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Heparin sodium tube sealing injection and preparation method thereof

A tube-locking injection and heparin sodium technology, which is applied in the field of heparin sodium tube-locking injection and its preparation, can solve the problems of interference of the test results of the injection, poor stability of the injection, and inability to use children, etc., so as to avoid local Effects of blood coagulation and blockage, reduction of local irritation and bleeding, and improvement of safety

Inactive Publication Date: 2013-07-10
范克
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And the conventional products in the market have the following defects: 1. Some products cannot be directly used for intravenous injection because they fail to meet the requirement of isotonicity, but must be diluted in normal saline injection before use; , can not be used for children; 3. Since its volume is only 2ml, the volume is insufficient when used to seal the intravenous indwelling needle; 4. The stability of the injection is not good
However, how to not only meet the requirements of low concentration and isotonicity, but also solve the problems of insufficient volume, poor stability of injection solution, pain and avoiding interference of the test results of injection solution when used for intravenous indwelling needle sealing, is the main task. The problem the invention is trying to solve

Method used

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  • Heparin sodium tube sealing injection and preparation method thereof
  • Heparin sodium tube sealing injection and preparation method thereof
  • Heparin sodium tube sealing injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Take 5 million units of heparin sodium, 1,250,000 mg of glucose, 50,000 mg of mannitol, 200,000 mg of sodium dihydrogen phosphate, and 300,000 mg of disodium hydrogen phosphate, dissolve them in an appropriate amount of water for injection, measure the pH value, and adjust it to 6 with a pH regulator such as NaOH or phosphoric acid if necessary. Between ~7, add water to 50000ml, filter with 0.1 micron microporous membrane, fill in ampoules, each 5ml or 10ml, seal. High-temperature sterilization at 115°C for 30 minutes, lamp inspection, and packaging to obtain 5ml: 500 units sealed tube injection. The accelerated test (40°C±2°C, RH=75%±5%) of this product and ordinary heparin sodium tube locking injection was compared, and the results showed that this product has better efficacy than ordinary heparin sodium locking injection stability. The specific test conditions are shown in the table below:

[0026] Stability comparison test results (1)

[0027]

Embodiment 2

[0029]Take 500,000 units of heparin sodium, 1,250,000 mg of glucose, 50,000 mg of mannitol, 200,000 mg of sodium dihydrogen phosphate, and 300,000 mg of disodium hydrogen phosphate, dissolve them in an appropriate amount of water for injection, measure the pH value, and adjust it to 6 with a pH regulator such as NaOH or phosphoric acid if necessary. Between ~7, add water to 50000ml, filter with a 0.05 micron microporous membrane, fill in ampoules, 5ml or 10ml each, and seal. High-temperature sterilization at 115°C for 30 minutes, light inspection, and packaging to obtain 5ml: 50 units sealed tube injection. The accelerated test (40°C±2°C, RH=75%±5%) of this product and ordinary heparin sodium tube locking injection was compared, and the results showed that this product has better efficacy than ordinary heparin sodium locking injection stability. The specific test conditions are shown in the table below:

[0030] Stability comparison test results (2)

[0031]

[0032] ...

Embodiment 3

[0034] Take 5 million units of heparin sodium, 1,250,000 mg of glucose, 50,000 mg of mannitol, 200,000 mg of sodium dihydrogen phosphate, and 300,000 mg of disodium hydrogen phosphate. In order to further reduce the pain of injection, 50,000 mg of lidocaine hydrochloride was dissolved in an appropriate amount of water for injection, and the pH value was measured. , if necessary, use NaOH or phosphoric acid and other pH regulators to adjust to between 6 and 7, add water to 50,000ml, filter with a 0.2 micron microporous membrane, fill in ampoules, 5ml or 10ml each, and seal. High-temperature sterilization at 115°C for 30 minutes, lamp inspection, and packaging to obtain 5ml: 500 units sealed tube injection. The accelerated test (40°C±2°C, RH=75%±5%) of this product and ordinary heparin sodium tube locking injection was compared, and the results showed that this product has better efficacy than ordinary heparin sodium locking injection stability. The specific test conditions are...

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Abstract

The invention provides heparin sodium tube sealing injection, comprising heparin sodium, glucose, mannitol, sodium dihydrogen phosphate, disodium hydrogen phosphate and the balance of water, wherein the tube sealing injection of which the volume is 5ml or 10ml, the osmotic pressure is 260-320 mOsmol / Kg, and the pH value is 6-7 is prepared. By adopting the isotonic injection with low concentration, large volume and stability disclosed by the invention, untoward effects such as local irritation and haemorrhage caused by injection are reduced; the local blood coagulation and tube jamming phenomena are avoided; the anaphylaxis which can be generated by heparin sodium is reduced; meanwhile, the stability of the injection is increased; the sterile level is higher; a plurality of defects in the prior art are solved; and the security of the heparin sodium injection is greatly improved.

Description

technical field [0001] The invention relates to a heparin sodium tube sealing injection and a preparation method thereof. Background technique [0002] Heparin sodium is derived from the small intestinal mucosa of pigs. It is an acidic mucopolysaccharide containing sulfate groups. It is a typical anticoagulant drug, which can prevent the coagulation process of blood and prevent the formation of thrombus. Because heparin sodium can inhibit the conversion of prothrombin into thrombin with the participation of a-globulin. Heparin sodium also has the functions of clarifying plasma lipids, lowering cholesterol and enhancing the effectiveness of anticancer drugs. It is widely used clinically to prevent thrombosis and embolism before and after surgery, to prevent blood coagulation during blood transfusion and as an anticoagulant for preserving fresh blood. Eliminate uremia caused by nephropathy in children. [0003] CN 1965856A discloses an injection solution suitable for intrav...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/727A61K47/26A61K47/04A61P7/02
Inventor 范克
Owner 范克
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