CN101843636A - Preparation process of non-PVC-soft-bag-packaged hemofiltration replacement liquid and product - Google Patents
Preparation process of non-PVC-soft-bag-packaged hemofiltration replacement liquid and product Download PDFInfo
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- CN101843636A CN101843636A CN201010186223A CN201010186223A CN101843636A CN 101843636 A CN101843636 A CN 101843636A CN 201010186223 A CN201010186223 A CN 201010186223A CN 201010186223 A CN201010186223 A CN 201010186223A CN 101843636 A CN101843636 A CN 101843636A
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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
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 displacement types of drugs that present blood purification technology is clinically used seldom, 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 use one hour for the patient, also existed 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 for using in hospital.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, the basic recipe of hemofiltration replacement liquid can't satisfy clinical requirement, needs medical personnel's later stage to add many other compositions on the basis of basic hemofiltration replacement liquid prescription.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 at the prior art existence, the invention provides a kind of preparation technology and product of non-PVC-soft-bag-packaged hemofiltration replacement liquid, reserved enough liquid spaces that adds, 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 be achieved through the following technical solutions: 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: the water for injection that adds at least 60% recipe quantity in the dense preparing tank, the anhydrous glucose, calcium chloride, the magnesium chloride that add at least 102.0% recipe quantity again, the potassium chloride of the sodium lactate solution of at least 104.0% recipe quantity and at least 100.0% recipe quantity and sodium chloride, 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, vanning, promptly.
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 invention provides a kind of special use filtration displacement liquid preparation method that makes things convenient for the clinical blood purification techniques, use two-tube, bivalve technology, special dosing mouth is set, but carried out the liquid adding type design studies, enough liquid spaces that adds have been reserved, 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, by 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), the requirement condition height, and be 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: the water for injection that adds at least 60% recipe quantity in the dense preparing tank, the anhydrous glucose, calcium chloride, the magnesium chloride that add at least 102.0% recipe quantity again, the potassium chloride of the sodium lactate solution of at least 104.0% recipe quantity and at least 100.0% recipe quantity and sodium chloride, 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, vanning, promptly.
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, by 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 restriction to invention, the present invention also be not limited to above-mentioned for example, those skilled in the art, the variation of making in essential scope of the present invention, remodeling, interpolation or replacement also should belong to protection scope of the present invention.
Claims (3)
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:
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: the water for injection that adds at least 60% recipe quantity in the dense preparing tank, the anhydrous glucose, calcium chloride, the magnesium chloride that add at least 102.0% recipe quantity again, the potassium chloride of the sodium lactate solution of at least 104.0% recipe quantity and at least 100.0% recipe quantity and sodium chloride, 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, vanning, promptly.
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 ".
3. 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101862233A CN101843636B (en) | 2010-05-31 | 2010-05-31 | Preparation process of non-PVC-soft-bag-packaged hemofiltration replacement liquid and product |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101862233A CN101843636B (en) | 2010-05-31 | 2010-05-31 | Preparation process of non-PVC-soft-bag-packaged hemofiltration replacement liquid and product |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101843636A true CN101843636A (en) | 2010-09-29 |
| CN101843636B CN101843636B (en) | 2012-07-04 |
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|---|---|---|---|
| CN2010101862233A Active CN101843636B (en) | 2010-05-31 | 2010-05-31 | Preparation process of non-PVC-soft-bag-packaged hemofiltration replacement liquid and product |
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|---|---|
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104622894A (en) * | 2014-12-19 | 2015-05-20 | 周飞虎 | Blood purifying displacement liquid |
| CN107890568A (en) * | 2017-10-31 | 2018-04-10 | 华仁药业股份有限公司 | The hemofiltration replacement liquid and its preparation technology of a kind of less harmful |
-
2010
- 2010-05-31 CN CN2010101862233A patent/CN101843636B/en active Active
Non-Patent Citations (4)
| Title |
|---|
| 《国家食品药品监督管理局国家药品标准》 20041222 国家食品药品监督管理局药品注册司 "血液滤过置换液" 1-3 , 2 * |
| 《塑料包装》 20071231 未知 "行业信息" 第61－63页 2 第17卷, 第5期 2 * |
| 《泰山医学院学报》 20071231 谷红霞等 "血液滤过置换液的两种配制方法" 第62－63页 1-3 第28卷, 第1期 2 * |
| 《现代中西医结合杂志》 20081231 冯雅琳 "非PVC软袋双管双塞输液包装的先进性、合理性" 第3496－3497页 1-3 第17卷, 第22期 2 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104622894A (en) * | 2014-12-19 | 2015-05-20 | 周飞虎 | Blood purifying displacement liquid |
| CN107890568A (en) * | 2017-10-31 | 2018-04-10 | 华仁药业股份有限公司 | The hemofiltration replacement liquid and its preparation technology of a kind of less harmful |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101843636B (en) | 2012-07-04 |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C56 | Change in the name or address of the patentee |
Owner name: HUAREN PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME: HUAREN PHARMACEUTICAL CO., LTD., QINGDAO |
|
| CP03 | Change of name, title or address |
Address after: 266101 No. 187, Zhuzhou Road, hi tech park, Shandong, Qingdao Patentee after: Huaren Pharmaceutical Co., Ltd. Address before: 266101 Zhuzhou Road, Laoshan District, Shandong hi tech park, No. 187, No. Patentee before: Huaren Pharmaceutical Co., Ltd., Qingdao |