Sodium bialginate for injection and its preparation method
A technology for sodium alginate diester and injection, which is applied in the field of freeze-dried sodium alginate diester for injection, can solve the problems of instability in the shelf life, degradation of active ingredients, low bioavailability, etc., and achieves improvement of microcirculation. , stable performance, the effect of reducing blood viscosity
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Embodiment 1
[0158] The proportioning ratio of each raw material is:
[0159] Sodium alginate 200g
[0160] Sodium chloride 25 grams
[0161] 2000ml water for injection to make 1000 bottles
[0162] The preparation method is as follows: take 1600 ml of water for injection, adjust the pH value to 4.5 with 10% hydrochloric acid solution or 4% sodium hydroxide solution, add 25 grams of sodium chloride, and stir until completely dissolved; take sodium alginate diester 200 grams and 2 grams of activated carbon for needles were added to the above solution, stirred until completely dissolved, then added water for injection to 2000 milliliters, and the pH value was adjusted to 4.5 with a concentration of 10% hydrochloric acid solution or a concentration of 4% sodium hydroxide solution. After decarbonization, filter with a 0.45 μm microporous membrane and then filter with a 0.22 μm microporous membrane; bottle the obtained fine filtrate, half-stopper, and freeze-dry for 36 hours, of which: freezi...
Embodiment 2
[0165] The proportioning ratio of each raw material is:
[0166] Sodium alginate 100g
[0167] Mannitol 50g
[0168] 2000ml water for injection to make 1000 bottles
[0169] The preparation method is basically the same as in Example 1, freeze-drying for 37 hours, wherein: freezing temperature -40°C, freezing for 7 hours; first sublimation temperature from -40°C to 30°C, 20 hours; second sublimation temperature by 30°C -38°C, 10 hours.
Embodiment 3
[0171] The proportioning ratio of each raw material is:
[0172] Sodium alginate 25g
[0173] Dextran 40 200g
[0174] 2000ml water for injection to make 1000 bottles
[0175] The preparation method is basically the same as in Example 1, freeze-drying for 36 hours, wherein: freezing temperature -40°C, freezing for 6 hours; first sublimation temperature from -40°C to 30°C, 20 hours; second sublimation temperature from 30°C -38°C, 10 hours.
[0176] The sources and quality standards of the raw and auxiliary materials used in each embodiment are as follows:
[0177] Quality Standards for Sources of Raw and Excipient Materials Sodium Alginate Diester Sodium Alginate Dalian Aosen Pharmaceutical Factory Haibin Branch Standard issued by the Ministry of Health of China Part II Part IV Volume 1995 Sodium Chloride Weihai Asia Pacific Pharmaceutical Co., Ltd. Chinese Pharmacopoeia 2000 Edition Mannitol Jilin City Cornell Pharmaceutical Co., Ltd. Chinese Pharmacopoeia 2000 Edition Dex...
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