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Diammonium glycyrrhizinate freeze drying powder for injection and its prepn

A technology of diammonium glycyrrhizinate and freeze-dried powder injection, which is applied in the field of medicine, can solve problems such as inconvenient storage and transportation of medicines, hypernatremia, diabetes and hyperglycemia, and achieve convenient storage and transportation, prolong storage period, improve The effect of stability

Inactive Publication Date: 2004-09-08
肖广常 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the dosage forms of diammonium glycyrrhizinate that have been listed in China include diammonium glycyrrhizinate injection, diammonium glycyrrhizinate glucose injection, and diammonium glycyrrhizinate sodium chloride injection. Diammonium Glycyrrhizinate Glucose Injection is likely to cause hyperglycemia due to its water and sodium retention.
In addition, water injection and infusion bring inconvenience to the storage and transportation of medicines.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1: Diammonium glycyrrhizinate freeze-dried powder for injection, the components are as follows, all in weight percentage:

[0028] Diammonium Glycyrrhizinate 25%

[0029] Anhydrous Sodium Sulfite 25%

[0030] Mannitol 50%

[0031] The preparation method is as follows:

[0032] Take 50g of diammonium glycyrrhizinate raw material, 50g of anhydrous sodium sulfite, add 1.5L of water for injection, stir to dissolve, add 100g of mannitol, stir to dissolve, then adjust the pH value to 5.6 with 1mol / L NaOH solution, add water for injection to 2L, and stir well. Add 0.03% charcoal for needles, stir at room temperature for 30 minutes, filter with a titanium filter stick to decarbonize, and filter through a double-layer 0.22μm microporous sterile filter. After the filtrate is divided into 2ml each, put it in a vacuum freeze dryer , cool down to -35°C, freeze for 2 hours, turn on the vacuum pump, turn off the vacuum freeze dryer, naturally raise the tem...

Embodiment 2

[0033] Embodiment 2: Diammonium glycyrrhizinate freeze-dried powder for injection, the components are as follows, all in percent by weight:

[0034] Diammonium Glycyrrhizinate 50%

[0035] Anhydrous Sodium Bisulfite 50%

[0036] The preparation method is as follows:

[0037] Take 50g of diammonium glycyrrhizinate raw material, 50g of anhydrous sodium sulfite, add 1.5L of water for injection, stir and dissolve, then adjust the pH value to 6 with 1moL / L NaOH solution, add water for injection to 2L, and stir well. Add 0.03% charcoal for needles, stir at room temperature for 30 minutes, filter and decarbonize with a titanium filter stick, filter through a double-layer 0.15μm microporous sterile filter, divide the filtrate into 2ml each, and put it in a vacuum freeze dryer , lower the temperature to -40°C, freeze for 4 hours, turn on the vacuum pump, turn off the vacuum freeze dryer, naturally raise the temperature to 40°C, continue vacuuming for 12 hours, control the t...

Embodiment 3

[0038] Embodiment 3: Diammonium glycyrrhizinate freeze-dried powder for injection, the components are as follows, all in percent by weight:

[0039] Diammonium Glycyrrhizinate 25%

[0040] Hydroxypropyl-beta-cyclodextrin 75%

[0041] The preparation method is as follows:

[0042] Take 150g of diammonium glycyrrhizinate raw material, 750g of hydroxypropyl-β-cyclodextrin, add 3L of water for injection, stir and dissolve, then adjust the pH value to 6.2 with 1mol / L NaOH solution, add water for injection to 4L, and stir well. Add 0.03% charcoal for needles, stir at room temperature for 30 minutes, filter with a titanium filter stick to decarbonize, filter through a double-layer 0.22μm microporous sterile filter, divide the filtrate into 6ml each, and put it in a vacuum freeze dryer , lower the temperature to -40°C, freeze for 3 hours, turn on the vacuum pump, turn off the vacuum freeze dryer, naturally raise the temperature to 35°C, continue vacuuming for 13 hours, con...

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PUM

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Abstract

The present invention relates to medicine technology. The diammonium glycyrrhizinate freeze drying powder for injection includes the following components: diammonium glycyrrhizinate 10-100 wt%, solabilizer 0-90 wt% and excipient 0-80 wt%. Its preparation process includes dissolving the above said components, regulating pH value, filtering, packing and freeze drying. The medicine is used clinically in intravenous dripping for treating chronic organizing hepatitis accompanied with raised glutamic pyruvic transaminase and chronic mobile hepatitis. It has stable quality, long storage period and fast dissolution in water, and may be matched with glucose injection and / or sodium chloride injection clinically.

Description

(1) Technical field [0001] The invention relates to diammonium glycyrrhizinate freeze-dried powder injection and a preparation method thereof, belonging to the technical field of medicine. (2) Background technology [0002] Licorice, as a traditional Chinese medicine, has a history of thousands of years in my country. Since it was first reported in 1964 that licorice can treat ulcers, many scholars at home and abroad have devoted themselves to the research of the active ingredients and mechanism of action of licorice. With the development of science and technology, new theories and new technologies are constantly emerging, and the research on glycyrrhizic acid extract and its derivatives is also deepening. [0003] The first and second generation products that have been identified, extracted and clinically applied as effective monomers in licorice are Glycyrrhizin Tablets and Qianglining Injection. [0004] At this stage, it has been confirmed that the main active substance...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/56A61P1/16A61P31/12
Inventor 肖广常张颖
Owner 肖广常
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