CN101843636B - Preparation process of non-PVC-soft-bag-packaged hemofiltration replacement liquid and product - Google Patents

Abstract

The invention provides a preparation process of non-PVC-soft-bag-packaged hemofiltration replacement liquid and a product. The preparation process is characterized by comprising the following steps: a. preparing medicine liquid: adding water for injection into a tank for high-concentration preparation, and then adding anhydrous glucose, and stirring to be dissolved; then adding 0.05% (W / V) of activated carbon, and holding at a temperature of 40 DEG C-70 DEG C, stirring and de-carbonizing for 30 minutes; removing carbon through titanium rod filtration, taking clear liquid to be put in a tank for dilution preparation, and adding the water for injection to the full amount, and evenly stirring; b. filling: filtering through a filter, bag-making and filling in a non-PVC soft plastic infusion bag with a double-pipe and double-valve structure, adding a stopper and sealing, wherein the reserving space of the soft infusion bag is 15% or above 200ml; c. sterilizing; and d. packaging. Enough liquid adding space is reserved, the double-pipe and double-valve structure can facilitate to add liquid so as to prevent the secondary pollution and facilitate the clinical flexible adjustment of prescriptions; and the non-PVC soft infusion bag does not contain plasticizers, adhesives and other substances harmful to the human body, and does not introduce new harmful substances.

Description

A kind of preparation technology of non-PVC-soft-bag-packaged hemofiltration replacement liquid and product

Technical field

The present invention relates to medical technical field, particularly a kind of preparation technology of non-PVC-soft-bag-packaged hemofiltration replacement liquid and product.

Background technology

Hemofiltration replacement liquid is that hemofiltration, hemodiafiltration reach the special use displacement medicine when continuing blood purification treatment, and the each property of patient use amount is bigger, and general each use amount is about 2000ml～4000ml.The filtration of blood purification technology usefulness is replaced types of drugs seldom clinically at present; Hospital is prepared by nurse's manual method mostly; And preparing one bag of displacement liquid, a nurse needs more than half a hour; One bag of displacement liquid but only can supply the patient to use one hour, also exists problems such as metering is inaccurate, pollution risk height.Along with country's strict day by day to drug control, hospital preparation need reach the GPP standard, seldom have hospital to possess the condition of preparation, and this hospital preparation is only in hospital, using.Though there are several families can produce the hemofiltration replacement liquid product in the market; But because patient's the concrete state of an illness is all inequality clinically; When accepting the hemofiltration treatment; Demand to different nutriments or ion elements is also different, and the basic recipe of hemofiltration replacement liquid can't satisfy clinical requirement, needs medical personnel's later stage on the basis of basic hemofiltration replacement liquid prescription, to add many other compositions.And traditional hemofiltration replacement liquid product does not have the bivalve design, no special dosing mouth, and it is less to add liquid space, can't meet the need of market.

Summary of the invention

The objective of the invention is problem to the prior art existence; The present invention provides a kind of preparation technology and product of non-PVC-soft-bag-packaged hemofiltration replacement liquid, has reserved enough liquid spaces that adds, and can make things convenient for liquid feeding; Stop secondary pollution, made things convenient for clinical flexible adjustment prescription; Aspect packaging material, harmful material such as plasticizer-containing and binding agent is not introduced new harmful substance.

The objective of the invention is to realize through following technical scheme: a kind of preparation technology of non-PVC-soft-bag-packaged hemofiltration replacement liquid is characterized in that:

A, raw material are by weight ratio:

Sodium chloride (NaCl) 0.5-6.0g

Calcium chloride (CaCl ₂2H ₂O) 0-0.50g

Magnesium chloride (MgCl ₂6H ₂O) 0.05-0.20g

Potassium chloride (KCl) 0-0.40g

Sodium lactate (C ₃H ₅NaO ₃) 0-5.0g

Sodium bicarbonate (NaHCO ₃) 0-5.0g

Glucose (C ₆H ₁₂O ₆H ₂O) 0.5-2.0g

Water for injection is an amount of

Full dose 1000ml

B, preparation technology

A. medicinal liquid preparation: add the water for injection of at least 60% recipe quantity in the dense preparing tank, add anhydrous glucose, calcium chloride, the magnesium chloride of at least 102.0% recipe quantity again, the potassium chloride and the sodium chloride of the sodium lactate solution of at least 104.0% recipe quantity and at least 100.0% recipe quantity; Stirring and dissolving; Add the active carbon of 0.05% (W/V) amount then, 40 ℃ of-70 ℃ of insulated and stirred were taken off charcoal at least 30 minutes, and the titanium rod filters carbon removal; Get clear liquid and add in dilute preparing tank and add to the full amount of water for injection, stir;

B. fill: filter through 10 μ m, 0.5 μ m and 0.22 μ m filter; Bag, fill are in the soft bag of non-PVC plastic infusion, and described non-PVC plastic infusion bag has two-tube, double-valve structure, jumps a queue; Seal, the transfusion flexible bag headspace is at least 15% or more than the 200ml;

C. sterilization: the hemofiltration replacement liquid that fill is good is put in the sterilization cabinet, and 110 ℃ of-125 ℃ of water-baths were sterilized 5 minutes-30 minutes;

D. lamp inspection adds external packaging, and vanning promptly gets.

Improvement to such scheme: described non-PVC plastic infusion bag is the co-extrusion film, with the form production of " double width film ".

A kind of non-PVC-soft-bag-packaged hemofiltration replacement liquid product is characterized in that:

A, raw material are by weight ratio:

Sodium chloride (NaCl) 0.5-6.0g

Calcium chloride (CaCl ₂2H ₂O) 0-0.50g

Magnesium chloride (MgCl ₂6H ₂O) 0.05-0.20g

Potassium chloride (KCl) 0-0.40g

Sodium lactate (C ₃H ₅NaO ₃) 0-5.0g

Sodium bicarbonate (NaHCO ₃) 0-5.0g

Glucose (C ₆H ₁₂O ₆H ₂O) 0.5-2.0g

Water for injection is an amount of

Full dose 1000ml

Product adopts non-PVC plastic infusion bag packing, and non-PVC plastic infusion bag has two-tube, double-valve structure.

The present invention compared with prior art has following advantage and good effect:

The present invention provides a kind of and makes things convenient for the special use of clinical blood purification techniques to filter the displacement liquid method for preparing; Use two-tube, bivalve is technological; Special dosing mouth is set, but has carried out the liquid adding type design studies, reserved enough liquid spaces that adds; Make things convenient for clinical flexible adjustment prescription, stopped secondary pollution; On packaged form, adopt present infusion solutions state-of-the-art non-PVC-soft-bag-packaged, harmful material such as plasticizer-containing and binding agent is not introduced new harmful substance.On quality control, through the pyrogen index in the endotoxin inspection technique control hemofiltration replacement liquid, have that sense cycle is short, highly sensitive, favorable reproducibility, easy and simple to handle, result and can draw advantage such as assay accurately and reliably at short notice.Not only time-consuming, its complex operation of traditional by contrast pyrogen test (rabbit method), requirement condition is high, and is subject to medicine pharmacology, toxicological effect interference.

The specific embodiment

The preparation technology's of a kind of non-PVC-soft-bag-packaged hemofiltration replacement liquid of the present invention embodiment:

A, raw material are by weight ratio:

Sodium chloride (NaCl) 0.5-6.0g

Calcium chloride (CaCl ₂2H ₂O) 0-0.50g

Magnesium chloride (MgCl ₂6H ₂O) 0.05-0.20g

Potassium chloride (KCl) 0-0.40g

Sodium lactate (C ₃H ₅NaO ₃) 0-5.0g

Sodium bicarbonate (NaHCO ₃) 0-5.0g

Glucose (C ₆H ₁₂O ₆H ₂O) 0.5-2.0g

Water for injection is an amount of

Full dose 1000ml

B, preparation technology

A. medicinal liquid preparation: add the water for injection of at least 60% recipe quantity in the dense preparing tank, add anhydrous glucose, calcium chloride, the magnesium chloride of at least 102.0% recipe quantity again, the potassium chloride and the sodium chloride of the sodium lactate solution of at least 104.0% recipe quantity and at least 100.0% recipe quantity; Stirring and dissolving; Add the active carbon of 0.05% (W/V) amount then, 40 ℃ of-70 ℃ of insulated and stirred were taken off charcoal at least 30 minutes, and the titanium rod filters carbon removal; Get clear liquid and add in dilute preparing tank and add to the full amount of water for injection, stir;

B. fill: filter through 10 μ m, 0.5 μ m and 0.22 μ m filter; Bag, fill are in the soft bag of non-PVC plastic infusion, and described non-PVC plastic infusion bag has two-tube, double-valve structure, jumps a queue; Seal, the transfusion flexible bag headspace is at least 15% or more than the 200ml.

C. sterilization: the hemofiltration replacement liquid that fill is good is put in the sterilization cabinet, and 110 ℃ of-125 ℃ of water-baths were sterilized 5 minutes-30 minutes.

D. lamp inspection adds external packaging, and vanning promptly gets.

The above-mentioned non-PVC plastic infusion bag of stating is the co-extrusion film, with the form production of " double width film ".

A kind of non-PVC-soft-bag-packaged hemofiltration replacement liquid product of the present invention embodiment:

A, raw material are by weight ratio:

Sodium chloride (NaCl) 0.5-6.0g

Calcium chloride (CaCl ₂2H ₂O) 0-0.50g

Magnesium chloride (MgCl ₂6H ₂O) 0.05-0.20g

Potassium chloride (KCl) 0-0.40g

Sodium lactate (C ₃H ₅NaO ₃) 0-5.0g

Sodium bicarbonate (NaHCO ₃) 0-5.0g

Glucose (C ₆H ₁₂O ₆H ₂O) 0.5-2.0g

Water for injection is an amount of

Full dose 1000ml

Product adopts non-PVC plastic infusion bag packing, and non-PVC plastic infusion bag has two-tube, double-valve structure.

On quality control, through the pyrogen index in the endotoxin inspection technique control hemofiltration replacement liquid, have that sense cycle is short, highly sensitive, favorable reproducibility, easy and simple to handle, result and can draw advantage such as assay accurately and reliably at short notice.

Certainly, above-mentioned explanation is not to be the restriction to invention, and the present invention also is not limited to above-mentioned giving an example, those skilled in the art, and the variation of in essential scope of the present invention, making, remodeling, interpolation or replacement also should belong to protection scope of the present invention.

Claims (2)

1. the preparation technology of a non-PVC-soft-bag-packaged hemofiltration replacement liquid is characterized in that:

A, raw material are by weight ratio:

B, preparation technology

A. medicinal liquid preparation: add the water for injection of at least 60% recipe quantity in the dense preparing tank, add anhydrous glucose, calcium chloride, the magnesium chloride of at least 102.0% recipe quantity again, the potassium chloride and the sodium chloride of the sodium lactate solution of at least 104.0% recipe quantity and at least 100.0% recipe quantity; Stirring and dissolving; Add mass volume ratio then and be 0.05% active carbon, 40 ℃ of-70 ℃ of insulated and stirred were taken off charcoal at least 30 minutes, and the titanium rod filters carbon removal; Get clear liquid and add in dilute preparing tank and add to the full amount of water for injection, stir;

B. fill: filter through 10 μ m, 0.5 μ m and 0.22 μ m filter; Bag, fill are in the soft bag of non-PVC plastic infusion, and described non-PVC plastic infusion bag has two-tube, double-valve structure, jumps a queue; Seal, the transfusion flexible bag headspace is at least 15% or more than the 200ml;

C. sterilization: the hemofiltration replacement liquid that fill is good is put in the sterilization cabinet, and 110 ℃ of-125 ℃ of water-baths were sterilized 5 minutes-30 minutes;

D. lamp inspection adds external packaging, and vanning promptly gets.

2. according to the preparation technology of the described non-PVC-soft-bag-packaged hemofiltration replacement liquid of claim 1, it is characterized in that: described non-PVC plastic infusion bag is the co-extrusion film, with the form production of " double width film ".