CN103446181B - A kind of preparation technology of peritoneal dialysis solution of physiological pH value - Google Patents
A kind of preparation technology of peritoneal dialysis solution of physiological pH value Download PDFInfo
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Abstract
The invention provides a kind of preparation technology of peritoneal dialysis solution of physiological pH value, comprise preparation of raw material and preparation technology, be characterized in: preparation technology is: in preparation container, add fresh water for injection, drop into the glucose of recipe quantity, sodium chloride, calcium chloride, magnesium chloride and magnesium chloride, after stirring and dissolving, adding adds to the full amount of water for injection makes A liquid, fresh water for injection is added in another preparation container, drop into sodium lactate, after stirring and dissolving, adding adds to the full amount of water for injection makes B liquid; After stirring, A liquid, B liquid add pH value regulator respectively, regulate medicinal liquid to suitable pH value, after pre-filtering and end-filtration, by A liquid, B liquid with the volume ratio of 1:1, fill is in two Room of double-chamber transfusion bag respectively, jump a queue, water-bath sterilization, obtains LG catabolite, has the peritoneal dialysis solution of physiological pH value after sterilizing, make A liquid, the mixed pH value of B liquid reaches 6.8 ~ 7.4.
Description
Technical field
The invention belongs to medical art, relating to the peritoneal dialysis solution being suitable for Renal Failure Patients and using, is a kind of preparation technology of peritoneal dialysis solution of physiological pH value specifically.
Background technology
Peritoneal dialysis treats the method for End-stage renal disease (end stage renal disease, ESRD) as one, and due to easy and simple to handle, can reduce blood borne disease and propagate, the special benefits such as protection residual renal function, are widely used.First successful peritoneal dialysis solution depends on the good peritoneum of function.Factors all can cause the damage of this natural semipermeable membrane, as relatively bad in peritonitis, peritoneal dialysis solution biocompatibility, abdominal cavity uses various medicines etc. all can cause peritoneum generation pathological change, comprise permeability changes, ultrafiltration failure, defence capability reduction, easily cause infection, fibrosis etc. occurs, finally cause dialysis insufficient, have to abandon this kind for the treatment of.
Along with updating of peritoneal dialysis technology, incidence of peritonitis declines gradually.And the poor biocompatibility of peritoneal dialysis solution, caused peritoneal fibrosis and ultrafiltration failure, become the major issue be badly in need of at present and must solved.Traditional peritoneal dialysis solution take glucose as penetrating agent, lactate is buffer agent, although low price, can form glucose degradation products in heating process, has the bio-incompatibility of high glucose catabolite, low pH value.
The formation of VEGF and peritoneum new vessels, will cause the exhaustion of peritoneum ultrafiltration function, Change of Peritoneal Permeability increase and peritoneal fibrosis.The glucose degradation products of low concentration, can cause the increase of vascular endothelial cell growth factor, further response to oxidative stress occur.The glucose of high concentration says hydrolysis products, can cause the increase of peritoneum vessel area, infringement peritoneum blood vessel and peritoneum interstitial.
Therefore, life-time service conventional peritoneal dialysis liquid, has obvious cytotoxic effect to Peritoneal Mesothelial Cells, and cause peritoneal fibrosis and ultrafiltration failure, this has become the one of the main reasons that patient exits peritoneal dialysis solution treatment.
PH value condition residing for traditional peritoneal dialysis solution is 5.0 ~ 6.5, and in autoclaving process, glucose degradation products significantly increases.And the pH value of dialysis solution is on the low side, do not reach abdominal cavity at physiological ph about 7.35.
Because existing peritoneal dialysis solution exists above-mentioned many problem and shortage, therefore, by selecting new composition in peritoneal dialysis solution, study rational formula, by improving manner of packing, production technology, make novel peritoneal dialysis liquid product have stable physiological pH value, LG catabolite, this is current the art technical problem urgently to be resolved hurrily.
Summary of the invention
The present invention is for solving prior art Problems existing, a kind of preparation technology of peritoneal dialysis solution of physiological pH value is provided, by selecting new composition in peritoneal dialysis solution, and filter out rational formula, study rational formula, by improving manner of packing, production technology, peritoneal dialysis liquid product is made to have stable physiological pH value and LG catabolite.
The object of the invention is to be achieved through the following technical solutions: a kind of preparation technology of peritoneal dialysis solution of physiological pH value, comprises preparation of raw material and preparation technology, it is characterized in that,
Described preparation of raw material is by weight ratio:
A liquid:
Calcium concentration is 1.25-1.75mmol/L
Anhydrous glucose 27.2-77.2g
Sodium chloride 10.76g
Calcium chloride 0.366-0.514g
Magnesium chloride 0.1016g
Water for injection is appropriate
Full dose 1000ml
B liquid:
Sodium lactate 8.96g
Water for injection is appropriate
Full dose 1000ml
Described preparation technology is:
Fresh water for injection is added in preparation container, drop into glucose, sodium chloride, calcium chloride, the magnesium chloride of recipe quantity, after stirring and dissolving, adding adds to the full amount of water for injection makes A liquid, fresh water for injection is added in another preparation container, drop into sodium lactate, after stirring and dissolving, adding adds to the full amount of water for injection makes B liquid; After stirring, A liquid, B liquid add pH value regulator respectively, regulate medicinal liquid to suitable pH value, after pre-filtering and end-filtration, by A liquid, B liquid with the volume ratio of 1:1, fill is in two Room of double-chamber transfusion bag respectively, jump a queue, water-bath sterilization, obtains LG catabolite, has the peritoneal dialysis solution of physiological pH value after sterilizing, make A liquid, the mixed pH value of B liquid is 6.8 ~ 7.4.
Improvement to technique scheme: when preparation A liquid and B liquid, the water for injection that first adds to be temperature be 40 DEG C ~ 80 DEG C, the fresh water for injection of 60% ~ 80% recipe quantity in preparation container, after dropping into raw material stirring dissolving, adding temperature is that the water for injection of 40 DEG C ~ 80 DEG C is to full dose.
Further improvement to technique scheme: it is dilute hydrochloric acid that A liquid adds pH value regulator, regulates solution ph 2.8 ~ 3.2; It is sodium bicarbonate and sodium hydroxide that B liquid adds pH value regulator, and after first adding 2 ~ 6mmol/L sodium bicarbonate, hydro-oxidation sodium solution is adjusted to pH value 7.8 ~ 9.5.
Further improvement to technique scheme: connect the saturating drainage system of single use abdomen after jumping a queue, described water-bath sterilization is 115 DEG C ~ 125 DEG C water-bath sterilizations 8 ~ 30 minutes.
Preferably, the anhydrous glucose in described A liquid preparation of raw material selects 27.2g, 45.4g or 77.2g, and described calcium chloride is 0.366g, and described calcium concentration is 1.25mmol/L.
Preferably, the anhydrous glucose in described A liquid preparation of raw material selects 27.2g, 45.4g or 77.2g, and described calcium chloride is 0.514g, and described calcium concentration is 1.75mmol/L.
Preferably, described A liquid, the mixed pH value of B liquid are 7 ~ 7.2.
The present invention compared with prior art tool has the following advantages and good effect:
Peritoneal dialysis solution prepared by the present invention has the feature of physiological pH value, LG catabolite, and comparatively conventional peritoneal dialysis liquid has better biocompatibility.With conventional peritoneal dialysis liquid phase ratio, this product can improve Peritoneal Mesothelial Cells biologic activity, reduce the local formation of advanced glycation end products and deposition, delay the generation of peritoneal fibrosis and alleviate local inflammatory response etc.By the protection to peritoneal membrane function, improve the service life of patient's peritoneum, extend the peritoneal dialysis treatment time.In addition, physiological pH value can alleviate patient's discomfort in use, increases the compliance of patient.
Dialysis solution in the present invention is compared with traditional dialysis solution, and basic prescription is unchanged, increase only the consumption of pH value regulator, and adopts two room bag fill.As the substitute products of conventional peritoneal dialysis liquid, cost increases little, but effectively can improve the problem of conventional peritoneal dialysis liquid high glucose catabolite, non-physiologic pH value, in product up-gradation, have positive social meaning.
Detailed description of the invention
The detailed description of the invention of the preparation technology of the peritoneal dialysis solution of a kind of physiological pH value of the present invention, comprises preparation of raw material and preparation technology, it is characterized in that,
Described preparation of raw material is by weight ratio:
A liquid:
Calcium concentration is 1.25-1.75mmol/L
Anhydrous glucose 27.2-77.2g
Sodium chloride 10.76g
Calcium chloride 0.366-0.514g
Magnesium chloride 0.1016g
Water for injection is appropriate
Full dose 1000ml
B liquid:
Sodium lactate 8.96g
Water for injection is appropriate
Full dose 1000ml
Described preparation technology is:
Fresh water for injection is added in preparation container, drop into glucose, sodium chloride, calcium chloride, magnesium chloride, after stirring and dissolving, adding adds to the full amount of water for injection makes A liquid, fresh water for injection is added in another preparation container, drop into sodium lactate, after stirring and dissolving, adding adds to the full amount of water for injection makes B liquid.After stirring, A liquid, B liquid add pH value regulator respectively, regulate medicinal liquid to suitable pH value, after pre-filtering and end-filtration, by A liquid, the fill of B liquid difference in double-chamber transfusion bag, jump a queue, water-bath sterilization, obtains LG catabolite, has the peritoneal dialysis solution of physiological pH value after sterilizing.
Embodiment 1
The specific embodiment of the preparation technology of the peritoneal dialysis solution of a kind of physiological pH value of the present invention, comprise preparation of raw material and preparation technology, described preparation of raw material is by weight ratio:
A liquid:
Calcium concentration is 1.25mmol/L
Anhydrous glucose 27.2g
Sodium chloride 10.76g
Calcium chloride 0.366g
Magnesium chloride 0.1016g
Water for injection is appropriate
Full dose 1000ml
B liquid:
Sodium lactate 8.96g
Water for injection is appropriate
Full dose 1000ml
Described preparation technology is:
In preparation container, add that temperature is 40 DEG C, the fresh water for injection of 60% recipe quantity, glucose, sodium chloride, calcium chloride, magnesium chloride (A liquid) or sodium lactate (B liquid) is dropped into by recipe quantity, after stirring and dissolving, add temperature be 40 DEG C of waters for injection to full dose, stir.After stirring, A liquid adds dilute hydrochloric acid and regulates solution ph 3.0; After B liquid adds 6mmol/L sodium bicarbonate, hydro-oxidation sodium solution is adjusted to pH value 8.7, after pre-filtering and end-filtration, A liquid and B liquid are to be about the volume ratio of 1:1, and fill is in two Room of double-chamber transfusion bag respectively, jump a queue, the saturating drainage system of single use abdomen is connected, pack, sealing) after jumping a queue, 115 DEG C of water-bath sterilizations 30 minutes, after sterilizing, namely obtain the peritoneal dialysis solution that LG is said hydrolysis products, had physiological pH value.
Embodiment 2:
The specific embodiment of the preparation technology of the peritoneal dialysis solution of a kind of physiological pH value of the present invention, comprise preparation of raw material and preparation technology, described preparation of raw material is by weight ratio:
A liquid:
Calcium concentration is 1.25mmol/L
Anhydrous glucose 45.4g
Sodium chloride 10.76g
Calcium chloride 0.366g
Magnesium chloride 0.1016g
Water for injection is appropriate
Full dose 1000ml
B liquid:
Sodium lactate 8.96g
Water for injection is appropriate
Full dose 1000ml
Described preparation technology is:
In preparation container, add that temperature is 60 DEG C, the fresh water for injection of 70% recipe quantity, glucose, sodium chloride, calcium chloride, magnesium chloride (A liquid) or sodium lactate (B liquid) is dropped into by recipe quantity, after stirring and dissolving, add temperature be 60 DEG C of waters for injection to full dose, stir.After stirring, A liquid adds dilute hydrochloric acid and regulates solution ph 3.0; After B liquid adds 5mmol/L sodium bicarbonate, hydro-oxidation sodium solution is adjusted to pH value 8.8, after pre-filtering and end-filtration, A liquid and B liquid are to be about the volume ratio of 1:1, fill is in two Room of double-chamber transfusion bag respectively, jump a queue 121 DEG C of water-bath sterilizations 15 minutes, after sterilizing, namely obtain the peritoneal dialysis solution that LG is said hydrolysis products, had physiological pH value.
Embodiment 3:
The specific embodiment of the preparation technology of the peritoneal dialysis solution of a kind of physiological pH value of the present invention, comprise preparation of raw material and preparation technology, described preparation of raw material is by weight ratio:
A liquid:
Calcium concentration is 1.25mmol/L
Anhydrous glucose 77.2g
Sodium chloride 10.76g
Calcium chloride 0.366g
Magnesium chloride 0.1016g
Water for injection is appropriate
Full dose 1000ml
B liquid:
Sodium lactate 8.96g
Water for injection is appropriate
Full dose 1000ml
Described preparation technology is:
In preparation container, add that temperature is 80 DEG C, the fresh water for injection of 80% recipe quantity, glucose, sodium chloride, calcium chloride, magnesium chloride (A liquid) or sodium lactate (B liquid) is dropped into by recipe quantity, after stirring and dissolving, add temperature be 80 DEG C of waters for injection to full dose, stir.After stirring, A liquid adds dilute hydrochloric acid and regulates solution ph 3.1; After B liquid adds 4mmol/L sodium bicarbonate, hydro-oxidation sodium solution is adjusted to pH value 8.9, after pre-filtering and end-filtration, A liquid and B liquid are to be about the volume ratio of 1:1, and fill is in two Room of double-chamber transfusion bag respectively, jump a queue, the saturating drainage system of single use abdomen is connected, pack, sealing after jumping a queue, 121 DEG C of water-bath sterilizations 8 minutes, after sterilizing, namely obtain the peritoneal dialysis solution that LG is said hydrolysis products, had physiological pH value.
Embodiment 4:
The specific embodiment of the preparation technology of the peritoneal dialysis solution of a kind of physiological pH value of the present invention, comprise preparation of raw material and preparation technology, described preparation of raw material is by weight ratio:
A liquid:
Calcium concentration is 1.75mmol/L
Anhydrous glucose 27.2g
Sodium chloride 10.76g
Calcium chloride 0.514g
Magnesium chloride 0.1016g
Water for injection is appropriate
Full dose 1000ml
B liquid:
Sodium lactate 8.96g
Water for injection is appropriate
Full dose 1000ml
Described preparation technology is:
In preparation container, add that temperature is 50 DEG C, the fresh water for injection of 80% recipe quantity, glucose, sodium chloride, calcium chloride, magnesium chloride (A liquid) or sodium lactate (B liquid) is dropped into by recipe quantity, after stirring and dissolving, add temperature be 50 DEG C of waters for injection to full dose, stir.After stirring, A liquid adds dilute hydrochloric acid and regulates solution ph 3.2; After B liquid adds 3.5mmol/L sodium bicarbonate, hydro-oxidation sodium solution is adjusted to pH value 9.3, after pre-filtering and end-filtration, A liquid and B liquid are to be about the volume ratio of 1:1, fill is in two Room of double-chamber transfusion bag respectively, jump a queue 115 DEG C of water-bath sterilizations 30 minutes, after sterilizing, namely obtain the peritoneal dialysis solution that LG is said hydrolysis products, had physiological pH value.
Embodiment 5:
The specific embodiment of the preparation technology of the peritoneal dialysis solution of a kind of physiological pH value of the present invention, comprise preparation of raw material and preparation technology, described preparation of raw material is by weight ratio:
A liquid:
Calcium concentration is 1.75mmol/L
Anhydrous glucose 45.4g
Sodium chloride 10.76g
Calcium chloride 0.514g
Magnesium chloride 0.1016g
Water for injection is appropriate
Full dose 1000ml
B liquid:
Sodium lactate 8.96g
Water for injection is appropriate
Full dose 1000ml
Described preparation technology is:
In preparation container, add that temperature is 60 DEG C, the fresh water for injection of 60% recipe quantity, glucose, sodium chloride, calcium chloride, magnesium chloride (A liquid) or sodium lactate (B liquid) is dropped into by recipe quantity, after stirring and dissolving, add temperature be 60 DEG C of waters for injection to full dose, stir.After stirring, A liquid adds dilute hydrochloric acid and regulates solution ph 3.2; After B liquid adds 2mmol/L sodium bicarbonate, hydro-oxidation sodium solution is adjusted to pH value 9.5, after pre-filtering and end-filtration, A liquid and B liquid are to be about the volume ratio of 1:1, and fill is in two Room of double-chamber transfusion bag respectively, jump a queue, the saturating drainage system of single use abdomen is connected, pack, sealing after jumping a queue, 121 DEG C of water-bath sterilizations 15 minutes, after sterilizing, namely obtain the peritoneal dialysis solution that LG is said hydrolysis products, had physiological pH value.
Embodiment 6:
The specific embodiment of the preparation technology of the peritoneal dialysis solution of a kind of physiological pH value of the present invention, comprise preparation of raw material and preparation technology, described preparation of raw material is by weight ratio:
A liquid:
Calcium concentration is 1.75mmol/L
Anhydrous glucose 77.2g
Sodium chloride 10.76g
Calcium chloride 0.514g
Magnesium chloride 0.1016g
Water for injection is appropriate
Full dose 1000ml
B liquid:
Sodium lactate 8.96g
Water for injection is appropriate
Full dose 1000ml
Described preparation technology is:
In preparation container, add that temperature is 70 DEG C, the fresh water for injection of 80% recipe quantity, glucose, sodium chloride, calcium chloride, magnesium chloride (A liquid) or sodium lactate (B liquid) is dropped into by recipe quantity, after stirring and dissolving, add temperature be 60 DEG C of waters for injection to full dose, stir.After stirring, A liquid adds dilute hydrochloric acid and regulates solution ph 2.9; After B liquid adds 4mmol/L sodium bicarbonate, hydro-oxidation sodium solution is adjusted to pH value 8.7, after pre-filtering and end-filtration, A liquid and B liquid are to be about the volume ratio of 1:1, and fill is in two Room of double-chamber transfusion bag respectively, jump a queue, the saturating drainage system of single use abdomen is connected, pack, sealing after jumping a queue, 121 DEG C of water-bath sterilizations 8 minutes, after sterilizing, namely obtain the peritoneal dialysis solution that LG is said hydrolysis products, had physiological pH value.
The control of product quality of the present invention: pH value is pressed Chinese Pharmacopoeia version in 2010 two annex VI H A and checked, traditional peritoneal dialysis solution pH value should be 4.5 ~ 6.5, the pH value of the peritoneal dialysis solution mixed liquor in the present invention should be 6.8 ~ 7.4, and preferably, the pH value of A liquid, B liquid mixed liquor is 7 ~ 7.2.
The use of product of the present invention: after product is preheated to body temperature, opens outsourcing, is opened by the rosin joint in the bag of two rooms, rocks medicinal fluid bag, makes A liquid wherein, B liquid mix homogeneously.The medicinal liquid of mix homogeneously is poured in abdominal cavity, dialyses, after dialysis terminates, discharge dialysis solution.
Certainly, above-mentioned explanation is not the restriction to invention, and the present invention is also not limited to above-mentioned citing, those skilled in the art, the change made in essential scope of the present invention, remodeling, interpolation or replacement, also should belong to protection scope of the present invention.
Claims (5)
1. a preparation technology for the peritoneal dialysis solution of physiological pH value, comprises preparation of raw material and preparation technology, it is characterized in that, described preparation of raw material is by weight ratio:
A liquid:
Calcium concentration is 1.25-1.75mmol/L
Anhydrous glucose 27.2-77.2g
Sodium chloride 10.76g
Calcium chloride 0.366-0.514g
Magnesium chloride 0.1016g
Water for injection is appropriate
Full dose 1000ml
B liquid:
Sodium lactate 8.96g
Water for injection is appropriate
Full dose 1000ml
Described preparation technology is:
Fresh water for injection is added in preparation container, drop into glucose, sodium chloride, calcium chloride, the magnesium chloride of recipe quantity, after stirring and dissolving, adding adds to the full amount of water for injection makes A liquid, fresh water for injection is added in another preparation container, drop into sodium lactate, after stirring and dissolving, adding adds to the full amount of water for injection makes B liquid; After stirring, A liquid, B liquid add pH value regulator respectively, regulate medicinal liquid to suitable pH value, after pre-filtering and end-filtration, by A liquid, B liquid with the volume ratio of 1:1, fill is in two Room of double-chamber transfusion bag respectively, jump a queue, water-bath sterilization, obtains LG catabolite, has the peritoneal dialysis solution of physiological pH value after sterilizing, make the mixed pH value of A liquid, B liquid be 6.8 ~ 7.4;
When preparation A liquid and B liquid, the water for injection that first adds to be temperature be 40 DEG C ~ 80 DEG C, the fresh water for injection of 60% ~ 80% recipe quantity in preparation container, drop into after raw material stirring dissolves, adding temperature is that the water for injection of 40 DEG C ~ 80 DEG C is to full dose;
It is dilute hydrochloric acid that A liquid adds pH value regulator, regulates solution pH value 2.8 ~ 3.2; It is sodium bicarbonate and sodium hydroxide that B liquid adds pH value regulator, and after first adding 2 ~ 6mmol/L sodium bicarbonate, hydro-oxidation sodium solution is adjusted to pH value 7.8 ~ 9.5.
2. according to the preparation technology of the peritoneal dialysis solution of the physiological pH value described in claim 1, it is characterized in that, connect the saturating drainage system of single use abdomen after jumping a queue, described water-bath sterilization is 115 DEG C ~ 125 DEG C water-bath sterilizations 8 ~ 30 minutes.
3. according to the preparation technology of the peritoneal dialysis solution of the physiological pH value described in claim 1 or 2, it is characterized in that, anhydrous glucose in described A liquid preparation of raw material selects 27.2g, 45.4g or 77.2g, and described calcium chloride is 0.366g, and described calcium concentration is 1.25mmol/L.
4. according to the preparation technology of the peritoneal dialysis solution of the physiological pH value described in claim 1 or 2, it is characterized in that, anhydrous glucose in described A liquid preparation of raw material selects 27.2g, 45.4g or 77.2g, and described calcium chloride is 0.514g, and described calcium concentration is 1.75mmol/L.
5. according to the preparation technology of the peritoneal dialysis solution of the physiological pH value described in claim 1, it is characterized in that, the mixed pH value of described A liquid, B liquid is 7 ~ 7.2.
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| CN106821748A (en) * | 2015-12-07 | 2017-06-13 | 华仁药业股份有限公司 | A kind of peritoneal dialysis dual-chamber bag |
| CN107281219B (en) * | 2017-06-30 | 2020-08-04 | 华仁药业股份有限公司 | Peritoneal dialysis solution for resisting peritoneal fibrosis and infection and preparation method thereof |
| CN109364098B (en) * | 2018-11-30 | 2021-09-21 | 威高泰尔茂(威海)医疗制品有限公司 | Neutral pH peritoneal dialysis solution and preparation process thereof |
| CN110025631B (en) * | 2019-04-19 | 2021-06-04 | 西安乐析医疗科技有限公司 | Novel peritoneal dialysis solution and preparation method thereof |
| CN112798549B (en) * | 2021-01-15 | 2022-09-02 | 西安乐析医疗科技有限公司 | Method for determining sodium ion content in peritoneal dialysis solution by ultra-low acid hydrolysis-atomic absorption method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1336825A (en) * | 1999-09-10 | 2002-02-20 | 巴克斯特国际公司 | Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1336825A (en) * | 1999-09-10 | 2002-02-20 | 巴克斯特国际公司 | Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy |
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