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Medicament composition for improving stability of Ulinastatin

A technology of ulinastatin and composition, applied in the field of pharmaceutical composition, capable of solving problems such as easy inactivation

Inactive 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

[0004] The purpose of the present invention is to overcome the problem that the existing ulinastatin freeze-dried powder is easily inactivated in clinical use, and provide a stable ulinastatin freeze-dried powder injection pharmaceutical composition, which has obvious stability of biological activity at room temperature improve

Method used

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  • Medicament composition for improving stability of Ulinastatin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1: the preparation of ulinastatin freeze-dried powder injection

[0024] Prescriptions 1-9 are as follows:

[0025]

Ulinastatin

(10,000 units) Mannitol

(g) Hydrolyzed Ming

Glue (g) Dextrose

Anhydride (g) Sodium chloride

(g) Ulinastatin: excipients (million

Unit: g) Prescription 1 10000 5 —— —— 0.05 10：0.005 Prescription 2 10000 5 5 —— 0.05 10：0.01 Prescription 3 10000 5 5 5 0.05 10：0.015 Prescription 4 10000 15 —— —— 0.1 10：0.015 Prescription 5 10000 15 10 —— 0.1 10：0.025 Prescription 6 10000 15 —— 10 0.1 10：0.025 Prescription 7 10000 15 10 5 0.09 10：0.03 Prescription 8 10000 15 10 10 0.08 10：0.035 Prescription 9 10000 0 0 0 0 10：0

[0026] Preparation:

[0027] (1) pH7.0 phosphate buffer preparation:

[0028] 0.2mol / L phosphate buffer solution, pH7.0, the preparation method is as follows:

[0029] Benchmark prepar...

Embodiment 2

[0039] Embodiment 2: Stability test of ulinastatin in glucose infusion

[0040] Take one 100,000 unit ulinastatin freeze-dried powder injection prepared according to the method of prescription 1-9 in Example 1, pour into 100 ml of 5% glucose isotonic solution, shake well, place at 25°C, and place at 2 and 4 respectively. , 8, 12, 16, and 24 hours (h) sampling and determination of activity residual rate, the results are as follows:

[0041] Table 1 The active residual rate (%) of ulinastatin prepared by prescription 1-10 in glucose infusion

[0042] |Sampling time (h) 0 2 4 8 12 16 24

[0043] Prescription 1 100 100 99.3 98.9 96.8 94.2 93.5 Prescription 2 100 100 99.1 97.5 93.5 92.8 90.0 Prescription 3 100 100 99.2 98.6 95.7 93.6 92.3 Prescription 4 100 100 100 100 99.9 99.8 99.4 Prescription 5 100 100 99.9 98.7 97.2 96.4 95.2 Prescription 6 100 100 99.9 98.6 96.9 95.7 94.2 Pr...

Embodiment 3

[0044] Example 3 Stability Test of Ulinastatin in Sodium Chloride Infusion

[0045] Take one 100,000 unit ulinastatin freeze-dried powder injection prepared according to the method of prescription 1-9 in Example 1, pour into 100 milliliters of 0.9% sodium chloride solution and shake well, place it at 25°C, and place it at 2 and 4 respectively. , 8, 12, 16, and 24 hours (h) sampling and determination of activity residual rate, the results are as follows:

[0046] Table 2 The active residual rate (%) of Ulinastatin prepared in Examples 1-4 in large sodium chloride infusions

[0047] Sampling time (h) 0 2 4 8 12 16 24 Prescription 1 100 99.8 98.6 96.8 94.6 92.7 91.8 Prescription 2 100 99.8 98.9 97.0 95.2 93.6 92.5 Prescription 3 100 99.8 98.9 97.5 95.6 94.7 93.6 Prescription 4 100 100 100 100 99.8 99.8 99.5 Prescription 5 100 100 99.9 98.9 97.6 95.9 94.2 Prescription 6 100 100 99.8 98.7 97.9 96...

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Abstract

The invention discloses a stable ulinastatin sterile injection powder pharmaceutical composition which contains an effective dose of ulinastatin and a pharmaceutical excipient, and the excipient is one or the combination of a plurality of kinds of mannitol, hydrolyzed gelatin, dextran and sodium chloride. The composition is generally used in the form of the freeze-dried sterile injection powder, when in clinical application, the composition is dissolved in glucose or physiological saline and other large infusions, and the composition can significantly reduce the decrease of the activity of the ulinastatin in water solution.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to the composition of ulinastatin and pharmaceutical auxiliary materials. Background technique [0002] Ulinastatin (Urlinary Trypsin Inhibitor, Ulinary Trypsin Inhibitor, UTI) is a glycoprotein extracted from the urine of healthy adult males, consisting of 143 amino acids, with alanine at the N-terminus and alanine at the C-terminus Leucine, there are sugar chains at the 10th serine and 45th aspartic acid. The O-glycosidic chain on serine contains multiple chondroitin sulfate units. The molecular weight of ulinastatin is 60-70KD as determined by HPLC, 40-50KD as determined by SDS-PAGE, and the isoelectric point is 2.6. It is a heat-stable acidic protein. [0003] Ulinastatin has inhibitory effects on trypsin, hyaluronidase, plasmin and other enzymes, and is often used clinically to treat acute pancreatitis. As a biologically active protein, the current problem of ulinastatin in us...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/57A61K47/02A61K47/10A61K47/36A61K47/42A61P1/18
Inventor 雷瑶郑少亮侯永敏
Owner GUANGDONG TECHPOOL BIO-PHARMA CO LTD
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