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A kind of 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: 2017-04-12
GUANGDONG TECHPOOL BIO-PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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 then affects its drug efficacy. effect
The present inventor discloses a pharmaceutical composition of ulinastatin powder injection in Chinese patent application CN101439180A, the pharmaceutical composition can remain relatively stable at 25°C, but the stability at higher temperatures is not ideal

Method used

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  • A kind of ulinastatin freeze-dried powder preparation and preparation method thereof
  • A kind of ulinastatin freeze-dried powder preparation and preparation method thereof
  • A kind of ulinastatin freeze-dried powder preparation and preparation method thereof

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Embodiment 1

[0042] Embodiment 1: A kind of ulinastatin freeze-dried powder preparation

[0043] The formula of the ulinastatin freeze-dried powder preparation is, per 1000 vials: 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 described ulinastatin freeze-dried powder preparation is:

[0045] ⑴. Weigh mannitol, sodium chloride, disodium hydrogen phosphate or sodium dihydrogen phosphate in the liquid mixing tank according to the dosage of the formula, stir with water for injection at a temperature of 2°C until dissolved; add medical activated carbon with an average particle size of 2 μm and stir After mixing, use a 0.45 μm filter membrane to filter decarburization twice, and keep the temperature at 2°C. This solution is the excipient solution; dissolve ulinastatin with water for injection at 2°C, and mix it with the above-mentioned excipient solution at 2°C. To obtain the...

Embodiment 2

[0055] Embodiment 2: a kind of ulinastatin freeze-dried powder preparation

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

[0057] The preparation method of described ulinastatin composition freeze-dried powder injection is:

[0058] ⑴. Weigh mannitol, sodium chloride, disodium hydrogen phosphate or sodium dihydrogen phosphate in the liquid mixing tank according to the dosage of the above formula, stir with water for injection at a temperature of 3°C until dissolved; add medical activated carbon with an average particle size of 4 μm After stirring and mixing, use a 0.45μm filter membrane to filter decarburization twice, and keep the temperature at 3°C. This solution is the excipient solution; dissolve ulinastatin with 3°C water for injection, and mix well with the above 3°C excip...

Embodiment 3

[0068] Embodiment 3: A kind of ulinastatin freeze-dried powder preparation

[0069] The formula of the ulinastatin freeze-dried powder preparation is, per 1000 vials: 100 million units of ulinastatin, 10 g of mannitol, 5 g of sodium chloride, 0.51 g of sodium dihydrogen phosphate, and 0.93 g of disodium hydrogen phosphate.

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

[0071] ⑴. Weigh mannitol, sodium chloride, disodium hydrogen phosphate or sodium dihydrogen phosphate in the liquid mixing tank according to the dosage of the above formula, stir with water for injection at a temperature of 4°C until dissolved; add medical activated carbon with an average particle size of 5 μm After stirring and mixing, use a 0.45μm filter membrane to filter decarburization twice, and keep the temperature at 4°C. This solution is the excipient solution; dissolve ulinastatin with 4°C water for injection, and mix well with the above 4°C excipient sol...

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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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Patent Type & Authority Patents(China)
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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