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Cinobufotalin lyophilized powder for injection and its preparation method

A technology of freeze-dried powder injection and cinobufacin, which is applied in the field of cinobufacin freeze-dried powder injection and its preparation, which can solve the problem of difficulty in ensuring the quality and curative effect of injections, harmful extracts and many ineffective impurities, and no cinobufacin found. Freeze-dried powder injection reports and other issues

Inactive Publication Date: 2005-07-06
张平
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Cinobufacin injection (WS3-B-30) is a sterilized aqueous solution obtained by extracting and processing dried toad skin. The preparation method of this injection failed to effectively extract bufotoxin components, and only 5-hydroxytryptamine was determined in the quality standard. The amount of total indole alkaloids calculated without measuring and controlling another important component of bufolide, which is both toxic and active, makes it difficult to guarantee the quality and curative effect of the injection, and the stability requirements of the injection High, and the inherent defects of aqueous injections are stability problems and easy breakage during carrying, storage, and transportation, which brings a lot of trouble
[0004] Patent (Application No. 98103562) "A Cinobufacin Capsule and Its Preparation Method" extracts the active ingredients by water extraction and alcohol precipitation to make capsules. The invention process is simple and has no novelty; Cinobufacin preparation drug and its preparation method” uses microwave extraction, decompression concentration, and supersonic jet technology to make nano-cinobufacin preparation drug. The biggest defect of this process is that it is not refined, and there are many harmful and invalid impurities in the extract. It is difficult to make an injection form, and there are problems with the feasibility of the process
[0005] No reports about cinobufacin freeze-dried powder injection were found in the data search

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0102] (1) The raw material medicine is: 500g of dried toad skin.

[0103] (2) Take the dry toad skin, wash it, add 5 times of 80% ethanol to reflux and extract twice, the first time is 45 minutes, the second time is 30 minutes, combine the ethanol solution, filter, and the filtrate is concentrated to contain 1g crude drug / ml, The concentrated solution was centrifuged for 30 minutes (2500r / min), and the supernatant was taken, and adsorbed on D101 macroporous adsorption resin, first eluted with 3 times the column volume of water, then 4 times the column volume of 40% ethanol, and then eluted with ethanol The solution was concentrated under reduced pressure and dried to obtain 6.1 g of cinobufacin alcohol extract.

[0104] (3) Preparation prescription: 6.1 g of cinobufacin alcohol extract, 90 g of mannitol.

[0105](4) Take the above-mentioned cinobufacin alcohol extract and mix it with pharmaceutical excipients, add water for injection to dissolve, add water for injection to t...

Embodiment 2

[0107] (1) Raw material drug The raw material drug is: dry toad skin 450g.

[0108] (2) Take the dry toad skin, wash it, add 6 times of 80% ethanol to reflux and extract twice, the first time is 45 minutes, the second time is 30 minutes, combine the ethanol liquid, filter, and the filtrate is concentrated to contain 1g crude drug / ml, The concentrated solution was centrifuged for 30 minutes (2500r / min), and the supernatant was taken, adsorbed on AB-8 macroporous adsorption resin, first eluted with 4 times column volume of water, then 3 times column volume of 35% ethanol, and the ethanol The eluate was concentrated under reduced pressure and dried to obtain 5.5 g of cinobufacin alcohol extract.

[0109] (3) Preparation prescription: 5.5 g of cinobufacin alcohol extract, 95 g of polyvinylpyrrolidone.

[0110] (4) Take the above-mentioned cinobufacin alcohol extract and mix it with pharmaceutical excipients, add water for injection to dissolve, add water for injection to the spec...

Embodiment 3

[0112] (1) Raw material drug The raw material drug is: dried toad skin 550g.

[0113] (2) Take the dry toad skin, wash it, add 6 times of 80% ethanol to reflux and extract twice, the first time is 45 minutes, the second time is 30 minutes, combine the ethanol liquid, filter, and the filtrate is concentrated to contain 1g crude drug / ml, The concentrated solution was centrifuged for 30 minutes (2500r / min), and the supernatant was taken, adsorbed on NKA-9 macroporous adsorption resin, first eluted with 4 times column volume of water, and then 5 times column volume of 30% ethanol, and the ethanol was taken The eluate was concentrated under reduced pressure and dried to obtain the cinobufacin alcohol extract.

[0114] (3) Preparation prescription: cinobufacin alcohol extract 7.5g, fructose 90g.

[0115] (4) Take the above-mentioned cinobufacin alcohol extract and mix it with pharmaceutical excipients, add water for injection to dissolve, add water for injection to the specified am...

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PUM

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Abstract

A cinobufotalin freeze dried injection and preparation process thereof are disclosed. It is prepared by cinobufotalin effective part and pharmaceutical adjuvant extracted from dry toad skin. The effective part of cinobufotalin is obtained by alcohol extraction, centrifugation and macropore polymeric adsorbent separation and purification. Wherein, the main effective component indole total alkaloid content is over than 30%. The content assay result and pharmaceutical examination result indicates that the cinobufotalin freeze dried injection has a higher content of effective part and stronger pharmaceutical function.

Description

Technical field [0001] The invention belongs to the technical field of traditional Chinese medicine pharmacy, and in particular relates to a cinobufacin freeze-dried powder injection and a preparation method thereof. Background technique [0002] Cinobufacin is a preparation obtained by extracting dry toad skin of the bufo family Bufo Bufo or Bufo Bufo, which has the effects of detoxification, swelling and pain relief. It is used for advanced tumors and chronic hepatitis B. Its water-soluble In addition to containing active ingredients indole alkaloids, such as 5-hydroxytryptamine, bufotryptamine, bufoteni, toad sulfur, etc., it also contains a certain amount of amino acids, reducing sugars, steroids, peptides, toad poisons, etc. Aglycone and arginine complex, studies have shown that the bufolide contained in toad skin is an important anti-tumor active ingredient and a toxic ingredient. Pharmacological and clinical studies in recent years have proved that in addition to ant...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/56A61P1/16A61P31/12A61P35/00
Inventor 张平
Owner 张平
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