A kind of safflower injection, preparation method and content determination method
A technology for injection and safflower, applied in the field of medicine, can solve the problems that the content is not controlled, the method for the content of p-hydroxybenzoic acid in the safflower injection has not been reported, and the safety of drugs cannot be guaranteed.
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Embodiment 1
[0168] Embodiment 1 (preparation of safflower injection)
[0169] Take 500g of safflower medicinal material, soak in purified water at 80-90°C for three times, the first time for 30-60 minutes, the second time for 30-60 minutes, and the third time for 30-60 minutes, combine the decoction liquid, refrigerate overnight, filter, and once Stage filtration with 10μm membrane, secondary filtration with 0.05μm membrane, the filtrate is concentrated to a relative density of 1.1-1.3 at 50-60°C, add 90%-95% ethanol to make the alcohol content reach 70%, refrigerate, and stand still for 24-72 hours , filtered, the filtrate recovered ethanol and concentrated to a relative density of 1.1-1.3 at 50-60°C, added 10 times the amount of water, refrigerated, left to stand for 16-24 hours, filtered, the cation exchange resin removed potassium, and the filtrate was concentrated to 50-60 ℃600-800ml, add 0.1-0.5% activated carbon, stir at room temperature for 30 minutes, filter the carbon, adjust th...
Embodiment 2
[0170] Embodiment 2 (preparation of safflower injection)
[0171] Take 500g of safflower medicinal material, soak in purified water at 80-90°C for three times, the first time for 30-60 minutes, the second time for 30-60 minutes, and the third time for 30-60 minutes, combine the decoction liquid, refrigerate overnight, filter, and once Stage filtration with 10μm membrane, secondary filtration with 0.05μm membrane, the filtrate is concentrated to a relative density of 1.1-1.3 at 50-60°C, add 80%-90% ethanol to make the alcohol content reach 70%, refrigerate, and stand still for 24-72 hours , filtered, the filtrate recovers ethanol and concentrates to a relative density of 1.1-1.3 at 50-60°C, adds 8 times the amount of water, refrigerates, stands for 16-24 hours, filters, removes potassium from the cation exchange resin, and concentrates the filtrate to 50-60 ℃600-800ml, add 0.1-0.5% activated carbon, stir at room temperature for 30 minutes, filter the carbon, adjust the pH value...
Embodiment 3
[0172] Embodiment 3 (determination of p-hydroxybenzoic acid content)
[0173] Measured according to high performance liquid chromatography (Appendix VI D of Chinese Pharmacopoeia 2005 edition):
[0174] Step 1, preparation of reference substance solution: take an appropriate amount of p-hydroxybenzoic acid reference substance, accurately weigh it, and use 50% methanol to make a solution containing 30 µg per 1 ml, to obtain final product;
[0175] Step 2. Determination method: Precisely draw 10 μl each of the reference substance solution and this product respectively, inject it into a liquid chromatograph, measure it, and obtain it;
[0176] High performance liquid chromatography conditions:
[0177] Chromatographic column: Grace VisionHT C18 HL 5µm chromatographic column (column length is 250mm, inner diameter is 4.6mm); methanol-0.02% trifluoroacetic acid aqueous solution (5:95) is used as mobile phase; detection wavelength is 254nm; column temperature is 25°C ; The flow ra...
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