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Preparation method and detection method of Stauntonia chinensis DC injection

A detection method and the technology of wild papaya are applied in the field of traditional Chinese medicine to achieve the effects of exclusive detection method, improved safety and reduced total saponin content

Active Publication Date: 2018-06-22
JIANGXI HERBI SKY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The hemolysis test under the inspection item in the wild papaya injection standard stipulates that there should be no hemolysis after half an hour of observation, but the "Chinese Pharmacopoeia" 2015 edition, an appendix XⅢH hemolysis and coagulation test method already requires 3 hours of observation. The applicant injected wild papaya It was found that hemolysis occurred after 3 hours, so it is necessary to improve the preparation method of wild papaya injection to improve its safety.

Method used

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  • Preparation method and detection method of Stauntonia chinensis DC injection
  • Preparation method and detection method of Stauntonia chinensis DC injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1, wild papaya injection

[0044] Take 2500g of wild papaya, add water and decoct three times. Combine the decoctions for 2 hours each time, filter, concentrate the filtrate to 1000ml under reduced pressure, add 5000ml of ethanol, stir well, refrigerate for 24 hours, let it settle, filter, recover the ethanol from the filtrate under reduced pressure, add water to 500ml; use 6mol / L hydrochloric acid solution to adjust the pH value to 2.0, heat in a water bath at 80°C for 4 hours, refrigerate for 24 hours, let it settle, filter, adjust the pH value of the filtrate to neutral with 20% sodium hydroxide, concentrate under reduced pressure to form a thick paste , add 8 times the amount of ethanol, stir well, refrigerate for 24 hours, place to precipitate, filter, and recover ethanol from the filtrate under reduced pressure; add 500ml of water for injection, adjust the pH value to 7.5 with 8% sodium hydroxide solution, add 10g poly Sorbitate 80 and benzyl alcohol ...

Embodiment 2

[0051] Embodiment 2, wild papaya injection

[0052] Take 2500g of wild papaya, add water and decoct three times. Combine the decoctions for 2 hours each time, filter, concentrate the filtrate to 1000ml under reduced pressure, add 5000ml of ethanol, stir well, refrigerate for 24 hours, let it settle, filter, recover the ethanol from the filtrate under reduced pressure, add water to 500ml; use 6mol / Adjust the pH value to 2.0 with L hydrochloric acid solution, heat in a 60°C water bath for 4 hours, refrigerate for 24 hours, let it settle, filter, adjust the pH value of the filtrate to neutral with 20% sodium hydroxide, concentrate under reduced pressure to form a thick paste , add 8 times the amount of ethanol, stir well, refrigerate for 24 hours, place to precipitate, filter, and recover ethanol from the filtrate under reduced pressure; add 500ml of water for injection, adjust the pH value to 7.5 with 8% sodium hydroxide solution, add 10g poly Sorbitate 80 and benzyl alcohol 1...

Embodiment 3

[0054] Embodiment 3, wild papaya injection

[0055] Take 2500g of wild papaya, add water and decoct three times. Combine the decoctions for 2 hours each time, filter, concentrate the filtrate to 1000ml under reduced pressure, add 5000ml of ethanol, stir well, refrigerate for 24 hours, let it settle, filter, recover the ethanol from the filtrate under reduced pressure, add water to 500ml; use 6mol / L hydrochloric acid solution to adjust the pH value to 2.0, heat in a water bath at 70°C for 4 hours, refrigerate for 24 hours, let it settle, filter, adjust the pH value of the filtrate to neutral with 20% sodium hydroxide, concentrate under reduced pressure to form a thick paste , add 8 times the amount of ethanol, stir well, refrigerate for 24 hours, place to precipitate, filter, and recover ethanol from the filtrate under reduced pressure; add 500ml of water for injection, adjust the pH value to 7.5 with 8% sodium hydroxide solution, add 10g poly Sorbitate 80 and benzyl alcohol ...

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Abstract

The invention discloses a preparation method and a detection method of Stauntonia chinensis DC injection. Compared with the preparation method in the current standard (WS3-B-4003-98) of Stauntonia chinensis DC injection, the preparation method provided by the invention has the key point that heating treatment is carried out after the first-time alcohol precipitation on a concentrated solution andacid adjustment, and then refrigeration is carried out. For the prepared Stauntonia chinensis DC injection provided by the invention, the content of total flavonoids has small change, but the contentof total saponins is obviously reduced, and the safety of the product is improved. The invention further provides a method for measuring the content of total saponins in the Stauntonia chinensis DC injection.

Description

technical field [0001] The invention relates to the field of traditional Chinese medicines, in particular to a preparation method of wild papaya injection and a detection method thereof. Background technique [0002] Wild papaya injection is recorded in the twentieth volume of the Ministry of Health's drug standards for traditional Chinese medicine preparations. It is a sterilized aqueous solution made from wild papaya. Collateral trigeminal neuralgia, sciatica. [0003] The preparation method recorded in the standard of wild papaya injection (WS3-B-4003-98) is: take 2500g of wild papaya, add water to decoct three times, 2 hours each time, combine the decoction, filter, and concentrate the filtrate to 1000ml under reduced pressure , add 5000ml of ethanol, stir well, refrigerate, leave to precipitate, filter, and depressurize the filtrate to recover ethanol, add water to 500nl; adjust the pH value to 2.0 with 6mol / L hydrochloric acid solution, refrigerate, leave to precipita...

Claims

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Application Information

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IPC IPC(8): A61K36/185A61K9/08A61P25/02G01N21/78G01N21/31
CPCA61K9/0019A61K9/08A61K36/185A61K2236/331A61K2236/53G01N21/31G01N21/78G01N2021/786
Inventor 吴安明童玉华何杨虎吴孔松郭烨
Owner JIANGXI HERBI SKY CO LTD
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