CN1338972A - Method and apparatus for control of compounding pharmaceutical admixtures - Google Patents

Method and apparatus for control of compounding pharmaceutical admixtures Download PDF

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Publication number
CN1338972A
CN1338972A CN00803366A CN00803366A CN1338972A CN 1338972 A CN1338972 A CN 1338972A CN 00803366 A CN00803366 A CN 00803366A CN 00803366 A CN00803366 A CN 00803366A CN 1338972 A CN1338972 A CN 1338972A
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China
Prior art keywords
component
prescription
prescription medicine
medicine
equipment
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Pending
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CN00803366A
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Chinese (zh)
Inventor
约瑟夫·J·基歇尔
罗纳德·W·恰尔内
罗伯特·E·刘易斯
戴安娜·M·尼茨基-乔治
约瑟夫·E·米勒
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Baxter International Inc
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Baxter International Inc
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Publication of CN1338972A publication Critical patent/CN1338972A/en
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    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q50/00Systems or methods specially adapted for specific business sectors, e.g. utilities or tourism
    • G06Q50/10Services
    • G06Q50/22Social work
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002Compounding apparatus specially for enteral or parenteral nutritive solutions
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00Other mixers; Mixing plants; Combinations of mixers
    • B01F33/80Mixing plants; Combinations of mixers
    • B01F33/84Mixing plants with mixing receptacles receiving material dispensed from several component receptacles, e.g. paint tins
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00Other mixers; Mixing plants; Combinations of mixers
    • B01F33/80Mixing plants; Combinations of mixers
    • B01F33/84Mixing plants with mixing receptacles receiving material dispensed from several component receptacles, e.g. paint tins
    • B01F33/844Mixing plants with mixing receptacles receiving material dispensed from several component receptacles, e.g. paint tins with means for customizing the mixture on the point of sale, e.g. by sensing, receiving or analysing information about the characteristics of the mixture to be made
    • B01F33/8442Mixing plants with mixing receptacles receiving material dispensed from several component receptacles, e.g. paint tins with means for customizing the mixture on the point of sale, e.g. by sensing, receiving or analysing information about the characteristics of the mixture to be made using a computer for controlling information and converting it in a formula and a set of operation instructions, e.g. on the point of sale
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00Other mixers; Mixing plants; Combinations of mixers
    • B01F33/80Mixing plants; Combinations of mixers
    • B01F33/84Mixing plants with mixing receptacles receiving material dispensed from several component receptacles, e.g. paint tins
    • B01F33/848Mixing plants with mixing receptacles receiving material dispensed from several component receptacles, e.g. paint tins using data, i.e. barcodes, 3D codes or similar type of tagging information, as instruction or identification codes for controlling the dispensing and mixing operations
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/80Forming a predetermined ratio of the substances to be mixed
    • B01F35/83Forming a predetermined ratio of the substances to be mixed by controlling the ratio of two or more flows, e.g. using flow sensing or flow controlling devices
    • B01F35/832Flow control by weighing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/70Device provided with specific sensor or indicating means
    • A61J2200/74Device provided with specific sensor or indicating means for weight
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/22Mixing of ingredients for pharmaceutical or medical compositions

Abstract

A method and apparatus for controlling the compounding of pharmaceutical parenteral admixtures id disclosed. The apparatus preferably comprises a computer that contains a memory for storing instructions for operating the apparatus and for controlling compounders that prepare a prescription admixture, with the memory including data relating to a plurality of the pharmaceutical components that may be transferred to prepare the prescription admixture, and data concerning the operating characteristics of the compounders that the apparatus is adapted to control. The apparatus determines the order of admixing by general rules of admixing and by categorized compatibility groups of components, so that the number of rinses that must be done are minimized.

Description

The method and apparatus of control compounding pharmaceutical admixtures
Usually, the present invention relates to prepare and illustrate the method and apparatus of medicine, more specifically, the present invention relates to be used to prepare the prescription of non-intestinal medicine, the equipment that control is made up a prescription and the scheme that prepared medicine is described rightly with the embedded scheme of computer software.
Background of invention
Medical non-intestinal medicine is the mixture that aseptic medicine mixes under aseptic condition, and is used for intravenous injection.These medicines may be quite simple, also may be extremely complicated, and complexity increases along with comprising multiple active drug component simultaneously.Nutrient drug is an example of these complicated non-intestinal medicines, and it usually is that the patient who is used for the treatment of hospital prepares in the pharmacy of hospital.Usually, non-enteral nutrition medicine (" PN ") refers to the polytype nutritional solution that is used for intravenous administration.Complete non-enteral nutrition medicine (" TPN ") generally refers to the PN that those do not contain the lipid drug component, and full nutrient drug (" TNA ") refers to the PN that those contain lipid.
The pharmacy of hospital is normally determined separately by the doctor as make up a prescription preparation of center or health institution or preparation, is perhaps united definite prescription with nutritionist, pharmacists or other health worker.Every day, the pharmacy all needed to prepare a large amount of PN.In fact the preparation of PN mainly is to be finished by the dynamo-electric mixing apparatus that is called dispensing machine, and this dispensing machine is very complicated, is suitable for mixing the of different nature multiple different component that provides on the prescription.
Dispensing machine comprises the large volume dispensing machine, and it is suitable for by carrying those to prepare PN with the component that big relatively volume is present among the PN usually with high relatively speed, for example aminoacid, sterilized water, lipid and glucose.This dispensing machine comprises the AUTOMIX3+3 dispensing machine by the Clintec nutrition branch company manufacturing of Baxter health care company.
Dispensing machine also comprises the small size dispensing machine, and for example the trade mark of being made by above-mentioned same company is the dispensing machine of MICROMIX.The MICROMIX dispensing machine is suitable for accurately carrying those to be present in component among the PN with relatively little volume usually.
In the pharmacy, generally use MICROMIX and AUTOMIX dispensing machine to prepare prescription PN, normally the component of large volume is joined final container or final bag, then final bag is transported to the component that the MICROMIX dispensing machine is carried smaller size smaller with the AUTOMIX dispensing machine.It should be understood that single dispensing machine can not only carry the large volume component but also carry the small size component continuously or side by side.That is to say that single dispensing machine can existing large volume module have small footprint modular again, this module can deliver fluids into the common person in charge, i.e. common carrier pipe that links to each other with final bag or container perhaps is transported to final bag independent opening.
For this PN of preparation under the acceptable cost, it is important preparing PN as far as possible efficiently.Usually, efficient realizes by PN or " output " of pursuing maximum number in cycle preset time usually.But the complexity for preparing PN rightly certainly will cause the reduction of this output.This complexity is present in the appropriate PN of the given prescription of determining especial patient, accurately prepares PN and explanation or explain PN.But patient safety is very important, and the preparation of efficient PN must be finished under the prerequisite that occurs mistake hardly.
When preparing appropriate prescription for special patient, the pharmacists must carry out a lot of tasks, comprises suitable drug component and quantity are separately made assessment and judgement.Also to consider patient's material elements, comprise type of patient (as neonate) and patient body weight.The ability that the raising pharmacists makes assessment and judgement also reduces the probability of makeing mistakes with productivity gain.For reservation record, also wish and need sometimes why prescription is different with general source solution requirement under pharmacists's HC hard copy.
Known as the real work in the pharmacy, a lot of complexity relevant with preparation PN come from the consistency problem of the component of using among the relevant prescription PN.The compatibility is defined as the interaction between medicine and all other components that is in contact with it other medicines in diluent, container and the same PN.The compatibility is divided into two classes: physical compatibility and chemical compatibility.Physical compatibility is defined as the incompatibility that can change the medicine physical property, produces visible variation such as precipitation, gaseous volatilization or change color usually.Chemical incompatibility is not that vision is visible, must analytical test.The appearance of chemical incompatibility is the variation of active drug, as oxidation or photodegradative result.The factor that influences the compatibility including, but not limited to, total diluent volume, concentration level, order by merging and pH value.
The assessment compatibility and non-intestinal medicine have two steps.At first, before preparation, be evaluated at medication preparation and input to the compatibility of whole PN in time of patient fully.Secondly, the set-up procedure of preparation must be considered the compatibility plan when process for preparation carries out.For example should assess final mixer to be added or any in the middle of the compatibility between the solution that existed in the source solution of mixer and these containers.Under many circumstances, must before being in contact with one another in these chambers, they dilute with source solution with the inconsistent concentration packing of other solution.
Be appreciated that when the diluted fluid of maximum quantity Already in those solution will add container the time, farthest dilution will take place.For example, aminoacid or source of glucose solution will form the major part among the PN, and they are compatible with most of additives usually.Therefore, at first these solution to be transported to final container or any middle mixing chamber, to dilute the source solution that will add.
The complexity that needs in addition to consider is the contact that prevents along between the mobile mutual exclusive highly concentrated solution of the same pipeline of dispensing machine.In a representational example, although source solution can flow along the independent pipeline in a lot of conveyance conduits, may have certain part in the flow duct is that two kinds of mutual exclusive source solution are shared.This shared flow duct may be present in the arbitrary portion of flow duct, for example in middle mixing chamber, or after the middle mixing chamber, or after the switch valve.
A kind of solution and inconsistent with it second kind of solution of reducing is to carry this shared flow duct of afterflush at every kind of solution along the method for the mobile probability of same flow duct.This flushing is to use all compatible solution of solution that adds with preceding a kind of solution and flushing back to finish.Be understandable that, thereby often the inconsistent solution of flushing dilution makes them compatible, also will reduce output.
Therefore, must there be a provenance solution to be used for this rinse mode.This flushing source solution can be the compatible source solution that forms a prescription part, also can be the solution that is present in the downstream chamber, as the medicine in the final mixer.But, in present actual making up a prescription, be used as the solution of the proportional quantity of rinse solution, at first be transported in the final container usually for purpose convenient and dilution, and can not be used as rinse solution.Under this situation and other situation, the solution in the final bag must with will be compatible as the solution that washes, rinse solution will be discharged from final container.Flushing liquor is discharged from final bag or flushing liquor returned final bag all reduce output.On the other hand, keep a certain amount of diluent source solution that is used for washing and to cause two kinds of inconsistent solution to be in contact with one another, and can not be diluted to compatible degree rightly at final mixing chamber.
In the effort of raising the efficiency, the pharmacists divides into groups the container of dress solution according to the operator scheme of dispensing machine usually, and like this, compatible mutually component (with the concentration of source solution) sequentially adds between the flushing that the pharmacists sets together.After the compatibility of different solutions made judgement, pharmacists's compatible solution of a cover that divides into groups was placed on the estrade 1-4, and the compatible solution of second cover is placed on estrade 5-8 and goes up or the like, and flushing is set in estrade 4, estrade 8 back or the like.But a kind of special medicine may need 5 kinds of compatible solution.Need a lot of times and work owing to setting flushing, the pharmacists can hang over the 5th kind of component on the estrade, before or after flushing is set in, rather than the arrangement and the rinse mode of adjustment estrade.But this neither be best.
When a plurality of prescriptions of preparation comprised TNA and TPA, another problem that need consider of pharmacists was the lipid muddiness when trace lipid occurring in the final solution that does not contain lipid.The quantity that lipid exists low to 1/1000000th to 3 also can be become turbid.This muddiness does not occur when and then preparation does not contain the prescription of lipid after preparation contains the prescription of lipid usually.It has been generally acknowledged that the lipid muddiness can not produce harm to health, will be subsequently wrongly in the compatible PN solution of preparation think unacceptable precipitation that PN has but the lipid among the PN to be injected is muddy, and this turbid solution is abandoned mistakenly.
If the lipid muddiness becomes problem, the pharmacists avoids this problem by the prescription afterflush dispensing machine that each preparation contains lipid.But this flushing will reduce output, and not be in full force and effect.In order to increase output, the pharmacists can be by dividing into groups to reduce this flushing with the lipid prescription.But this grouping has negative effect to adaptability.If the lipid muddiness is not a problem, should be notified to the probability of lipid muddiness obtain solution and PN is administered to patient's people, unstable to prevent that medication person from erroneously believing medicine.
The other method that prevents the lipid muddiness is that corresponding lipid is used fully independently flow channel, leads to final mixer.But, in case there is lipid in the final container, use the solution flushing in the final container to take lipid in the flow channel to, cause the lipid muddiness among the PN subsequently.
Except the complexity of preparation, the pharmacists must consider the degree of accuracy restriction of dispensing machine, makes to have the prescription of component that quantity is lower than the degree of accuracy restriction of dispensing machine and be easy to use that syringe is manual adds.Reduced output this manual the adding.Also must consider to use inefficient intrinsic factor, for example remaining dose in the administration set in the process of PN to patient.It is time-consuming having confirmed to calculate these complexity, and causes low production efficiency.
In order to compensate and reservation record, must the medicine of preparation be illustrated, this generally is to give illustrative system in the facility by craft or automated manner with information conveyance.For raising the efficiency, the pharmacists must carry out to guarantee that the step that medicine is appropriately illustrated should minimize to raise the efficiency.
Therefore, the main purpose of the present invention provides a kind of improved method and apparatus that is used to prepare and illustrate non-enteral nutrition liquid.Another object of the present invention provides the method and apparatus of the non-intestinal medicine of preparation, to reduce the generation of incompatibility, wherein preferably include embedded software, can hold a lot of known active components that in various prescription medicines, occur and other component about method.More preferably, its purpose is to be provided for preparing the prescription of non-intestinal medicine, the equipment that control is made up a prescription and the scheme that prepared medicine is described rightly with the scheme of software performing.
Another main purpose of the present invention is, by increasing the output of dispensing machine, mainly is by the number of times that must wash being reduced to a minimum, this improved method and apparatus that is used to prepare non-intestinal medicine being provided.
Another purpose of the present invention has been to provide selectivity to determine that complicated drug solution in the prescription maybe can be present in compatible group order in the prescription, thereby more effectively prepares prescription, for example the number maximization by the prescription that can prepare in the time of setting.
The more detailed purpose of the present invention provides a kind of so improved method and apparatus that is used to control dispensing machine, used middle mixing chamber in the dispensing machine type of being controlled such as funnel, come the hybrid medicine component, afterwards the content of mixing chamber is transported to final mixing chamber such as final bag.
A further object of the present invention provides patient's concrete data, to strengthen the pharmacists according to the prescription ability of compounding pharmaceutical effectively and safely.
Another object of the present invention is to provide improved method and apparatus, makes the pharmacists effectively compensate the degree of accuracy restriction of dispensing machine and the poor efficiency of PN medication in the patient, the fluid that for example loses in administration set.
The present invention also aims to provide improved method and apparatus, comprise that the component with the higher concentration proportioning replaces the prescription medicine, but determine whether diluted fluid is provided by other compatible component, so that the injection volume minimum that obtains.
Another object of the present invention provides the method and apparatus of this improved control preparation, caution user during the limit of recommending when exceeding, and this alarm can unexpectedly not ignored.Xiang Guan purpose provides input and the record of ignoring the alarm reason therewith.
Another object of the present invention provides a kind of method and apparatus, reduces or warn the user to exist the probability of lipid muddiness and this lipid muddiness to be thought by mistake unacceptable sedimentary probability once in a while.
With reference to following accompanying drawing and the following detailed description of reading, the one of ordinary skilled in the art will more can clearly understand above and other objects of the present invention.
Fig. 1 is the block diagram of expression present device, and wherein present device is arranged in the hospital system with central authorities' record keeping and patient's computer, computer and present device networking, and present device also operationally is connected with printer with dispensing machine.
Fig. 2 is by the three-dimensional view of the typical dispensing machine of the inventive method and equipment control, shows the dispensing machine with funnel or intermediate receptacle especially, and wherein original components is before being sent to final bag or place successively in order or placed side by side.
Fig. 3 is the three-dimensional view by second typical dispensing machine of the inventive method and equipment control.
Fig. 4 a-h has constituted the present invention together and has controlled the flow chart that the prescription medicine is prepared.
Describe in detail
In a broad sense, the present invention relates to control the method and apparatus of compounding pharmaceutical, wherein the preparation finish by one or more dispensing machine, this dispensing machine can with respect to interconnective Control Computer of dispensing machine or blood processor long range positioning.With reference to figure 1, Control Computer or controller 10 have enough big memorizer to be used for data base's form storage drug data and the function software that is used to control dispensing machine and other ancillary equipment.Computer 10 is multi-user, multitask computer preferably, it have by communication connect 22 with dispensing machine 12,14 and 16 and the communication interface that is connected with 20 of other ancillary equipment such as printer 18, it can be wireless or wired connecting 22, can be the ingredient of LAN, wide area network, the Internet or this triplicity.Computer 10 has display 23 and keyboard 25, and common attribute and the feature of other present business computer.
Other ancillary equipment can comprise the treatment facility of instruction that is suitable for importing prescription and input operation Control Computer software of dumb terminal 24, other input equipment such as portable computer 26 with keyboard and display and other.Computer can be positioned at the zones of different of health institution such as hospital, and the perhaps different floors of hospital are perhaps even in different hospitals.In Fig. 1, dispensing machine 12 and 14 and printer 18 and terminal 24 be arranged in the B of hospital, and the miscellaneous equipment shown in the figure is arranged in the A of hospital.As shown in the figure, preferred, near every dispensing machine or associating dispensing machine, a printer is arranged all, be used to print the label on the prescription medicine that is attached to preparation.Control Computer 10 is preferred to be connected with hospital total computer 28, and the total computer of hospital is used for foundation and writes down account bill and other function.
The present invention is suitable for controlling dispensing machine, and for example dispensing machine 12,14 and 16.In the B of hospital, use two machines to represent the associating use, for example above-mentioned AUTOMIX and MICROMIX dispensing machine, but this example not only with two kinds of compounding pharmaceutical dissimilar dispensing machines.Like this, dispensing machine 12 can be a kind of dispensing machine that is suitable for carrying the large volume additive, and dispensing machine 14 can be a kind of dispensing machine that is suitable for carrying the small size additive.In addition, dispensing machine 16 can not only be suitable for the drug component carrying large volume but also be suitable for carrying small size quantity.
With reference to figure 2, there is shown the three-dimensional view of low speed flow module dispensing machine, it is suitable for carrying the drug component of small size, for example trace nutrient and other medicines from independent source container 30.But, the prescription medicine can by one independent, be suitable for carrying the dispensing machine 16 of large volume and small size additive to prepare, perhaps finish by being connected to many dispensing machines on the independent final bag 46.
In one embodiment, when the needs pinpoint accuracy, for example when the additive of small size joins among the PN, be transported to the independent intermediate receptacle or funnel 34 suspended from loading unit assembly 36 by independent conduit 32 from the fluid of container 30.Loading unit assembly 36 weighs up the gross weight of funnel 34 and provides output signal, and this signal is used for being illustrated in the amount of fluid of any given time funnel 34.Funnel 34 be close and be connected to manometer tube 38, manometer tube 38 is connected to pressure apparatus or locking device such as valve 40.The preferred independent peristaltic pump of pressure apparatus, it can optionally produce normal pressure or negative pressure in funnel 34, with the direction and the flow of control fluid turnover funnel 34.Funnel 34 also is connected to outlet 42, and outlet 42 extends to second locking device, 44, the second locking devices 44 between funnel 34 and final bag or container 46.By selectivity operation locking device 40 and 44 and pressure apparatus, can be pumped into funnel to fluid and therefrom transfer out.These same sections in the machine also can be controlled mobile direction, therefore can deliver fluids into final bag 46, also can shift out fluid from final bag to be used to wash funnel 34.
This to be suitable for carrying the detail operations of an example of dispensing machine of small size drug component be to be described in the United States Patent (USP) 5228485 in April nineteen ninety at least, and this patent is entrusted to same agent of the present invention, at this as special list of references.Having compared some and improved at present commercial MICROMIX dispensing machine and 5228485 patents, but be describe in the patent therewith similar certainly.
Dispensing machine 12 also can comprise utilize other method of work for example independent or with measure method that volume carries and unite the one or more pumping mechanisms or the switching mechanism of use, come the assembly of feeding additive, the commercialization that also can comprise the BAXA company of standardized equipment such as the state of Colorado Englewood equipment that makes up a prescription.
Referring to Fig. 3, represented the dispensing machine 50 of another embodiment, it is particularly suitable for carrying the large volume additive.Dispensing machine 50 comprises a plurality of pumping plants 52, and it is pumped into final container 58 to fluid from independent source container 56 with interchangeable conveyer device 54.This to be suitable for carrying the detail operations of an example of small size medicament dispensing machine be to be described in United States Patent (USP) 4712590 and 5927349 in 1999 at least, and this patent is entrusted to same agent of the present invention, at this as special list of references.Having compared some and improved at present commercial AUTOMIX dispensing machine and the patent 5228485 and 5927349, but be describe in the patent therewith similar certainly.Prepare prescription
In an example that uses preferred embodiment of the present invention process, doctor or other health worker or health care group determine patient's non-enteral nutrition needs and leave prescription.Then the pharmacists need convert prescription to concrete quantity or concentration that additive among patient's the PN is given in medication.These quantity change according to different patients.For example, can not receive the fluidic patient of a large amount of non-intestinals, the fluid that just needs minimum number is to satisfy nutritional need.Restricted patient's a example is a neonatal patient.In order to use the additive of aequum with the less form of cumulative volume, the additive concentration level in the final bag 46 can be than the height among the PN, in case use the more dilute agent.This higher concentration can make the chance that other additive compatibility problem occurs among the PN increase, and surpasses the limit that patient can receive.
Referring to Fig. 4 a, in a preferred embodiment, the pharmacists imports controller to patient's recognition data such as patient's identification card number with keyboard 25 (square frame 70).Then, controller 10 is from the data storage station such as in-house computer system 28 is asked and the specific data (square frame 72) of reception patient, and shows these information on display 23.In a preferred embodiment, by preferred one type the patient's particular datas that use of controller 10 be type of patient, for example premature infant, neonate, department of pediatrics or adult or the like.In a further embodiment, the health worker directly imports patient's particular data memorizer controller 10 or there.
Controller 10 has also kept the preferable range that different pharmaceutical in the final bag 46 can receive concentration level in memorizer.In one embodiment, controller 10 has also kept the used drug concentrations scope of different patient's types in data storage, and is provided with the preferred concentration range for that is used for those concrete patients.In a further embodiment, kept the value range corresponding with patient's attribute in data storage, as different patient age and body weight, controller 10 is provided with the preferred concentration range for of corresponding patient's particular community scope.
In a further embodiment, also contain with good grounds predetermined patient's material elements in the controller,, regulate the algorithm of concentration range as patient age.
Therefore, according to the concrete data of patient, whether controller 10 assessment preferred range are suitable for patient's particular type, then can regulate these scopes (square frame 74).
Then the health worker imports prescription (square frame 76), for example by using keyboard 25 to finish.When the input prescription, the health worker is provided with the concentration level of drug solution, so that the PN of preparation will be corresponding with prescription.Controller 10 can allow prescription to import with several different-formats.As an example, controller 10 can receive each component in the final drug solution of input percent, per unit volume concentration or with the corresponding quantity of unit patient body weight.
When the health worker imported prescription, controller 10 was according to the concentration (square frame 78) of predetermined range check input.If the concentration of input goes beyond the scope, on display 23, show error message.In addition, the component form of health worker's input is incorrect, then shows mistake or warning message, caution health worker on display.The example of incorrect form is, the concentration of input is the concentration of per unit patient body weight, and patient's body weight is not as the part input of the concrete data of patient.
In another embodiment, after all concentration inputs, the various components of controller 10 checks drop on the outer component of component set point for those, with the error message demonstration of highlight.
In a further embodiment, the template that in memorizer, has kept the various prescriptions of corresponding different patient's types.Then pharmacists or controller 10 access this template, perhaps receive this template, or adjust this template.In other embodiment, previous patient's prescription is kept in the memorizer.Then pharmacists or controller 10 access previous prescription, perhaps accept previous prescription as current prescription, or adjust previous prescription and as current prescription.
When showing alarm, although concentration goes beyond the scope, whether this concentration is required still can make medical judgment by the health worker.Under some default situation, controller 10 can allow the health worker to remove alarm (square frame 82).Controller 10 allows to remove a factor or some factor is united appearance.A factor is whether the health worker who imports prescription has the right to remove special alarm.Before removing was accepted, each alarm all needed the authority of different brackets.Some alarm can not be eliminated.
Health worker's the identity and the foundation of Permission Levels are that controller 10 needs and the unique password realization of input at quarter in due course by entering, and the above-mentioned suitable moment is for example in the beginning of login prescription or when alarm occurs (square frame 84).Other method of setting up health worker's identity also is fine, as key card, retina scanning or similar method.
Except the authority of setting up the health worker, in order to verify that the health worker has discerned and received error message and for the purpose of reservation record, controller 10 need be input to the reason of removing in the annotations window that is presented on the display 23.For some alarm situations, even reasonable grounds is arranged, controller 10 does not allow any removing (square frame 86) yet.Compatibility grouping
Preferred embodiment of the present invention assessment component, the component solution that is in contact with one another and the preparation compatibility that is contained in the solution in the final solution bag 46 after finishing therein in process for preparation.
In the present invention, the assessment to the PN of final preparation is the conventional process of pharmacists's routine.The pharmacists forms the medicine of final preparation and the document contrast that comprises the information relevant with the compatibility.Under a lot of situations, can not be in the document enough specific to the definite type in the drug prepared, this just needs the pharmacists to make professional judgment to decide whether drug prepared is compatible.
According to the present invention, mainly concentrate in the preparation of non-enteric nutrient for the comprehensive compatibility assessment of complicated medicine, this assessment comprises that very widely PN screening and calcium phosphate dissolubility screen.
This process preferably includes the first screening step, promptly the scope of all PN additives and controller 10 settings is compared, and this just comprises the step of setting preferred concentration range for as mentioned above.
Second step comprises the data base of the basis set branch of aminoacid, glucose and fat and institute's testing drug is contrasted.The aminoacid contrast is the concrete trade mark.The foundation of drug data base is by to the test of medicine and utilize published document.Drug data base preferably includes the concentration of stable and labile drug, provides study condition such as time and temperature simultaneously.Preferably, the medicine that the data base comprises has the source component of discerning, for example aminoacid of trademark naming.
In second step, prescription medicine and the contrast of data base's medicine.Preferably, at first compare with medicine with source component of discerning.If the prescription medicine drops in the scope of stablizing medicine, the present invention does not produce prompting to the pharmacists with regard to carrying out next step.This scope is set by some deviates, for example the corresponding concentration level of solvent in percent by setting quantity or setting and the stable medicine.
But, with the labile drug that comprises among the data base (departing from solvent quantity one setting value) coupling (or mixed stability and unstable coupling) but be decided to be latent instability by the medicine of the first screening step with plus or minus preferably.
In embodiments of the present invention, if prescription medicine and labile drug coupling are then carried out other step, whether the study condition of for example screening coupling medicine is identical with present condition.The present invention proposes a caution to the pharmacists, and promptly the prescription medicine is the latent instability medicine under the study condition of coupling medicine.
In a further embodiment, with the data base in any stable or unmatched medicine of labile drug that comprises to reappraise.When this process of execution, ignore amino acid whose trade mark, this medicine and entire database contrast.Correlated result adopts the step identical with above-mentioned steps to handle.Preferably, provide one about ignoring the caution of aminoacid trade mark in data base's medicine to the pharmacists.If reappraise after the entire database medicine still can not with database matching, the present invention will provide an information warning to the pharmacists, not have the tested mistake of similar PN before promptly.
Consider the screening of calcium phosphate dissolubility again, calcium salt and phosphatic dissolubility depend on a lot of variablees in identical solution, comprise form, order by merging, pH value, amino acid concentration, other additive and the time of temperature, salt, but are not limited thereto.Formerly the pharmacists contrasts the specific solubility curve of calcium salt and phosphatic ultimate density and given aminoacid brand and ultimate density in the technology.
In the present invention, the screening to the calcium phosphate dissolubility in complicated process for preparation is finished by controller 10, promptly calcium salt and phosphatic ultimate density is all contrasted with a series of known compatibilitys.The pharmacists is this series of values input store, perhaps previous input database.This series of values that the present invention uses is with the compatibility of sorting of aminoacid brand and ultimate density.For example, for a given aminoacid brand, have in the calcium phosphate solubility table with solution be compatible calcium salt and the phosphate concn of 1%, 2% and 4% final aminoacid.The present invention has determined the dissolubility boundary that is exceeded, and if surpass this boundary and just produce a caution to the pharmacists.
In another embodiment, controller 10 produces a representative for the curve of the calcium phosphate dissolubility of specific amino acids and be presented on the display 23, and also provided the design of the prescription medicine of relative this solubility curve, left compatible prescription to help the pharmacists.
But, whether the medicine in determining final bag is compatible, the compatibility in also must the assessment process for preparation.For example, must the assessment a kind of solution and the compatibility of second solution when contacting.Second fluid is present in common pipeline, middle mixing chamber or final bag.In order to overcome this potential problem, the pharmacists can adopt whole rules to be used for process for preparation.For example, usually all diluent are at first added final bag, so that all additives in the final bag play the effect of diluent as much as possible when other component adds in the bag.But this practice has reduced the ability of washing this diluent in process for preparation.
According to a key character of the present invention, Control Computer 10 can be utilized the known compatibility of component, makes the parallel preparation in final bag or middle mixing chamber of this compatible components.In addition, can be with finishing flushing process with the forward and backward compatible source solution of flushing solution partly that flows through of flushing.Therefore, the heavy addition agent is transported to final container or bag, or mixing chamber in the middle of being transported to, and a small amount of additive is as flush fluid simultaneously.This compatibility screening and parallel preparation can make the speed of compounding pharmaceutical of the present invention reach the fastest degree, thereby can more effectively use dispensing machine and Control Computer.
According to a key character of the present invention, utilize the drug compatibility test to set up the data base, the data base comprises a plurality of groups, represents the relation of the concentration and the compatibility on the drug test basis.In an example, according to present know-how, there is the medicine group of 7 identifications to list in the following table 1.Should be understood that, even arranged when group, perhaps or even same composition when under variable concentrations, having several groups, when the knowledge obtained more about various component compatibilities, can tell more medicine group in each independent component.
Table 1
The compatibility of group
Group Compatible Inconsistent
??1 ?1,2,3,6 ?4,5,7
??2 ?1,2,3,4,6,7 ?5
??3 ?1,2,3,4,6 ?5,7
??4 ?2,3,4,6 ?1,5,7
??5 ?6 ?1,2,3,4,5,7
??6 ?1,2,3,4,5,6,7 ?-
??7 ?2,6,7 ?1,3,4,5
On the basis of test result, can draw compatibility group, and be included among the data base of Control Computer, can use data base's information to carry out process for preparation like this.Preferably, the data base only is stored in the Control Computer, and do not distribute to other memorizer, thereby when obtaining other knowledge and information, can control, manage and revise the data base reliably by medical history, follow-on test and other medicine or component adding data base.
In the preferred embodiment of the invention, based on the data base, controller is divided into compatibility group to the fluid logic in the source container 30 (Fig. 2) ground, and no matter the physical location among their in dispensing machine 12,14,16 one.
In another embodiment of the present invention, controller will calculate concrete prescription, at present group number and these groups are lined up the ordering of compatibility group, in these group intermediate demands flushings so that total flushing decreased number to minimum degree.
In yet another embodiment of the present invention, controller utilizes other input, as the physical constraint of system, determines appropriate preparation order, thereby more effectively uses source solution as flushing liquor, and do not use the flushing liquor of final bag.The example of physical constraint comprises the volume of medial compartment or funnel 34 and is used for the flush volume of this chamber.
In an example, medial compartment has the flush volume of funnel and the 30ml of volume 60ml.If prescription needs the group 1 of 5ml, the group 2 of 20ml, the group 3 of 20ml, the group 4 of 55ml and the group 6 of 40ml, then the preparation of controller 10 employings is group 1, group 2, group 3, group 6 in proper order and organizes 4, rather than top order.
When group 1, group 2, group 3 and 10ml organize 6 parts and are full of funnel 34, the funnel that evacuation section is full of before adding remaining group 6, after funnel 34 is full of for the first time, group 6 fluids of remaining at least 30ml, this part organizes 6 fluids can be used as flushing liquor, thereby does not need the flushing liquor of final bag.
Controller also can use other ordering relation and algorithm, to reach user's needs, for example can distribute to other compatible group to the volume of a group to reduce chamber or the inferior minimum degree of counting to of funnel 34 dischargings.
In this regard and reaffirm repeatedly as mentioned above, though table 1 comprises 7 independently groups, wish more to organize according to more advanced knowledge and test definition.Compare with all other component utilized, the exact number of group finally is the function of advanced person's compatibility knowledge, is envisioned that a large amount of groups will be defined.
This will make Control Computer can more accurately control preparation steps, improve the efficient of preparation, accelerate the speed of preparation.In addition, along with data base's complicated increase, the data base also can be proprietary, the control in independent storaging position data storehouse is protected greatly to it exactly, but for example, if the data base distributes to the processor of every dispensing machine, just do not had this protection.Preparation program
Fig. 4 b-h shows the hybrid plan or the method for another embodiment of the present invention, this scheme or method recognize and mix and use fluid preferably the use of final bag flushing liquor to be reduced to the probability of minimum degree, wherein shows the preferred embodiment of at least one dispensing machine work of definition with method that the nutrient formulation medicine is provided.The beginning of Fig. 4 b method for expressing or process (square frame 100), it occurs after prescription input Control Computer.
In another preferred embodiment of the present invention, at first controller 10 filters out prescription according to above-mentioned one or more methods.
Next step is to determine the scheme of making up a prescription (square frame 102), and this part depends on the kind of the equipment that makes up a prescription at present.
At this on the one hand, as mentioned above, only there is flow at high speed module dispensing machine 12 (Fig. 1) in hospital, other health-care facilities or pharmacy, are suitable for carrying under suitable flow at high speed speed the fluid of large volume.But, also have in health-care facilities under the situation of low speed flow module dispensing machine 12, just can be under the low speed flowing velocity delivered solution, can add the medicine of very little volume or quantity in the bag substantially.Therefore, under the situation of selecting large volume and small size dispensing machine especially for use, controller is determined preparation program (square frame 102), promptly determines to use which kind of scheme.Used program can be controlled flow at high speed speed (square frame 104), for example control flow at high speed module dispensing machine, and low speed flowing velocity (square frame 106), for example control low speed flow module dispensing machine, also can control high and low speed flowing velocity (square frame 108), for example two kinds of machines all will use, and perhaps independent dispensing machine 16 is suitable for the conveying of large volume and small size simultaneously.
Beginning is only with reference to flow at high speed, and controller only begins for calculatings (square frame 104) of making up a prescription of the flow at high speed equipment of making up a prescription, and comprising several calculating, will carry out this program for every kind of large volume medicine as a part of final bag.If use the weight number of medicine when carrying, do not use the volume number to carry when promptly carrying, just comprise calculating according to proportion, promptly the volume number conversion is become the weight number.In this regard, the linear module the when prescription opened uses input, i.e. the gram number of final solution, milliliter number or percent, if weighing of the medicine of carrying depended in the conveying of dispensing machine, this just needs software that these linear modules are converted to weight.For example, flow at high speed module dispensing machine 14 and the preparation of low speed flow module dispensing machine 12 operating weight units perhaps change middle or final container weight.
After calculating was finished, line 110 extended to Fig. 4 c, determined at this whether the prescription that contains lipid should at first be transported to lipid final bag (square frame 112), and this is set by the user.In this regard, the user wishes that lipid at first or at last is transported to final bag, and this is that the user can specified selection fully.This appointment is preferably according to standard, and standard is at first to set up before the dispensing machine in facility turns round.
This comprises all additives is ranked into compatibility group that this is to finish by the common medicine that divides into groups, shown in above-mentioned table 1.If lipid at first is transported to final bag, then determine the number and the required Xian's times N (square frame 114) of dashing of compatibility subgroup, then program is specified the order of carrying large volume, wherein at first carries lipid.In case determined order, then line 118 extends to Fig. 4 d, is sent to dispensing machine (square frame 120) in this instruction of operating dispensing machine.
In addition, controller 10 can use other user to set conveyance fluid, comprises that reflection mixes the setting (square frame 116,124) of the general rule of TPN.About mixing the general rule of whole non-enteral nutritions, comprise following content:
1. before calcium salt, add phosphate;
2. the volume of determining to add according to calcium solution in the fashionable TPN bag of calcium phosphate dissolubility;
3. unless need lipid as last additive, calcium should be the last additive that adds the TPN bag, if possible carries out once flushing always;
4. compatibility group is arranged according to the serial number identical with order by merging, unless identify specific exception.
If dispensing machine 14 has independent pipe that each source solution is led to final bag, controller 10 is set the pumpings order, joins in the final bag to guarantee fluid, mainly determine the pumping order be the fluid that enters bag with bag in the existing fluidic compatibility.
Referring to Fig. 4 c, if lipid is not at first to enter final bag, also determine the number of compatibility group, and the number of times (square frame 122) of required flushing, use one or more compound methods to determine to carry and produce the conveying instruction (square frame 120) that is sent to dispensing machine by line 126 final steps that represent, that extend to Fig. 4 d with the order that lipid is washed.
Seeing only has the low speed flowing circuit again, and it starts from only having the mobile preparation of low speed to calculate (square frame 106), and this is to be used to prepare the hybrid medicine prescription, and for example, this process is to use low speed flow module dispensing machine to finish.Even may have the flow at high speed equipment that makes up a prescription at the same area, if the amount of final bag to be added is quite little, then select the low speed dispensing machine that flows usually for use, for example be used for neonatal prescription or considerably less injection.
Begin to judge in the final bag and whether contained lipid (square frame 130).The reason of carrying out this judgement is, the prescription that has might be by two stages preparations, and the mobile component of large volume has been transported in the bag, then this bag is put into the nutrient of input trace on the low speed flow module.If in the bag lipid has been arranged, how to enter funnel or the middle mixing chamber that is present on the low speed flow module dispensing machine as for final bag flushing liquor, this will produce difference.
Program judges the bag whether contain lipid from prescription, if having, then checks whole mixing prescription, judges that lipid is whether in final bag or will be added in final bag.If then send the user notes whether whether having the lipid muddiness in hybrid medicine prescription subsequently inquiry (square frame 132).This is because if use the fluid in the final bag to wash, some lipid will remain in the funnel.These lipids are transported in a plurality of bags of back, and its quantity enough produces visible muddiness in solution.If in the current bag lipid is arranged, there is not lipid in the next bag, the not flushing of surface that contact with material in two bags, lipid just may make next bag muddy, and particularly previous bag is all the more so when having used final bag flushing liquor.Unit does not wish under the situation of lipid muddiness in health care, and needn't prepare this moment, but still be retained in the task, in other time preparation (square frame 134).If hospital receives the lipid muddiness, then, illustrate in funnel, to have lipid muddiness (square frame 136) by printer prints information warning (or by visual display).
If final bag does not contain lipid (square frame 130), if perhaps contain lipid but be indifferent to lipid muddiness (square frame 136), use dissolubility and compatibility table, continue to calculate preparation, what need keep firmly in mind is that flushing liquor can come from final bag (square frame 138).This step be for calculate, design these calculating be for the flushing a number of times be reduced to minimum level, so that efficient is brought up to maximum, this can use above-mentioned a kind of method.When carrying out this step, line 140 extends to Fig. 4 d, and then the conveying instruction to dispensing machine is sent to dispensing machine (square frame 142).
Height among the 4b with the aid of pictures again and low speed flow branch, initial step is to start device for formulating (square frame 108), and this need carry out conversion Calculation, with reference to the description (square frame 104) that only has flow at high speed to do, line 144 extends to Fig. 4 c, determines the number (square frame 146) of compatibility group and flushing at this.Basically, if whether this judgement is according to preparing of being write in the prescription, to have problems in the prescription.
Then judge (square frame 152) to whether containing lipid in the final bag.Lipid if desired, then to whether at first, last or carry lipid to judge (square frame 154) with other optimal way.Whether be at first, carry lipid at last or in the mode of optimizing, this, the mode of this design is in program if being user's preferential selection, in a single day the user defines this selection, and after this this selects with prescription irrelevant.Optimize and to mean usually always and at first add lipid.Like this, the preparation standard of user's foundation is determined the path of execution in step at first.If at first or in the mode of optimizing add, line 156 extends to Fig. 4 d and Fig. 4 e, and this step will be described below.If do not contain lipid in the final bag, line 158 extends to Fig. 4 d and Fig. 4 e, and step wherein is described below.If need lipid at last, line 160 extends to Fig. 4 d, and judging does not have whether the lipid prescription is stable (square frame 162).
If there is not lipid prescription medicine instability, program prompts user, if the last adding of lipid then can not prepare prescription, and the prompting user would need the pharmacists to check (square frame 164).Then, program judges whether that lipid at first is transported in the final bag (square frame 166), if not, the result does not carry out preparing (square frame 168).If at first carry lipid, then line 170 extends to Fig. 4 e, calculates the flushing number that comprises the lipid volume, and lipid at first is transported to final bag (square frame 172).
Seeing square frame 162 again, is stable if there is not lipid prescription medicine, and program is calculated all dissolubility that contain lipid, and lipid is transported to final bag (square frame 174) (Fig. 4 d) at last.Do not contain the calculating (square frame 174) of lipid dissolubility, based on calculating the volume calculation calcium phosphate dissolubility that may lack than the volume in the original screening thing.Therefore, for example, if 50ml lipid is arranged in the PN of cumulative volume 200ml, the assessment of calcium phosphate dissolubility will be carried out on 150ml.
Back (square frame 172 and 174) has been calculated in compatibility group and flushing, and program judges whether remove the outer cumulative volume of lipid surpasses funnel volume (square frame 176).If line 178 extends to Fig. 4 f, judge that in this program whether lipid be at first to add (square frame 180), if, program judge the washing time of source container flushing liquor whether can remain can the reception order flushing (square frame 182).If can, program enters compatible group, continues preparation, and required flushing liquor is from selected source container (square frame 184), and instruction is sent to dispensing machine (square frame 186).As mentioned above, the step of describing in the square frame 182 and 184 though can be divided into independent step on flow chart, is actually and is mutually related.This is because washing time is the function of compatibility group, in order to tell the place that flushing occurs, must determine compatibility group as mentioned above.
If the cumulative volume of removing lipid is no more than the volume of funnel, use the low speed flow module can finish preparation, in the funnel of low speed flow module dispensing machine, also can finish.Program judges whether to stop the source flushing liquor of drug solution to be used for final flushing liquor (square frame 188), if, then produce and stop, when final bag is prepared and be transported to the source flush volume of basic components and all other components in funnel, then, carry instruction to be sent to dispensing machine (square frame 192) with the preservation partial flushing funnel (square frame 190) that is transported to final bag flushing liquor.
In order to judge whether the source flushing liquor is stopped in when mixing in the funnel of the flushing liquor that dilution effect is not housed, and just needs the present fluid of screening, and to confirm whether allow to stop any material, whether the hybrid medicine that promptly obtains is stable.And, consider used quantity to finish flushing, the capacity of funnel is important.For example, if the volume of funnel is 50ml, and only have 30ml to be prevented from, then the funnel flushing is incomplete, and whether the user can make about this is enough judgements.Also considered to use purging method from the final flushing liquor of source component, for example sterilized water, glucose or aminoacid use the solution in the final bag to carry out the centre flushing, and the source flushing liquor of drug component is arranged in the final bag, it is retained in the final bag and is used for final flushing, and funnel is cleaned as much as possible.
If there are not enough source flushing liquors, program judges whether to remain with any amount of source flushing liquor and is used for final flushing (square frame 194).If, just keeping the source flushing liquor and be used for final flushing, all other components are prepared in funnel, with the partial flushing funnel of preserving (square frame 196).Then carry instruction to be sent to dispensing machine (square frame 198).
Be not used for final flushing if keep any amount of source flushing liquor, just preparation (square frame 200) in the funnel of not doing any flushing of all components, instruction is sent to dispensing machine (square frame 202).
It should be noted that square frame 152, if answer is not have lipid in the final bag, long-pending the extending to above the volumetrical path of funnel of hypothetical population judges whether at first to add lipid in the flow chart in the square frame 180, and this actual can not application is not because there is lipid.In this case, execution in step 182 and 184 o'clock source flushing liquors are from source container and/or final bag.As mentioned above, needs have been deleted in controller flushing of preferentially selecting for use and the preparation order to final bag flushing liquor.
Get back to square frame 204, if answer is negated, if perhaps contain lipid in the medicine, just at first carry lipid, need the flushing liquor (square frame 182) in the final bag, program judges whether lipid adds (square frame 206) at last, if not, whether program inquiry lipid muddiness can accept (square frame 208), if not, then can not continue preparation (square frame 210).If can accept, program produces the prompting (square frame 212) about the lipid muddiness.
If lipid can be carried at last, then program judges whether that the washing time of source flushing liquor can satisfy flushing and can carry out the acceptable order, and wherein once flushing is from final bag (square frame 214).If can, then analyze the compatibility group of prescription, carry out process for preparation, carry out between flushing in due course, preferred final rinse solution uses final bag, and source component (square frame 216) is used in all other flushing.In this manner, promptly use the inclusions flushing of final bag, the component in the final bag is diluted as wide as possible, makes the ultimate source container obtain flushing simultaneously.This instruction is sent to dispensing machine (square frame 218).
If whether the answer of square frame 214, line 220 extends to Fig. 4 g, and program judges whether that flushing subtracts 2, the number that (N-2) multiply by the flushing of source component can satisfy can the acceptance order flushing, wherein definite twice flushing is from final bag (square frame 222).If then carry out the step (square frame 224) of compatibility group and the step (square frame 226) that instruction is sent to dispensing machine again.If not, judge that then flushing subtracts 3 number, (N-3) (square frame 228) is if carry out Analysis of Compatibility (square frame 230) and instruction and be sent to dispensing machine (square frame 232).If not, N-4 is made judgement (square frame 234).If being judged as of square frame 234 is to carry out Analysis of Compatibility (square frame 236) and instruction once more and be sent to dispensing machine (square frame 238).If be judged as on online 240 not, program judges whether that then the source flushing liquor can satisfy final flushing (square frame 242), if carry out Analysis of Compatibility (square frame 244) once more and prepare instruction being sent to dispensing machine (square frame 246).
If not, program judges whether to stop the source solution of some to make to remove outer volume required less than funnel volume (square frame 248) of lipid.If answer then stops molten source, suitable source for being, drug component is prepared in funnel, and this part component of prevention is used to wash funnel (square frame 250), and move instruction is to dispensing machine (square frame 252).If not, program judges whether lipid (square frame 254) is arranged in the prescription, and if not, program is carried out preparation, and all flushings come from final bag (square frame 256), and instruction is sent to dispensing machine (square frame 258).If but had lipid, program would judge whether to be concerned about lipid muddiness (square frame 259).If not, provide warning prompt (square frame 260), if then do not carry out preparation (square frame 262).After providing warning prompt, continue preparation, all flushings come from final bag (square frame 256), carry instruction to be sent to dispensing machine (square frame 258).
When instruction is sent to dispensing machine (square frame 192,186 or the like), dispensing machine and controller use several method and measure to prepare.For example, controller 10 sends to instruction on the controller as dispensing machine 12,14,16 parts, perhaps controller straightforward manipulation dispensing machine, the perhaps method of combination in any, perhaps similar methods.
Except according to the preparation program that carries out in conjunction with the described mode of flow chart 4a-4h, the present invention also has other function.About this point, Control Computer 10 is checked the composition of every prescription medicine, and these prescription medicines are lined up formation in order and existed, and instruction is sent on the dispensing machine of compounding pharmaceutical.By checking the composition of every prescription medicine in the formation, determine that those contain the medicine of lipid, for example, those medicines that contain lipid are divided into one group, thereby do not relate to the lipid muddiness, preparation to the last contains the medicine of lipid.
As described in United States Patent (USP) 4653010, the prescription medicine can be according to component ordering or grouping commonly used.In embodiments of the present invention, can determine other grouping of required medicine, for example patient's type according to similar mode.The rearrangement of this prescription medicine in formation has the effect of productivity gain, because medical institutions' demand and this effect of needs.
Another important feature of the present invention relates to the ability of computer 10, promptly by the volume that adds every kind of component in the prescription medicine is increased predetermined quantity, user-defined excess volume is regulated, make the medicine that obtains identical with prescription, but volume is slightly high, set or relate to the required volume of degree of accuracy thereby compensation reaches the manager, the drug level that in prescription, needs very hour, thereby in fact the medicine of correct number flows to patient with required concentration.
Another key character of the present invention is the ability that computer 10 receives the convertible option of user, when activating, can be replaced the higher concentration component of dilution by above-mentioned low concentration component.Do not have a lot of patients under the situation of fluid restriction, with compatible flushing liquor, sterilized water for example dilutes the solution of higher concentration, will obtain the minimum prescription medicine of latent instability degree.In another one embodiment of the present invention, particularly when patient fluid limits, by considering that other component removes or minimize dilute solution as diluted fluid, controller 10 is determined stability of drug, uses above-mentioned method to determine during the medicine preparation and the stability after preparing.
In another embodiment of the inventive method, carry out the preparation program of the final bag 46 of excessive filling.As mentioned above, for the quantity that compensates medicine is wished excessive filling since the medication system this part can not medication.Even for example after medication, some solution is retained in the final bag.
According to feature of the present invention, designed the volume required method of excessive filling of setting especially.The volume settings of excessive filling becomes absolute value as an example, according to percent or the like, so that final bag has required especially volume.When this prescription of preparation, the new quantity of the method calculating drug component makes new medicine be equivalent to the prescription medicine fully but volume is bigger.
For definite appropriate group component, the medicine that controller 10 obtains according to different standard inspections judges whether the medicine that obtains can medication.For example, for the patient's who limits fluid, excessive filling will make the quantity of medicinal fluid surpass the quantity that is allowed.Produce this moment and report to the police, and error message is shown to the user.
In a further embodiment, the volume of medicine is adjusted or advised adjusting to controller 10, avoids the quantity of one or more components to be lower than predetermined concentration, for example corresponding to dispensing machine 12,14,16 desired minimum exact values.As an example, the quantity of component is 90% of minimum recommended value.Then controller increases the cumulative volume of medicine, makes the quantity of component reach minimum recommended value, and the prompting user has only the medication of part gained medicine to patient.
Should be understood that in the different preferred embodiments of the present invention, the arrangement of these steps can change.For example, the judgement of final medicine stability can be carried out before or after appropriate preparation program is judged.Report
Dispensing machine 12,14,16 in process for preparation and the preparation after can both with controller 10 communications.For example, the sensor of describing in the United States Patent (USP) 5927349 detects wrong source flow of solution and crosses a conduit 32, just transmits alarm signal, and this United States Patent (USP) at this as a reference.Similarly, in process for preparation or after the preparation, the accurate quantity that is transported to final bag 46 Chinese medicine components is sent to controller 10.
Receive the quantity of carrying component during the preparation, controller 10 is provided as notebook data to the pharmacists, perhaps these data is sent to the computer system 28 of hospital.Controller 10 can be adjusted to notebook data, so that the actual cost of the medicine that provided to be provided.As an example, some component enters container, only can receive once before abandoning.Therefore, if the used quantity of this component is lower than the quantity in container, controller 10 will be indicated the cost of entire container, rather than in medicine the cost of used that part of component.
From as can be seen above, described the method and apparatus that improved control prepares non-intestinal medicine above, thereby can faster, more effectively prepare non-intestinal medicine, and do not sacrificed any safety.And several characteristic wherein provides extra safety.The present invention has carried out extensive analysis to drug component, utilized known drug component feature, controlled dispensing machine in a new way, thereby these prescription medicines can reliably and safely be prepared, with known preparation principle contradiction not, but also consistent with the preferential selection of certain user's definition.
Described different embodiments of the invention though illustrate, should be understood that,, other modification, substituted and conversion is conspicuous for persons skilled in the art.

Claims (31)

1. equipment that is used to control at least one medical dispensing machine work in order to prepare the prescription medicine, is suitable for optionally the medical medicine of prescription quantity is transported to final container from the conveyer device of one source container by elongate hollow, and described equipment comprises:
Accountant with memorizer, memory stores is used for operating equipment and is used to control the instruction that dispensing machine prepares the prescription medicine, described memorizer comprises the data relevant with multiple drug component, be used to prepare the prescription medicine after these drug components are transferred, also comprise at least one working characteristic data that is subjected to the dispensing machine of equipment control in the memorizer;
Described accountant comprises at least one communication port, sets up communication with every dispensing machine being controlled and is connected;
Described accountant is suitable for receiving prescription, drug component on the identification prescription, determine the drug component compatibility each other, determine the sequence of batching products of component when preparation prescription medicine, and the instruction that will prepare the prescription medicine is sent to the dispensing machine that is used to prepare the prescription medicine.
2. equipment as claimed in claim 1 is characterized in that described accountant is suitable for the quantity of every kind of component is converted to the measurement unit that the dispensing machine of preparation prescription medicine can be carried.
3. equipment as claimed in claim 2 is characterized in that described accountant is suitable for the volume amount of each component in the prescription medicine is converted to weight by the proportion of component being multiply by its volume in the prescription medicine.
4. equipment as claimed in claim 1, it is characterized in that the relevant data of described and multiple drug component comprise the data base with a plurality of compatibility groups, every group has a kind of described drug component at least, and described data base illustrates each group and the compatibility of other group and/or the data of incompatibility in addition.
5. equipment as claimed in claim 4 is characterized in that described at least compatible group first comprises the component that contains lipid, and described compatible group second comprises sterilized water.
6. equipment as claimed in claim 4 is characterized in that described accountant determines the sequence of batching products of drug component, and this is that this basic principle comprises according to the blended basic principle of cover order in proper order:
Before calcium salt, add phosphate;
The volume of solution is determined the dissolubility of calcium phosphate in the prescription medicine when adding calcium;
Calcium is the last additive that adds in the prescription medicine.
7. equipment as claimed in claim 6, it is characterized in that described accountant determines number of times and the position of washing in the process of carrying drug component in order, flushing is a part of cleaning in the elongate hollow conveyer device near final container at least, and used rinse solution is with a kind of drug component that continues transported to final container is compatible down.
8. equipment as claimed in claim 6 is characterized in that described cleaning solution comes from an independent source container or final container.
9. equipment as claimed in claim 4, it is characterized in that described accountant comprises that at least one receives the port of input data, whether the drug component that is used to select to contain lipid will determine the order of carrying, so that contain the conveying of lipidic component, with respect to all other medicines components, be first or last.
10. equipment as claimed in claim 1, it is characterized in that described communication connect comprise that Internet connection, LAN connect and wireless connections at least a.
11. equipment as claimed in claim 1, it is characterized in that described equipment is suitable for using for the user two positions at least, each position has a dispensing machine at least, the printer of a Print Label, and has the terminal that display and being used to is imported the input equipment of prescription medicine, the selectable equipment relevant with dispensing machine work with equipment.
12. equipment as claimed in claim 11 is characterized in that described accountant is suitable at two dispensing machines of each Position Control, a dispensing machine wherein is suitable for carrying drug component under than the obviously high flowing velocity of another dispensing machine.
13. equipment as claimed in claim 9, it is characterized in that described accountant is suitable for checking the prescription medicine and judges that whether lipidic component is a part wherein, judge whether the user opposes the prescription medicine that will prepare subsequently, might become turbid, because lipidic component is present in the prescription medicine of present preparation, indicate the user under the situation of opposition to stop to prepare the prescription medicine, the user indicate send under the unopposed situation this may muddy alarm.
14. equipment as claimed in claim 9, it is characterized in that described accountant is suitable for receiving multiple prescription medicine, they are lined up the preparation formation in order, described accountant is suitable for checking every kind of prescription medicine in the formation, determine the wherein general character of predetermined component, to the prescription medicine in described formation rearrangement, the described prescription medicine branch of this predetermined component with general character at one group.
15. equipment as claimed in claim 1, it is characterized in that described accountant is suitable for finding out the data relevant with patient characteristics, the prescription medicine of being prepared is patient's medication, it is characterized in that the patient characteristics data comprise patient's name at least, age and body weight, described accountant is suitable for finding out the data about a plurality of kind patients, each kind has predetermined limits, to the effective drug component of this kind, described accountant be suitable for relatively being used for a kind of described kind patient prescription medicine component quantity and when component exceeds the predetermined limits of component described in the prescription medicine, send signal.
16. equipment as claimed in claim 15, the kind that it is characterized in that described patient comprise adult, paediatric, neonate and patient premature infant.
17. equipment as claimed in claim 15 is characterized in that described signal is suitable for stoping the preparation of prescription medicine.
18. equipment as claimed in claim 15, it is characterized in that described patient characteristics data also comprise the history of patient body weight and medication in the past period, described blood processor is suitable for preparing the report about patient, is included in the development of patient body weight in a period of time in the future.
19. equipment as claimed in claim 1, it is characterized in that described accountant is suitable for finding out the data relevant with patient characteristics, the prescription medicine of being prepared is patient's medication, it is characterized in that the patient characteristics data comprise patient's name at least, age and body weight, described accountant is suitable for finding out the data about drug component quantity limit, these drug components can be added into the prescription medicine of especial patient, described accountant is suitable for the quantity of component in comparison patient's the prescription medicine, and need to authorize logon data, explain the reason that surpasses one or more this limits.
20. equipment as claimed in claim 19, it is characterized in that authorizing logon data is the data of at least one doctor or pharmacists's login.
21. equipment as claimed in claim 19 is characterized in that lacking and explains that the required data of reason that exceed one or more this limits cause described accountant to stop to prepare described prescription medicine.
22. equipment as claimed in claim 1, it is characterized in that described memorizer comprises the data about amount of fluid, this part fluid is that to be full of dispensing machine through the conveyer device of elongate hollow to final container from source container needed, and described blood processor is suitable for the quantity of drug component is increased to and is full of the required quantity of dispensing machine.
23. equipment as claimed in claim 1, it is characterized in that described blood processor is suitable for receiving the convertible input about preparation prescription medicine, diluent and the quite little other component of one or more quantity that described first component of first component, some of predetermined quantity is arranged in the prescription medicine, it is characterized in that the total prescription medicine is a predetermined sum, described accountant is suitable for quite little described one or more annexing ingredients of usage quantity, the diluent that replaces equal volume, thus can not surpass predetermined sum.
24. the method for at least one medical dispensing machine work of a control, in order to prepare the prescription medicine, described dispensing machine is suitable for optionally the drug component of prescription quantity is transported to final container from the conveyer device of independent source container by elongate hollow, described method has been used the accountant with memorizer, memory stores is used for operating equipment and is used to control the instruction that dispensing machine prepares the prescription medicine, described memorizer comprises the data relevant with multiple drug component, after being transferred, these drug components are used to prepare the prescription medicine, also comprise at least one working characteristic data that is subjected to the dispensing machine of equipment control in the memorizer, accountant comprises that at least one communication port is used for setting up communication with every in check dispensing machine and is connected, and said method comprising the steps of:
Receive the prescription medicine at accountant;
The quantity of identification and definite prescription medicine Chinese medicine component;
Determine the compatibility each other of prescription medicine;
Determine sequence of batching products in preparation prescription medicine process Chinese medicine component; With
The instruction of preparation prescription medicine is sent at least one dispensing machine that is used to prepare the prescription medicine.
25. method as claimed in claim 24 is characterized in that discerning step with quantification and comprises the quantity of every kind of drug component is converted to the unit of quantity that the function of making up a prescription of preparation prescription medicine is used to carry.
26. method as claimed in claim 24, it is characterized in that the data relevant with multiple drug component comprise the data base of the drug component that is categorized into a plurality of groups, every group component has the common compatibility, described data base illustrates each group and the compatibility of other group and/or the data of incompatibility in addition, and the step of described definite compatibility also comprises:
Check the medicine prescription, the specific group grouping that identification wherein exists, and each group is with respect to the compatibility of other group of discerning.
27. method as claimed in claim 26, the step that it is characterized in that described definite order also comprises: the order of determining medicine, so that it is mutual compatible component joins final container side by side or continuously in the group, and consistent with known general mixing rule.
28. method as claimed in claim 27 is characterized in that described known general mixing rule comprises:
Before calcium salt, add phosphate;
When adding calcium according to the prescription medicine in the volume of solution determine the dissolubility of calcium phosphate; With
Calcium adds in the prescription medicine at last.
29. method as claimed in claim 26, the step that it is characterized in that described definite order also comprises: the order of determining medicine, so that mutual compatible component joins final container continuously in the group, thereby the number of times of flushing is reduced to minimum, washing is in order to clean the hollow conveyer device near final container, because the component in group is incompatible with sequenced next another component in organizing of carrying.
30. method as claimed in claim 24, the step that it is characterized in that described identification and definite drug component quantity also comprises in the identification prescription medicine lipid as component, if the user selects to stop to prepare the prescription medicine, provide the option that stops to prepare the prescription medicine for the user.
31. method as claimed in claim 30 is characterized in that giving the alarm under the situation that the medicine prescription that contains lipid does not have to stop, described alarm is: owing to there is lipid, the prescription medicine of next preparation may show muddy phenomenon.
CN00803366A 1999-12-03 2000-12-01 Method and apparatus for control of compounding pharmaceutical admixtures Pending CN1338972A (en)

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ATE332739T1 (en) 2006-08-15
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DE60029301D1 (en) 2006-08-24
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