Ulinastatin freeze-dried powder preparation and preparation method thereof

A technology of dry powder preparation and ulinastatin, which is applied in the field of ulinastatin freeze-dried powder preparation and its preparation, can solve problems such as unsatisfactory stability, affecting activity, affecting drug efficacy, etc., and achieve reconstitution performance and stability Excellent, prevents failure, and accelerates the drying rate

Active Publication Date: 2016-05-25
GUANGDONG TECHPOOL BIO-PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the object of ulinastatin to exert clinical effects is the human body. The normal body temperature of the human body is 36.2-37.2°C. The stability of ulinastatin in a temperature range similar to the normal body temperature of the human body directly affects its activity, and the

Method used

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  • Ulinastatin freeze-dried powder preparation and preparation method thereof
  • Ulinastatin freeze-dried powder preparation and preparation method thereof
  • Ulinastatin freeze-dried powder preparation and preparation method thereof

Examples

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Example Embodiment

[0042] Example 1: A lyophilized powder formulation of Ulinastatin

[0043] The formulation of the freeze-dried ulinastatin powder preparation is: per 1,000 sticks: 25 million units of ulinastatin, 1 g of mannitol, 0.17 g of sodium dihydrogen phosphate, and 0.32 g of disodium hydrogen phosphate.

[0044] The preparation method of the ulinastatin freeze-dried powder preparation is:

[0045] ⑴. Weigh out mannitol, sodium chloride, disodium hydrogen phosphate or sodium dihydrogen phosphate according to the dosage of the formula, and stir with water for injection at a temperature of 2°C until it dissolves; add medical activated carbon with an average particle size of 2μm and stir After mixing, use a 0.45μm filter membrane twice to filter and decarburize, and keep the temperature at 2°C. This solution is the excipient solution; dissolve Ulinastatin with 2°C water for injection and mix it with the above 2°C excipient solution. Obtain medicinal solution A, all medicinal solutions involved i...

Example Embodiment

[0055] Example 2: A lyophilized powder formulation of Ulinastatin

[0056] The formulation of the freeze-dried ulinastatin powder preparation is: per 1000 sticks: ulinastatin 50 million units, mannitol 5g, sodium chloride 1g, sodium dihydrogen phosphate 0.34g, and disodium hydrogen phosphate 0.64g.

[0057] The preparation method of the freeze-dried powder injection of the Ulinastatin composition is:

[0058] ⑴. Weigh out mannitol, sodium chloride, disodium hydrogen phosphate or sodium dihydrogen phosphate in the mixing tank according to the above formula and stir with water for injection at a temperature of 3℃ until dissolved; add medical activated carbon with an average particle size of 4μm After stirring and mixing, use a 0.45μm filter membrane twice to filter and decarburize, and keep the temperature at 3℃. This solution is the excipient solution; dissolve Ulinastatin with 3℃ water for injection and mix it with the above 3℃ excipient solution. , To obtain liquid medicine A, all ...

Example Embodiment

[0068] Example 3: A lyophilized powder formulation of Ulinastatin

[0069] The formulation of the freeze-dried ulinastatin powder preparation is: per 1,000 sticks: ulinastatin 100 million units, mannitol 10g, sodium chloride 5g, sodium dihydrogen phosphate 0.51g, and disodium hydrogen phosphate 0.93g.

[0070] The preparation method of the ulinastatin freeze-dried powder preparation is:

[0071] ⑴. Weigh out mannitol, sodium chloride, disodium hydrogen phosphate or sodium dihydrogen phosphate according to the dosage of the above formula, and stir with water for injection at 4℃ until dissolved; add medical activated carbon with an average particle size of 5μm After stirring and mixing, use a 0.45μm filter membrane twice to filter and decarburize, and keep the temperature at 4℃. This solution is the excipient solution; dissolve Ulinastatin with 4℃ water for injection and mix it with the above 4℃ excipient solution. , To obtain liquid medicine A, all liquid medicines involved in the fo...

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Abstract

The invention relates to an ulinastatin freeze-dried powder preparation and a preparation method thereof. Each 1,000 ulinastatin freeze-dried powder preparations are prepared from 25,000,000-100,000,000 units of ulinastatin, 1-30g of mannitol, 0-10g of sodium chloride, 0-5g of sodium hydrogen phosphate and 0-5g of sodium dihydrogen phosphate. The preparation method of the ulinastatin freeze-dried powder preparation provided by the invention has the characteristics that the ulinastatin and auxiliary materials are separately dissolved, and the active component ulinastatin is prepared when used; a freeze-dried former solution is prepared in a low-temperature environment of 2-4 DEG C, and the temperature range is kept in the overall configuration process, so that the stability of the ulinastatin is ensured; and a 'fast-slow-fast' three-step pre-freezing method is adopted in the freeze-drying pre-freezing process, so that the drying rate is improved, and the solubility is improved. The ulinastatin freeze-dried powder preparation prepared by the formula and the preparation method is relatively excellent in solubility and stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a ulinastatin freeze-dried powder preparation with excellent reconstitution performance and stability and a preparation method thereof. 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 ci...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/57A61P29/00A61P25/00A61P1/18
CPCA61K9/0019A61K9/19A61K38/57A61K47/02A61K47/10
Inventor 王旭郑少亮许文勤肖益热
Owner GUANGDONG TECHPOOL BIO-PHARMA CO LTD
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