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Emodin freeze-dried powder and preparation method thereof

A technology for freeze-dried powder injection and emodin, applied in the field of freeze-dried powder injection of emodin and its preparation, can solve the problems of slow absorption, delayed treatment timing, patient loss and the like

Inactive Publication Date: 2014-06-04
QINGDAO BAICAOHUI INST OF CHINESE HERBAL MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because emodin is insoluble in water, the oral bioavailability is low, usually 20% to 30%, with large individual differences
In addition, when some acute and severe patients are treated, the absorption rate of oral administration is slow, which often delays the timing of treatment and causes unnecessary losses to patients.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Dosing: Weigh 500.00g of emodin, put it in a container, add 100g of mannitol, 10g of sodium bisulfite, 0.5g of EDTA-2Na, add water to dissolve, adjust the pH to 10.5 with sodium hydroxide solution, add water to 10000ml , stir evenly;

[0015] Filtration and packaging: filter with 0.22μ microporous membrane, and pack the filtrate into 2.0 ml per bottle; freeze-drying: cool down at a rate of 5°C per minute until the temperature of the product drops to -40°C, and maintain for 3 hours; start vacuuming , control the vacuum degree at 100±50μbas, control the product temperature at -20℃, and maintain it for 15 hours; then, gradually increase the temperature to 20℃, control the vacuum degree at 200±50μbas, after reaching 20℃, continue to maintain it for 3 hours, and vacuum plug , that is.

Embodiment 2

[0017] Dosing: Weigh 100.00g of 2-hydroxypropyl-β-cyclodextrin, add water to dissolve it, weigh 100.00g of emodin, put it in the above solution, and stir evenly; then add 400g of lactose and 3.0g of sodium thiosulfate , EDTA-2Na0.5g, stir to dissolve, adjust pH to 9 with sodium hydroxide solution, add water to 10000ml, stir evenly; filter and pack: use 0.22μ microporous filter membrane to filter, filtrate is divided into 1.0 ml per bottle ;Freeze-drying: Cool down at a rate of 5°C per minute until the product cools to -40°C and maintain for 3 hours; start vacuuming, control the vacuum at 100±50μbas, control the product temperature at -20°C, and maintain for 15 hours; then , gradually raise the temperature to 20°C, control the degree of vacuum at 200±50μbas, after reaching 20°C, continue to maintain it for 3 hours, and vacuum stopper.

Embodiment 3

[0019] Dosing: Weigh 50.00g of 2-hydroxypropyl-β-cyclodextrin, add water to dissolve, weigh 100.00g of emodin, put it in the above solution, and stir well; then add mannitol 400g, sodium thiosulfate 5.0 g, EDTA-2Na0.5g, stir to dissolve, adjust the pH to 9.5 with sodium hydroxide solution, add water to 10000ml, and stir evenly; filter and pack: use 0.22μ microporous filter membrane to filter, and divide the filtrate into 2.0 ml each Packing; freeze-drying: cool down at a rate of 5°C per minute until the product cools to -40°C, and maintain for 3 hours; start vacuuming, control the vacuum degree at 100±50μbas, and control the product temperature at -20°C, and maintain for 15 hours; Then, gradually raise the temperature to 20°C, control the degree of vacuum at 200±50μbas, after reaching 20°C, continue to maintain it for 3 hours, and vacuum stopper to obtain the product.

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PUM

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Abstract

The invention provides emodin freeze-dried powder which is characterized by comprising a pH regulator, a solubilizer or a combination of the pH regulator and the solubilizer.

Description

[0001] Summary [0002] The invention provides emodin freeze-dried powder, which is characterized in that it contains a pH regulator, a solubilizer or a combination thereof. technical field [0003] The invention relates to a freeze-dried powder injection and a preparation method thereof, in particular to a freeze-dried powder injection of emodin and a preparation method thereof. Background technique [0004] Emodin is the dry rhizome and root of Polygonum cuspidatum, almost insoluble in water, soluble in ethanol and alkaline solution. Emodin has the effects of anti-tumor, anti-microbial growth, immunosuppression, antispasmodic and cough-relieving, antihypertensive and diuretic effects. However, because emodin is insoluble in water, the oral bioavailability is low, usually 20% to 30%, with large individual differences. In addition, during the treatment of some acute and severe patients, the absorption rate of oral administration is relatively slow, which often delays the t...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/122A61P7/10A61P9/12A61P11/14A61P35/00A61P37/06
Inventor 毕玉轩
Owner QINGDAO BAICAOHUI INST OF CHINESE HERBAL MEDICINE