Polyoxyethylene-660-12-hydroxy stearate containing mulberry ginger cold injection preparation and preparation method thereof
A polyethylene glycol lauryl hydroxystearate and injection preparation technology, which is applied in the field of Sangjiang Ganmao injection preparation and its preparation, can solve the problems of increased impurity content, a small amount of precipitation, and solution turbidity, so as to achieve high solubilization ability and improve Safety, the effect of avoiding adverse reactions
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Embodiment 1
[0024] Example 1 (the dosage of HS15 is 0.3g / 100ml)
[0025] Mulberry leaves 150g Chrysanthemum 20g,
[0026] Perilla 80g Forsythia 80g,
[0027] Bitter almond 80g Dried ginger 50g
[0028] Benzyl alcohol 10ml HS15 3g
[0029] Take 150g of mulberry leaves, 20g of chrysanthemum, 80g of perilla, 80g of forsythia, 80g of bitter almond, and 50g of dried ginger. The above six flavors are decocted twice with water, the first time is 2 hours, the second time is 1 hour, the decoction is combined, filtered, and the filtrate is concentrated to 100ml. Add ethanol so that the alcohol content is 60%, 70%, and 80% respectively, stand still, filter, recover ethanol, dissolve the residue in water and boil for 10 minutes, add an appropriate amount of activated carbon, filter, add water to 900ml, add benzyl alcohol 10ml, use 4% sodium hydroxide solution to adjust the pH value to 7.5, adjust to isotonicity with sodium chloride, let it stand for 48 hours, filter, add 3gHS15, boil, filter, ad...
Embodiment 1
[0036] Embodiment 1 and comparative example 1 safety contrast
[0037] Safety judgment basis: according to different prescription products of the present invention ( Embodiment 1 and comparative example 1 ) and the difference and degree of immune response produced by different prescription products and the difference and degree of hemolysis in animals to compare their safety.
[0038] Results: Both the immune response and the hemolytic reaction produced in Example 1 were lower than those in Control Example 1.
[0039] Conclusion: The safety of the Sangjiang Ganmao injection preparation of the present invention (using polyethylene glycol lauryl hydroxystearate as a solubilizer) is obviously better than that of the current commercially available Sangjiang Ganmao drug injection preparation (using polysorbate 80 as a solubilizer). Solubilizers). It can be expected that in the future clinical application, the occurrence of adverse reactions such as allergy and hemolysis caused...
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