CN102353436A - Method and instrument for analyzing medicament weighing record - Google Patents
Method and instrument for analyzing medicament weighing record Download PDFInfo
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- CN102353436A CN102353436A CN2011101651025A CN201110165102A CN102353436A CN 102353436 A CN102353436 A CN 102353436A CN 2011101651025 A CN2011101651025 A CN 2011101651025A CN 201110165102 A CN201110165102 A CN 201110165102A CN 102353436 A CN102353436 A CN 102353436A
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Abstract
The invention discloses a method and an instrument for analyzing a medicament weighing record, which are used for checking the weight difference, the loading difference and the minimum loads of medicaments. The method for analyzing the medicament weighing record comprises the following steps of: inputting experiment parameters; acquiring balance weighing data; processing the acquired weighing data to obtain a conclusion which indicates whether the weighing data are accordant with specifications or whether reexamination is required; saving the received data, a processing result and the experiment parameters; saving the using record of the instrument; and inquiring, printing and outputting the saved information. In the technical scheme, the instrument can be connected with balances of a plurality of models, has the functions of storing and inquiring original data and can immediately and automatically generate a detection report and the using record of the instrument, so that item review is easier and more convenient, the working efficiency is increased, and errors caused by human factors are reduced.
Description
Technical field
The present invention relates to a kind of medicine weighing log analysis methodology and instrument, particularly a kind of weighing log analysis methodology and instrument that is used for weight differential, content uniformity and the minimum fill inspection of medicine.
Background technology
Medicine is meant and is used for preventing, treating, diagnose the illness, and physiological function and the regulation of on purpose regulating body has that indication or function cure mainly, the material of usage and consumption, comprises people's medication and veterinary drug.Drug dose unit all in the lump according to the rules usage and dosage take or use just and can effectively prevent, treat, diagnose the illness, the excessive use medicine can produce toxic and side effect, dosage then can not produce a desired effect inadequately.Weight differential, content uniformity and minimum fill inspection are the important inspection items of drug dose unit's homogeneity check; People from various countries medication and veterinary drug pharmacopeia are all stipulated weight differential, content uniformity and the minimum fill of medicine; The limit of regulation is generally a plurality of intervals, and there is different limit requirements in different intervals, and as in 2010 editions appendix I of the Pharmacopoeia of the People's Republic of China B injection injection content uniformity being defined as: every bottle of (propping up) loading amount is compared with average loading amount; Should meet following regulation; Against regulation if any 1 bottle (propping up), should get 10 bottles of (propping up) retrials in addition, should be up to specification; Average loading amount is that the following content uniformity limit of 0.05g and 0.05g is ± 15%, and 0.05g is above, and 0.15g is above to being ± 7% below the 0.50g to being ± 10% below the 0.15g, and 0.50g is above to be ± 5%.The general step of these inspections is: draw samples, sample is successively placed on weighing on the balance, and write down weighing data one by one, calculate nt wt net weight, nt wt net weight mean value then, calculated difference relatively judges whether up to specification with the limit of stipulating.
Utilizing special-purpose balance printer at present is known with weighing data output.Yet still have a lot of shortcomings and inconvenience in the inspection of these projects: manual calculation and judgement go wrong inefficiency easily; Original weighing data can't the direct electron storage, inquiry etc.; Can not directly generate survey report and instrument service recorder; Be unfavorable for realizing information system management.
Summary of the invention
For realizing above-mentioned purpose; The present invention provides a kind of medicine weighing log analysis methodology that is specifically designed to drug weight difference, content uniformity and minimum fill inspection; The inspection of project is carried out according to the pharmacopeia regulation; Contain the multiple formulation of people's medication and veterinary drug, Chinese medicine chemical drug and biological products, experimental implementation, record and report meet the GMP requirement.This method may further comprise the steps:
1) experiment parameter input;
2) obtain the balance weighing data;
3) weighing data that obtains is carried out data processing;
Said processing comprises: the mean value of the weighing data that obtains is calculated in inspection for weight differential; For content uniformity and minimum fill inspection the gross weight amount of obtaining, drug packaging weight weighing data are obtained loading amount through calculating; Difference value between calculated weight/loading amount mean value and each sample and mean value or the sign value then; The criterion of defined under parameters value that calculates and the given formulation item of pharmacopeia is compared, draw whether up to specification after compared result is analyzed or need the conclusion of retrial;
4) received data and result and experiment parameter are preserved;
5) information of being preserved is inquired about and printout;
6) the instrument service recorder is preserved.
The method that has the input of quickening information in the step 1).System has the nomenclature of drug private database, and integrated all nomenclature of drugs of pharmacopeia are accelerated the nomenclature of drug input speed through the initial prompt input method; This external system is saved in the last experiment parameter in the internal memory automatically, when testing next time, reads automatically, simplifies the input of repetition parameter.
Step 2) said balance weighing data comprise identical or different balance interface type and data transmission specification data.Said balance different interface type comprises serial port, LPT, USB mouth and meets at least a in the self defined interface of above-mentioned Data Transport Protocol that said different pieces of information transmission specification comprises at least one in message transmission rate, data bit length, verification, the position of rest length.System searches for balance coupling related protocol automatically, and whole process need not manual intervention, has both made things convenient for experiment, can avoid again because the loss of data that wrong setting causes.
In the step 5) information of being preserved is inquired about and printout, can check institute's content recorded, or export through the common ink-jet or the laser printer that meet PCL language printing standard through display.Information format unification attractive in appearance is conveniently had access to, and is convenient to medicine prison department and internal institution and verifies.
Automatically write down use information such as each switching on and shutting down time, institute's weighing sample title, operator's name in the step 6), the record of formation generates the instrument operation report according to the time range of being formulated, and is recorded in the external memory storage of internal storage or appointment.Automatically record is more convenient, avoids the people to go wrong for forgetting record or record, meets the equipment of drug inspection in the GSP and the requirement that instrument should have usage log better.
Because present laboratory institute employing balance brand and model disunity; Interface and communications protocol that the different brands balance externally transmits data also have nothing in common with each other; This method can connect one or connect many identical or different model balances simultaneously and carry out the weighing record analysis; Working simultaneously is independent of each other, and integrates lab resources, practices thrift buying expenses.
System possesses one or more authenticating user identification schemes, comprises that protection of software startup cryptoguard, administrator right and radio-frequency card are swiped the card to start protection, and preferred three kinds of schemes are used simultaneously, are convenient to instrument management, increase the security and the reliability of check data.
The present invention also provides a kind of medicine weighing recording assay device of realizing said method, comprising:
1) load module is used to import experiment parameter
2) data acquisition module is used for obtaining weighing data from balance;
3) data processing unit is used for the weighing data that obtains is carried out data processing;
Said processing comprises: the mean value of the weighing data that obtains is calculated in inspection for weight differential; For content uniformity and minimum fill inspection the gross weight amount of obtaining, drug packaging weight weighing data are obtained loading amount through calculating; Difference value between calculated weight/loading amount mean value and each sample and mean value or the sign value then; The criterion of defined under parameters value that calculates and the given formulation item of pharmacopeia is compared, draw whether up to specification after compared result is analyzed or need the conclusion of retrial;
4) storer is used to preserve the received data of instrument and result, experiment parameter and instrument service recorder;
5) display module and printing drive module are inquired about and printout the information of being preserved.
The invention has the beneficial effects as follows:
The laboratory technician need only be placed on the sample that extracts on the balance as requested, and instrument just provides survey report automatically, makes that weight differential, content uniformity and minimum fill inspection are more simple and convenient, increases work efficiency, and reducing the people is the mistake that causes; Instrument has the storage and the query function of raw data and survey report and can generate the instrument service recorder automatically; Information format unification attractive in appearance; Conveniently have access to, be convenient to medicine prison department and internal institution and verify, meet the requirement of people's medication and veterinary drug quality of production management regulation better.
Description of drawings
In order to be illustrated more clearly in the embodiment of the invention; To do simple introduction to the accompanying drawing of required use among the embodiment below; Obviously, the accompanying drawing in describing below only is some embodiments of the present invention, for those of ordinary skills; Under the prerequisite of not paying creative work, can also obtain other accompanying drawing according to these accompanying drawings.
Fig. 1 is the process flow diagram of the medicine weighing log analysis methodology of the embodiment of the invention 1;
Fig. 2 is the data acquisition interface shown in Fig. 1;
Fig. 3 is the content uniformity analysis report that prints shown in Fig. 1;
Fig. 4 is the instrument service recorder of the generation shown in Fig. 1;
Fig. 5 is a medicine weighing recording assay device structural representation.
Embodiment
To combine the accompanying drawing in the embodiment of the invention below, the technical scheme in the embodiment of the invention is carried out clear, intactly description, obviously, described embodiment only is the present invention's part embodiment, rather than whole embodiment.Based on the embodiment among the present invention, those of ordinary skills are not making under the creative work prerequisite, and the every other embodiment that is obtained belongs to protection domain of the present invention.
Embodiment 1: medicine weighing log analysis methodology of the present invention is described, and the process flow diagram of this method is as shown in Figure 1, comprising:
The S10 user rs authentication
The effect of user rs authentication step is that the user is carried out authentication, and authentication can avoid the unauthorized user data accident that maloperation causes to instrument to lose or damage, and is convenient to instrument management, the integrality and the reliability of protection experimental data.In the instance of the present invention, user rs authentication can adopt simple input username and password mode to login, and also can accomplish login through the non-contact radio-frequency card mode of swiping the card.
The search of S20 balance
Because present laboratory institute employing balance brand and model and disunity; Interface and communications protocol that the different brands balance externally transmits data also have nothing in common with each other; Though the various brands balance all is illustrated its data-interface definition and host-host protocol; But need manual in its host-host protocol such as baud rate, data bits, parity checking, stop figure place etc. and set, just can output in the general device such as dedicated printer that is attached thereto.Because the user is difficult to grasp the interface definition and concrete host-host protocol establishing method of each balance; Present embodiment is according to the characteristics of each balance Data Transport Protocol; Added automatic search module, instrument can be selected the Data Transport Protocol that is fit to automatically according to the data that the balance that connected sends, and specific operation process is: when data and the current employing data acquisition protocol of instrument not simultaneously; Self protocol rule is analyzed and revised to instrument to received data after balance sent data; When revised agreement was consistent with Data Transport Protocol that balance sends, instrument provided prompting and preserves current protocol contents, and whole process need not manual intervention; Both made things convenient for experiment, avoided again because the loss of data that wrong setting causes.
The S30 experimental technique is selected
In the inspection of drug dose unit's homogeneity; Stipulated the index that weight differential, content uniformity, 3 kinds of need of minimum fill inspection are checked through balance weighing; Present embodiment is put into the experimental technique storehouse with above-mentioned 3 kinds of methods together with the immediate data recording method, makes system suitability wider.
The input of S40 parameter
Before the experiment, the user need import parameters such as formulation, sample title, lot number, source, test basis, humiture, and this method is carried out the optimal design of two aspects to input method.At first, design the medicine name special input method, only needed the input Pinyin initial; Can carry out nomenclature of drug and import fast, this input method contains the medicine name of all pharmacopeia regulations, need not typing in advance; Directly use to get final product, for example: in the time of importing " gentamicine sulphate injection ", only need input " lsqd "; System can enumerate out with all medicines that satisfy the initial condition automatically, supplies the user to select input.Secondly, system is saved in the last experiment parameter in the internal memory automatically, when testing next time, reads automatically, simplifies the input of repetition parameter.
The S50 data acquisition
Present embodiment can be gathered many balance data simultaneously, in addition, according to the pharmacopeia specified standard in drug weight difference, content uniformity and minimum fill detect; To the pairing collection quantity of different samples condition of different; Automatically judge that system stops to receive automatically after the quantity of arrival regulation, and next step operation is carried out in prompting; Shown in the data acquisition interface as shown in Figure 2; Stipulated that in experiment sample size is 5, instrument stops to receive data and providing prompting after full 5 of this group data acquisition automatically.
The S60 data processing
Data acquisition is calculated, and is stored in the computation process variable subsequent use the desired net content of check criteria, net content mean value, difference percentage, isoparametric one or more data of standard deviation after finishing.
S70 result judges
Utilize the process variable that obtains in the data processing step,, check result is judged with reference to the criterion as a result of pharmacopeia regulation; And provide this part report conclusion whether up to specification automatically; Make the prompting that increases amount of sampling and carry out retrial for critical qualified situation, for example: in the inspection of parenteral solution content uniformity, get 5 samples earlier; If 1 go beyond the limit, system will point out and need to extract 10 in addition and carry out retrial.
The S80 printed report
Experiment parameter, the data of being gathered and result are judged related content generation standard reports such as conclusion, the printer of printing standard through any a PCL of meeting is then exported reporting printing, is the content uniformity analysis report that prints like Fig. 3.
S90 reports storage
After generating report; The user can store resulting report through manual mode or automatic mode, and in the automatic mode storage, system generates store path and file automatically according to proving time, sample title and lot number; Simplify the operation course, reach the permanent preservation of check data.
S100 generates the instrument service recorder
After experiment finished, system was a unit with the certain hour section, forms instrument operation report as shown in Figure 4 automatically, realized that the electronization of instrument service recorder stores.
Embodiment 2: medicine weighing recording assay device of the present invention is described; This apparatus structure synoptic diagram is as shown in Figure 5, comprising: data processing module 100, data acquisition module 200, memory module 300, the module of swiping the card 400, display module 500, printing drive module 600, load module 700.
The module of swiping the card 400 is used for user's login authentication, and load module 700 is used for the input of experiment parameter etc.Data acquisition module 200 obtains the balance data of identical or different interface type and data transmission standard; Transferring to data processing module 100 handles; Said processing comprises: the mean value of the weighing data that obtains is calculated in inspection for weight differential; For content uniformity and minimum fill inspection the gross weight amount of obtaining, drug packaging weight weighing data are obtained loading amount through calculating; Difference value between calculated weight/loading amount mean value and each sample and mean value or the sign value then; The criterion of defined under parameters value that calculates and the given formulation item of pharmacopeia is compared, draw whether up to specification after compared result is analyzed or need the conclusion of retrial.Data that memory module 300 storing apparatus are received and result, experiment parameter and instrument service recorder.Display module 500 is inquired about and printout with 600 pairs of data recording of being preserved of printing drive module and instrument service recorder.
The module of swiping the card 400 can be supported simple user name password authentification, also can support the stored value card formula login authentication of withholing.
To the above-mentioned explanation of the disclosed embodiments, make this area professional and technical personnel can realize or use the present invention, will be conspicuous concerning those skilled in the art to the multiple modification of these embodiment.Therefore, the present invention will can not be restricted to these embodiment shown in this paper, but will meet and novel features disclosed herein the wideest corresponding to scope.
Claims (10)
1. a medicine weighing log analysis methodology is used for drug weight difference, content uniformity and minimum fill inspection, it is characterized in that comprising:
1) experiment parameter input;
2) obtain the balance weighing data;
3) weighing data that obtains is carried out data processing;
Said processing comprises: the mean value of the weighing data that obtains is calculated in inspection for weight differential; For content uniformity and minimum fill inspection the gross weight amount of obtaining, drug packaging weight weighing data are obtained loading amount through calculating; Difference value between calculated weight/loading amount mean value and each sample and mean value or the sign value then; The criterion of defined under parameters value that calculates and the given formulation item of pharmacopeia is compared, draw whether up to specification after compared result is analyzed or need the conclusion of retrial;
4) received data and result and experiment parameter are preserved;
5) information of being preserved is inquired about and printout;
6) the instrument service recorder is preserved.
2. experiment parameter input according to claim 1 is characterized in that having the method that adds the fast parameter input.
3. balance weighing data according to claim 1 is characterized in that comprising identical or different balance interface type and data transmission specification data.
4. according to claim 1 the information of being preserved is inquired about and printout, it is characterized in that and to check institute's content recorded or print the printer of standard and export through display through meeting the PCL language.
5. the preservation of instrument service recorder according to claim 1; It is characterized in that writing down automatically each switching on and shutting down time, institute's weighing sample title, operator's name; The record that forms generates the instrument operation report according to the time range of being formulated, and is recorded in the external memory storage of internal system storer or appointment.
6. medicine weighing log analysis methodology according to claim 1 is characterized in that connecting one or connect many identical or different model balances simultaneously and carry out record analysis.
7. medicine weighing log analysis methodology according to claim 1 is characterized in that possessing one or more authenticating user identification schemes.
8. medicine weighing recording assay device of implementing claim 1 method is characterized in that comprising:
1) load module is used to import experiment parameter
2) data acquisition module is used for obtaining weighing data from balance;
3) data processing unit is used for the weighing data that obtains is carried out data processing;
Said processing comprises: the mean value of the weighing data that obtains is calculated in inspection for weight differential; For content uniformity and minimum fill inspection the gross weight amount of obtaining, drug packaging weight weighing data are obtained loading amount through calculating; Difference value between calculated weight/loading amount mean value and each sample and mean value or the sign value then; The criterion of defined under parameters value that calculates and the given formulation item of pharmacopeia is compared, draw whether up to specification after compared result is analyzed or need the conclusion of retrial;
4) storer is used to preserve the received data of instrument and result, experiment parameter and instrument service recorder;
5) display module and printing drive module are inquired about and printout the information of being preserved.
9. medicine weighing recording assay device according to claim 8 is characterized in that connecting simultaneously many identical or different model balances and carries out record analysis.
10. medicine weighing recording assay device according to claim 8 is characterized in that having the radio-frequency card module of swiping the card.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2011101651025A CN102353436A (en) | 2011-06-20 | 2011-06-20 | Method and instrument for analyzing medicament weighing record |
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| CN2011101651025A CN102353436A (en) | 2011-06-20 | 2011-06-20 | Method and instrument for analyzing medicament weighing record |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103512641A (en) * | 2013-10-21 | 2014-01-15 | 辽宁新纳斯消防检测有限公司 | Automatic quality measurement system in constant temperature and humidity box |
| CN104515576A (en) * | 2014-12-23 | 2015-04-15 | 广州杰信检验技术服务有限公司 | High-efficiency inputting and testing method of chemical detection sample weighing data |
| CN104991979A (en) * | 2015-07-09 | 2015-10-21 | 熊贝贝 | Laboratory data processing method and processing system |
| CN105737508A (en) * | 2016-01-27 | 2016-07-06 | 青岛海尔科技有限公司 | Method and device for identifying medical freezer samples |
| CN105953879A (en) * | 2016-06-03 | 2016-09-21 | 北京智衡物联科技有限公司 | Material weighing terminal |
| CN105953882A (en) * | 2016-06-03 | 2016-09-21 | 北京智衡物联科技有限公司 | Weighing system |
| CN110353995A (en) * | 2019-06-13 | 2019-10-22 | 江苏康缘药业股份有限公司 | A kind of detection method of capsule preparations loading amount deviation |
| CN110703711A (en) * | 2019-10-24 | 2020-01-17 | 信远德怡医疗科技（北京）有限公司 | Powder blending quality control system and method |
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2011
- 2011-06-20 CN CN2011101651025A patent/CN102353436A/en active Pending
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103512641A (en) * | 2013-10-21 | 2014-01-15 | 辽宁新纳斯消防检测有限公司 | Automatic quality measurement system in constant temperature and humidity box |
| CN104515576A (en) * | 2014-12-23 | 2015-04-15 | 广州杰信检验技术服务有限公司 | High-efficiency inputting and testing method of chemical detection sample weighing data |
| CN104515576B (en) * | 2014-12-23 | 2017-01-25 | 广州杰信检验技术服务有限公司 | High-efficiency inputting and testing method of chemical detection sample weighing data |
| CN104991979A (en) * | 2015-07-09 | 2015-10-21 | 熊贝贝 | Laboratory data processing method and processing system |
| CN105737508A (en) * | 2016-01-27 | 2016-07-06 | 青岛海尔科技有限公司 | Method and device for identifying medical freezer samples |
| CN105737508B (en) * | 2016-01-27 | 2018-11-27 | 青岛海尔科技有限公司 | Medical refrigerator specimen discerning method and device |
| CN105953879A (en) * | 2016-06-03 | 2016-09-21 | 北京智衡物联科技有限公司 | Material weighing terminal |
| CN105953882A (en) * | 2016-06-03 | 2016-09-21 | 北京智衡物联科技有限公司 | Weighing system |
| CN110353995A (en) * | 2019-06-13 | 2019-10-22 | 江苏康缘药业股份有限公司 | A kind of detection method of capsule preparations loading amount deviation |
| CN110353995B (en) * | 2019-06-13 | 2021-10-01 | 江苏康缘药业股份有限公司 | Method for detecting loading deviation of capsule preparation |
| CN110703711A (en) * | 2019-10-24 | 2020-01-17 | 信远德怡医疗科技（北京）有限公司 | Powder blending quality control system and method |
| CN110703711B (en) * | 2019-10-24 | 2021-03-30 | 信远德怡医疗科技（北京）有限公司 | Powder blending quality control system and method |
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Application publication date: 20120215 |