Rebescensine A powder injection and preparing process thereof

A technology for oridonin A and freeze-dried powder injection, which is applied in the field of medicine, can solve the problems of complex preparation process, inability to realize industrialized production and the like, and achieve the effects of enhancing in vivo stability, simple composition and high efficacy.

Inactive Publication Date: 2010-07-14
ZHEJIANG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process of the preparation disclosed in this patent is complicated, and the condition control is relatively strict, and industrial production cannot be realized at present.

Method used

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  • Rebescensine A powder injection and preparing process thereof
  • Rebescensine A powder injection and preparing process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Dissolve 1200g of glucose, 300g of dextran in about 10L of distilled water, 60g of oridonin, and 100g of soybean lecithin in an appropriate amount of ethanol, and drop them into the above water phase under stirring. Heat and continue to stir or evaporate part or all of the organic solvent under reduced pressure, and set the volume to 10L. Then use a 0.22μm microporous membrane to filter and sterilize, divide into 16.6ml each, and freeze-dry at -10~-55°C. During the freeze-drying process, remove the residual solvent, cover the rubber stopper, and roll the cap to get each tube. 100mg (oridonin active ingredient) freeze-dried powder injection.

Embodiment 2

[0031] 50g of lecithin, dissolved in about 10L of distilled water, 50g of oridonin, dissolved in an appropriate amount of ethanol, and injected into the aqueous phase obtained above under stirring conditions, heated and stirred or evaporated part or all of the organic solvent under reduced pressure, Add 600g of glucose, dissolve 200g of dextran, and dilute to 10L. Use a 0.22μm microporous membrane to filter and sterilize, divide into 20ml each, freeze-dry at -10~-55°C, remove residual solvent during the freeze-drying process, cover with rubber stopper, and crimp the cap to obtain 100mg per vial ( oridonin active ingredient) freeze-dried powder injection.

Embodiment 3

[0033] Oridonin 80g, Poloxamer 188 or Poloxamer F68 160g was dissolved in an appropriate amount of ethanol, and slowly poured into about 20L of distilled water while stirring. Heat and continue to stir or evaporate part or all of the organic solvent under reduced pressure, add 2000 g of dextran, and set the volume to 20 L. Then use a 0.22μm microporous membrane to filter and sterilize, pack into 25ml each, freeze-dry at -10~-55°C, remove residual solvent during the freeze-drying process, cover with rubber stopper, and roll the cap to obtain 100mg per tube (Oridonin A active ingredient) freeze-dried powder injection.

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Abstract

The invention discloses an oridonin freeze-dried powder, which mainly contains the following materials measured by weight: oridonin 0.1-20 parts, amphiphile 0.1-25 parts, excipient of frozen-dried powder 0.1-400 parts, and antioxidant 0.05-5 parts. The invention discloses the preparation process as well. The freeze-dried powder for intravenous injection takes phosphatide, excipient of frozen-dried powder as the medicinally auxiliary material, and is made by freeze-dried technique. The invention has the advantages of simple components, small toxic and side effects, steady property, convenient transportation, and is applicable to intravenous injection of industry production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an oridonin intravenous injection preparation and a preparation method thereof. Background technique [0002] Oridonin is a tetracyclic diterpenoid with kaurene as the skeleton isolated from Labtea plants of the genus Rabdosia. This component has strong anti-tumor activity, and has obvious inhibitory effect on various tumors. In vitro tests show that Rubescensine A has the effect on various tumor cells such as: human liver cancer BEL7402, Ehrlich ascites carcinoma ECA, sarcoma S180, leukemia L 1210 , human leukemia HL-60, K562, NB4, human esophageal squamous cell carcinoma cell line CAES-17, gastric adenocarcinoma MGc80-3, nasopharyngeal carcinoma CNE, lung adenocarcinoma SPC-A-1, lung squamous cell carcinoma LTEP-78, human son Cervical cancer HeLa cells, human melanoma A375-S2 cells, etc. have different degrees of anti-tumor effect. It is clinically used in the treatment of ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/352A61K9/19A61K47/24A61K47/34A61K47/36A61P35/00A61K47/10
Inventor 梁文权孙晓译董思宇
Owner ZHEJIANG UNIV
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