Preparation method for ulinastatin freeze-dried powder preparation

Abstract

The invention discloses a preparation method of an ulinastatin freeze-dried powder preparation, belonging to the field of pharmaceutical preparations. According a prescription for the ulinastatin freeze-dried powder preparation, every 1000 bottles of the ulinastatin freeze-dried powder preparation comprise 25,000,000 to 100,000,000 units of ulinastatin, 0-20 g of mannitol, 0-2 g of sodium chloride, 0-2 g of disodium hydrogen phosphate and 0-2 g of sodium dihydrogen phosphate. The preparation method for the ulinastatin freeze-dried powder preparation provided by the invention has the followingcharacteristics: preparation is implemented at room temperature, so the problem that industrial production temperature is low and difficult to control is overcome, and energy consumption is lowered; and a phosphate buffer solution is prepared at room temperature at first, and then the active ingredient ulinastatin is added, so the buffer solution has protective effect on the active ingredient ulinastatin. The ulinastatin freeze-dried powder preparation prepared by using the prescription and the preparation method provided by the invention is convenient for industrial production, reduces energyconsumption and can improve the stability of the active ingredient--an ulinastatin solution.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of ulinastatin freeze-dried powder preparation. Background technique [0002] Ulinastatin is a glycoprotein isolated and purified from human urine, which is also known as Human Urinary Trypsin Inhibitor. Ulinastatin has the following pharmacological activities: reducing the production and release of pro-inflammatory cytokines; regulating coagulation function, inhibiting hyperfibrinolysis, and protecting platelets; stabilizing lysosomal membranes and inhibiting the activity of various hydrolytic enzymes; immunomodulatory effects. Therefore, ulinastatin plays an important role in clinical anti-inflammation, organ protection, brain injury neuroprotection, and microcirculation improvement. Clinically, ulinastatin is often used in the treatment of acute pancreatitis, acute circulatory disturbance, and acute organ failure; organ protection during large a...

AI Technical Summary

Problems solved by technology

Although the reconstitution performance of the ulinastatin freeze-dried powder prepared by the prior art is excellent, there are still the following problems: 1. The pharmaceutical composition in the prior art can maintain relative Stable, but the chilled water is generally controlled at about 7-11°C in the industrial production process, and then lowering the temperature will consume a lot of energy, so it is difficult to control the product preparation environment, equipment, and water for injection at 2-4 in actual large-scale production 2. The mannitol, sodium chloride, disodium hydrogen phosphate and sodium dihydrogen phosphate in the prior art are prepared by adding in the liquid mixing barrel at the same time, and then adding ulinastatin, the mixed solution cannot Ulinastatin plays sufficient protection, affects the stability of active ingredient ulinastatin medicinal liquid; 3, adopts 2 mole / liter hydrochloric acid or 2 mole / liter sodium hydroxide solution to regulate step (1) obtained medicinal liquor in the prior art The pH value of A, the instant addition of a large concentration of pH regulator will affect the stability of the active ingredient ulinastatin liquid; 4, the existing technology uses activated carbon in the preparation process, which may lead to the risk of a small amount of activated carbon entering the drug and thus entering the blood of the human body

Images