CN111086701B - Powder-liquid double-chamber bag liquid medicine online preparation and filling system and method - Google Patents
Powder-liquid double-chamber bag liquid medicine online preparation and filling system and method Download PDFInfo
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Abstract
The invention relates to a powder-liquid double-chamber bag liquid medicine online preparation and filling system and method, belongs to the technical field of double-chamber bag preparation, and aims to solve the problems of low liquid medicine quality and low filling efficiency caused by preparation and filling separation and activated carbon residue in the traditional process. The system comprises a liquid preparation tank, a buffer tank and a filling gun head, wherein the filling gun head is arranged on the buffer tank, a liquid outlet of the liquid preparation tank is communicated to a liquid inlet of the buffer tank through a main pipeline, a liquid outlet of the buffer tank is communicated to the liquid preparation tank through a first circulating pipeline to form liquid medicine circulation, and a main valve, a circulating pump, a first switching valve, a 1.0 mu m filter, a 0.45 mu m filter and a 0.22 mu m filter are sequentially arranged on the main pipeline from one end of the liquid outlet of the liquid medicine tank to one end of the liquid inlet of the buffer tank. The invention has the effects of effectively solving the problem of activated carbon residue and improving the production quality and efficiency of the powder-liquid double-chamber bag.
Description
Technical Field
The invention relates to the technical field of double-chamber bag preparation, in particular to a powder-liquid double-chamber bag liquid medicine online preparation and filling system and method.
Background
The powder-liquid double-chamber bag product relies on the special cold-solder technique, the antibiotic medicine powder and the solvent are instantly dissolved in a closed system, the possible secondary pollution in the conventional medicine dispensing process is avoided in clinical use, the operation of medical staff is convenient, the configuration flow and time are shortened, and the medicine safety of a patient is more effectively ensured.
The existing powder-liquid medicine preparation is generally separated from the powder-liquid double-chamber bag filling, when liquid medicine (solvent) is prepared, raw materials and preparation liquid are added into a liquid preparation tank, activated carbon is added for purification, then the liquid medicine is filtered through a filter, and due to the existence of the activated carbon, the liquid medicine needs to be preliminarily filtered through activated carbon filtering equipment.
However, in the actual production process, the activated carbon filtering equipment cannot filter the activated carbon completely, and due to the long-time operation of the equipment, the activated carbon and other impurities are very easy to cause filter blockage, even damage to a filter element, and frequent shutdown cleaning and maintenance are needed. The production of two rooms bag requires very high to the cleanliness factor, often overhauls after accomplishing, still need carry out washing again, disinfect to this filling line, and this filling efficiency and the production efficiency that has influenced two rooms bag greatly lead to the quality of same batch of two rooms bag to be different very easily, and the active carbon can not be filtered clean and cause the residue, influences the quality of liquid medicine very much and the continuous preparation of liquid medicine. How to avoid the activated carbon residue and improve the filling efficiency becomes an important improvement direction in the field.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a powder-liquid double-chamber bag liquid medicine online preparation and filling system and method which can integrate liquid medicine preparation and filling, effectively solve activated carbon residue and improve the production quality and efficiency of a powder-liquid double-chamber bag.
One of the above objects of the present invention is achieved by the following technical solutions: a powder-liquid double-chamber bag liquid medicine online preparation and filling system comprises a liquid preparation tank, a buffer tank and a filling gun head, wherein the filling gun head is arranged on the buffer tank, a liquid outlet of the liquid preparation tank is communicated to a liquid inlet of the buffer tank through a main pipeline, a liquid outlet of the buffer tank is communicated to the liquid preparation tank through a first circulating pipeline to form liquid medicine circulation, and a main pipeline is sequentially provided with a main valve, a circulating pump, a first switching valve, a 1.0 mu m filter, a 0.45 mu m filter and a 0.22 mu m filter from one end of the liquid outlet of the liquid medicine tank to one end of the liquid inlet of the buffer tank.
The invention in a preferred example may be further arranged to: and a pressure gauge and a pressure regulating valve are sequentially arranged on the first circulating pipeline from one end of the liquid outlet of the buffer tank to the liquid distribution tank.
The invention in a preferred example may be further arranged to: the circulating pump is characterized by further comprising a second circulating pipeline and a second switching valve, one end of the second circulating pipeline is communicated to the liquid distribution tank, the other end of the second circulating pipeline is communicated to a main pipeline between the circulating pump and the first switching valve, and the second switching valve is arranged on the second circulating pipeline.
The invention in a preferred example may be further arranged to: a sampling port is arranged on a main pipeline between the 0.22 μm filter and the buffer tank.
The invention in a preferred example may be further arranged to: the filter element of the 1.0 μm filter and/or the 0.45 μm filter and/or the 0.22 μm filter is a PP filter element or a PES filter element.
The second purpose of the invention is realized by the following technical scheme: the method is implemented by adopting the online preparation and filling system of the powder-liquid double-chamber bag liquid medicine, and comprises the following steps:
a. adding 80% of water for injection into the liquid preparation tank, adding the raw materials, and dissolving to 100%;
b. opening the main valve and the first switching valve, pumping the liquid medicine in the liquid preparation tank into the main pipeline by the circulating pump, and filtering the liquid preparation in sequence by 1.0 μm, 0.45 μm and 0.22 μm;
c. filtered liquid medicine gets into the buffer tank to directly carry out quantitative filling to the two room bags of powder liquid through the filling head on the buffer tank, the liquid medicine circulates back to in joining in marriage the liquid jar through second circulation pipeline simultaneously.
The invention in a preferred example may be further arranged to: after the liquid medicine is filtered by 0.22 mu m, the liquid medicine is checked on a pipeline before entering a buffer tank for filling, and insoluble particles and liquid medicine endotoxin are mainly detected.
The invention in a preferred example may be further arranged to: in the process of filling the liquid medicine, the pressure in the buffer tank is regulated to 1.5Mpa by a pressure regulating valve arranged on the second circulating pipeline.
In summary, the present invention includes at least one of the following beneficial effects:
1. the system and the method of the invention omit the step of adding activated carbon for purification, filter the liquid medicine by sequentially carrying out filtering apertures of 1.0 μm, 0.45 μm and 0.22 μm on the liquid medicine, do not need to be additionally provided with activated carbon filtering equipment, can achieve better liquid medicine quality on the whole, avoid the residue of the activated carbon, reduce the step of preparing the liquid medicine, reduce the loss of raw materials and simultaneously reduce the occupied space of the equipment; meanwhile, the preparation and filling of the liquid medicine are integrated, so that the filling quality of the liquid medicine is improved;
2. the invention improves the solubility of the liquid medicine by 'small circulation', and then further filters the liquid medicine by 'large circulation', thereby reducing the filtering pressure of the filter and improving the filtering quality and efficiency of the liquid medicine.
3. The powder-liquid double-chamber bag filling machine can maintain the buffered filling pressure through the pressure regulating valve and the pressure gauge, can stably carry out quantitative filling on the powder-liquid double-chamber bag by matching with the hydraulic flowmeter, and improves the filling quality and the filling efficiency of the powder-liquid double-chamber bag.
Drawings
FIG. 1 is a system diagram of an embodiment of the present invention.
Fig. 2 is a flow chart of a method of an embodiment of the present invention.
Reference numerals: 1. preparing a liquid tank; 2. a main valve; 3. a circulation pump; 4. a first switching valve; 5. a 1.0 μm filter; 6. a 0.45 μm filter; 7. a 0.22 μm filter; 8. a buffer tank; 9. a pressure gauge; 10. a pressure regulating valve; 11. a first circulation circuit main valve; 12. a main pipeline; 13. a first circulation line; 14. a second switching valve; 15. a second circulation line; 16. filling the gun heads; 17. a hydraulic flowmeter.
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings.
Referring to fig. 1, the system for online preparation and filling of a powder-liquid dual-chamber bag liquid medicine disclosed in the embodiment of the present invention includes a liquid preparation tank 1, a buffer tank 8 and a filling gun head 16, wherein the filling gun head 16 is disposed on the buffer tank 8, a liquid medicine outlet of the liquid preparation tank 1 is communicated to a liquid inlet of the buffer tank 8 through a main pipeline 12, and a liquid medicine outlet of the buffer tank 8 is communicated to a liquid inlet of the liquid preparation tank 1 through a first circulation pipeline 13, so as to form liquid medicine circulation of the main pipeline 12. A main valve 2, a circulating pump 3, a first switching valve 4, a 1.0 μm filter 5, a 0.45 μm filter 6 and a 0.22 μm filter 7 are sequentially arranged on the main pipeline 12 from a liquid outlet of the liquid preparation tank 1 to a liquid inlet of the buffer tank 8; a pressure gauge 9, a pressure regulating valve 10 and a first circulation pipeline main valve 11 are sequentially arranged on the first circulation pipeline 13 from one end of the liquid outlet of the buffer tank 8 to one end of the liquid inlet of the liquid distribution tank 1. The embodiment of the invention integrates the preparation and filling of the liquid medicine, can ensure the quality of the liquid medicine and improve the liquid medicine filling efficiency of the powder-liquid double-chamber bag.
The mixing tank 1 may be provided with a stirring device for stirring the raw material and the injection water or other preparation liquid to be added into the mixing tank 1, thereby accelerating the dissolution of the raw material injection water. "1.0 μm", "0.45 μm" and "0.22 μm" in the 1.0 μm filter 5, the 0.45 μm filter 6 and the 0.22 μm filter 7 refer to the filtration pore size of the filters. The filter element can be a PP filter element (polypropylene melt-blown filter element) or a PES filter element (polytetrafluoroethylene filter element), wherein the PP filter element adopts nontoxic and tasteless polypropylene particles, and the tubular filter element is manufactured through a series of operation steps. The PES filter element has a unique hydrophilic filter membrane structure, uniform pore size distribution, high porosity, wide compatibility and good acid and alkali resistance.
Further, the system further comprises a second circulation pipeline 15, one end of the second circulation pipeline 15 is communicated to the liquid distribution tank 1, the other end of the second circulation pipeline 15 is communicated to a main pipeline 12 between the circulation pump 3 and the first switching valve 4, and a second switching valve 14 is arranged on the second circulation pipeline 15. After the raw materials and water are added, the mixed liquid medicine is first subjected to "small circulation", which means that the liquid medicine circulates through the second circulation pipeline 15 while being stirred until the liquid medicine is completely dissolved, and then "large circulation", which means that the liquid medicine circulates in the main pipeline 12, and then the liquid medicine is filtered and filled. Through the "microcirculation" that sets up, can accelerate dissolving, the mixture of raw materials and preparation liquid on the one hand, in addition, it also has "short circuit" ability, when spare parts such as the filter of main line 12 need overhaul, maintain, can break off main line 12, guarantees the continuous circulation of liquid medicine, has avoided the system to shut down and has caused the waste of raw materials.
In the process of preparing and filling the liquid medicine, insoluble particles and endotoxin in the liquid medicine need to be detected, and for this purpose, a sampling port is arranged on the main pipeline 12 between the 0.22 μm filter 7 and the liquid inlet of the buffer tank 8.
In this embodiment, a plurality of filling lances 16, preferably four, are mounted to the buffer vessel 8. And a valve is arranged on a connecting pipe between each filling gun head 16 and the buffer tank 8, each filling gun head 16 is connected with a hydraulic flowmeter 17, and each filling gun head 16 can realize quantitative filling of the liquid medicine.
The pressure regulating valve 10 in the first circulation line 13 regulates the pressure in the buffer tank 8 by regulating the valve opening degree, and the pressure in the buffer tank 8 is smaller as the valve opening degree is larger and the chemical liquid flows back more, whereas the pressure in the buffer tank 8 is larger as the valve opening degree is smaller and the chemical liquid flows back less.
The embodiment of the invention also discloses an online preparation and filling method of the powder-liquid double-chamber bag liquid medicine, which is realized by applying the online preparation and filling system of the powder-liquid double-chamber bag liquid medicine, and the method comprises the following steps:
a. 80% of water for injection is added into the liquid preparation tank 1, and then the raw material medicines are added and dissolved to 100%;
b. opening the main valve 2 and the first switching valve 4, pumping the liquid medicine in the liquid preparation tank 1 into the main pipeline 12 by the circulating pump 3, and filtering the liquid preparation by 1.0 micrometer, 0.45 micrometer and 0.22 micrometer in sequence;
c. the filtered liquid medicine enters the buffer tank 8, and is directly and quantitatively filled into the powder-liquid double-chamber bag through the filling gun head 16 on the buffer tank 8, and meanwhile, the liquid medicine circularly flows back into the liquid preparation tank 1 through the first circulating pipeline 13.
Further, the method comprises the following steps: after the step a and before the step b, the liquid medicine is subjected to small circulation, specifically, the main valve 2 and the second switching valve 14 are opened, and the liquid medicine in the liquid preparation tank 1 is pumped into the second circulation pipeline 15 for circulation until the raw materials and the water for injection are completely mixed.
In addition, in the process of preparing and filling the liquid medicine, insoluble particles and endotoxin in the liquid medicine are detected regularly, if the insoluble particles exceed the standard, the 0.22 mu m filter 7 is damaged, and the filter element needs to be replaced in time; if the endotoxin in the liquid medicine at the detection part needs to be stopped, the whole pipeline is cleaned and sterilized, and all the filled powder-liquid double-chamber bags between the last detection and the detection need to be discarded.
Meanwhile, in the production process, the production environment needs to be strictly checked, and the purification level needs to be improved.
In one example, such as: preparing sodium chloride liquid medicine, firstly adding preparation water and weighed sodium chloride raw materials into a liquid preparation tank 1, and dissolving to 100%; then, opening a main valve 2, a second switching valve 14 and a first circulation pipeline main valve 11, keeping a first switching valve 4 closed, starting a circulation pump 3, stirring in the liquid preparation tank 1, pumping the sodium chloride solution into a second circulation pipeline 15 through the circulation pump 3 and circulating to the liquid preparation tank 1, wherein the circulation lasts for about 15 min; then, opening a first switching valve 4 and closing a second switching valve 14, conveying a sodium chloride solution to a 1.0-micrometer filter 5, a 0.45-micrometer filter 6 and a 0.22-micrometer filter 7 through a circulating pump 3, sequentially filtering, allowing a sodium chloride preparation solution subjected to three-stage filtration to enter a buffer tank 8, adjusting through a first pressure adjusting valve 10 and a pressure gauge 9 arranged on a first circulating loop, so that the pressure in the buffer tank 8 reaches 1.5Mpa, and quantitatively filling a powder-liquid double-chamber bag through a filling gun head 16 on the buffer tank 8 under the control of a hydraulic flowmeter 17; the rest of the preparation solution in the buffer tank 8 circularly flows back to the preparation tank 1 through the first circulating pipeline 13 to be stirred and circulated again.
Compared with the traditional system/process, the powder-liquid double-chamber bag liquid medicine online preparation and filling system and the method thereof omit related equipment for filtering active carbon, such as an active carbon filter and a titanium rod filter, and abandon the way of adding active carbon in the liquid preparation tank 1 for filtering in the traditional system/process, thereby integrally reducing the steps of liquid preparation, reducing the loss of raw materials, having no active carbon in the whole system/process, being capable of completely overcoming the problem of active carbon residue in the traditional process, and being beneficial to improving the liquid medicine preparation quality; meanwhile, due to the fact that activated carbon filtering equipment is omitted, the area of a field is reduced, labor cost is reduced, and input cost is reduced.
The embodiments of the present invention are preferred embodiments of the present invention, and the scope of the present invention is not limited by these embodiments, so: all equivalent changes made according to the structure, shape and principle of the invention are covered by the protection scope of the invention.
Claims (6)
1. An on-line preparation and filling method of a powder-liquid double-chamber bag liquid medicine is characterized in that the method is implemented by adopting an on-line preparation and filling system of the powder-liquid double-chamber bag liquid medicine, the powder-liquid double-chamber bag liquid medicine online preparation and filling system comprises a liquid preparation tank (1), a buffer tank (8) and a filling gun head (16), wherein the filling gun head (16) is arranged on the buffer tank (8), a liquid outlet of the liquid preparation tank (1) is communicated to a liquid inlet of the buffer tank (8) through a main pipeline (12), a liquid outlet of the buffer tank (8) is communicated to the liquid preparation tank (1) through a first circulating pipeline (13) to form liquid medicine circulation, a main valve (2), a circulating pump (3), a first switching valve (4), a 1.0 μm filter (5), a 0.45 μm filter (6) and a 0.22 μm filter (7) are sequentially arranged on the main pipeline (12) from one end of the liquid outlet of the liquid medicine tank to one end of the liquid inlet of the buffer tank (8);
the device is characterized by further comprising a second circulating pipeline (15) and a second switching valve (14), wherein one end of the second circulating pipeline (15) is communicated to the liquid distribution tank (1), the other end of the second circulating pipeline is communicated to a main pipeline (12) between the circulating pump (3) and the first switching valve (4), and the second switching valve (14) is arranged on the second circulating pipeline (15);
the liquid medicine forms circulation through the main pipeline (12), the second circulation pipeline (15) and the liquid preparation tank (1) until the liquid medicine is completely dissolved; after the liquid medicine is completely dissolved, the main pipeline (12), the first circulating pipeline (13) and the liquid preparation tank (1) are circulated, and then filtering and filling are carried out;
the online preparation and filling method of the powder-liquid double-chamber bag liquid medicine comprises the following steps:
a. 80% of water for injection is put into the liquid preparation tank (1), and then the raw material medicines are put into the liquid preparation tank and dissolved to 100%;
b. opening the main valve (2) and the first switching valve (4), pumping the liquid medicine in the liquid preparation tank (1) into the main pipeline (12) by the circulating pump (3), and filtering the liquid preparation by 1.0 mu m, 0.45 mu m and 0.22 mu m in sequence;
c. the filtered liquid medicine enters a buffer tank (8), and is directly and quantitatively filled into a powder-liquid double-chamber bag through a filling head on the buffer tank (8), and the rest of preparation liquid in the buffer tank (8) circularly flows back into the preparation tank (1) through a first circulating pipeline (13) to be stirred and circulated again;
after the step a and before the step b, the liquid medicine is subjected to small circulation, a main valve (2) and a second switching valve (14) are opened, and the liquid medicine in the liquid preparation tank (1) is pumped into a second circulation pipeline (15) for circulation until the raw materials and the water for injection are completely mixed;
the small circulation means that the liquid medicine circulates through the second circulation pipeline (15) while being stirred until the liquid medicine is completely dissolved, then the large circulation is carried out, namely the liquid medicine circulates in the main pipeline (12), and then the filtering and filling are carried out;
through the microcirculation that sets up, can accelerate dissolving, the mixture of raw materials and preparation liquid on the one hand, in addition, it also has "short circuit" ability, when the filter of main line (12) need overhaul, maintain, can break off main line (12), guarantees the continuous circulation of liquid medicine, has avoided the system to shut down and has caused the waste of raw materials.
2. The online preparation and filling method of the powder-liquid double-chamber bag liquid medicine according to claim 1, wherein a pressure gauge (9) and a pressure regulating valve (10) are sequentially arranged on the first circulating pipeline (13) from one end of the liquid outlet of the buffer tank (8) to the liquid preparation tank (1).
3. The online preparation and filling method of the powder-liquid double-chamber bag liquid medicine according to claim 1, wherein a sampling port is arranged on the main pipeline (12) between the 0.22 μm filter (7) and the buffer tank (8).
4. The online preparation and filling method of the powder-liquid double-chamber bag liquid medicine according to claim 1, wherein the filter element of the 1.0 μm filter (5) and/or the 0.45 μm filter (6) and/or the 0.22 μm filter (7) is a PP filter element or a PES filter element.
5. The online preparation and filling method of the powder-liquid dual-chamber bag liquid medicine according to claim 1, wherein after the liquid medicine is filtered by 0.22 μm, and before the liquid medicine is filled in the buffer tank (8), the liquid medicine is checked to detect insoluble particles and endotoxin in the liquid medicine.
6. The online preparation and filling method of the liquid medicine in the powder-liquid dual-chamber bag according to claim 1, wherein the pressure in the buffer tank (8) is adjusted to 1.5Mpa by the pressure adjusting valve (10) disposed on the second circulation pipeline (15) during the liquid medicine filling process.
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| CN201911286605.0A CN111086701B (en) | 2019-12-14 | 2019-12-14 | Powder-liquid double-chamber bag liquid medicine online preparation and filling system and method |
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| CN113072025B (en) * | 2021-04-24 | 2022-07-26 | 深圳市九明药业有限公司 | Quantitative filling equipment and medicine filling production line |
| CN114056621B (en) * | 2021-12-10 | 2023-04-25 | 楚天科技股份有限公司 | Filling method of filling system |
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