbon to absorb for 20 minutes according to the weight ratio of 0.7%, removed carbon, adjusted the pH value to 6.9, added water for injection to 25000ml, stirred evenly, Fine filtration below 30°C, filling, semi-corking, freeze-drying, corking, capping, visual inspection, packaging, and the finished product is obtained.

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Abstract

The invention discloses a freeze dried injection of potassium sodium dehydroandrographolide succinate which is prepared from potassium sodium dehydroandrographolide succinate, ionic cushion pairs and anti-oxidizing agents, the preferred ionic cushion pairs being phosphate cushion pairs, and the antioxidant can be L-cysteine hydrochloride.

Description

technical field [0001] The invention relates to a medicament and a preparation method thereof, in particular to Yanhuning freeze-dried powder injection and a preparation method thereof. Background technique [0002] Yanhuning, chemical name: 14-dehydroxy-11,12-didehydroandrographolide-3,19-disuccinate half ester potassium sodium salt, molecular formula: C28H34KNaO10·H2O; molecular weight: 610.68. It can inhibit early capillary permeability increase and inflammatory exudation and edema, can specifically stimulate the pituitary-adrenal cortex function, promote the release of ACTH, and increase the biosynthesis of ACTH in the anterior pituitary; in vitro it has inactivated adenovirus, The role of various viruses such as influenza virus and respiratory virus. Animal experiments have anti-early and middle-pregnancy effects. It has heat-clearing, detoxifying and antiviral effects, and is mainly used for viral pneumonia and viral upper respiratory tract infections. [0003] The ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/365A61K9/19A61K47/16A61P11/00A61P31/12
Inventor 方同华
Owner HARBIN ZHENBAO PHARMA
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