Stable potassium sodium dehydroandroan drographolide succinate compound and pharmaceutical composition thereof
A compound, the technology of Yanhuning, applied in the field of Yanhuning compound and its preparation, can solve problems such as more than 0.2%, and achieve the effects of long storage time, strong stability and low impurity content
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[0040] Example 1:
[0041] Add 300ml of 95% ethanol to a 1000ml round bottom flask, add 100g of andrographolate into the reaction flask, stir to obtain a white suspension, add 5% sodium bicarbonate aqueous solution dropwise at room temperature and normal pressure, and replace with nitrogen during the dropping process The air in the reaction flask was stirred and reacted until it became clear, and a yellow solution was obtained. The solution was placed in a refrigerator at 4 degrees for 12 hours to precipitate crystals. 88.5g of crystals were obtained by filtration. The crystals were added to 700ml of a 2:1 mixed solution of ethyl acetate and ethanol, and 35g was added. Activated carbon was heated and refluxed for 2 hours. After cooling, it was placed in a 4 degree refrigerator for 12 hours to precipitate crystals. The crystals were obtained after filtration. The recrystallization step was repeated. After filtration, it was washed and dried with water to obtain 79.2 g of white crys...
Example Embodiment
[0042] Example 2
[0043] 100g of Yanhuning pure product obtained in Example 1
[0044] Sodium bisulfite 10g
[0045] Edetate disodium 5g
[0046] PEG-400 50g
[0047] Disodium hydrogen phosphate-sodium dihydrogen phosphate buffer 10L
[0048] The preparation method is as follows:
[0049] Take 100g of Yanhuning, mix and grind with PEG-400, dissolve the ground material of Yanhuning and PEG-400 with 8000ml of prepared disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution with a pH of 6.5, and add 0.5% Activated carbon, heated to 80°C and maintained for 15 minutes, filtered to remove the carbon, then added sodium bisulfite, disodium edetate, stirred to dissolve, add disodium hydrogen phosphate-sodium dihydrogen phosphate buffer to 10000ml, add 0.5% Activated carbon, boil, finely filter with 0.45μm microporous membrane, and use 0.20μm microporous membrane for sterilization filtration, canning, sterilization, and labeling, ready to be obtained.
Example Embodiment
[0050] Example 3
[0051] Yanhuning 100g
[0052] Sodium bisulfite 10g
[0053] Edetate disodium 5g
[0054] PEG-400 50g
[0055] Disodium hydrogen phosphate-sodium dihydrogen phosphate buffer 10L
[0056] The preparation method is as follows:
[0057] Take 100g of Yanhuning, mix and grind with PEG-400, dissolve the ground material of Yanhuning and PEG-400 with 8000ml of prepared disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution with a pH of 6.5, and add 0.5% Activated carbon, heated to 80°C and maintained for 15 minutes, filtered to remove the carbon, then added sodium bisulfite, disodium edetate, stirred to dissolve, add disodium hydrogen phosphate-sodium dihydrogen phosphate buffer to 10000ml, add 0.5% Activated carbon, boiled, finely filtered with 0.45μm microporous membrane, and sterilized and filtered with 0.20μm microporous membrane, canned, semi-sealed, placed in a freeze-drying box, lyophilized, sealed, and labeled , Package is available.
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