Sodium citrate injection for sealing tube and preparation method thereof

A sodium citrate and injection technology, applied in the fields of food, medicine, and beverages, can solve the problems of not being or not seeing high-concentration sodium citrate products, and not being used for indwelling catheters and sealing tubes.

Inactive Publication Date: 2011-12-21
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 , the specification is 30ml), but it is not an official drug approved by the FDA, it is limited to be used for in vitro granulocyte separation, 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 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 sealing tube and preparation method thereof
  • Sodium citrate injection for sealing tube and preparation method thereof
  • Sodium citrate injection for sealing tube and preparation method thereof

Examples

Experimental program
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preparation example Construction

[0336] 1.4.1 Preparation of plasma Take 9ml of fresh blood from the heart of New Zealand white rabbits, anticoagulate with 1ml of 3.28% sodium citrate solution, mix well and centrifuge (10min, 700r / min, 37℃), the supernatant is rich in platelets plasma (PRP). The remaining liquid was centrifuged again (10 min, 2000 r / min, 37° C.), and the supernatant was platelet-poor plasma (PPP).

[0337] 1.4.2 Preparation of Heparin Sodium Solution Take 1ml of Heparin Sodium Injection, and prepare 50mg / ml~1.5625mg / ml (125 units is equivalent to 1mg) with normal saline according to half-dilution method, that is, the specification of Heparin Sodium Injection is 2ml: 100mg ) 6 concentrations of heparin sodium solutions.

[0338] 1.4.3 Determination of maximum platelet aggregation rate PAG(M) Add 200 μl PRP and 10 μl different test drugs, pre-warm at 37°C for 5 minutes, add 6 μl ADP to induce platelet aggregation rate.

[0339] 1.4.4 Determination of APTT, PT and TT Add 100 μl of PPP and 10 μ...

Embodiment 1

[0471] Embodiment 1, the preparation of sodium citrate injection for sealing the tube

[0472] 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 water for injection to the full amount, and stir well; use a plate and frame filter for decarbonization, and the filter material is Microporous membrane, pore size 1.2μm, 0.8μm; microporous filter disc for terminal filtration, filter material is microporous 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 the seal; temperature 110 ℃, time 20 minutes, autoclaving; place the ampoule before the clarity test with an illuminance of 2000-3000LX, visual inspection, according to the clarity inspection requirements, light inspection The visual acuity of personnel should be above 5.0, without color b...

Embodiment 2

[0473] Embodiment 2, the clinical application of sodium citrate injection for sealing tube 1

[0474] To study the effect of 47% sodium citrate solution on long-term indwelling catheter lock in hemodialysis patients. Select 40 patients with uremia maintenance dialysis and long-term indwelling catheter, and randomly divide them into 20 cases of citric acid test group and 20 cases of heparin control group. After each dialysis, the test group was sealed with 47% sodium citrate solution, and the control group was sealed with heparin sodium solution. They were used continuously for 6 months. The patency of the catheter was recorded 6 months before and 6 months after the medication, and the catheter-related infection was observed. Condition. Before the medication and at the end of January, March and June, the arteriovenous and venous catheter sealing fluids were collected for bacterial culture. Determination of electrolytes in patients before medication, and after 2 weeks and 6 mo...

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Abstract

The invention relates to a formula of sodium citrate injection, a tube lock solution, a preparation method and an application thereof. The extracorporeal central venous intubation simulation device designed by the present invention has the advantages of simple equipment, low cost and good simulation performance, and provides an in vitro test device for screening the lock solution for preclinical research on the lock solution. The screened tube lock solution has dual functions of preventing blood coagulation and anti-infection. It has strong pharmacological effects, exact curative effect, stable properties, safety and low toxicity, and controllable quality. It is a big problem, avoiding the adverse effects of antibiotics on patients, and has significant advantages compared with similar products. Moreover, the source of raw materials is abundant, the preparation process is simple, the feasibility is strong, it is suitable for large-scale production, and it is easy to popularize and apply. As the number of patients with middle and end-stage renal failure increases year by year, the demand for hemodialysis will also increase accordingly. Therefore, the present invention can generate huge social and economic benefits in a relatively short period of time.

Description

technical field [0001] The present invention relates to the technical fields of medicine, food and beverage, in particular to a formula for locking tube solution and its preparation method and application, more specifically to a formula of sodium citrate injection and its preparation method and uses. Background technique [0002] (1) The application of anticoagulants in hemodialysis [0003] In the process of hemodialysis, blood is prone to coagulation when it passes through the dialyzer, blood line and central venous indwelling catheter, and anticoagulant treatment is often required. There are many methods for anticoagulation during hemodialysis to keep the pipeline unobstructed, such as: small-dose heparin method, low molecular weight heparin method, local heparin method in which protamine neutralizes heparin, heparin-free saline flushing method, Prostacyclin anticoagulant method, recombinant hirudin anticoagulant method, etc. However, the above methods have their own l...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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