Single-dosage package arenobufagin and preparation method thereof

A single-dose, toad venom technology, applied in pharmaceutical formulations, drug delivery, amphibian medical raw materials, etc., can solve the problems of toad venom limitation, inaccurate dose control and safety, etc., to solve the problem of safety in use, low drying temperature, Guaranteed freshness

Active Publication Date: 2016-08-31
四川仟源中药饮片有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the lack of accurate scales for on-site weighing in clinical applications, the use of Chansu is largely limited to traditional Chinese medicine preparations.
And its method of use has b

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Take 100g of toad venom and grind it through 100 mesh to get the finest powder of toad venom. According to the standard test under the item of toad venom in Part One of the Pharmacopoeia of the People's Republic of China, the content of cinobufonitoxin and redibufagenin in the toad powder powder is 6.67%. Using an analytical balance with an accuracy of 0.01 mg, accurately weigh 15.00 mg of toad powder according to the total amount of cinobufacien and bufabugenin as 1.00 mg, dispense it into small glass bottles, screw caps to seal, and check the difference in loading The limit is -4.27%~+5.80%, that is to say, a single-dose packaged toad venom is obtained.

Embodiment 2

[0029] Take 100g of toad venom, crush it through 80 meshes, and obtain the fine powder of toad venom. According to the standard test under the item of toad venom in the first part of Pharmacopoeia of the People's Republic of China, the total amount of effective components cinobufagin and redibufagenin was detected to be 7.62%. Using an analytical balance with an accuracy of 0.01 mg, weigh 50.00 mg of toad powder according to the total amount of cinobufacien and bufabugenin as 3.81 mg, pack in small plastic bottles, screw the caps to seal, and check the limit of the difference in the amount It is -2.36%~+4.34%, and the single-dose packaged toad venom is obtained.

Embodiment 3

[0031] Get 100g of toad venom, pulverize it through 65 meshes to obtain medium powder of toad venom, and then pulverize it with a jet mill to obtain superfine powder of toad venom. According to the standard inspection under the item of toad venom in the Pharmacopoeia of the People's Republic of China, the content of the active ingredients cinobufinin and lipobufin in the toad powder was detected to be 7.30%. The total amount of bufagenin is 0.73 mg, and 10.00 mg of toad venom powder is accurately weighed, divided into double-layer composite aluminum foils, sealed, and the difference limit of checking the filling amount is -2.80% to +6.70%, and a single-dose package of toad venom is obtained.

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PUM

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Abstract

The invention discloses single-dosage package arenobufagin. The single-dosage package arenobufagin is characterized in that white slurry of ear-side glands and dermal gland of bufo bufo gargarigans or bufo melanostictus is taken to be screened to remove impurities and to be dried at low temperature, and smashing is conducted to obtain arenobufagin powder. Single-dosage package is conducted according to the adult single dosage of the total amount, being 0.08-10 mg, of cinobufagin and resibufogenin, and the package difference limit is smaller than or equal to +/-15% according to the net weight, being 1-100 mg, of arenobufagin in the single-dosage package. The small-package arenobufagin is suitable for traditional Chinese medicine decoctions, pills and powder and suitable for external application. By means of the low-temperature drying, particularly freezing drying technology, active components of arenobufagin are kept to the maximum extent; by strictly controlling the total amount of cinobufagin and resibufogenin in the single-dosage package, the use safety problem of arenobufagin is effectively solved, and the last barrier is broken for clinical application of arenobufagin.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicines, and in particular relates to a single-dose packaged toad venom with advanced technology, stable quality, precise dosage and safe use 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, resibufogenin, etc. They are the main active ing...

Claims

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Application Information

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IPC IPC(8): A61K35/65A61K9/00
CPCA61K9/00A61K35/65
Inventor 茅仁刚代向向吴献荣
Owner 四川仟源中药饮片有限公司
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