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A kind of bufagenin solid dispersion and its preparation method

A technology of solid dispersion and bufagenin, which is applied in the field of medicine and can solve problems such as low bioavailability, poor absorption, and poor water solubility

Active Publication Date: 2020-10-27
NINGXIA MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Studies have shown that Bufafalin, Cinobufagenin and Libufagenin are the three components with high content and strong activity in Bufabugenin, which not only have anti-tumor effect, but also can improve the body's immunity. Reduce the toxic and side effects of chemotherapy, reduce the incidence of cancer pain, and enhance the body's tolerance to radiotherapy and chemotherapy, but its water solubility is extremely poor, resulting in poor absorption and low bioavailability in the body, which ultimately restricts the clinical efficacy.

Method used

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  • A kind of bufagenin solid dispersion and its preparation method
  • A kind of bufagenin solid dispersion and its preparation method
  • A kind of bufagenin solid dispersion and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1: Preparation of Bufagenin Solid Dispersion by Spray Condensation

[0048] Weigh 8.0g of Poloxamer 407, put it in a heating tank and melt it completely at 120°C, turn on the stirrer, and slowly add 1.8g of bufoginin raw material medicine and hypromellose acetate under the action of mechanical stirring (300rpm) Susuccinate 0.2 g was stirred continuously for 15 minutes to form a suspension. Put the above suspension in a preheated spray device, and spray the suspension into In the freezing chamber of the spray condensing machine, solidify for 3 to 5 minutes to obtain the bufagenin solid dispersion.

Embodiment 2

[0049] Example 2: Preparation of Bufagenin Solid Dispersion by Spray Condensation

[0050] Weigh 8.0 g of Poloxamer 188 and melt in a heating tank at 110°C. Under the action of mechanical stirring (rotating speed 250 rpm), 0.5 g of hypromellose and 1.5 g of Bufagenin raw material drug were slowly added, and then the stirring was continued for 12.5 minutes. Put the above suspension in a preheated spray device, and spray the suspension into In the freezing chamber of the spray condensing machine, solidify for 3 to 5 minutes to obtain the bufagenin solid dispersion.

Embodiment 3

[0051] Example 3: Preparation of Bufagenin Solid Dispersion by Spray Condensation

[0052] Weigh 8.0g of polyethylene glycol 4000 and 0.5g of povidone K30, and melt at 150°C in a heating tank. Under the action of mechanical stirring (rotating speed: 500 rpm), 1.5 g of Bufagenin crude drug was slowly added, and the stirring was continued for 10 minutes to form a suspension. Place the above suspension in a preheated spray device, and spray the suspension under the conditions of atomization nozzle temperature of 120°C, atomization pressure of 0.2MPa, and freezer temperature of -70°C (refrigerant is liquid nitrogen and cold air). The liquid is sprayed into the freezing chamber of the spray condenser, solidified for 3 to 5 minutes, and the bufagenin solid dispersion is obtained.

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Abstract

The invention relates to a bufotalin solid dispersoid and a preparation method thereof. The bufotalin solid dispersoid is obtained by mixing bufotalin, a hydrophilic carrier and a deposition inhibitorand processing a mixture through solid disperse preparation technology. A drug loading amount is 1-30%. The bufotalin solid dispersoid does not use an organic solvent, which is safe and efficient, the obtained bufotalin solid dispersoid can increase a dissolution rate of three components in the bufotalin, the drug loading mount is high, stability is good, the method provides a good intermediate for other oral solid preparations of the bufotalin, the preparation technology is simple, efficient, and safe, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a bufagenin solid dispersion and a preparation method thereof. Background technique [0002] Bufonis Venenum is derived from "Materia Medica Yanyi", which is a traditional Chinese medicine in my country. "The Pharmacopoeia of the People's Republic of China" (2015 Edition, Part One) clearly records that toad venom is the white serous gland secreted by the post-auricular glands and skin glands of Bufobufogargarzans Cantor or Bufomelanostictus Schneider, which is the source animal of Bufodaidae. Dried. Studies have shown that bufalin, cinobufagenin and bufabugenin are the three components with higher content and stronger activity in bufabugenin, which not only have anti-tumor effects, but also improve the body's immunity. Reduce the toxic and side effects of chemotherapy, reduce the incidence of cancer pain, and enhance the body's tolerance to radiotherapy and chemoth...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K9/16A61K31/585A61K47/38A61K47/32A61P35/00A61P37/04
CPCA61K9/1635A61K9/1652A61K9/19A61K31/585A61K47/32A61K47/38
Inventor 杨建宏左文宝侯延辉刘艳华李莉李治芳
Owner NINGXIA MEDICAL UNIV