CN106606509A - Powder liquid bicarbonate peritoneal dialysis solution and preparing method thereof - Google Patents
Powder liquid bicarbonate peritoneal dialysis solution and preparing method thereof Download PDFInfo
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- CN106606509A CN106606509A CN201510688047.6A CN201510688047A CN106606509A CN 106606509 A CN106606509 A CN 106606509A CN 201510688047 A CN201510688047 A CN 201510688047A CN 106606509 A CN106606509 A CN 106606509A
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- bicarbonate
- liquid
- powder
- peritoneal dialysis
- dialysis solution
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Abstract
The invention relates to a powder liquid bicarbonate peritoneal dialysis solution and a preparing method thereof and belongs to the field of medicines. The dialysis solution comprises solid bicarbonate powder and a liquid mixed solution. The mixed solution is the mixed solution where water for injection is used as a solvent, and a penetrating agent, an electrolyte and buffer base are dissolved. Meanwhile, the invention provides the preparing method of the powder liquid bicarbonate peritoneal dialysis solution. The problem that bicarbonate is reacted with calcium and magnesium ions, and sediment is generated is solved, and meanwhile stability of the mixed solution is improved; and the problem that the bicarbonate is not stable after being dissolved in water is solved, the product does not need to be packaged by a high-isolation outer packaging bag, cost is reduced, and use is convenient.
Description
Technical field
The present invention relates to a kind of powder liquid bicarbonate peritoneal dialysis solution and preparation method thereof, belongs to field of medicaments.
Background technology
Peritoneal dialysis solution using buffer have three kinds：Acetate, lactate, bicarbonate, dialysis of the acetate as base
Liquid poor biocompatibility, by market.At present, the peritoneal dialysis liquid sold on market is lactate and bicarbonate.Lactic acid salt form
Peritoneal dialysis solution is in buffer base, high sugar, high glucose catabolite (GDPs), high-glycosylation dead end product (AGEs) and low pH
All many-sided meetings such as value have a negative impact to patient, peritoneal fibrosiss and ultrafiltration volume can be caused to reduce, be abdomen after long-time use
Patient exits the main cause of PD treatments thoroughly.Bicarbonate peritoneal dialysis liquid biocompatibility preferably, but the calcium and magnesium in dialysis solution from
Son is encountered bicarbonate and can form Calcium Carbonate and carbonic acid magnesium precipitate.
The bicarbonate peritoneal dialysis liquid for using in European countries at present isolates bicarbonate and calcium ions and magnesium ions by the structure of dual-chamber bag, faces
Use front mixing.But, the sodium bicarbonate in the liquid liquid bicarbonate peritoneal dialysis solution of this dual-chamber bag packaging is dissolved in water and is easily decomposed into
Carbon dioxide and water, in sterilization process, the molecular level expansion of pores of bag material, carbon dioxide can be discharged, part
It is discharged into outside packaging bag by hole, is partly discharged into and remains in packaging bag, is caused peritoneal dialysis liquid pH value unstable, affect to make
Use effect.CN103432164A intercepts outer bag using the method for CO2 gases being filled with liquid, pH is adjusted and is increased
Method so that bicarbonate liquid is in ion homeostasis state, it is ensured that sodium bicarbonate quality during sterilizing and storage
Stability.But the bad control of standard for pouring the amount of CO2 gases, and increase the outer bag cost raising of obstruct.
The content of the invention
It is an object of the invention to provide a kind of powder liquid bicarbonate peritoneal dialysis solution and preparation method thereof, solves bicarbonate and is dissolved in
After water there is sedimentation problem with calcium ions and magnesium ions reaction in unstable and bicarbonate.
The technical scheme is that：
A kind of powder liquid bicarbonate peritoneal dialysis solution includes that the mixed solution of the bicarbonate powder and liquid of solid fraction (is hereinafter referred to as mixed
Close solution)；The preferred sodium bicarbonate powder of the bicarbonate powder, the mixed solution are referred to water for injection as solvent, are dissolved
There is the mixed solution of penetrating agent, electrolyte and buffer base.
The penetrating agent selects glucose, glucosan, L-carnitine, aminoacid, icodextrin or dextrin, preferred glucose or
Glucosan, its role is to, and when dialysis solution is used, control the osmotic pressure of penetrating fluid, preferably to promote abdominal cavity blood capillary
In noxious substance be discharged in dialysis solution.
The mixture of the electrolyte selective chlorination calcium, magnesium chloride and Sodium Chloride, its role is to：It is when dialysis solution is used, real
Existing people's cylinder electrolyte balance；
The buffer base selection lactate or citrate, preferably lactate, its role is to：When dialysis solution is used,
Play acid-base balance；
The powder liquid bicarbonate peritoneal dialysis solution is prepared according to following weight parts proportioning and (is said on the basis of 1L mixed solutions
It is bright)：
Bicarbonate powder：1.5-3.0g, mixed solution：1L；
In mixed solution, the ratio of each component is：
Penetrating agent：13-39g/L, in electrolyte：Calcium chloride is 0.16-0.20g/L, magnesium chloride is 0.04-0.07g/L, Sodium Chloride
For 5-8g/L, buffer base：Sodium lactate is 1.5-2.5g/L or sodium citrate is 0.25-0.42g/L；
Hydrochloric acid is adopted to adjust the pH of mixed solution for 3.0-4.0.
In the present invention, the pH of mixed solution is most important, because stability when which to be considered glucose storage, Jing researchs are sent out
, with the change of pH, glycation product also can be different for existing glucose, and wherein in mixed solution, pH regulator is 3.0-4.0 intervals model
When enclosing interior, the 5 hydroxymethyl furfural value after sterilizing is minimum, metabolite of the 5 hydroxymethyl furfural for glucose, therefore 5- methylols
The amount of furfural is fewer, illustrates that stability of the glucose in mixed solution is better.In addition it is also necessary to consider mixed carbonic acid hydrogen salt powder
Behind end and mixed solution, the pH of solution will be in the range of the pH that human body bears, and preferred bicarbonate powder and mixed solution mix
Afterwards, pH is 6.0-7.0.
A kind of preparation method of powder liquid bicarbonate peritoneal dialysis solution, comprises the following steps：
(1) solids chamber fill：
Add quantitative bicarbonate powder to the solids chamber in dual-chamber bag, jump a queue.
(2) liquid chamber prepares fill：
Into preparing tank add 50～60 DEG C, the fresh water for injection of 65%-75% recipe quantities, successively put into recipe quantity penetrating agent,
Electrolyte and buffering alkali dissolution, are sufficiently stirred for 10～15 minutes, inject water to enough, measure pH until completely dissolved,
PH is adjusted to into 3.0-4.0 with dilute hydrochloric acid, is stirred evenly and is obtained medicinal liquid, then carried out fill, be filled in the liquid chamber of dual-chamber bag.
In the step (2), using spray pump, make medicinal liquid distinguish Jing filter element filterings, then carry out fill, be filled into double
In the liquid chamber of room bag.
The bicarbonate powder and mixed solution of the solid fraction is divided in the solids chamber and liquid chamber of dual-chamber bag, solids chamber and liquid
Rosin joint bar, the two separate storage are set between room；Face the liquid chamber of used time extruding dual-chamber bag, open rosin joint bar, fully mix
After use.
Compared with prior art, beneficial effects of the present invention are：
(1) solve bicarbonate and sedimentation problem occurs with calcium ions and magnesium ions reaction, while increased the stability of mixed solution.
(2) solve the problems, such as that bicarbonate is dissolved in unstable after water, product does not need the outer bag packaging of high-barrier, reduces into
Originally it is and easy to use.
Specific embodiment
With reference to embodiments the present invention is explained in detail.
Embodiment 1：
Bicarbonate is 3.0g powders, is mounted in solids chamber；In liquid chamber, mixed liquor volume is 1000ml, each in mixed solution
Composition quality is shown in Table 1：
Each composition quality in 1 embodiment of table, 1 mixed solution
After mixing, each composition quality is shown in Table 2：
Each composition quality after the mixing of 2 embodiment of table 1
Embodiment 2：
Bicarbonate is 1.50g powders, is mounted in solids chamber；In liquid chamber, mixed liquor volume is 1000ml, in mixed solution
Each composition quality is shown in Table 3：
Each composition quality in 3 embodiment of table, 2 mixed solution
After mixing, each composition quality is shown in Table 4：
Each composition quality after the mixing of 4 embodiment of table 2
Prepare embodiment：
(1) solids chamber fill：
Add quantitative bicarbonate powder to the solids chamber in dual-chamber bag, jump a queue.
(2) liquid chamber prepares fill
50～60 DEG C, the fresh water for injection of 70% recipe quantity are added into preparing tank, stirring paddle is opened, is put into recipe quantity successively
Penetrating agent, electrolyte and buffering alkali dissolution, be sufficiently stirred for 12 minutes, inject water to until completely dissolved it is enough, determine
PH is adjusted to 3.0-4.0 with dilute hydrochloric acid by pH, is stirred evenly, and obtains medicinal liquid.Spray pump is opened, makes medicinal liquid distinguish 5 μm, 0.45 μm of Jing
Filter element, is ready for fill, and medicine liquid irrigation is loaded in the liquid chamber of dual-chamber bag.
Jump a queue：Medicine plug is added on the less A rooms flexible pipe of bag, and connection folding core is added on the larger B rooms flexible pipe of bag.Per 30
Minute checks a presentation quality, according to practical situation, if any adjustment, a circulation is tracked after adjustment, and per bag should all check.
A loading amount was checked per 30 minutes；Visible foreign matters, a leak test are checked per hour, should be qualified, or suitably adjusted.
Addition abdomen uses drainage bag thoroughly, first flexible pipe and waste fluid bag pipeline is managed straight, and makes waste fluid bag touch medicinal fluid bag.Both hands are beaten
Over bag, medicinal fluid bag bottom is initially charged with outer bag, after medicinal fluid bag and waste fluid bag are loaded in outer bag, the neat pipeline of paving,
And ensure that pipeline prolongs outer bag surrounding and uniformly spreads out.
Product after pack is finished carefully should be placed in product on transfer table, be sealed with sealing machine.It is 115 DEG C of sterilizings 30 in parameter
Minute, the F0 values per cabinet are more than 8 (probe need to be inserted in the larger medicinal fluid bag of capacity during sterilizing).
Experiment effect and analysis：
Bicarbonate peritoneal dialysis solution (the control sample of the liquid liquid packed with commercially available employing dual-chamber bag after the product sterilizing of measurement embodiment
Product) property, respectively measurement accelerate storage 1,3,6 months and room temperature deposit sodium bicarbonate content after the mixing of 3,6 months,
The content of pH value, 5 hydroxymethyl furfural after mixing；Wherein accelerate deposit condition be：40 ± 2 DEG C, 25 ± 5%RH, room temperature are deposited
The condition put is：25 ± 2 DEG C, 40 ± 5%RH；Experimental result refers to table 5.
The storage result detection of 5 sample of table
(note * 0.01<P<0.05 has significant difference)
As can be seen from the above table, after 6 months, after sample mix, the embodiment powder liquid that the present invention is provided is double for acceleration, room temperature
Room bag is higher than commercially available liquid liquid double-chamber bag bicarbonate content, illustrate the present invention by by sodium bicarbonate in the form of pressed powder
Individually it is stored in powder bag, it is more preferable than the effect that liquid liquid is preserved in the effect for facing used time mixing.
Claims (10)
1. a kind of powder liquid bicarbonate peritoneal dialysis solution, it is characterised in that：Including the mixing of the bicarbonate powder and liquid of solid fraction
Solution；The mixed solution referred to water for injection as solvent, is dissolved with the mixed solution of penetrating agent, electrolyte and buffer base.
2. powder liquid bicarbonate peritoneal dialysis solution according to claim 1, it is characterised in that：The bicarbonate powder is excellent
Select sodium bicarbonate powder.
3. powder liquid bicarbonate peritoneal dialysis solution according to claim 1, it is characterised in that：The penetrating agent selects Fructus Vitis viniferae
Sugar, glucosan, L-carnitine, aminoacid, icodextrin or dextrin.
4. according to the arbitrary described powder liquid bicarbonate peritoneal dialysis solution of claim 1-3, it is characterised in that：The electrolyte choosing
Select the mixture of calcium chloride, magnesium chloride and Sodium Chloride.
5. powder liquid bicarbonate peritoneal dialysis solution according to claim 4, it is characterised in that：The buffer base selects lactic acid
Salt or citrate.
6. powder liquid bicarbonate peritoneal dialysis solution according to claim 5, it is characterised in that：The dialysis solution is according to following
Weight is prepared：Bicarbonate powder：1.5-3.0g, mixed solution：1L；Wherein,
In mixed solution, the ratio of each component is：Penetrating agent：13-39g/L, in electrolyte：Calcium chloride be 0.16-0.20g/L,
Magnesium chloride be 0.04-0.07g/L, Sodium Chloride be 5-8g/L, buffer base：Sodium lactate is 1.5-2.5g/L or sodium citrate is
0.25-0.42g/L。
7. according to the arbitrary described powder liquid bicarbonate peritoneal dialysis solution in claim 1-3,5 and 6, it is characterised in that：Using
It is 3.0-4.0 that hydrochloric acid adjusts the pH of mixed solution.
8. the preparation method of the arbitrary powder liquid bicarbonate peritoneal dialysis solution of a kind of claim 1-7, it is characterised in that：Including
Following steps：
(1) solids chamber fill：
Add quantitative bicarbonate powder to the solids chamber in dual-chamber bag, jump a queue.
(2) liquid chamber prepares fill：
Into preparing tank add 50～60 DEG C, the fresh water for injection of 65%-75% recipe quantities, successively put into recipe quantity penetrating agent,
Electrolyte and buffering alkali dissolution, are sufficiently stirred for 10～15 minutes, inject water to enough, measure pH until completely dissolved,
PH is adjusted to into 3.0-4.0 with dilute hydrochloric acid, is stirred evenly and is obtained medicinal liquid, then carried out fill, be filled in the liquid chamber of dual-chamber bag.
9. the preparation method of powder liquid bicarbonate peritoneal dialysis solution according to claim 8, it is characterised in that：The step (2)
In, using spray pump, make medicinal liquid distinguish Jing filter element filterings, then carry out fill.
10. the preparation method of powder liquid bicarbonate peritoneal dialysis solution according to claim 8 or claim 9, it is characterised in that：It is described
Rosin joint bar is set between solids chamber and liquid chamber.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201510688047.6A CN106606509A (en) | 2015-10-21 | 2015-10-21 | Powder liquid bicarbonate peritoneal dialysis solution and preparing method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510688047.6A CN106606509A (en) | 2015-10-21 | 2015-10-21 | Powder liquid bicarbonate peritoneal dialysis solution and preparing method thereof |
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| CN106606509A true CN106606509A (en) | 2017-05-03 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109200215A (en) * | 2018-10-25 | 2019-01-15 | 湖南博隽生物医药有限公司 | A kind of peritoneal dialysis solution and preparation method thereof |
| CN109589466A (en) * | 2017-10-03 | 2019-04-09 | 美敦力公司 | Peritoneal dialysis solution humidity control system |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1147304C (en) * | 1999-09-10 | 2004-04-28 | 巴克斯特国际公司 | Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy |
| CN103432164A (en) * | 2013-09-11 | 2013-12-11 | 华仁药业股份有限公司 | Peritoneal dialysis solution and preparation method thereof |
| CN103445961A (en) * | 2013-08-16 | 2013-12-18 | 华仁药业股份有限公司 | Liquid medicine bag for PD (Peritoneal Dialysis) |
-
2015
- 2015-10-21 CN CN201510688047.6A patent/CN106606509A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1147304C (en) * | 1999-09-10 | 2004-04-28 | 巴克斯特国际公司 | Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy |
| CN103445961A (en) * | 2013-08-16 | 2013-12-18 | 华仁药业股份有限公司 | Liquid medicine bag for PD (Peritoneal Dialysis) |
| CN103432164A (en) * | 2013-09-11 | 2013-12-11 | 华仁药业股份有限公司 | Peritoneal dialysis solution and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 刘玉梅等: "两种人工肾血液透析液的配制及应用", 《齐齐哈尔医学院学报》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109589466A (en) * | 2017-10-03 | 2019-04-09 | 美敦力公司 | Peritoneal dialysis solution humidity control system |
| CN109200215A (en) * | 2018-10-25 | 2019-01-15 | 湖南博隽生物医药有限公司 | A kind of peritoneal dialysis solution and preparation method thereof |
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Application publication date: 20170503 |