CN103479667B - One kind of multiple micro-element injections (II) pharmaceutical composition and preparation method thereof - Google Patents
One kind of multiple micro-element injections (II) pharmaceutical composition and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a kind of multi-microelement injecta that improves compatibility stability (II) pharmaceutical composition and preparation method thereof. The present invention utilizes citric acid-Na2HPO4Cushion right strong buffer capacity and citric acid and micro-chelation, make multi-microelement injecta (II) pharmaceutical composition prepared by the present invention in the time using with other parenteral solution compatibility, still can keep stable pH degree, avoid making trace element form precipitation of hydroxide because pH after compatibility changes, also sheltered the interaction of trace element with other medicines simultaneously, greatly improve the security of medication, improved the compliance of patient to medicine.
Description
Technical field
The present invention belongs to field of pharmaceutical preparations, be specifically related to one kind of multiple micro-element injections (II) pharmaceutical composition andIts preparation method.
Background technology
Human body is made up of 50 multiple elements, and the content difference according to element in human body, can be divided into macroelement and micro-The large class of secondary element two. Every human total weight's ten thousand/above element that accounts for, as carbon, hydrogen, oxygen, nitrogen phosphate and sulfur,Calcium, magnesium, sodium etc., be called macroelement; Every human total weight's ten thousand/following element that accounts for, as iron, zinc, copper,Manganese, chromium, selenium, molybdenum, cobalt, fluorine etc., be called trace element (iron claims again semimicro element). Trace element is in the human bodyContent is really very little, and as zinc only accounts for human total weight's 1,000,000/33, iron also only has 60/1000000ths.
Trace element mainly exists with two kinds of forms in human body: one is and protein, nucleic acid (RNA) and Adenosine triphosphateGlycosides (ATP) etc. form metal complex; Another kind is to be combined with the active site of enzyme to form various enzymes, hormone or vitamin,As hundreds of enzymes of iron content, copper, zinc, manganese and selenium, containing the thyroid hormone of iodine, the cytochromes of iron content etc., can make metalBiological action, physiological function and the biochemical reaction of the various uniqueness of-organic composite deposits yields, produce human life activityTremendous influence. Sugar and fatty oxidation, the generation of water in vital movement, all urging at the cytochromes of enzyme and iron content or copperUnder change, complete.
Each trace element has its special function, lacks or exceed limitation all unfavorable to health. Therefore trace unitElement is closely bound up with people's existence and health, and people's life is played to vital effect. Their excess intake, deficiency,Uneven or shortage all can cause to some extent the abnormal of Human Physiology or disease, even threat to life occur.
Approximately 30% disease is directly due to microelement deficiencies or imbalance, can cause mouthful, eye, anus or vulva as lacked zincPortion's redness, papule, eczema, iron deficiency can cause hypoferric anemia. Abroad studies have reported that, iron content in body, copper, zinc are totalAmount reduces, and all can weaken immunologic mechanism, reduces the ability of resist the disease. Trace element disease-resistant, give protection against cancer, promote longevity etc.Aspect all also plays very important effect. Healthy People can absorb every day from food, if but patient at disease shapeState or for a long time can only be using intravenous hyperalimentation as energy nutrient time, will cause micro-shortage and affect human body health andNormal physiological function. Therefore, micro-element injection is widely used clinically. Multi-microelement injecta (I)Supplement the daily need of adult to trace element chromium, iron, molybdenum, zinc, copper, manganese, selenium for PN solution, multiple micro-It is medium to the fundamental sum of chromium, copper, iron, manganese, molybdenum, selenium, zinc, fluorine and iodine that secondary element parenteral solution (II) can meet per day for adultsNeed, be also applicable to gravid woman's microelement-supplementing.
Micro-element injection is micro-concentrate, containing various trace elements metal ion, complicated component, therefore works asWhile use as the compatibility such as amino acid, vitamin C with other parenteral solution medicine, there will be the phenomenon such as muddiness, variable color. There is literary compositionChapter report (Zhao Weili, multi-microelement injecta and pharmaceutical incompatibility analysis, Chinese journals of practical medicine, 2012,29 (8):711-712) multi-microelement injecta with cefoperazone sodium, Ceftriaxone Sodium, fleraxacin, Furbenicillin sodium, westMiaow is for fourth, Pantoprazole Sodium, Cobastab6, occur when the parenteral solution compatibility of drugs such as amino acid, vitamin C cotton-shaped heavy, therefore there is incompatibility in the phenomenons such as shallow lake, muddiness, variable color and intensification. This is mainly that pH occurs their systems in the time of compatibilityChange and make some metal ions in trace element form that precipitation of hydroxide and oxidation cause. This incompatibility pairThe security that multi-microelement injecta uses has produced very large impact, is therefore badly in need of clinically now a kind of stable, noThe multi-microelement injecta product that affected by compatibility, exploitation does not have the multi-microelement injecta product one of incompatibilityIt is directly difficult problem urgently to be resolved hurrily of the art.
Summary of the invention
For the technical problem existing in above-mentioned prior art, inventor has carried out system research, repetition test, finally pleasantly surprisedGround is found, is introduced citric acid-Na in composition2HPO4Buffering can solve above-mentioned various trace elements injection well to systemLiquid incompatibility problem. Therefore the technical problem to be solved in the present invention is: be directed to the deficiencies in the prior art, provide one manyKind of micro-element injection composition and method of making the same, thus this prepared injecta composition product with other injectionLiquid compatibility still can keep stable pH degree while use, nondiscolouring, does not produce precipitation, thereby can greatly improve the safety of medicationProperty, improve the compliance of patient to medicine.
Technical scheme of the present invention is as follows:
Multi-microelement injecta provided by the invention (II) pharmaceutical composition comprises chromium chloride (CrCl3·6H2O）、Copper chloride (CuCl2·2H2O), iron chloride (FeCl3·6H2O), manganese chloride (MnCl2·4H2O), sodium molybdate（Na2MoO4·2H2O), sodium selenite (Na2SeO3·5H2O), zinc chloride (ZnCl2), KI (KI),Sodium fluoride (NaF), sorbierite, taurine and glycine.
It is right that said composition also comprises pH buffering.
Above-mentioned pH cushions being citric acid-Na2HPO4。
In the every 2mL unit formulation of said composition, each supplementary material and consumption are as follows:
Further, in the every 2mL unit formulation of said composition, each supplementary material and consumption are as follows:
The present invention also provides the preparation method of this multi-microelement injecta (II) pharmaceutical composition, and it comprises the following steps:
(1) prepare the citric acid-Na of pH2.0～2.4 with water for injection2HPO4Buffering to lysate, wherein every 1 liter moltenSeparate citric acid (C in liquid6H8O7·H2O) consumption is 19.698～20.895g, Na2HPO4Consumption is 0.142～1.7608g；
(2) get recipe quantity chromium chloride, copper chloride, manganese chloride, zinc chloride, sodium fluoride with cushioning lysate is dissolved in right amount;
(3) sorbierite, taurine, the glycine of getting recipe quantity are used and are cushioned after lysate stirring and dissolving in right amount, add stepSuddenly in the solution that (2) make, mix;
(4) add 0.02% active carbon (W/V) of step (3) gained liquor capacity, stirring and adsorbing 10～15min, followsThe de-charcoal 10～20min of ring;
(5) get recipe quantity ferric trichloride, sodium selenite, KI, sodium molybdate, molten to lysate by appropriate buffering respectivelyXie Hou, adds after the de-charcoal of step (4) in solution successively, stir add after 10～15min buffering to lysate to full dose,Stir and circulating filtration;
(6) after visible foreign matters and pH value passed examination, 0.22 μ m filter essence filter, embedding, sterilizing, to obtain final product.
Iron, zinc, manganese, copper, selenium, molybdenum, chromium, potassium in multi-microelement injecta of the present invention (II) pharmaceutical compositionAssay adopt ICP-AES method to carry out as follows:
(1) instrument and reagent
IRISAdvantageER/S type high-resolution Induction Couple Plasma (U.S.'s thermoelectricity public affairsDepartment), the concentric spray chamber of glass, echelle grating, two-dimension chromatic dispersion system, CID charge injection formula solid-state detector, wavelength modelEnclose 170-900nm. Testing pure water used is the UPW-3-90Z type ultra-pure water mechanism that Chengdu Ultra Pure Science & Technology Co., Ltd producesStandby, pure resistivity of water is 18.23M Ω CM. Hydrochloric acid (A.R level), nitric acid (A.R level), micro-element injection(injection stage).
(2) running parameter of instrument
Radio-frequency signal generator power output is the wherein measurement employing 750W of potassium of 1150W(), frequency is 27.12MHz; AtomizationPressure 192.9KPa, the time of integration: shortwave and long wave are respectively 20s and 10s, sample size is 1.85mLmin-1。
(3) preparation of standard liquid
Standard reserving solution: iron, zinc, manganese, copper, selenium, molybdenum, chromium, the standard liquid of potassium is 1000mgL-1. CountryThe Iron and Steel Research Geueral Inst preparation of ferrous materials test center.
Mixed standard solution: by 1% nitric acid or 1% hydrochloric acid stepwise dilution for standard reserving solution, be first mixed with 100mgL-1，Be made into respectively the more mixed mark of high, medium and low three kinds of series.
Mixed mark (1) high standard liquid: manganese 10.0mgL-1, copper 10.0mgL-1, iron 10.0mgL-1, zinc 10.0mgL-1；
Mixed mark (1) low mark liquid: manganese 1.0mgL-1, copper 1.0mgL-1, iron 1.0mgL-1, zinc 1.0mgL-1；
Mixed mark (2) high standard liquid: potassium 5.0mgL-1；
Mixed mark (2) low mark liquid: potassium 0.5mgL-1；
Mixed mark (3) high standard liquid: chromium 1.0mgL-1, molybdenum 1.0mgL-1, selenium 1.0mgL-1；
Mixed mark (3) acceptance of the bid liquid: chromium 0.5mgL-1, molybdenum 0.5mgL-1Selenium 0.5mgL-1；
Mixed mark (3) low mark liquid: chromium 0.1mgL-1, molybdenum 0.1mgL-1, selenium 0.1mgL-1。
(4) sample preparation
Multi-microelement injecta matrix is the aqueous solution, do not need to clear up, and directly to measure after 1% hydrochloric acid dilution, dilutionMultiple be respectively and survey 12.5 times, manganese, each 50 times of copper and iron. 10 times of chromium, molybdenum, potassium, each 5 times of selenium, 333 times, zinc. OnlyHave within test solution concentration is controlled at the optimum measurement scope of instrument, the degree of accuracy of measurement and precision could improve.
(5) sample in measurement
According to the test job condition of instrument, first suck high standard solution, carry out surveyed element standard spectral line automatic calibration; Treat eachSpectral line that element is surveyed has carried out after calibration, then carries out the setting of background deduction point. Setting completed for best background dot, tests each unitThe calibration curve of element, test sample concentration and blank solution under same test parameter condition.
Multi-microelement injecta provided by the invention (II) pharmaceutical composition and preparation method thereof has the following advantages:
(1) solved current multi-microelement injecta (II) in the time using with other parenteral solution compatibility because pH changes shapeBecome micro-metal hydroxides and occur the phenomenons such as flocculent deposit, muddiness, variable color and intensification and the incompatibility that produces is askedTopic, has improved security and the compliance of patient to medicine of clinical application.
(2) increasing on the basis of glycine, taurine, newly introduce citric acid-Na2HPO4It is right to cushion, in enhancing systemWhen oxidation resistance, improve the stable of system pH degree, thereby make each trace element in product possess better stability.
(3) multi-microelement injecta provided by the invention (II) pharmaceutical composition preparation method is easy, is easy to realizeIndustrialization.
Detailed description of the invention
Below will by embodiment, the invention will be further described, these descriptions are not that content of the present invention is done furtherRestriction. One skilled in the art will understand that the replacement that is equal to that content of the present invention is done, or improve accordingly, still belong toWithin protection scope of the present invention.
The preparation of embodiment 1 multi-microelement injecta (II) pharmaceutical composition
Prescription:
Preparation method, as follows preparation:
(1) with citric acid-Na of water for injection preparation pH2.42HPO4Buffering is to lysate, wherein in every 1 liter of lysateCitric acid (C6H8O7·H2O) consumption is 19.698g, Na2HPO4Consumption is 1.7608g;
(2) get recipe quantity chromium chloride, copper chloride, manganese chloride, zinc chloride, sodium fluoride with cushioning lysate is dissolved in right amount;
(3) sorbierite, taurine, the glycine of getting recipe quantity are used and are cushioned after lysate stirring and dissolving in right amount, add stepSuddenly in the solution that (2) make, mix;
(4) add 0.02% active carbon (W/V) of step (3) gained liquor capacity, stirring and adsorbing 15min, the de-charcoal of circulation20min；
(5) get recipe quantity ferric trichloride, sodium selenite, KI, sodium molybdate, molten to lysate by appropriate buffering respectivelyXie Hou, adds after the de-charcoal of step (4) in solution successively, stir add after 15min buffering to lysate to full dose, stirEven also circulating filtration 15min;
(6) after visible foreign matters and pH value passed examination, 0.22 μ m filter essence filter, 2mL/ props up embedding, 121 DEG C of 15minSterilizing, to obtain final product.
The preparation of embodiment 2 multi-microelement injectas (II) pharmaceutical composition
Prescription:
Preparation method, as follows preparation:
(1) with citric acid-Na of water for injection preparation pH2.22HPO4Buffering is to lysate, wherein in every 1 liter of lysateCitric acid (C6H8O7·H2O) consumption is 20.58g, Na2HPO4Consumption is 0.568g;
(2) get recipe quantity chromium chloride, copper chloride, manganese chloride, zinc chloride, sodium fluoride with cushioning lysate is dissolved in right amount;
(3) sorbierite, taurine, the glycine of getting recipe quantity are used and are cushioned after lysate stirring and dissolving in right amount, add stepSuddenly in the solution that (2) make, mix;
(4) add 0.02% active carbon (W/V) of step (3) gained liquor capacity, stirring and adsorbing 10min, the de-charcoal of circulation10min；
(5) get recipe quantity ferric trichloride, sodium selenite, KI, sodium molybdate, molten to lysate by appropriate buffering respectivelyXie Hou, adds after the de-charcoal of step (4) in solution successively, stir add after 10min buffering to lysate to full dose, stirEven also circulating filtration 10min;
(6) after visible foreign matters and pH value passed examination, 0.22 μ m filter essence filter, 2mL/ props up embedding, 121 DEG C of 10minSterilizing, to obtain final product.
The preparation of embodiment 3 multi-microelement injectas (II) pharmaceutical composition
Prescription:
Preparation method, as follows preparation:
(1) with citric acid-Na of water for injection preparation pH2.02HPO4Buffering is to lysate, wherein in every 1 liter of lysateCitric acid (C6H8O7·H2O) consumption is 20.895g, Na2HPO4Consumption is 0.142g;
(2) get recipe quantity chromium chloride, copper chloride, manganese chloride, zinc chloride, sodium fluoride with cushioning lysate is dissolved in right amount;
(3) sorbierite, taurine, the glycine of getting recipe quantity are used and are cushioned after lysate stirring and dissolving in right amount, add stepSuddenly in the solution that (2) make, mix;
(4) add 0.02% active carbon (W/V) of step (3) gained liquor capacity, stirring and adsorbing 20min, the de-charcoal of circulation15min；
(5) get recipe quantity ferric trichloride, sodium selenite, KI, sodium molybdate, molten to lysate by appropriate buffering respectivelyXie Hou, adds after the de-charcoal of step (4) in solution successively, stir add after 15min buffering to lysate to full dose, stirEven also circulating filtration 20min;
(6) after visible foreign matters and pH value passed examination, 0.22 μ m filter essence filter, 2mL/ props up embedding, 115 DEG C of 30minSterilizing, to obtain final product.
Test example 1---compatibility test
Get the sample of embodiment 1～3 preparation, with 10% calcium gluconae, vitamin C, Cobastab6, compound aminoThe parenteral solution medicines such as acid, cefoperazone sodium, Ceftriaxone Sodium, Furbenicillin sodium, Cimetidine respectively compatibility (are pressed each 2mLSuction 30mL syringe leaves standstill 5min), all do not occur producing the incompatibility phenomenons such as precipitation, muddiness, variable color, after compatibilityAdmixing medical solutions place after 24 hours and still keep good clarity. And with commercially available multi-microelement injecta (II)Replace the sample of embodiment 1～3 preparation to carry out compatibility test by above-mentioned same operation, and result and document (Zhao Weili, manyKind of micro-element injection and pharmaceutical incompatibility analysis, Chinese journals of practical medicine, 2012,29 (8): 711-712) report oneCause, all occurred the incompatibility phenomenons such as precipitation in various degree, muddiness, variable color. This illustrates the embodiment of the present invention 1～3The sample of preparation there will not be the problem of incompatibility in the time using with other parenteral solution compatibility of drugs.
Test example 2(study on the stability)---accelerated test
The sample of getting embodiment 1～3 preparation detects by preceding method and the countries concerned's standard, and indices meets ruleFixed, each sample is placed under 30 DEG C ± 2 DEG C of temperature, relative humidity 65% ± 5% condition, to place after 12 months and rechecks, everyIndex testing result sees the following form 1:
Table 1 multi-microelement injecta of the present invention (II) pharmaceutical composition accelerated test testing result
Accelerated test investigate result show: multi-microelement injecta of the present invention (II) pharmaceutical composition after accelerated test,Every detection index, without significant change, all meets quality standard requirement, shows that composition stable is good.
Claims (2)
1. one kind of multiple micro-element injections (II) pharmaceutical composition, is characterized in that: each former in its 2mL unit formulationAuxiliary material and consumption are as follows:
Prepare by comprising the following steps:
(1) prepare the citric acid-Na of pH2.0～2.4 with water for injection2HPO4Cushion to lysate wherein every 1 liter of dissolvingIn liquid, Citric Acid Monohydrate consumption is 19.698～20.895g, Na2HPO4Consumption is 0.142～1.7608g;
(2) get recipe quantity CrCl3·6H2O、CuCl2·2H2O、MnCl2·4H2O、ZnCl2, NaF is with cushioning molten in right amountSolution liquid dissolves;
(3) sorbierite, taurine, the glycine of getting recipe quantity are used and are cushioned after lysate stirring and dissolving in right amount, add step (2)In the solution making, mix;
(4) add 0.02% active carbon (W/V) of step (3) gained liquor capacity, stirring and adsorbing 10～15min, circulationDe-charcoal 10～20min;
(5) get recipe quantity FeCl3·6H2O、Na2SeO3·5H2O、KI、Na2MoO4·2H2O is right by appropriate buffering respectivelyAfter lysate dissolves, add successively after the de-charcoal of step (4) in solution, add buffering to lysate extremely after stirring 10～15minFull dose, stirs and circulating filtration;
(6) after visible foreign matters and pH value passed examination, 0.22 μ m filter essence filter, embedding, sterilizing, to obtain final product.
2. pharmaceutical composition as claimed in claim 1, it is characterized in that in its 2mL unit formulation each supplementary material and consumption asUnder:
Prepare by comprising the following steps:
(1) with citric acid-Na of water for injection preparation pH2.42HPO4Buffering is to lysate, wherein in every 1 liter of lysate,Citric Acid Monohydrate consumption is 19.698g, Na2HPO4Consumption is 1.7608g;
(2) get recipe quantity CrCl3·6H2O、CuCl2·2H2O、MnCl2·4H2O、ZnCl2, NaF is with cushioning molten in right amountSolution liquid dissolves;
(3) sorbierite, taurine, the glycine of getting recipe quantity are used and are cushioned after lysate stirring and dissolving in right amount, add step (2)In the solution making, mix;
(4) add 0.02% active carbon (W/V) of step (3) gained liquor capacity, stirring and adsorbing 10～15min, circulationDe-charcoal 10～20min;
(5) get recipe quantity FeCl3·6H2O、Na2SeO3·5H2O、KI、Na2MoO4·2H2O is right by appropriate buffering respectivelyAfter lysate dissolves, add successively after the de-charcoal of step (4) in solution, add buffering to lysate extremely after stirring 10～15minFull dose, stirs and circulating filtration;
(6) after visible foreign matters and pH value passed examination, 0.22 μ m filter essence filter, embedding, sterilizing, to obtain final product.
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