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Andrographolide succinic acid half-ester natrium potassium salt and preparations

A technology of andrographolide and disuccinic acid half ester, applied in anti-inflammatory agents, non-central analgesics, medical preparations containing active ingredients, etc., can solve the problems of easy fluctuation of pH value and insufficient content, and achieve dissolution Rapid, stable, high content effect

Inactive Publication Date: 2008-08-27
YAOPHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the production process, adding activated carbon for decolorization and then filtering will easily lead to insufficient content, and the pH value will easily fluctuate during product storage. The present invention provides a new formula and process to overcome the above defects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Prescription: Yanhuning 80g

[0024] Disodium hydrogen phosphate 3.868g

[0025] Sodium dihydrogen phosphate 0.449g

[0026] Mannitol 80g

[0027] Calcium Sodium EDTA 2g

[0028] Vitamin C 0.8g

[0029] Make 1000 pieces

[0030] Preparation: Take Yanhuning, mannitol, calcium sodium EDTA, vitamin C and 80% of the total volume of phosphate buffer to dissolve, then use phosphate buffer to make up to 2000ml, sterile filter, measure pH, and molecular weight cut off through pore size 10,000 polyethersulfone is filtered, and after the clarity is qualified, it is filled, half-tightened, and freeze-dried in a box. Out of the box, capping, crimping, light inspection, packaging, and you get it.

Embodiment 2

[0032] Prescription: Yanhuning 200g

[0033] Disodium hydrogen phosphate 3.868g

[0034] Sodium dihydrogen phosphate 0.449g

[0035] Mannitol 80g

[0036] Calcium Sodium EDTA 2g

[0037] Vitamin C 0.8g

[0038] Make 1000 pieces

[0039] Preparation: Take Yanhuning, mannitol, calcium sodium EDTA, vitamin C and 80% of the total volume of phosphate buffer to dissolve, then use phosphate buffer to make up to 2000ml, sterile filter, measure pH, and molecular weight cut off through pore size 10,000 polyethersulfone is filtered, and after the clarity is qualified, it is filled, half-tightened, and freeze-dried in a box. Out of the box, capping, crimping, light inspection, packaging, and you get it.

Embodiment 3

[0041] Prescription: Yanhuning 80g

[0042] Disodium hydrogen phosphate 3.868g

[0043] Sodium dihydrogen phosphate 0.449g

[0044] Mannitol 80g

[0045] Calcium Sodium EDTA 2g

[0046] Vitamin C 0.8g

[0047] Make 1000 pieces

[0048] Preparation: Take Yanhuning, mannitol, calcium sodium EDTA, vitamin C and 80% of the total volume of phosphate buffer to dissolve, then use phosphate buffer to make up to 2000ml, sterile filter, measure pH, and molecular weight cut off through pore size 10,000 polyethersulfone is filtered, and after the clarity is qualified, it is filled, half-tightened, and freeze-dried in a box. Out of the box, capping, crimping, light inspection, packaging, and you get it.

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PUM

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Abstract

The invention relates to a potassium sodium dehydroandroandrographolide succinate and a composition thereof. The composition contains andrographolide as pharmaceutically-active component, mannitol, calcium sodium EDTA, vitamin C and phosphate buffer. The composition for injection contains, per 1000, 20-200g of potassium sodium 14-dehydro-11,12- didehydroandrographolide-3,19-succinate, 3.868g of disodium hydrogen phosphate, 0.449g of sodium dihydrogen phosphate, 20-200g of mannitol, 0.5-5g of calcium sodium EDTA and 0.2-2g of vitamin C.

Description

Technical field: [0001] The invention relates to a pharmaceutical composition, in particular to a freeze-dried pharmaceutical composition of Yanhuning for injection. Background technique: [0002] Yanhuning, the chemical name is: 14-dehydro-11,12-didehydroandrographolide-3,19-disuccinic acid half ester sodium potassium salt, abbreviation: andrographolide succinic acid half ester sodium potassium salt, It is a medicine made from pure traditional Chinese medicine after extraction and synthesis, and has the characteristics of good solubility. It has pungent and cool solution, cool and detoxification, antiviral and antibacterial effects. [0003] The already-marketed Yanhuning injection is a freeze-dried powder injection, which is stabilized by adding sodium bicarbonate to adjust the pH value to achieve a potassium-sodium balance. However, low-temperature storage is still required to avoid discoloration of the drug during use. In the production process, adding activated carbon...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/365A61K31/13A61K47/02A61P29/00
Inventor 朱江
Owner YAOPHARMA CO LTD
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