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Ulinastatin injection and preparation method for same

A technology for ulinastatin and injection, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., can solve problems such as microbial contamination, activity reduction, etc. , high stability, the effect of reducing production costs

Active Publication Date: 2016-05-04
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, most of the ulinastatin preparations currently used clinically are powder injections, and the preparation process takes a certain amount of time, during which there is a possibility of reduced activity and microbial contamination

Method used

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  • Ulinastatin injection and preparation method for same
  • Ulinastatin injection and preparation method for same
  • Ulinastatin injection and preparation method for same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1: a kind of ulinastatin injection

[0036] The formula is as follows: per 1000 sticks

[0037]

[0038] Preparation method:

[0039]⑴. Excipient solution preparation: Weigh mannitol, disodium hydrogen phosphate and sodium dihydrogen phosphate according to the formula, add water for injection with a total volume of 450mL and a temperature of 2°C, stir until dissolved, add 1g and stir at 2°C for 20min for adsorption After treatment, use a 0.45 μm filter membrane to filter and decarburize to obtain an excipient solution, and keep the temperature of the solution at 2°C;

[0040] ⑵. Weigh ulinastatin according to the dosage of the formula, and add the excipient solution and ulinastatin obtained in step 1 into the liquid preparation tank in sequence, and stir until completely dissolved to obtain medicinal solution A, and keep the temperature of the medicinal solution at 2°C ;

[0041] (3) Use 3M hydrochloric acid or sodium hydroxide solution to adjust the pH...

Embodiment 2

[0045] Embodiment 2: a kind of ulinastatin injection

[0046] The prescription ratio is as follows: per 1000 sticks

[0047]

[0048] Preparation method:

[0049] ⑴. Excipient solution preparation: weigh mannitol, sodium chloride, disodium hydrogen phosphate and sodium dihydrogen phosphate according to the formula, add water for injection with a total volume of 750mL and a temperature of 3°C, stir until dissolved, add 2g at 3°C Stir under low pressure for 18 minutes after adsorption treatment, use a 0.45 μm filter membrane to filter and decarburize to obtain an excipient solution, and keep the temperature of the solution at 3°C;

[0050] ⑵. Weigh ulinastatin according to the dosage of the formula, and add the auxiliary material solution and ulinastatin obtained in step 1 into the liquid mixing tank in sequence, and stir until completely dissolved to obtain medicinal solution A, and keep the temperature of the medicinal solution at 3°C ;

[0051] (3) Use 3M hydrochloric a...

Embodiment 3

[0055] Embodiment 3: a kind of ulinastatin injection

[0056] The prescription ratio is as follows: per 1000 sticks

[0057]

[0058] Preparation method:

[0059] ⑴. Excipient solution preparation: Weigh mannitol, sodium chloride, disodium hydrogen phosphate and sodium dihydrogen phosphate according to the formula, add water for injection with a total volume of 850mL and a temperature of 3°C, stir until dissolved, add 3g at 3°C Stir under low pressure for 16 minutes after adsorption treatment, use a 0.45 μm filter membrane to filter and decarburize to obtain an excipient solution, and keep the temperature of the solution at 3°C;

[0060] ⑵. Weigh ulinastatin according to the dosage of the formula, and add the auxiliary material solution and ulinastatin obtained in step 1 into the liquid mixing tank in sequence, and stir until completely dissolved to obtain medicinal solution A, and keep the temperature of the medicinal solution at 3°C ;

[0061] (3) Use 3M hydrochloric a...

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Abstract

The invention relates to ulinastatin injection and a preparation method for the same. A formula of every 1,000 tubes of ulinastatin injection comprises 2,500 to 10,000 million units of ulinastatin, 1 to 30 grams of mannitol, 0 to 10 grams of sodium chloride, 0 to 5 grams of sodium hydrogen phosphate, 0 to 5 grams of monosodium phosphate and water for injection. The preparation method for the ulinastatin injection comprises the following steps of preparing an auxiliary solution of 2 to 4 DEG C, adding 1 to 5 grams of activated carbon with an average particle size of 6 to 9 microns to perform low-temperature adsorption treatment on the prepared auxiliary solution for 12 to 20 minutes at 2 to 4 DEG C, and dissolving ulinastatin with the treated auxiliary solution. The ulinastatin injection prepared by the preparation method according to the formula is relatively lower in adverse reaction rate and relatively higher in stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a ulinastatin injection and a preparation method thereof. Background technique [0002] Ulinastatin is a glycoprotein isolated and purified from human urine. Its essence is a trypsin inhibitor, so it is also called Human Urinary Trypsin Inhibitor. The existence of this trypsin inhibitor in human urine was first reported by Beurer and Reich et al. in 1909. Ulinastatin is composed of 143 amino acid residues, with a relative molecular weight of 60-70KD and an isoelectric point of 2.6. It is an acidic protein. Ulinastatin mainly has three functional domains: O-glycosidic bond-linked glycosylation region (Ala1-Lys21), N-terminal Kunitz-type domain I (Lys22-Arg77) and C-terminal Kunitz-type structure with trypsin inhibitory activity Domain II (Thr78-Leu143). The two Kunitz-type domains have certain homology, and each domain contains 6 conserved cysteines, which...

Claims

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Application Information

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IPC IPC(8): A61K38/57A61K9/08A61K47/26A61K47/02A61K47/24A61P1/18A61P29/00A61P37/02
CPCA61K9/0019A61K9/08A61K38/57A61K47/02A61K47/24A61K47/26
Inventor 王旭郑少亮许文勤肖益热
Owner GUANGDONG TECHPOOL BIO-PHARMA CO LTD
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