Bear-ball total bound cholic acid injection, its production and usage
A bile acid injection and injection technology, applied in the preparation of the total bear bile combined bile acid injection, bear bile total combined bile acid injection field, can solve the problems of no reports, no research reports and publications, etc., to achieve preparation Good safety, the effect of treating cardiovascular and cerebrovascular diseases, and low production cost
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preparation example Construction
[0126] Preparation of reference substance solution Precisely weigh an appropriate amount of tauroursodeoxycholic acid, taurourchenodeoxycholic acid, taurocholic acid, and taurodeoxycholic acid reference substance, and add methanol to make each 1ml of tauroursodeoxycholic acid. Deoxycholic acid 0.1mg, taurochenodeoxycholic acid 0.1mg, taurocholic acid 0.003mg, taurodeoxycholic acid 0.003mg solution, ready to use.
[0127] Preparation of the test solution Take an appropriate amount of this product, accurately weigh it, add methanol to dissolve and dilute, and obtain.
[0128] Determination method Precisely draw 5 μl of the above-mentioned reference substance solution and 10 μl of the test solution, inject it into the liquid chromatograph, measure it, and obtain it.
Embodiment 1
[0130] Embodiment 1: the preparation of bear bile total bound bile acid extract
[0131] Get bear bile powder 1Kg, add 5 times of amount of water heating and dissolving, filter, get bear bile aqueous solution, pass through 30 liters of pretreated D 101 Macroporous adsorption resin column, add 60L of water to elute, discard the aqueous solution, continue to elute with 70% ethanol, collect the 70% ethanol eluate, recover ethanol under reduced pressure and concentrate to a relative density of about 1.08-1.12 (60°C ) clear paste, spray-dried to obtain 700g of bear bile total combined acid extract. Determined by high-performance liquid chromatography, the extract of total bound cholic acid of bear bile contains 89.4% of total bound cholic acid of bear bile, including 46.2% of tauroursodeoxycholic acid, 40.5% of taurochenodeoxycholic acid, taurine Sulfocholic acid 2.2%, taurodeoxycholic acid 0.5%.
Embodiment 2
[0132] Embodiment 2: Preparation of small volume bear bile total combined bile acid injection
[0133] Take 100g of bear bile total bound cholic acid extract (calculated as total bound cholic acid), add 5000ml of water for injection to dissolve, add 10g of sodium bisulfite, 10g of sodium citrate, heat to boil, add 5g of activated carbon, stir well, and boil After 30 minutes, filter, add water for injection to the filtrate to 10000ml, fine filter, pack in 10ml ampoules, make 1000 tubes, melt seal, sterilize, check clarity, pack, and get ready.
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