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Sodium citrate injection for tube-enveloping and method for preparing the same

A technology of sodium citrate and injection, which is applied in the fields of beverage, food, and medicine. See High Concentration Sodium Citrate Products and other issues

Inactive Publication Date: 2008-01-30
SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0026] U.S. Medcomp also produces and supplies 46.7% sodium citrate injection (trade name: Tricitrasol ®, specification is 30ml), but it is not a formal drug approved by the FDA, and is limited to the separation of granulocytes in vitro, and is not used for indwelling catheter lock.
[0027] 2.4.2 Situation in China At present, there is no report on the clinical application of high-concentration sodium citrate as indwelling catheter lock in China, and there is no official market supply of high-concentration sodium citrate products in China.
[0032] Through literature search, so far, no relevant reports have been found on the in vitro model device for the study of catheter lock solution, new sodium citrate injection formulations, preparation methods, and new uses.

Method used

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  • Sodium citrate injection for tube-enveloping and method for preparing the same
  • Sodium citrate injection for tube-enveloping and method for preparing the same
  • Sodium citrate injection for tube-enveloping and method for preparing the same

Examples

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preparation example Construction

[0332] 1.4.1 Preparation of Plasma Take 9ml of fresh blood from the heart of New Zealand white rabbits, use 1ml of 3.28% sodium citrate solution for anticoagulation, mix and centrifuge (10min, 700r / min, 37℃), the supernatant is rich in platelets Plasma (PRP). The remaining liquid was centrifuged again (10min, 2000r / min, 37°C), and the supernatant was platelet-poor plasma (PPP).

[0333] 1.4.2 Preparation of Heparin Sodium Solution Take 1ml of heparin sodium injection and mix it with normal saline according to the half-dilution method to make 50mg / ml~1.5625mg / ml (125 units are equivalent to 1mg, that is, the specification of heparin sodium injection is 2ml:100mg ) 6 concentrations of heparin sodium solution.

[0334] 1.4.3 Determination of the maximum platelet aggregation rate PAG(M) With 200μl PRP plus 10μl different test drugs, pre-warm at 37°C for 5min, add 6μl ADP to induce, and measure the platelet aggregation rate.

[0335] 1.4.4 Determination of APTT, PT and TT, respectively...

Embodiment 1

[0467] Example 1. Preparation of Sodium Citrate Injection for Tube Sealing

[0468] According to the prescription, weigh the raw materials according to the weighing SOP; take an appropriate amount of hot water for injection, add sodium citrate and citric acid and stir to dissolve, add the water for injection to the full amount, stir well; plate and frame filter for decarbonization filtration, the filter material is Microporous filter membrane, pore size 1.2μm, 0.8μm; microporous filter disc for terminal filtration, filter material is microporous filter membrane, pore size 0.65μm; intermediate quality control content: content is 97.0%-103.0% of the labeled amount, pH value 6.8-7.5; Filling; check and seal; temperature 110℃, time 20 minutes, autoclave sterilization; put the ampoule before the clarity inspection of 2000-3000LX illumination, inspect it visually, perform according to the requirements of clarity inspection, light inspection The visual acuity of the personnel should be a...

Embodiment 2

[0469] Example 2. Clinical application of the sodium citrate injection for tube sealing 1

[0470]To study the effect of 47% sodium citrate solution on long-term indwelling catheter sealing in hemodialysis patients. Forty patients with uremic maintenance dialysis with long-term indwelling catheters were selected and randomly divided into citric acid test group with 20 cases and heparin control group with 20 cases. After each dialysis, the test group was sealed with 47% sodium citrate solution, and the control group was sealed with heparin sodium solution. Both of them were used continuously for 6 months. The patency of the catheter was recorded 6 months before and 6 months before the medication, and the catheter-related infections were observed. Happening. Before the medication and at the end of January, March, and June, the arterial and venous end-sealing fluids were drawn for bacterial culture. The electrolytes were measured before the patient's medication, and 2 weeks and 6 mon...

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Abstract

The present invention relates to a formula of the tube-sealing solution sodium citrate injection and the preparation method and the usage. The in vitro central venous catheter simulation device designed by the present invention has simple equipment, low cost and good simulation, which provides the test device for the in vitro screening of the tube-sealing solution for the pre-clinical studies of the tube-sealing solution. The screened tube-sealing solution has the dual-function of the prevention and treatment of the blood coagulation and anti-infection, the pharmacological effect is stronger, the efficacy is accurate, the nature is stable; furthermore, the present invention has safety, low toxicity, controllable quality, direct use and better effect, which can overcome the two difficulties of blood coagulation and infection in the sealing tube, avoid the adverse effects of antibiotics to the patients and have significant advantages compared with the similar products. In addition, the sources of the raw materials are rich, the preparation process is simple, the feasibility is strong, so the present invention is applicable to large-scale production and easy to popularize. The demand of the blood dialysis is increasing along with the increasing number of the patients with the medium and end-stage renal failure year by year; therefore the present invention can generate tremendous social and economic benefits in a short period.

Description

Technical field [0001] The invention relates to the technical fields of medicine, food and beverages, in particular to a formulation of a tube-sealing liquid and a preparation method and application thereof, and more specifically to a formulation of sodium citrate injection and a preparation method thereof And uses. Background technique [0002] (1) The application of anticoagulants in hemodialysis [0003] In the process of hemodialysis, blood is prone to coagulation when passing through the dialyzer, blood tube and central venous indwelling catheter, which often requires anticoagulation treatment. There are many methods for anticoagulation during hemodialysis to keep the pipeline unobstructed, such as: low-dose heparin method, low-molecular-weight heparin method, local heparin method for protamine neutralization heparin, saline flushing method without heparin, Prostacyclin anticoagulation method, recombinant hirudin anticoagulation method, etc. However, the above methods have t...

Claims

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Application Information

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IPC IPC(8): A61L31/16A61L33/04
Inventor 张纯叶朝阳樊蓉陈万生
Owner SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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