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Medicinal composition freezing-dried powder injection for cancer auxiliary treatment and its preparation method

A technology of freeze-dried powder injection and adjuvant therapy, which is applied in the field of freeze-dried powder injection and its preparation of pharmaceutical compositions for adjuvant cancer treatment, which can solve the problems of long reconstitution time and achieve good molding, consistent color, and crystallization thickness uniform effect

Inactive Publication Date: 2011-10-26
TIANJIN TASLY ZHIJIAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the inventors have found that the freeze-dried powder injection of this formula has a relatively long reconstitution time, and a freeze-dried powder injection with rapid reconstitution is required clinically.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Example 1 The preparation method of Codonopsis pilosula and Radix Astragali effective components

[0044] (1) Take the same amount of Codonopsis pilosula and Radix Astragali decoction pieces, add 6 times the amount of 70% ethanol, and reflux extraction 3 times, each time for 1.5 hours, to obtain the extract and medicinal residues, combine the extracts, recover the ethanol under reduced pressure and concentrate, add water to make Dissolve, stand still, centrifuge, take the supernatant and add it to the D101 macroporous adsorption resin column that has been treated, first wash the resin column with distilled water, then use 80% ethanol to elute the saponin components, and collect 80% ethanol The eluate was recovered from ethanol under reduced pressure and concentrated to a thick paste, and the concentrate was dried to obtain extracts of Codonopsis pilosula and total saponins of Radix Astragalus.

[0045] (2) Add 10 times the amount of water to the above-mentioned medicina...

Embodiment 2

[0047] The preparation method of the freeze-dried powder injection of embodiment 2 Codonopsis pilosula and Radix Astragali effective components

[0048] Active components of Codonopsis Radix and Astragali (prepared according to the method of Example 1) 1000g, mannitol 2375g, povidone k30125g

[0049] Add an appropriate amount of water for injection to dissolve, adjust the pH value to 7.0 with 10% NaOH, add water for injection to 25000ml, filter with a 0.22um microporous membrane, and pack in 7ml vials, each bottle 2.5ml, put it into a freeze dryer that has been cooled to -40°C in advance; vacuumize; heat up to -18°C within 13 hours; when the water in the container is basically sublimated, heat up for the second time, and raise the temperature within 4 hours to 40°C and hold for 4 hours after stabilization.

Embodiment 3

[0050] The preparation method of the freeze-dried powder injection of embodiment 3 Codonopsis pilosula and Radix Astragali effective components

[0051] Active components of Codonopsis Radix and Astragali (prepared according to the method of Example 1) 1000g, mannitol 2000g, povidone k30600g

[0052] Add an appropriate amount of water for injection to dissolve, adjust the pH value to 7.0 with 10% NaOH, add water for injection to 25000ml, filter with a 0.22um microporous membrane, and pack in 7ml vials, each bottle 2.5ml, put it into a freeze dryer that has been cooled to -40°C in advance; vacuumize; heat up to -18°C within 13 hours; when the water in the container is basically sublimated, heat up for the second time, and raise the temperature within 4 hours to 40°C and hold for 4 hours after stabilization.

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PUM

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Abstract

The invention provides a freeze dried injection of medicament for the subsidiary treatment of cancer. The injection has high quality of external appearance, better water-solubility. The invention also provides the process for preparing the freeze dried powder preparation.

Description

technical field [0001] The invention relates to a freeze-dried powder injection of a pharmaceutical composition for adjuvant cancer treatment and a preparation method thereof, in particular to a freeze-dried powder injection of a pharmaceutical composition for adjuvant cancer treatment with Chinese herbal medicine as a raw material and a preparation method thereof. Background technique [0002] The source of Astragalus is the dry root of A.membranaceus (Fisch.) Bge.var.mongholicus Bge.Hsiao, a leguminous plant. It is a traditional Qi-invigorating medicine. Traditionally used to improve human immunity and other effects, it is also used to replenish Qi, such as fatigue, lack of energy and other symptoms. There are many research reports on the chemical constituents of Radix Astragali, from which polysaccharides, saponins, flavonoids, amino acids, trace elements, etc. are isolated. Modern pharmacological studies have proved that astragalus polysaccharides (polysaccharides) and ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/481A61K9/19A61K47/26A61K47/10A61P35/00
Inventor 叶正良郑永锋夏忠庭李学敏
Owner TIANJIN TASLY ZHIJIAO PHARMA