Sodium bicarbonate injection and preparation method thereof

A technology of sodium bicarbonate and injection, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc. It can solve the problems affecting visible foreign matter in finished products, reduce visible foreign matter and ensure stability Sexuality, the effect of reducing the chance of spawning

Active Publication Date: 2016-06-01
CHINA OTSUKA PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At the same time, there are traces of metal ions in the activated carbon, which will also affect the visible foreign matter of the finished product.

Method used

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  • Sodium bicarbonate injection and preparation method thereof
  • Sodium bicarbonate injection and preparation method thereof
  • Sodium bicarbonate injection and preparation method thereof

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preparation example Construction

[0015] In the preparation process of sodium bicarbonate injection of the present invention, the following several factors have been considered emphatically:

[0016] First, the investigation of the amount of EDTA

[0017] The complexing agents commonly used in injections are disodium edetate (EDTA) and calcium sodium edetate (CaEDTA). Due to the presence of CO in sodium bicarbonate injection, 3 2- Ions, adding calcium sodium edetate is easy to form calcium carbonate, so that the visible foreign matter does not meet the regulations. However, if the amount of EDTA in the prescription is too high, it will form a water-soluble chelate with calcium in the blood and bones, and be excreted, causing hypocalcemia or loss of bone calcium. Therefore, the pH value, visible foreign matter, etc. were used as indicators, and the amount of EDTA in the liquid medicine was investigated through influencing factors (high temperature 60°C). The test results are shown in Table 1.

[0018] Table ...

Embodiment 1

[0046] The preparation method of the sodium bicarbonate injection of the present invention comprises the following steps: First, inject water for injection with a total configuration amount of 30% to 40% into the blending tank, control the water temperature to 20 to 35°C, and fill the tank with CO 2 The gas is saturated; put sodium bicarbonate into the mixing tank filled with water for injection, stir to fully dissolve the added sodium bicarbonate; use 10% NaOH solution to adjust the pH value to 7.40~8.50; continue to put injection into the mixing tank Water, to the standard formulation, the temperature of the liquid should be controlled at 20~35°C during this process; stir the liquid medicine for 10 minutes to make the content of the liquid medicine uniform; sterilize and filter; fill, and get ready. A simple flow chart of the preparation process is shown in figure 1 shown. Among them, the sterile filtration adopts two-stage filtration, the pore size of the first-stage filte...

Embodiment 2

[0048] The preparation method of the sodium bicarbonate injection of the present invention comprises the following steps: First, inject water for injection with a total configuration amount of 30% to 40% into the blending tank, control the water temperature to 20 to 30°C, and charge CO2 gas to saturation; Put sodium bicarbonate into the mixing tank filled with water for injection and stir to fully dissolve the added sodium bicarbonate; use 10% NaOH solution to adjust the pH value to 7.40~8.00; continue to put water for injection into the mixing tank until the standard During this process, the temperature of the liquid should be controlled at 20-30°C; stir the liquid medicine for 10 minutes to make the content of the liquid medicine uniform; sterilize and filter; fill, and get ready. Among them, the sterile filtration adopts two-stage filtration, the pore size of the first stage filter is 0.22 μm; the pore size of the second stage filter is 0.22 μm; the temperature of the liquid...

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Abstract

The invention provides a sodium bicarbonate injection. The injection consists of sodium bicarbonate, a pH value regulating agent and injection water, wherein the pH value regulating agent comprises a sodium hydroxide solution and carbon dioxide gas. The preparation method comprises the following steps: injecting the injection water into a preparation tank, controlling the water temperature to be 20-35 DEG C, introducing CO2 gas until the solution is saturated; putting sodium bicarbonate, stirring to sufficiently dissolve the put sodium bicarbonate; regulating the pH value to be 7.40-8.5; keeping on injecting the injection water to the preparation tank to a standard proportion; stirring the liquid medicine for 10 minutes to enable the content of the liquid medicine to be uniform; sterilizing and filtering; filling. The sodium bicarbonate injection does not contain edetate disodium and sodium calcium edentate, so that blood calcium or bone calcium caused by addition of edetate disodium can be prevented; the pH value of the liquid medicine is controlled to be 7.4-8.50, so that the stability of the pH value of the liquid medicine in the sterilizing and storing processes can be guaranteed.

Description

technical field [0001] The invention belongs to the field of medicine preparation, and relates to a sodium bicarbonate injection and a preparation method thereof. Background technique [0002] Sodium bicarbonate injection is an electrolyte liquid that clinically regulates the acid-base balance in the body, and is the drug of choice for correcting acidosis. As one of the important clinical medicines for regulating acid-base balance among the 307 kinds of national essential medicines, it is a common emergency medicine in clinical practice. The existing sodium bicarbonate injection usually uses disodium edetate (EDTA-2Na) and calcium sodium edetate (CaEDTA) as complexing agents to complex Ca2+, Mg2+ and other metal ions in the liquid medicine. However, due to the presence of trace amounts of CO in sodium bicarbonate injection 3 2- Ions, adding calcium sodium edetate is easy to form calcium carbonate, so that the visible foreign matter does not meet the regulations. However,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K33/00A61K9/08A61K47/02A61K47/04A61P3/12
Inventor 于玥宋金隆夏焱
Owner CHINA OTSUKA PHARM CO LTD
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