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A technology of Domod sodium and injection, which is applied in the new field of medicine, can solve problems such as incomplete sterilization, product contamination, and hidden dangers of product safety, and achieve the effects of high solubility, high safety, and improved stability
Inactive Publication Date: 2009-04-22
BEIJING HOPE HUGE PHARM SCI
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In addition, the circulating steam sterilization temperature used in this invention is 100°C. This sterilization meth...
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[0029] Add 244.26g of pidotimod and 40.01g of sodium hydroxide to 3500ml of water for injection, stir to dissolve completely, add 4g of charcoal for needles, and continue stirring for 20 minutes, filter to decarburize, add water for injection to 4485.2ml, Sterilize by fine filtration, subpackage, 2ml / bottle, sterilize at 121°C for 20min, and make injection solution.
[0031] Add 244.26g of pidotimod and 40.01g of sodium hydroxide to 4000ml of water for injection, stir to dissolve completely, add 50g of sodium chloride and 4g of charcoal for needles, stir at 60°C for 20 minutes, filter for decarburization, and add injection Make up to 6106.5ml with water, sterilize by fine filtration, aliquot, 5ml / bottle, and sterilize at 121°C for 20min to make injection.
[0033] Take 244.26g of pidotimod and 40.01g of sodium hydroxide and add it to 2000ml of ethanol, stir to dissolve completely, filter, concentrate under reduced pressure to recover ethanol, evaporate to dryness, and obtain solid powder, which is pidotimod sodium.
[0034] Add the above-mentioned pidotimod sodium into 4000ml of water for injection, stir to dissolve completely, add 4g of charcoal for needles, stir for 20 minutes, filter for decarburization, add water for injection to 6100ml, filter and sterilize, subpackage, 5ml / tube, sterilized at 121°C for 20 minutes, and made into injection solution.
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Abstract
The invention discloses an injection containing Pidotimod sodium. Pidotimod and sodium hydroxide in equal mol are reacted in water or alcohol or mixed liquid of the water and the alcohol to generate the Pidotimod sodium, and then the Pidotimod sodium is prepared into the injection. The chemical name of the Pidotimod sodium is (R)-3-[(S)-(5-oxy-2-pyrrolidinyl) carbonyl]-thiazolidine-4-sodium carboxylate, the molecular formula is C9H11N2O4SNa, and the molecular weight is 266.28. The injection is characterized in that the active component Pidotimod in the injection exists in the form of Pidotimod sodium salt, and pH value of the solution is between 4 and 6. The injection can be prepared into transfusion solution for intravenous administration, and can be added into injection containing 5 percent glucose or 0.9 percent sodium chloride and into dissolvent crystallization subpackaged powder injection and frozen dried powder injection.
Description
technical field [0001] The invention belongs to the field of new medicine technology and relates to an injection containing pidotimod sodium. The injection is used for the treatment of ①recurrent upper and lower respiratory tract infections (pharyngitis, bronchitis, bronchitis, tonsillitis); ②recurrent ENT infections (rhinitis, sinusitis, otitis); ③urinary system infections; ④gynecological infections; ⑤ Clinical patients with low cellular immune function after chemotherapy; ⑥ Specific and non-specific immunodeficiency diseases such as cancer. It is used to reduce the number of acute attacks, shorten the course of the disease, and reduce the degree of attacks; it can also be used as an adjuvant treatment of antibiotics in acute infections. Specifically, it relates to the preparation and application of an injection containing pidotimod sodium. Background technique [0002] The immune system of the human body is like a well-trained elite force, defending the health of the hum...
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