CN103610693B - A kind of parenteral nutrition injection composition - Google Patents
A kind of parenteral nutrition injection composition Download PDFInfo
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- CN103610693B CN103610693B CN201310648644.7A CN201310648644A CN103610693B CN 103610693 B CN103610693 B CN 103610693B CN 201310648644 A CN201310648644 A CN 201310648644A CN 103610693 B CN103610693 B CN 103610693B
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Abstract
The invention belongs to medical art, relate generally to a kind of parenteral nutrition injection composition.Specifically, method of the present invention improves stability and the safety of compatibility from technique source, by parenteral nutrition injection composition prepared by method of the present invention, can compatibility safe with clinical commonly used drug, thus improve the safety of clinical application, the suitability and convenience.
Description
Technical field
The invention belongs to medical art, be specifically related to a kind of parenteral nutrition injection composition improving incompatibility.
Background technology
Since having had venous transfusion from 1931, infusion treatment has become one of common, the most general clinical therapeutic modality.Infusion solutions packaged form mainly have passed through with the next stage in development: vial infusion solutions---plastic bottle infusion solutions---PVC big soft infusion bag---non-PVC-soft-bag infusion solutions.Three-layer co-extruded double-chamber transfusion bag is exactly the usually said soft bag of immediate dispensing infusion.
Can open easily in order to ensure sterilizing with when preserving the sealing of rosin joint in transportation and use, very high to the requirement of packaging material, production equipment and technique, how to ensure that product rosin joint in storage, transportation does not ftracture, and apply suitable pressure before use and can open rosin joint, make the medicament mixed of two chambers become the major criterion weighing double-chamber transfusion bag quality.
The parenteral nutrition injection that the present invention relates to is made up of 2 bag liquids, 1st bag comprises Freamine Ⅲ 200 milliliters, wherein contain: isoleucine 1.120 grams, alanine 1.240 grams, tryptophan 0.260 gram, leucine 2.500 grams, proline 0.660 gram, valine 0.900 gram, lysine acetate 2.480 grams, Aspartic Acid 0.760 gram, arginine 1.580 grams, methionine 0.700 gram, glycine 2.140 grams, histidine 1.200 grams, phenylalanine 1.870 grams, cysteine 0.200 gram, serine 0.440 gram, threonine 1.300 grams, 1.300 grams, glutamic acid and 0.070 gram, tyrosine.
2nd bag of 15% glucose solution 800 milliliters comprised containing inorganic salt, wherein contains: anhydrous glucose 120.0 grams, 2.920 grams, sodium chloride, potassium acetate 2.160 grams, potassium dihydrogen phosphate 1.088 grams, 0.740 gram, magnesium sulfate, calcium gluconate (C
12h
22caO
14h
2o) 1.792 grams and zinc sulfate (ZnSO
47H
2o) 5.752 milligrams.
The clinical indication of the parenteral nutrition injection (25) that the present invention relates to is: for can not or can not fully per os and/or the patient absorbed nourishment through gastrointestinal and those need the patient of central vein nutrition, this product can be used as the nutritional preparation of patient's supplementing water, electrolyte, aminoacid and heat.Its usage and dosage is intravenous drip.Treatment start and carbohydrate tolerance is unknown or when reducing as initial liquid, or when patient due to when morbidity causes carbohydrate tolerance to decline and needs the absorption of restriction glucose as maintenance medium.Open sealing coat during use, make two bag liquids be mixed and made into initial liquid or maintenance medium.
Gastrointestinal procedures patient is due to the impact of the factors such as operation wound, preoperative planning, INTESTINAL CLEANSING and early postoperation fasting; postoperatively often can cause protein and heat malnutrition; therefore postoperative supplementary appropriate in time aminoacid, glucose and electrolyte; for the nitrogen and the Power supply that ensure body; maintain the stable of organismic internal environment and organ function; reduce the generation of post-operative complication, promote that wound healing is significant.
Enforcement of the present invention can facilitate Clinical practice, reduces compatibility failure probability, improves quality stability.
Wang Yinjuan, takes longan, and Li Si, Li Li etc. publish an article the stability study (volume the 5th phase in " Central-South pharmacy " May the 11st in 2013) of 20AA Amino Acid Compound Injection and non-PVC co-extrusion infusion bag; Shao Yihong, Fan Jianwei, Ding Mei, etc. Amino Acid Compound Injection remaining oxygen controls the relation (" Shandong medicine thing ", 2010,29(8) with tryptophan stability: 497-499); All mention in moriamin-s, the stability of tryptophan is unusual key factor.The stability improving tryptophan by adding outer package is mentioned in patent documentation CN202376453U.
All beautiful, Peng Rongzhen Amino Acid Compound Injection untoward reaction document analysis (" Chinese Hospitals medication evaluation and application " the 4th volume the 2nd phase in 2004) of publishing an article inquires into universal law and the feature of untoward reaction caused by Amino Acid Compound Injection, instructs clinical rational drug use.Method: statistical analysis is carried out to the ADR of 137 routine amino acids of medical journals of Chinese report.How result: ADR caused by amino acid is higher in high age group incidence rate, occur in half an hour in medication process.ADR involves the multiple tract of body, and complicated clinical manifestation is various, and main manifestations is allergy, and it is even dead that severe patient can cause anaphylactic shock.Conclusion: the application monitoring should strengthening amino acid, to reduce the generation of serious ADR.
Improve the stability of tryptophan in aminoacids complex; Prevention untoward reaction is the problem that injectable composition of the present invention needs to solve.
Summary of the invention
For the tryptophan overcoming prior art is unstable and the potential threat of compatibility untoward reaction, a kind of parenteral nutrition injection composition improving incompatibility of the present invention.By enforcement of the present invention, inventor surprisingly finds, adds silver ion, significantly can improve the stability of parenteral nutrition injection compatibility, and the preventive effect to untoward reaction.
Specifically, in a kind of parenteral nutrition injection composition of the present invention, wherein form containing 2 bag liquids in compositions: the 1st bag comprises Freamine Ⅲ 200 milliliters, wherein contain: isoleucine 1.120 grams, alanine 1.240 grams, tryptophan 0.260 gram, leucine 2.500 grams, proline 0.660 gram, valine 0.900 gram, lysine acetate 2.480 grams, Aspartic Acid 0.760 gram, arginine 1.580 grams, methionine 0.700 gram, glycine 2.140 grams, histidine 1.200 grams, phenylalanine 1.870 grams, cysteine 0.200 gram, serine 0.440 gram, threonine 1.300 grams, 1.300 grams, glutamic acid and 0.070 gram, tyrosine, the silver ion of 50-200ppm,
2nd bag of 15% glucose solution 800 milliliters comprised containing inorganic salt, wherein contains: anhydrous glucose 120.0 grams, 2.920 grams, sodium chloride, potassium acetate 2.160 grams, potassium dihydrogen phosphate 1.088 grams, 0.740 gram, magnesium sulfate, calcium gluconate (C
12h
22caO
14h
2o) 1.792 grams and zinc sulfate (ZnSO
47H
2o) 5.752 milligrams.
Silver ion preferably containing 50-150ppm in above-mentioned composition.
Silver ion preferably containing 50-100ppm in above-mentioned composition.
Silver ion preferably containing 50-80ppm in above-mentioned composition.
Silver ion preferably containing 50ppm in above-mentioned composition.
Silver ion preferably containing 60ppm in above-mentioned composition.
Silver ion described in above-mentioned compositions adds with silver nitrate form.
Silver ion described in above-mentioned compositions is that the silver ion form of complexation is added.
Detailed description of the invention
Below in conjunction with specific embodiment and experimental example, the present invention is described in further detail, but be not to be construed as limiting the scope of the invention.
Embodiment 1
200 milliliters the 1st bag preparation comprising Freamine Ⅲ: water for injection leads to nitrogen to saturated, for subsequent use.Take the isoleucine 1.120 grams of recipe quantity, alanine 1.240 grams, tryptophan 0.260 gram, leucine 2.500 grams, proline 0.660 gram, valine 0.900 gram, lysine acetate 2.480 grams, Aspartic Acid 0.760 gram, arginine 1.580 grams, methionine 0.700 gram, glycine 2.140 grams, histidine 1.200 grams, phenylalanine 1.870 grams, cysteine 0.200 gram, serine 0.440 gram, threonine 1.300 grams, 1.300 grams, glutamic acid and 0.070 gram, tyrosine are in beaker, stirred under nitrogen atmosphere is miscible, slowly add recipe quantity 10% water for injection in amino-acid mixed solution, stirred under nitrogen atmosphere dissolves, add appropriate silver nitrate solution, mix homogeneously makes concentration of silver ions reach 50ppm, 0.2%NaOH adjusts pH6.9-7.3, add needle-use activated carbon (0.05%), stirring at normal temperature 15 minutes, 0.45 μm of microporous filter membrane coarse filtration.Control in filtrate, add water for injection to full dose, stir, 0.45 μm of microporous filter membrane fine straining, fill and get final product.
800 milliliters the 2nd bag 15% glucose solution preparation comprised containing inorganic salt: water for injection leads to nitrogen to saturated, for subsequent use.Take the anhydrous glucose 120.0 grams of recipe quantity, 2.920 grams, sodium chloride, potassium acetate 2.160 grams, potassium dihydrogen phosphate 1.088 grams, 0.740 gram, magnesium sulfate, calcium gluconate (C
12h
22caO
14h
2o) 1.792 grams and zinc sulfate (ZnSO
47H
2o) 5.752 milligrams in beaker, stirred under nitrogen atmosphere is miscible, slowly adds recipe quantity 10% water for injection in miscible fluid; stirred under nitrogen atmosphere dissolves 0.2%NaOH adjusts pH6.5-6.8; add needle-use activated carbon (0.05%), stirring at normal temperature 15 minutes, 0.45 μm of microporous filter membrane coarse filtration.Control in filtrate, add water for injection to full dose, stir, 0.45 μm of microporous filter membrane fine straining, fill and get final product.
Embodiment 2-12 is prepared below, all with the concentration conversion of silver ion in preparation process with the same procedure of embodiment 1.
| Concentration of silver ions | Silver ion form | |
| Embodiment 1 | 50ppm | Silver nitrate |
| Embodiment 2 | 80ppm | Silver nitrate |
| Embodiment 3 | 100pmm | Silver nitrate |
| Embodiment 4 | 150ppm | Silver nitrate |
| Embodiment 5 | 200ppm | Silver nitrate |
| Embodiment 6 | 300ppm | Silver nitrate |
| Embodiment 7 | 50ppm | EDTA complex silver |
| Embodiment 8 | 80ppm | EDTA complex silver |
| Embodiment 9 | 100ppm | EDTA complex silver |
| Embodiment 10 | 150ppm | EDTA complex silver |
| Embodiment 11 | 200ppm | EDTA complex silver |
| Embodiment 12 | 300ppm | EDTA complex silver |
| Embodiment 13(blank) | 0ppm | / |
The stability test of experimental example 1--injection of the present invention
Example 1-6 and 13 keeps sample test for a long time, from study on the stability result, parenteral nutrition injection composition of the present invention places 36 months by commercially available back (vial or soft bag), 5 hydroxymethyl furfural does not increase in put procedure, meet the standard of parenteral nutrition injection, its character, pH value, visible foreign matters, particulate matter, content etc. are keeping sample without significant change in process, show that this product is stablized.
The compatibility mechanism of experimental example 2-injection of the present invention
Two bags of transfusions of Example 1-6 and 13 mix afterwards and common drug carries out compatibility mechanism, the dilution factor of isotonic glucose or sodium chloride solution in dilution factor reference drug description during compatibility.Investigate the pH change before and after compatibility and profile variation, the results are shown in Table 1.
The compatibility mechanism result of table 1-injection of the present invention
When compatibe drug is injectable powder, due to the pH value of solid cannot be measured, therefore its pH value vacancy.,---: represent unchanged, solution is clear and bright, is special instruction in bracket.
As seen from the experiment, parenteral nutrition injection composition of the present invention and multiple common drug, all produce (embodiment 13 and daunorubicin hydrochloride have precipitation) without precipitation; Color and luster is the color (embodiment 13 has variable color) after medicine dilution itself, and injection of the present invention does not cause medicine color change; PH value has no significant change in 8 hours at compatibility.Show that the parenteral nutrition injection composition prepared by method of the present invention effectively improves compatibility stability and safety, thus improve the safety of clinical practice, the suitability and convenience.
Experimental example 3-outer packaging bag is to the sex investigation of preparation stabilization
Get pastille transfusion each 5 of the finished product of embodiments of the invention 1-6,25 DEG C, under the condition of relative humidity 45%, keep sample with the form adopted or do not adopt outer packaging bag to seal, measure the percentage contents of the relatively poor tryptophan of stability, investigate the stability of the present composition.
Can be reached a conclusion by this experiment: outer packaging bag is to the stability the being poured in compositions of the present invention effect of being significantly improved, more obvious to the improvement result of preparation stability.
Claims (8)
1. a parenteral nutrition injection composition, is characterized in that, described compositions is made up of 2 bag liquids:
1st bag comprises Freamine Ⅲ 200 milliliters, wherein contain: isoleucine 1.120 grams, alanine 1.240 grams, tryptophan 0.260 gram, leucine 2.500 grams, proline 0.660 gram, valine 0.900 gram, lysine acetate 2.480 grams, Aspartic Acid 0.760 gram, arginine 1.580 grams, methionine 0.700 gram, glycine 2.140 grams, histidine 1.200 grams, phenylalanine 1.870 grams, cysteine 0.200 gram, serine 0.440 gram, threonine 1.300 grams, 1.300 grams, glutamic acid and 0.070 gram, tyrosine, the silver ion of 50-200ppm;
2nd bag of 15% glucose solution 800 milliliters comprised containing inorganic salt, wherein contains: anhydrous glucose 120.0 grams, 2.920 grams, sodium chloride, potassium acetate 2.160 grams, potassium dihydrogen phosphate 1.088 grams, 0.740 gram, magnesium sulfate, calcium gluconate monohydrate (C
12h
22caO
14h
2o) 1.792 grams and Zinc vitriol (ZnSO
47H
2o) 5.752 milligrams.
2. compositions according to claim 1, is characterized in that, the silver ion containing 50-150ppm in described compositions.
3. compositions according to claim 2, is characterized in that, the silver ion containing 50-100ppm in described compositions.
4. compositions according to claim 3, is characterized in that, the silver ion containing 50-80ppm in described compositions.
5. compositions according to claim 3, is characterized in that, the silver ion containing 50ppm in described compositions.
6. compositions according to claim 3, is characterized in that, the silver ion containing 60ppm in described compositions.
7., according to the arbitrary described compositions of claim 1-6, it is characterized in that, described silver ion adds with silver nitrate form.
8. according to the arbitrary described compositions of claim 1-6, it is characterized in that, described silver ion is that the silver ion form of complexation is added.
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| CN105596291B (en) * | 2014-11-24 | 2020-09-08 | 辽宁海思科制药有限公司 | Fondaparinux sodium injection composition |
| CN108066360A (en) * | 2016-11-14 | 2018-05-25 | 华仁药业股份有限公司 | A kind of compound sodium acetate ringer's injection and preparation method thereof |
| US11278510B2 (en) | 2019-09-05 | 2022-03-22 | Baxter International Inc. | Parenteral nutrition formulation with optimized amino acid and glucose content |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN202376453U (en) * | 2011-07-28 | 2012-08-15 | 辽宁海思科制药有限公司 | Novel package of double-chamber transfusion bag of parenteral nutrition injection |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN202376453U (en) * | 2011-07-28 | 2012-08-15 | 辽宁海思科制药有限公司 | Novel package of double-chamber transfusion bag of parenteral nutrition injection |
Non-Patent Citations (1)
| Title |
|---|
| 氨基酸与银离子反应机理及氨基酸-银纳米微粒制备的研究;游玉华;《中国优秀博硕士学位论文数据库（硕士） 工程科技Ⅰ辑》;20061115(第11期);B014-87 * |
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