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High purity bufonis veneum direct oral decoction piece and preparation method thereof

A high-purity, toad venom technology is applied in the direction of dispersion liquid transportation, resistance to vector-borne diseases, and medical raw materials derived from amphibians. , can not be taken directly orally, etc., to prevent product agglomeration, ensure the content and curative effect of active ingredients, and increase the content of active ingredients

Inactive Publication Date: 2017-09-15
四川仟源中药饮片有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Toad venom is collected from living toads crawling on the roadside in the field, which inevitably brings in impurities such as soil, fine sand, dead branches and leaves, as well as parasites and a large number of microorganisms, and the conventional collection operations lack sanitation measures such as cleaning and disinfection, resulting in toad venom The ash, acid-insoluble ash and microorganisms exceed the standard
If it is not produced under the production conditions of a D-level clean area in accordance with the "Quality Management Standards for Drugs", and adopts processes such as disinfection and removal of impurities, the Chansu product does not meet the standards for direct oral decoction pieces and cannot be taken directly.

Method used

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  • High purity bufonis veneum direct oral decoction piece and preparation method thereof

Examples

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Effect test

Embodiment 1

[0035] Take toad venom medicinal material 1kg, carry out all-item inspection according to the quality standard of toad venom in Pharmacopoeia of the People's Republic of China, transport the qualified toad venom to the production workshop of direct oral decoction pieces, and disinfect the outer packaging surface with 75% ethanol in the outer cleaning room, and send it into the buffer room, sterilized by ultraviolet light for 5 minutes, and then sent to a class D clean workshop for production. Crush the toad venom medicinal material into the coarsest powder of 10 meshes, add 2 times the amount (g / g) of white wine with an alcohol content of 52% (v / v) to the toad venom powder, stir until it is uniform without lumps, and process it at 40°C for 6 hours , Press filtered through a 100 mesh sieve to remove impurities. Pour the toad venom ethanol solution into the tray, put it in a vacuum drying oven at 40°C and dry it under reduced pressure for 4 hours, pulverize it to 50 mesh, take a...

Embodiment 2

[0037] Take toad venom medicinal material 1kg, conduct all-item inspection according to the quality standard of toad venom in Pharmacopoeia of the People's Republic of China, transport the qualified toad venom to the production workshop of direct oral decoction pieces, take off the outer packaging in the outer cleaning room, send it to the buffer room, and sterilize it with ultraviolet light for 15 minutes. Send it to Class D clean workshop for production. Crush the toad venom medicinal material into a 50-mesh coarse powder, add 5 times the amount (g / g) of 38% ethanol concentration white wine to the toad venom powder, stir until it is uniform without lumps, process it at 20°C for 12 hours, and press filter through a 150-mesh sieve And 50μm precision filter to remove impurities. Pour the toad venom ethanol liquid into the tray, put it in an electric oven and dry it at 70°C for 3 hours, grind it into a very fine powder below 150 mesh, and use a precision automatic micro-packing ...

Embodiment 3

[0039] Take toad venom medicinal material 1kg, carry out all-item inspection according to the quality standard of toad venom in Pharmacopoeia of the People's Republic of China, transport the qualified toad venom to the production workshop of direct oral decoction pieces, and disinfect the outer packaging surface with 75% ethanol in the outer cleaning room, and send it into the buffer room, sterilized by ultraviolet light for 30 minutes, and sent to a class D clean workshop for production. Crush the toad venom medicinal material into the finest powder of 100 mesh, add 10 times the amount (g / g) of 30% (v / v) ethanol aqueous solution to the toad venom powder, stir at 80°C for 0.1 hour until uniform without lumps, press filter for 200 Mesh sieve and 0.2μm precision filter to remove impurities. Pour the toad venom ethanol solution into the tray, put it in a drying oven at 100°C for 1 hour, and steam-dry it for 1 hour, crush it to 40 mesh, and then air-jet crush it to make an ultrafi...

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Abstract

The invention discloses a high purity bufonis veneum direct oral decoction piece and a preparation method thereof. The bufonis veneum direct oral decoction piece is in single dose package with a specification of 1-60mg, and the bufonis veneum powder particle size is smaller than or equal to 50 meshes. Calculated on a dry product, the total amount of bufalin, cinobufagin and resibufogenin contained in the direct oral decoction piece is not less than 6.5% (g / g), the total ash is not more than 5.0%, and the acid-insoluble ash does not exceed 2.0%. Salmonella (10g) is not detected in the product, and bile salt resistant gram-negative bacteria is less than 10000cfu (1g). The bufonis veneum direct oral decoction piece is produced in workshops conforming to the "good manufacture practice of drugs". The preparation method includes: (1) raw material inspection; (2) primary crushing; (3) processing with wine; (4) filtering; (5) drying; (6) second crushing; (7) inner packing; (8) outer packaging; and (9) finished product inspection. Specifically, the steps (2)-(7) are carried out in a D grade clean production area, and the step (8) is conducted in a general production area. The bufonis veneum direct oral decoction piece is in single dose package, has the advantages of accurate dosage, controllable production process, good safety, and qualified microbial limit, the product is in accordance with the quality standards of direct oral drugs, and is suitable for direct oral taking.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicines, and in particular relates to a high-purity toad venom direct oral decoction piece with advanced technology, stable quality, precise dosage, safe use and qualified microbial limit and a preparation method thereof. Background technique [0002] Bufonis Venenum is the dry secretion of Bufo melanositictus Schneider or Bufo bufo gargarizans Cantor (Pharmacopoeia of the People's Republic of China, Part I, 2015 Edition). Toad Su is first recorded in the lost Tang Dynasty Materia Medica "Medicine Nature", formerly known as Toad Meizhi. It has detoxification, pain relief, and refreshing effects. It is used to treat carbuncle sores, sore throat, sunstroke, coma, abdominal pain, vomiting and diarrhea due to fever. More into pills and powder. Appropriate amount for external use. [0003] Toad venom contains a large amount of bufadienolide compounds, such as Bufotalin, bufalin, cinobufagin, res...

Claims

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Application Information

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IPC IPC(8): A61K35/65A61K9/14
CPCA61K9/0095A61K9/14A61K35/65Y02A50/30
Inventor 茅仁刚代向向
Owner 四川仟源中药饮片有限公司
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