CN103349669A - Malic acid-containing composite dialysis preparation and preparation method thereof - Google Patents
Malic acid-containing composite dialysis preparation and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a malic acid-containing composite dialysis preparation and a preparation method thereof. The composite dialysis preparation comprises an agent A and an agent B, wherein raw materials of the agent A comprise, by weight, 10-30 parts of sodium chloride, 0-2 parts of potassium chloride, 0.5-2 parts of calcium chloride, 0.2-0.5 part of magnesium chloride, 0.1-8 parts of malic acid, 0-8 parts of malate, 0-5 parts of glucose, and 0-8 parts of a pH value buffering agent, and a raw material of the agent B comprises, by weight, 5-10 parts of sodium bicarbonate. With the present invention, special treatment effects are provided in the fields of cellular immunity improvement, myocardial coordination improvement, tumor necrosis factor reduction, serum phosphorus content reduction, CO2CP increase, dialysis imbalance disorder treatment and the like.
Description
Technical field
The present invention relates to the blood purification treatment field, relate in particular to a kind of compound dialysis preparation of malic acid and preparation method thereof that contains.
Background technology
Hemodialysis is a kind of method for the treatment of chronic renal insufficiency.Be by dialysis machine patient's blood to be derived externally, finish transmission to solute in the blood and water by blood purification technology, remove creatinine in the patient body, the refuses such as blood urea nitrogen.Remove moisture, improve electrolyte concentration etc.Blood after will purifying is again led the Huis' body.Reach the purpose for the treatment of.
The hemodialysis technology in clinical practice decades.But some not clear complication claim again the hemodialysis unbalanced syndrome, are still perplexing us such as nauseating, vomiting, headache, fatigue, uneasiness, hypertension, hypotension even heart failure etc.In case occur, clinically generally only can adopt symptomatic treatment; As finishing in advance hemodialysis, high sodium chloride or Glucose Liquid and the mannitol etc. of oozing of intravenous drip, so far not yet effective control method.
Summary of the invention
The invention provides a kind of compound dialysis preparation of malic acid and preparation method thereof that contains, be intended to solve the problem that existing hemodialysis technology can not effectively be controlled complication.
The present invention addresses the above problem with following technical scheme, the invention provides a kind of compound dialysis powder preparation of malic acid that contains, and described compound dialysis powder preparation comprises A agent and B agent.Wherein:
Described A agent raw material by weight component is sodium chloride 10-30, potassium chloride 0-2, calcium chloride 0.5-2, magnesium chloride 0.2-0.5, hydroxyl succinic acid 0.1-8, malate 0-8, glucose 0-5, pH buffer agent 0-8;
Described B agent raw material by weight component is sodium bicarbonate 5-10, but or sodium chloride-containing 0-5.
Wherein, hydroxyl succinic acid has another name called malic acid.
The present invention also provides a kind of preparation method that contains the compound dialysis powder preparation of malic acid, and described method comprises the steps:
The electrolyte of more than one in the group that sodium chloride, potassium chloride, calcium chloride, magnesium chloride are formed sieves after crushed;
More than one Organic substances in the group of the compositions such as hydroxyl succinic acid and/or its salt, glucose, pH buffer agent are sieved after crushed, and each the component mix homogeneously after will sieving again is sub-packed in the packing container to get the A agent;
By sodium bicarbonate or also contain sodium chloride through pulverize, sieve, mix homogeneously be sub-packed in packing in the molten device the B agent.
The present invention also provides a kind of malic acid compound dialysate preparation that contains, and it is characterized in that, described compound dialysate preparation comprises A concentrated solution and B concentrated solution.Wherein:
Described A concentrated solution be raw material by weight component be sodium chloride 10-30, potassium chloride 0-2, calcium chloride 0.5-2, magnesium chloride 0.2-0.5, hydroxyl succinic acid 0.1-8, malate 0-8, glucose 0-5, pH buffer agent 0-8, be mixed with 1000ml unit's concentrated solution, pH2.0-7.8 with water for dialysis.
Described B concentrated solution be raw material by weight component be sodium bicarbonate 5-10, be mixed with 1000ml concentrate, pH6.8-9 with water-dialyzing.
The present invention also provides a kind of preparation method that contains malic acid compound dialysate preparation, it is characterized in that, described method comprises the steps:
Get described A agent and B agent, use respectively without the dissolving of thermal source water for dialysis, pH2.0-7.8 is adjusted in described A agent, and pH6.8-9.0 is adjusted in described B agent;
A agent after the described dissolving, B agent respectively through filtering with microporous membrane, are used the ultrafilter membrane separating and filtering again, be sub-packed in asepticly, in the apyrogenic container, get A concentrated solution and B concentrated solution.
When clinical use, the dialysis solution that A, B liquid are mixed mutually and add that water for dialysis is made into etc. and ooze by the ratio of dialysis machine requirement is for the patient.
The present invention has obtained special therapeutic effect at aspects such as improving cellular immunization and myocardium harmony, minimizing tumor necrosis factor, reduction serum paraoxonase content, raising CO2CP and the unbalance disease for the treatment of dialysis.
The specific embodiment
In order to make purpose of the present invention, technical scheme and advantage clearer, below in conjunction with embodiment, the present invention is further elaborated.Should be appreciated that specific embodiment described herein only in order to explain the present invention, is not intended to limit the present invention.
Embodiment one
The embodiment of the invention provides a kind of compound dialysis powder preparation of malic acid that contains, and is comprised of A agent and the B agent of packing.Wherein:
The A agent is mainly made by following weight portion component combination: sodium chloride 10-30, potassium chloride 0-2, calcium chloride 0.5-2, magnesium chloride 0.2-0.5, hydroxyl succinic acid (having another name called malic acid) 0.1-8, malate 0-8, glucose 0-5, pH buffer agent (comprising hydrochloric acid, acetic acid, citric acid, lactic acid, aminoacid and/or its salt) 0-8.
The B agent is mainly made by following weight portion material combination: sodium bicarbonate 5-10 or further sodium chloride-containing 0-5 also.
In embodiments of the present invention, A agent, B agent raw material are preferably following parts by weight of component:
The A agent is mainly made by following weight portion material combination: sodium chloride 21.0, potassium chloride 1.0, calcium chloride 1.4, magnesium chloride 0.7, malic acid 4.0, malate 1.0, glucose 0.5, pH buffer agent (comprising hydrochloric acid and acetic acid, citric acid, lactic acid, aminoacid and/or its salt) 1.0.
The B agent is mainly made by following weight portion material combination: sodium bicarbonate 8.0 or further sodium chloride-containing 3.3 also.This compound dialysis powder preparation is preferably the 60-100 order through pulverizing, sieving, and especially 80 orders are sealed in packing container.
When clinical use, A, B agent are added respectively reverse osmosis water dissolving, be prepared into compound dialysis A concentrated solution, the B concentrated solution mixes by the ratio of the required mutually again, the compound dialysate that oozes such as is diluted to for the patient.
In embodiments of the present invention, the preparation method of compound dialysis powder preparation, details are as follows:
Get in proportion described sodium chloride, potassium chloride, calcium chloride, magnesium chloride, malic acid, malate, glucose, pH buffer agent.Mixing, be crushed to fine powder, preferentially be crushed to the 60-100 order, especially is 80 orders, and with above-mentioned fine powder mix homogeneously, packing is the A agent; Other gets sodium bicarbonate or/and sodium chloride powder is broken to fine powder, preferentially is crushed to the 60-100 order, especially is 80 orders, and packing is compound dialysis powder B agent formulation.
Embodiment two
The embodiment of the invention two provides a kind of concentrated solution preparation that contains the malic acid compound dialysate, is comprised of A concentrated solution and the B concentrated solution of packing.Wherein:
The A concentrated solution is mainly made by following weight portion raw material components: A agent raw material components is mixed with 1000ml unit's concentrated solution, pH2.0-7.8 with water for dialysis.
The B concentrated solution is mainly made by following weight portion raw material components: B agent raw material components, be mixed with the 1000ml concentrate with water-dialyzing, and pH6.8-9, described A concentrated solution, the B concentrated solution is preferably pH7.1.The A of this compound dialysate, B concentrated solution, in coarse filtration, fine straining, ultrafiltration were sealed in respectively independently container, the dialysis solution that when clinical use A, B liquid is mixed mutually and add that water for dialysis is made into etc. and ooze by the ratio of dialysis machine requirement was for the patient.
In embodiments of the present invention, the preparation method of compound dialysis powder preparation, details are as follows:
Get the A agent of above-mentioned preparation, aseptic, the pyrogen-free water for dialysis through the reverse osmosis preparation is further used respectively in the B agent, be mixed with the 1000ml concentrated solution, check pH value, regulate with the pH buffer agent in case of necessity, preferential pH7.1, through micro-pore-film filtration, the ultrafilter membrane separating and filtering is in the filling and package container, make respectively the A concentrated solution, the B concentrated solution.The A of independent packaging, B concentrated solution form the concentrated solution preparation of compound dialysate.
Embodiment three
In embodiments of the present invention, contain the compound dialysis A of malic acid agent, B agent assembly packaging is:
A agent: get sodium chloride 210.7g, potassium chloride 5.2g, calcium chloride 7.7g, magnesium chloride 3.6g co-grinding to 60 order; Get malic acid 20g, malate 5.8g, pH buffer agent 2.5g, co-grinding to 80 order remixes said components, is sub-packed in the aseptic packing container.Improving dissolution velocity, in order to the dialysis solution that oozes such as be mixed with during clinical use; B agent: get sodium bicarbonate 80g, pulverized 100 mesh sieves, be sub-packed in the aseptic packing container.When clinical use, A, B agent are added respectively water for dialysis are dissolved to 1000ml, make compound dialysis A concentrated solution, the B concentrated solution, more by the ratio of the required mutually the solution that oozes such as mixed diluting one-tenth for clinical.
Embodiment four
In embodiments of the present invention, contain the compound dialysis A of malic acid agent, B liquid assembly packaging is:
The A agent; Get sodium chloride 214g, potassium chloride 5.2g, calcium chloride 6.4g, magnesium chloride 3.6g co-grinding to 80 order; Get glucose 1.5g, malic acid 20g, malate 5.8g, pH buffer agent 3.0g, co-grinding to 80 order remixes said components, is sub-packed in the aseptic packing container.Improving dissolution velocity, ooze dialysis solution in order to be mixed with during clinical use etc.; B liquid: get sodium bicarbonate 80g, pulverized 100 mesh sieves, adding is dissolved to 1000ml without the thermal source water for dialysis, behind the 0.22u filtering with microporous membrane.Use the ultrafilter membrane separating and filtering, be sub-packed in aseptic, the apyrogenic packing container.In the time of before clinical use, the A agent is added water for dialysis is dissolved to 1000ml and makes compound dialysis A liquid, again with B liquid on request the mutual mixed diluting of ratio become isosmotic solution for clinical.
Embodiment five
In embodiments of the present invention, contain the compound dialysis A of malic acid liquid, B agent assembly packaging is:
A liquid: get sodium chloride 210.7g, potassium chloride 5.2g, calcium chloride 67.7g, magnesium chloride 3.6g co-grinding to 60 order, get malic acid and/or its salt 24.8g, co-grinding to 60 order, said components is dissolved to 1000ml with water for dialysis, in case of necessity again with behind lactic acid or its salt adjustment pH2.4 usefulness 0.22u filtering with microporous membrane.Use the ultrafilter membrane separating and filtering, be sub-packed in aseptic, the apyrogenic packing container.B agent: get sodium bicarbonate 67g, sodium chloride 33g, pulverized 100 mesh sieves, be sub-packed in the aseptic packing container.When clinical use, the B agent is dissolved to 1000mL with water for dialysis makes B liquid, again with A liquid on request the mutual mixed diluting of ratio the compound dialysate that oozes such as become for clinical.
Embodiment six
In embodiments of the present invention, contain the compound dialysis A of malic acid concentrated solution, B concentrated solution assembly packaging is:
A liquid: get sodium chloride 214g, potassium chloride 5.2g, calcium chloride 6.7g, magnesium chloride 3.6g co-grinding to 60 order, get malic acid and/or its salt 25.8g, glucose 1.5g, pH buffer agent 3.0g, co-grinding to 60 order, said components is dissolved to 1000ml with water for dialysis, adjust pH2.4 with aminoacid and/or its salt in case of necessity, behind the 0.22u filtering with microporous membrane.Use the ultrafilter membrane separating and filtering, be sub-packed in aseptic, the apyrogenic packing container.
B liquid is got 70g, sodium chloride 30g, pulverizes 80 orders and sieves, after the adding water for dialysis is dissolved to 1000ml usefulness 0.22u filtering with microporous membrane after mixing.Use again the ultrafilter membrane separating and filtering, be sub-packed in aseptic, the apyrogenic packing container.With A liquid, B liquid on request ratio mixed diluting becomes the compound dialysate of equivalent for clinical in clinical use.
Compound dialysis powder/liquid in the embodiment of the invention is through result's confirmation of Clinical control experiment, and to correcting electrolyte balance and acidosis, cleaning serum urea nitrogen and creatinine always effectively are 100%.This product is not only effective equally with reference substance aspect above-mentioned treatment, has also obtained special therapeutic effect at aspects such as improving cellular immunization and myocardium harmony, minimizing tumor necrosis factor, reduction serum paraoxonase content, raising CO2CP and the unbalance disease for the treatment of dialysis.That traditional dialysis treatment institute is inaccessiable.
In embodiments of the present invention, the toxicity of compound dialysis powder/liquid and clinical trial situation, details are as follows:
One. the clinical relatively mool/L of sample main component that uses
Two. acute toxicity test:
20 of Kunming mouses, body weight 18-22g compound dialysate dilute 35 times with water for injection in proportion, tail vein multiple injection, and maximum tolerated dose＞200mL/kg observes seven days no abnormality seens after the injection.
Three. clinical observation result
1. the improvement situation of two groups of every biochemical indicators in patient treatment front and back sees Table 1,2.Wherein, table 1 is for dialysing front two groups of test indexes relatively, and table 2 compares n=30 for two groups of test indexes after dialysing.
Table 1
Table 2
All have clear improvement after two groups of every biochemical indicator dialysis of patient, but experimental group and matched group relatively improve Ca
2+With CO2CP significantly (P＜0.05), and to the clearance rate of serum paraoxonase also than matched group significantly (P＜0.05).
2. the surrounding blood lymphocyte group measures.
Before and after two groups of treatments, surrounding blood lymphocyte group measurement result comparative result sees Table 3 (X ± SX) (%).
Table 3
CD after the matched group dialysis
+4 decline highly significants (P＜0.001) and CD8 be without significant change, and CP4 is without change after the experimental group dialysis, and CD8 descends significantly (P＜0.05), so the CD4/CD8 matched group descends, and experimental group raises, and significant difference P＜0.05 is relatively arranged between two groups
3. IL-2 after two groups of treatments, the variation of TNFa relatively sees Table 4, (the ug/L of X ± SX).
Table 4
All raise to some extent behind two groups of TNF horizontal stretchers, and experimental group rising degree is lower, the two has highly significant difference P＜0.001, and two groups all decrease after the IL-2 treatment, and matched group reduces more obvious, and two groups have very significantly difference.
4. treat rear ultrasoundcardiograms for two groups, the result of MGBP relatively sees Table 5.
Table 5
Two groups of LVEF, right ventricle's ejection fraction (RVEF), peak, left chamber ejection rate (PER) is lower than normally, but no significant difference between two groups, phase angular travel (PSH) matched group is obviously greater than experimental group (P＜0.05).
5. two groups for the treatment of hemodialysis unbalanced syndrome clinical effectivenesses relatively see Table 6.
Table 6
Compound dialysis powder/liquid of the present invention has significant effect P＜0.05 to treatment hemodialysis unbalanced syndrome
Relatively having the following advantages of the comprehensive above-mentioned clinical effectiveness of the embodiment of the invention;
1. the compound dialysis powder/liquid of the embodiment of the invention not only can effectively be corrected electrolyte disturbance, remove the micromolecule toxin such as BUN, Cr in the blood, and significantly be better than traditional hemodialysis in the low calcium of correction, high phosphorus and correction metabolic acidosis (CO2CP).
2. the compound dialysis powder/liquid of the embodiment of the invention can effectively improve cellular immune function, and behind table 2 clinical blood dialysis treatment, traditional treatment is take decline CD4 as main, and experimental group to be to reduce CD8 as main, and namely the former CD4/CD8 descends, and the latter rises.IL-2 is the cytokine that t helper cell produces in addition, and it can promote increment and the differentiation of T lymphocyte and bone-marrow-derived lymphocyte, and chronic renal patient reduces mostly, and its reason it be unclear that.Above-mentioned clinical effectiveness shows: experimental group increases significantly than matched group IL-2 behind the dialysis treatment.Can point out after compound dialysis powder/liquid treatment from above CD4/CD8 ratio and IL-2 index, it is that traditional dialysis treatment is incomparable that patient's cellular immune function is improved.
Ultrasonic cardiography (MGBP) observe reflecting myocardium shrink harmony index PSH (as showing that greater than 70 ° cardiac muscle can not synchronous, myocardium inaccurate coordination) traditional treatment PSH be 81.64 ° obviously greater than 70 °.PSH is normal in compound dialysis powder of the present invention/liquid treatment, points out product of the present invention that heart is had protective effect.
4. important inflammatory cytokine TNF can activate synthesized acute to phase albumen, and the oxygen reduction free radical promotes fat, muscle, connective tissue decomposition etc.Clinically show as heating.The discomforts such as hypotension.Above-mentioned clinical observation shows the TNFa value of experimental group, the result who is lower than the comprehensive above-mentioned clinical indexes of matched group P＜0.001. of highly significant after the treatment, that has embodied clinical treatment hemodialysis unbalanced syndrome the results are shown in Table 5, shows compound dialysis powder of the present invention/fluid component reasonable mixture ratio.Clinical practice has reached the traditional treatment special medical effect that is beyond one's reach.
5. for fear of the imbalance of Renal Failure Patients internal metabolism process, alleviate the kidney burden, the patient all is subject to strict control at daily life and diet style.This has brought a lot of inconvenience for undoubtedly patient's treatment.And utilize the method for dialysis treatment, make medicine (as; Malic acids etc.) be transported to by semipermeable membrane and bring into play therapeutical effect in the body, be one has the administering mode of creating meaning very much.
6. the compound dialysis powder/liquid of the present invention preparation, solute effect is good, powder/liquid good stability.Apyrogeneity, without microgranule, various composition proportion are accurate.Use raw material all to meet the Pharmacopoeia of People's Republic of China standard.
Claims (10)
1. one kind contains the compound dialysis powder preparation of malic acid, it is characterized in that, described compound dialysis powder preparation comprises A agent and B agent.Wherein:
Described A agent raw material by weight component is sodium chloride 10-30, potassium chloride 0-2, calcium chloride 0.5-2, magnesium chloride 0.2-0.5, hydroxyl succinic acid 0.1-8, malate 0-8, glucose 0-5, pH buffer agent 0-8;
Described B agent raw material by weight component is sodium bicarbonate 5-10.
2. the compound dialysis powder preparation of malic acid that contains as claimed in claim 1 is characterized in that, but described B agent raw material by weight component be sodium bicarbonate 5-10 or sodium chloride-containing 0-5.
3. the compound dialysis powder preparation of malic acid that contains as claimed in claim 1 is characterized in that, described hydroxyl succinic acid can be L-hydroxysuccinic acid and/or DL-hydroxyl succinic acid.
4. the compound dialysis powder preparation of malic acid that contains as claimed in claim 1 is characterized in that, described pH buffer agent is at least a in the group that forms of free hydrochloric acid, acetic acid, citric acid, lactic acid, aminoacid and/or its salt.
5. a preparation method that contains the compound dialysis powder preparation of malic acid is characterized in that, described method comprises the steps:
The electrolyte of more than one in the group that sodium chloride, potassium chloride, calcium chloride, magnesium chloride are formed sieves after crushed;
More than one Organic substances in the group of the compositions such as hydroxyl succinic acid and/or its salt, glucose, pH buffer agent are sieved after crushed, and each the component mix homogeneously after will sieving again is sub-packed in the packing container to get the A agent;
By sodium bicarbonate or also contain sodium chloride through pulverize, sieve, mix homogeneously be sub-packed in packing in the molten device the B agent.
6. one kind contains malic acid compound dialysate preparation, it is characterized in that, described compound dialysate preparation comprises A concentrated solution and B concentrated solution.Wherein:
Described A concentrated solution be raw material by weight component be sodium chloride 10-30, potassium chloride 0-2, calcium chloride 0.5-2, magnesium chloride 0.2-0.5, hydroxyl succinic acid 0.1-8, malate 0-8, glucose 0-5, pH buffer agent 0-8, be mixed with 1000ml unit's concentrated solution, pH2.0-7.8 with water for dialysis.
Described B concentrated solution be raw material by weight component be sodium bicarbonate 5-10, be mixed with 1000ml concentrate, pH6.8-9 with water-dialyzing.
7. the malic acid compound dialysate preparation that contains as claimed in claim 6 is characterized in that, but described B agent raw material by weight component be sodium bicarbonate 5-10 or sodium chloride-containing 0-5.
8. the malic acid compound dialysate preparation that contains as claimed in claim 6 is characterized in that, described hydroxyl succinic acid can be L-hydroxysuccinic acid and/or DL-hydroxyl succinic acid.
9. the malic acid compound dialysate preparation that contains as claimed in claim 1 is characterized in that, described pH buffer agent is at least a in the group that forms of free hydrochloric acid, acetic acid, citric acid, lactic acid, aminoacid and/or its salt.
10. a preparation method that contains malic acid compound dialysate preparation is characterized in that, described method comprises the steps:
Get described A agent and B agent, use respectively without the dissolving of thermal source water for dialysis, pH2.0-7.8 is adjusted in described A agent, and pH6.8-9.0 is adjusted in described B agent;
A agent after the described dissolving, B agent respectively through filtering with microporous membrane, are used the ultrafilter membrane separating and filtering again, be sub-packed in asepticly, in the apyrogenic container, get A concentrated solution and B concentrated solution.
When clinical use, the dialysis solution that A, B liquid are mixed mutually and add that water for dialysis is made into etc. and ooze by the ratio of dialysis machine requirement is for the patient.
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| CN103638526A (en) * | 2013-12-12 | 2014-03-19 | 河北紫薇山制药有限责任公司 | Preparation for purifying blood as well as preparation method and application thereof |
| CN109432123A (en) * | 2018-11-23 | 2019-03-08 | 济南康和医药科技有限公司 | A kind of compound electrolyte glucose injection and preparation method thereof |
| CN110327371A (en) * | 2019-07-15 | 2019-10-15 | 武汉大学 | Sodium bicarbonate ringer's injection and preparation method thereof |
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| CN109432123A (en) * | 2018-11-23 | 2019-03-08 | 济南康和医药科技有限公司 | A kind of compound electrolyte glucose injection and preparation method thereof |
| CN109432123B (en) * | 2018-11-23 | 2021-07-20 | 济南康和医药科技有限公司 | Compound electrolyte glucose injection and preparation method thereof |
| CN110327371A (en) * | 2019-07-15 | 2019-10-15 | 武汉大学 | Sodium bicarbonate ringer's injection and preparation method thereof |
| CN110327371B (en) * | 2019-07-15 | 2021-07-06 | 武汉大学 | Sodium bicarbonate ringer's injection and preparation method thereof |
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Application publication date: 20131016 |