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Stable water injection medicament composition containing Ulinastatin

A technology of ulinastatin and composition, which is applied in the field of ulinastatin and a certain proportion of excipients, which can solve problems such as microbial contamination, affecting the treatment effect of patients, and reducing biological activity

Active Publication Date: 2009-05-27
GUANGDONG TECHPOOL BIO-PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Most of the ulinastatin currently used clinically is freeze-dried powder injection. If the preparation is too slow, it will easily lead to the reduction of biological activity and the possibility of microbial contamination, which will seriously affect the treatment effect of patients.
In particular, when ulinastatin is used for the treatment of acute organ failure, the time of administration is crucial. Waiting until the freeze-dried powder is dissolved and prepared may have delayed the best treatment time for the patient.

Method used

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  • Stable water injection medicament composition containing Ulinastatin
  • Stable water injection medicament composition containing Ulinastatin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1 Preparation of Ulinastatin Injection

[0023] The ulinastatin of the present invention can be prepared according to the preparation method disclosed in the patent "purified ulinastatin and its preparation method and pharmaceutical composition containing the ulinastatin" (ZL200610000200.2). Using fresh human urine as raw material, it is prepared through the following process steps:

[0024] a. Pump the urine into the stirring tank, adjust the pH to 4.5-6, add chitin for adsorption, elution with ammonium sulfate solution, suction filtration of the eluate, and the drained product is a crude Ulinastatin product;

[0025] b. After dissolving the crude Ulinastatin product with 2-3 times of water, filter, take the supernatant, adjust the pH to 6-7.5 and then precipitate with ethanol, dissolve the precipitate with water and filter, and apply the filtrate to an anion exchange column Elute with buffer containing 0.1-2mol / L NaCl and 0.1-0.5mol / L phosphate, and collect the el...

Embodiment 2

[0041] Example 2: Preparation of Ulinastatin Injection

[0042] The prescription 2-10 ratio is as follows:

[0043]

[0044] Prescription 2-10 Ulinastatin injection preparation method: according to the method described in Example 1.

Embodiment 3

[0045] Example 3 Stability test

[0046] Take one 100,000-unit ulinastatin injection prepared according to the prescription 1-10 method, and one 100,000-unit ulinastatin injection prepared according to the preparation method of Example 1 without excipients ; After being placed at 25°C for 2 years, use the following method to determine the activity of Ulinastatin, and calculate the residual activity of Ulinastatin according to the following formula:

[0047] Residual activity rate = activity after storage / activity before storage×100%

[0048] Ulinastatin activity determination method:

[0049] Preparation of standard solution Weigh an appropriate amount of ulinastatin standard, add 0.2mol / L triethanolamine buffer (take 29.8g of triethanolamine, add 900ml of water to dissolve, adjust pH to 7.8 with 4mol / L hydrochloric acid solution, add water to 1000ml , Shake well, and get it.) Make a solution containing 50 units per 1ml.

[0050] Preparation of the test solution: Weigh an appropri...

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PUM

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Abstract

The invention discloses a stable ulinastatin pharmaceutical composition which contains an effective dose of ulinastatin and a pharmaceutical excipient with a certain proportion. Wherein, the excipient can be one or more of mannitol, sodium chloride, sodium acetate and acetic acid, and the range of pH value is 4.2-6.0. The composition is generally used in the form of injection, when in clinical application, the composition can be directly used for intravenous infusion and the composition can significantly improve the problem that the activity of an ulinastatin freeze-dried sterile injection powder preparation is easy to decrease during the preparation.

Description

Technical field [0001] The invention relates to an aqueous injection pharmaceutical composition, in particular to a composition containing an effective dose of ulinastatin and a certain proportion of auxiliary materials. Background technique [0002] Ulinastatin (Ulinary Trypsin Inhibitor, UT I) is a glycoprotein extracted from the urine of healthy adult men. It consists of 143 amino acids, the N-terminus is alanine, and the C-terminus is Leucine has sugar chains at position 10 serine and aspartic acid at position 45. The O-glycoside chain on serine contains multiple chondroitin sulfate units. The molecular weight of Ulinastatin is 60-70KD by HPLC and 40-50KD by SDS-PAGE, and its isoelectric point is 2.6. It is an acidic protein that is stable to heat. [0003] Ulinastatin has inhibitory effects on trypsin, hyaluronidase, plasmin and other enzymes, and has obvious stabilizing effects on cell membranes and lysosomal membranes. It is often used clinically to treat acute pancreatiti...

Claims

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Application Information

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IPC IPC(8): A61K38/57A61K47/02A61K47/10A61K47/12A61P1/18A61P43/00
Inventor 雷瑶许文勤侯永敏
Owner GUANGDONG TECHPOOL BIO-PHARMA CO LTD
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