CN114397159B - Pretreatment method for drug preparation suspension content detection sample - Google Patents
Pretreatment method for drug preparation suspension content detection sample Download PDFInfo
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- CN114397159B CN114397159B CN202210054042.8A CN202210054042A CN114397159B CN 114397159 B CN114397159 B CN 114397159B CN 202210054042 A CN202210054042 A CN 202210054042A CN 114397159 B CN114397159 B CN 114397159B
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- 239000000725 suspension Substances 0.000 title claims abstract description 71
- 238000001514 detection method Methods 0.000 title claims abstract description 30
- 238000002203 pretreatment Methods 0.000 title claims abstract description 14
- 238000002360 preparation method Methods 0.000 title description 6
- 239000003814 drug Substances 0.000 title description 5
- 229940079593 drug Drugs 0.000 title description 5
- 239000003708 ampul Substances 0.000 claims abstract description 103
- 239000000825 pharmaceutical preparation Substances 0.000 claims abstract description 13
- 239000002904 solvent Substances 0.000 claims abstract description 12
- 238000005303 weighing Methods 0.000 claims abstract description 8
- 238000004090 dissolution Methods 0.000 claims abstract description 6
- 238000002156 mixing Methods 0.000 claims abstract description 6
- 238000004140 cleaning Methods 0.000 claims abstract description 5
- 238000005406 washing Methods 0.000 claims abstract 2
- 238000007789 sealing Methods 0.000 claims description 10
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 6
- 239000003085 diluting agent Substances 0.000 claims description 6
- 238000007865 diluting Methods 0.000 claims description 5
- 239000004615 ingredient Substances 0.000 abstract description 2
- 238000000034 method Methods 0.000 abstract 1
- 230000000694 effects Effects 0.000 description 3
- 210000003811 finger Anatomy 0.000 description 3
- 210000003813 thumb Anatomy 0.000 description 3
- 230000000712 assembly Effects 0.000 description 2
- 238000000429 assembly Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 230000004308 accommodation Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 210000004247 hand Anatomy 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/38—Diluting, dispersing or mixing samples
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/40—Concentrating samples
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- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Sampling And Sample Adjustment (AREA)
Abstract
The present application relates to the field of detection of pharmaceutical ingredients, and in particular to a pretreatment method for a pharmaceutical preparation suspension content detection sample. The method comprises the following steps of S1, taking a plurality of suspension branches; s2, weighing all suspension in a balance, and recording the weight w1; s3, opening an ampoule bottle for placing the suspension, and transferring the suspension into a volumetric flask; s4, cleaning the residual suspension in the ampoule bottle by using a solvent and transferring the suspension into the same volumetric flask; s5, adding a proper solvent into a volumetric flask for dissolution, uniformly mixing, and measuring; s6, taking all ampoule bottles with the transferred suspension in the step S3, and naturally airing after washing the inner wall; s7, taking all the dried ampoule bottles in the step S6, weighing on a balance, recording the weight w2, and taking the weight of all the suspension transferred into the to-be-measured volumetric flask as w1-w2. By adopting the technical scheme, the suspension is extracted and enriched to the greatest extent possible, so that a foundation is laid for subsequent instrument analysis, and the detection accuracy is improved.
Description
Technical Field
The application relates to the field of detection of pharmaceutical ingredients, in particular to a pretreatment method for a pharmaceutical preparation suspension content detection sample.
Background
The detection of the content of the suspension of the pharmaceutical preparation generally comprises 2 parts of sample pretreatment and instrument analysis, wherein the sample pretreatment is used for extracting and enriching target detection objects to the maximum extent and ensuring the accuracy of the instrument analysis detection. The existing pretreatment method for detecting the content of the suspension of the pharmaceutical preparation generally has the defect of insufficient extraction of the target detection object in the suspension of the pharmaceutical preparation.
Disclosure of Invention
In order to better extract and enrich the target detection object,
the pretreatment method for the drug preparation suspension content detection sample adopts the following technical scheme:
a pretreatment method for a drug preparation suspension content detection sample comprises the following steps of
S1, taking a plurality of suspensions of a pharmaceutical preparation, and independently splitting each suspension;
s2, weighing all suspension in a balance, and recording the weight w1;
s3, taking the suspension weighed in the step S2, opening an ampoule bottle for placing the suspension, and transferring the suspension into a volumetric flask;
s4, cleaning the residual suspension in the ampoule bottle for a plurality of times by using a proper solvent, and transferring the suspension to the same volumetric flask;
s5, adding a proper solvent into a volumetric flask for dissolution, diluting to a scale with a proper diluent, uniformly mixing, and measuring;
s6, taking all ampoule bottles with the transferred suspension in the step S3, rinsing the inner wall with ethanol, and naturally airing;
s7, taking all the dried ampoule bottles in the step S6, weighing on a balance, recording the weight w2, and taking the weight of all the suspension transferred into the to-be-measured volumetric flask as w1-w2.
By adopting the technical scheme, the suspension is extracted and enriched to the greatest extent possible, and the condition that the weight detection of the suspension is wrong due to residues in the ampoule bottle is reduced. Therefore, a foundation is laid for subsequent instrument analysis, and the detection accuracy is improved.
Optionally, in step S2, use detection auxiliary device to open the ampoule, detect auxiliary device and include frame, rack, be used for driving the rack along the first driving piece of vertical direction motion and break the lid mechanism off with the fingers and thumb, be formed with a plurality of standing groove that is used for placing the ampoule on the rack, the standing groove is the interval setting and forms one row, break the lid mechanism including the mounting panel, along the holding assembly that the standing groove range direction set up, be used for guiding the gliding driving assembly of holding assembly relative frame, the guide way has been seted up on the mounting panel, the guide way is including corresponding the first circular arc portion that the radian is 45, sliding connection has the guide block in the guide way, the holding assembly is installed on the guide block, the tangent line of first circular arc portion upper end sets up along the horizontal direction, the tangent line of first circular arc lower extreme is vertical direction setting.
Through adopting above-mentioned technical scheme, make the rack motion through first driving piece to make ampoule motion to clamping assembly department, then clip all ampoule upper ends through clamping assembly. Then drive the guide block through drive assembly and slide in the guide way to make whole clamping assembly follow the orbit motion of first circular arc portion, accomplish the action of breaking off the fingers and thumb, make a row of ampoule opened, convenient operation. Meanwhile, the ampoule bottle is not manually participated, and the probability of pouring out the suspension caused by shaking hands when the ampoule bottle is opened can be reduced.
Optionally, the guide groove further comprises a second arc part with a corresponding radian of 45 degrees, the upper end of the second arc part is connected with the lower end of the first arc part, the lower end of the second arc part is positioned at one end, far away from the first arc part, of the upper end of the second arc part, and the detection auxiliary device further comprises a collecting box for collecting ampoule bottle caps; when the guide block is positioned at the lower end of the second circular arc part, the clamping assembly is in a state of clamping the ampoule bottle cap body and is positioned right above the collecting box.
Through adopting above-mentioned technical scheme, after the ampoule bottle lid is broken off with the fingers and thumb to the clamping component, the guide block slides to second circular arc lower extreme for clamping component lower extreme is towards the collecting box, and clamping component loosens ampoule bottle lid, makes the ampoule fall into in the collecting box. The ampoule bottle cap body can be collected more conveniently, and meanwhile, operators are not easy to scratch.
Optionally, the clamping assembly includes the mount pad, sliding connection in two grip blocks of mount pad below, installs in the elastic block of the inboard side of grip block, is used for driving two grip blocks to be close to each other or the second driving piece that keeps away from, mount pad fixed mounting is in the guide block.
Through adopting above-mentioned technical scheme, be close to each other through two grip blocks for the ampoule bottle lid is pressed from both sides to the elastic block, simple structure, convenient operation.
Optionally, the mounting panel is the slope setting, and two mounting panels are the symmetry setting, two mounting panel lower extreme interval is greater than two the mounting panel upper end interval, the mounting panel is equipped with the friction block to one side inwards, the friction block is located the elastic block top, the mounting panel is in the frame along horizontal direction sliding connection, be equipped with in the frame and be used for driving the gliding third driving piece of mounting panel relative frame.
Through adopting above-mentioned technical scheme, before breaking open ampoule bottle lid, make ampoule move to the alignment friction block of lid lower part some point earlier, then make two grip blocks be close to for the friction block butt is in the ampoule. The third driving piece drives the mounting plate to reciprocate relative to the frame, so that the friction block rubs a certain point of the ampoule bottle cap body. So that the subsequent clamping assembly can break off the cover body of the ampoule bottle more easily.
Optionally, a volumetric flask for collecting suspension is further arranged between the two mounting plates, the volumetric flask comprises a collecting part and a constant volume part, the collecting part and the constant volume part are detachably connected, and the opening end of the collecting part is larger than the opening end of the constant volume part; when the constant volume portion is connected with the collecting portion, the constant volume portion is connected to the opening end of the collecting portion.
By adopting the technical scheme, the suspension is collected through the collecting part when being collected, and the suspension in the ampoule bottle can be poured conveniently due to the fact that the opening end of the collecting part is large. After the collection is finished, the constant volume part is installed on the collection part, so that the accuracy of measuring the liquid volume is improved.
Optionally, the constant volume portion includes the connecting portion that is used for the lid to establish sealed collecting portion open end and installs the constant volume pipe on the connecting portion, constant volume pipe lower extreme intercommunication connecting portion, be equipped with the scale on the constant volume pipe.
Through adopting above-mentioned technical scheme, after the collection finishes, install the constant volume portion on the collection portion, add suitable diluent again and dilute to the scale, mix. The section of the constant volume pipe is smaller, so that the measured liquid volume in the volumetric flask is more accurate.
Optionally, a sealing plate for sealing the opening end of the collecting part is integrally arranged at the upper end of the collecting part, and a through groove is formed in the sealing plate at a position corresponding to the ampoule bottle and is used for embedding the ampoule bottle; the rack is provided with a fourth driving piece for driving the rack to rotate so that the ampoule bottle is turned upside down.
Through adopting above-mentioned technical scheme, all being opened the back at the ampoule, can be directly with the collecting portion through logical groove insert establish on the ampoule for collecting portion and ampoule are fixed relatively. Then the placing frame is turned upside down, and the ampoule bottle and the collecting part are turned upside down, so that the suspension in the ampoule bottle is poured into
Optionally, be equipped with the connecting seat between two mounting panels, set up the holding tank that is used for the card to establish the volumetric flask on the connecting seat, the connecting seat both ends are equipped with the slider, set up the arc spout that the radian is 180 on the mounting panel, slider sliding connection is in the spout.
Through adopting above-mentioned technical scheme, slider and spout cooperation can play auxiliary guide and support's effect for the collecting part can be more stable along with ampoule takes place to turn upside down.
Optionally, a guide sleeve is fixedly connected to the sealing plate, each through groove corresponds to one guide sleeve, the lower end of the guide sleeve is connected with the corresponding through groove, and the inner diameter of the upper end of the guide sleeve is larger than that of the through groove.
Through adopting above-mentioned technical scheme to when making the ampoule insert logical groove, can enter into logical inslot along the inner wall of uide bushing, the uide bushing can play the effect of direction, makes the ampoule can more smoothly insert logical inslot steadily.
In summary, the present application includes at least one of the following beneficial technical effects:
1. the target detection object is extracted and enriched more fully;
2. the extraction process has less manual participation and low operation difficulty;
3. the enrichment efficiency is improved.
Drawings
Fig. 1 is a schematic structural diagram of embodiment 2.
Fig. 2 is a cross-sectional view of example 2.
Fig. 3 is a sectional view of embodiment 2 at the cover breaking mechanism.
Fig. 4 is an enlarged view at a in fig. 2.
Fig. 5 is a sectional view of the cover breaking mechanism in embodiment 2.
FIG. 6 is a schematic structural diagram of the volumetric flask in example 2.
Reference numerals illustrate: 1. a frame; 2. a placing rack; 3. a cover breaking mechanism; 4. a collection box; 5. a volumetric flask; 6. ampoule bottle; 7. a connection assembly; 8. a first driving member; 9. a fourth driving member; 10. a mounting plate; 11. a clamping assembly; 12. a drive assembly; 13. a guide groove; 14. a first arc portion; 15. a second arc portion; 16. a guide block; 17. a gear; 18. a rack; 19. a driving motor; 20. a mounting base; 21. a clamping plate; 22. a friction block; 23. an elastic block; 24. a second driving member; 25. a connecting groove; 26. a connecting block; 27. a screw rod; 28. a servo motor; 29. a third driving member; 30. a connecting seat; 31. a chute; 32. a slide block; 33. a collection section; 34. a constant volume part; 35. a closing plate; 36. a through groove; 37. a guide sleeve; 38. a connection part; 39. a constant volume pipe; 40. a plate body; 41. inserting blocks; 42. a scale.
Detailed Description
The present application is described in further detail below in conjunction with figures 1-6.
Example 1
Example 1 of the present application discloses a pretreatment method for a pharmaceutical formulation suspension content test sample. A pretreatment method for a drug preparation suspension content detection sample comprises the following steps of
S1, taking a plurality of suspensions of a pharmaceutical preparation, and independently splitting each suspension;
s2, weighing all suspension in a balance, and recording the weight w1;
s3, taking the suspension weighed in the step S2, opening an ampoule bottle 6 for placing the suspension, and transferring the suspension into a volumetric flask 5;
s4, cleaning the residual suspension in the ampoule bottle 6 for a plurality of times by using a proper solvent, and transferring the suspension into the same volumetric flask 5;
s5, adding a proper solvent into the volumetric flask 5 for dissolution, diluting to a scale 42 by a proper diluent, uniformly mixing, and measuring;
s6, taking all ampoule bottles 6 from which the suspension is transferred in the step S3, rinsing the inner wall with ethanol, and naturally airing;
s7, taking all the dried ampoule bottles 6 in the step S6, weighing on a balance, recording the weight w2, and taking the weight of all the suspension transferred into the volumetric flask 5 to be measured as w1-w2.
Example 2
Example 2 discloses a detection assisting apparatus for example 1. Referring to fig. 1, the detection assisting apparatus includes a frame 1, a placement frame 2, a cover breaking mechanism 3, a collection box 4, and a volumetric flask 5. The rack 2 is arranged on the frame 1. The placing frame 2 is provided with a plurality of placing grooves for placing ampoule bottles 6, and the placing grooves are arranged at intervals and form a row. When it is desired to open the ampoule 6, the ampoule 6 may be placed in a recess in the holder 2. And then the cover body of the ampoule bottle 6 which is integrally arranged on the placing frame 2 is broken through the cover breaking mechanism 3, so that the operation efficiency is improved. The cover body of the ampoule bottle 6 after being broken off is put into the collecting box 4.
Specifically, referring to fig. 1 and 2, connecting assemblies 7 are disposed on both sides of the placement frame 2, and the placement frame 2 is mounted on the frame 1 through the connecting assemblies 7. The connection assembly 7 comprises a first drive member 8 and a fourth drive member 9. The fourth driving piece 9 is a motor and the machine body of the fourth driving piece 9 is fixedly arranged on the frame 1. The first driving member 8 is an electric cylinder, and the first driving member 8 is disposed in a vertical direction. The output end of the fourth driving member 9 is fixedly connected to the cylinder of the first driving member 8. The piston rod of the first driving member 8 is fixedly connected to the holder 2. The first driving piece 8 is used for driving the placing frame 2 to move along the vertical direction. The fourth driving piece 9 is used for driving the placing frame 2 to rotate.
Referring to fig. 2 and 3, the cover breaking mechanism 3 includes a mounting plate 10, a grip assembly 11, and a driving assembly 12. The mounting plate 10 is provided with two mounting plates which are respectively positioned at two sides of the placing frame 2. The clamping assembly 11 is located right above the placing frame 2, and the clamping assembly 11 is used for clamping the cover body of the ampoule bottle 6. The mounting plate 10 is provided with a guide groove 13, and the guide groove 13 comprises a first arc part 14 with the corresponding radian of 45 degrees and a second arc part 15 with the corresponding radian of 45 degrees. The tangent line of the upper end of the first arc part 14 is arranged along the horizontal direction, and the tangent line of the lower end of the first arc part 14 is arranged along the vertical direction. The upper end of the second circular arc part 15 is connected with the lower end of the first circular arc part 14, and the lower end of the second circular arc part 15 is positioned at one end, far away from the first circular arc part 14, of the upper end of the second circular arc part 15. The guide groove 13 is slidably connected with a guide block 16. The two ends of the clamping mechanism are respectively connected with the two guide blocks 16. Mounted on the mounting plate 10 is a drive assembly 12 for driving the sliding of the guide block 16 along the guide slot 13.
The carrier 2 is moved by the first drive 8 such that the ampoule 6 is moved to the clamping assembly 11 and then all ampoule 6 upper ends are clamped by the clamping assembly 11. Then, the driving component 12 drives the guide block 16 to slide in the guide groove 13, so that the whole clamping component 11 moves along the track of the first arc part 14 to complete the breaking-off action. After the cover body of the ampoule bottle 6 is broken off by the clamping assembly 11, the guide block 16 slides to the lower end of the second circular arc portion 15, so that the lower end of the clamping assembly 11 faces the collecting box 4, the cover body of the ampoule bottle 6 is loosened by the clamping assembly 11, the ampoule bottle 6 falls into the collecting box 4, and collection is completed.
Referring to fig. 2 and 4, in particular, the drive assembly 12 includes a gear 17, a rack 18, and a drive motor 19. The rack 18 is mounted on the inner wall of the guide groove 13 and is disposed along the track direction of the guide groove 13. The gear 17 is rotatably connected to the guide block 16 and is engaged with the rack 18. The driving motor 19 is fixedly mounted on the guide block 16 and is used for driving the gear 17 to rotate relative to the guide block 16. The gear 17 rotates to enable the gear 17 to walk along the track of the rack 18, and finally the guide block 16 slides along the guide groove 13.
Referring to fig. 2 and 5, the clamping assembly 11 includes a mounting base 20, two clamping plates 21 slidably connected below the mounting base 20, a friction block 22 mounted on an inward side of the clamping plates 21, an elastic block 23 mounted on an inward side of the clamping plates 21, and a second driving member 24 for driving the two clamping plates 21 to approach or separate from each other.
Referring to fig. 5, the mount 20 is fixedly mounted to the guide block 16. The lower end surface of the mounting seat 20 is provided with a connecting groove 25 along the length direction, and a connecting block 26 is connected in a sliding manner in the connecting groove 25. The connection blocks 26 are provided with two and one connection block 26 corresponds to one clamping plate 21. The clamping plates 21 are fixedly mounted to their corresponding connection blocks 26. The mounting plates 10 are obliquely arranged, the two mounting plates 10 are symmetrically arranged, and the interval between the lower ends of the two mounting plates 10 is larger than the interval between the upper ends of the two mounting plates 10. The second driving member 24 includes a screw 27 and a servo motor 28. The screw 27 passes through the two connection blocks 26 and is rotatably connected to the mount 20. The screw 27 is positively threaded to one of the connection blocks 26 and negatively threaded to the other connection block 26. The servo motor 28 is fixedly mounted on the mounting seat 20, and the servo motor 28 is used for driving the screw rod 27 to rotate. The two connecting blocks 26 can be driven to be close to or far away from each other by rotating the connecting screw rod 27, so that the distance between the two clamping plates 21 is adjusted, and the ampoule bottle 6 cover body is clamped and loosened.
Referring to fig. 1 and 5, the friction block 22 is located above the elastic block 23. The mounting plate 10 is slidably connected to the frame 1 in the direction of arrangement of the ampoules 6. The frame 1 is provided with a third driving member 29 for driving the mounting plate 10 to slide relative to the frame 1. The third driving member 29 is a cylinder. The third driving member 29 is disposed in the horizontal direction. The cylinder body of the third driving member 29 is fixedly mounted to the frame 1, and the piston rod of the third driving member 29 is fixedly connected to the mounting plate 10.
Before the ampoule bottle 6 cover is broken, the ampoule bottle 6 is moved to a certain point at the lower part of the cover to align with the friction block 22, and then the two clamping plates 21 are close to each other, so that the friction block 22 is abutted against the ampoule bottle 6. The third driving piece 29 drives the mounting plate 10 to reciprocate relative to the frame 1, so that the friction block 22 rubs against a certain point of the ampoule bottle 6 cover body. So that the subsequent clamping assembly 11 can more easily break the cap of the ampoule 6.
Then the two clamping plates 21 are moved back to back, so that the ampoule bottle 6 moves to a certain point at the lower part of the cover body to be aligned with the elastic block 23, and finally the two clamping plates 21 are mutually close, so that the elastic block 23 clamps the cover body of the ampoule bottle 6, and the preparation is made for the cover breaking action.
Referring to fig. 2 and 3, for more convenient collection of the suspension in ampoule 6, a connection seat 30 is provided between mounting plates 10. The mounting plate 10 is provided with a circular arc-shaped chute 31 with the radian of 180 degrees, and the sliding block 32 is connected in the chute 31 in a sliding way. The connecting seat 30 is provided with a containing groove for clamping the volumetric flask 5.
Referring to fig. 6, the volumetric flask 5 includes a collection portion 33 and a constant volume portion 34, and the collection portion 33 is rectangular and has an upper end opening. The upper end of the collecting part 33 is integrally provided with a closing plate 35 for closing the opening end of the collecting part 33, and a through groove 36 is formed in the position, corresponding to the ampoule bottle 6, on the closing plate 35, and the through groove 36 is used for embedding the ampoule bottle 6. The sealing plate 35 is fixedly connected with a guide sleeve 37, each through groove 36 corresponds to one guide sleeve 37, the lower end of the guide sleeve 37 is opposite to the through groove 36, and the inner diameter of the upper end of the guide sleeve 37 is larger than that of the through groove 36. The constant volume portion 34 includes a connection portion 38 for covering the through groove 36 and a constant volume tube 39 mounted on the connection portion 38. The connecting portion 38 includes a plate body 40 and an insert 41, the plate body 40 is covered on the upper end of the closing plate 35, and the insert 41 is inserted into the guide sleeve 37 so that the through groove 36 is closed. The constant volume pipe 39 is arranged along the vertical direction, the lower end of the constant fusing is communicated with the connecting part 38, and scales 42 are arranged on the constant volume pipe 39.
Referring to fig. 2, in operation, the constant volume portion 34 is removed and the collection portion 33 is fitted into the accommodation groove. The collecting portion 33 is located directly above the placement frame 2 at this time. The clamping assembly 11 has been moved to the side of the pallet 2. Then, the first driving piece 8 drives the placing frame 2 to move upwards, and the open end of the ampoule bottle 6 is inserted into the collecting part 33 through the through groove 36, so that the collecting part 33 and the ampoule bottle 6 are relatively fixed. Then the rack 2 is turned upside down by the fourth driving member 9, and the ampoule bottle 6 and the collecting portion 33 are turned upside down, so that the suspension in the ampoule bottle 6 is poured into the collecting portion 33, and the operation is convenient.
After the suspension has been poured, the ampoule 6 is then moved away from the collecting portion 33 by driving the holder 2 upwards by means of the first drive member 8, and the ampoule 6 and the collecting portion 33 are treated separately. Specifically, the collection unit 33 is removed, the suspension remaining in the ampoule 6 is washed a small number of times with an appropriate solvent, transferred to the collection unit 33, and the constant volume unit 34 is inserted into the collection unit 33. Then adding a proper solvent into a volumetric flask 5 for dissolution, diluting to a scale 42 by a proper diluent, uniformly mixing, and measuring.
In order to allow the collecting portion 33 to be more stably inserted into the receiving groove, a rubber layer for increasing friction is provided in the receiving groove. In order to make it possible for the ampoule 6 to be placed more stably in the holding tank, a rubber layer for increasing the friction is also provided in the holding tank.
The implementation principle of this embodiment is as follows:
1. in the initial state, the clamping assembly 11 is positioned above the placing frame 2, and the connecting seat 30 provided with the collecting part 33 is positioned above the clamping assembly 11;
2. placing a row of ampoule bottles 6 to be opened on the placing frame 2;
3. the first driving piece 8 enables the placing frame 2 to move, so that the ampoule bottle 6 moves between the two clamping plates 21, at the moment, a certain point on the lower part of the cover body of the ampoule bottle 6 is aligned with the friction block 22, and then the two clamping plates 21 are close to each other, so that the friction block 22 is abutted against the ampoule bottle 6;
4. the third driving piece 29 drives the mounting plate 10 to reciprocate relative to the frame 1, so that the friction block 22 rubs against a certain point of the cover body of the ampoule bottle 6;
5. the two clamping plates 21 are moved back to back, so that the ampoule bottle 6 moves to a certain point at the lower part of the cover body to be aligned with the elastic block 23, and the elastic block 23 clamps the cover body of the ampoule bottle 6 by the mutual approach of the two clamping plates 21;
6. the guide block 16 is driven by the driving component 12 to slide in the guide groove 13, so that the whole clamping component 11 moves along the track of the first arc part 14 to complete the breaking action, and the cover body of the ampoule bottle 6 is broken off by the clamping component 11;
7. after the clamping assembly 11 breaks off the cover body of the ampoule bottle 6, the guide block 16 slides to the lower end of the second circular arc part 15, so that the lower end of the clamping assembly 11 faces the collecting box 4, and the clamping assembly 11 releases the cover body of the ampoule bottle 6, so that the ampoule bottle 6 falls into the collecting box 4 to finish collection; the clamping component 11 is positioned at one side of the placing frame 2;
8. the first driving piece 8 drives the placing frame 2 to move upwards, and the open end of the ampoule bottle 6 is inserted into the collecting part 33 through the through groove 36, so that the collecting part 33 and the ampoule bottle 6 are relatively fixed;
9. the rack 2 is turned upside down by the fourth drive 9, and the ampoule 6 and the collection portion 33 are turned upside down, so that the suspension in the ampoule 6 is poured into the collection portion 33;
10. after the suspension is poured, the ampoule bottle 6 is separated from the collecting part 33 by driving the placing frame 2 upwards through the first driving piece 8;
11. taking down the collecting part 33, cleaning the residual suspension in the ampoule bottle 6 for a plurality of times by using a proper solvent, transferring the suspension into the collecting part 33, and inserting and installing the constant volume part 34 on the collecting part 33;
12. adding a proper solvent into a volumetric flask 5 for dissolution, diluting to a scale 42 by a proper diluent, uniformly mixing, and measuring.
The foregoing are all preferred embodiments of the present application, and are not intended to limit the scope of the present application in any way, therefore: all equivalent changes in structure, shape and principle of this application should be covered in the protection scope of this application.
Claims (5)
1. A pretreatment method for a pharmaceutical preparation suspension content detection sample, characterized in that: comprises the following steps of
S1, taking a plurality of suspensions of a pharmaceutical preparation, and independently splitting each suspension;
s2, weighing all suspension in a balance, and recording the weight w1;
s3, taking the suspension weighed in the step S2, opening an ampoule bottle (6) for placing the suspension, and transferring the suspension into a volumetric flask (5);
s4, cleaning the residual suspension in the ampoule bottle (6) for a plurality of times by using a proper solvent, and transferring the suspension into the same volumetric flask (5);
s5, adding a proper solvent into the volumetric flask (5) for dissolution, diluting to a scale (42) by a proper diluent, uniformly mixing, and measuring;
s6, taking all ampoule bottles (6) with the transferred suspension in the step S3, washing the inner wall with ethanol, and naturally airing;
s7, taking all the dried ampoule bottles (6) in the step S6, weighing on a balance, and recording the weight w2, wherein the weight of all the suspension transferred into the volumetric flask (5) to be measured is w1-w2;
in step S2, an ampoule bottle (6) is opened by using a detection auxiliary device, the detection auxiliary device comprises a rack (1), a placement frame (2) and a first driving piece (8) and a cover breaking mechanism (3) which are used for driving the placement frame (2) to move along the vertical direction, a plurality of placement grooves used for placing the ampoule bottle (6) are formed in the placement frame (2), the placement grooves are arranged at intervals and form a row, the cover breaking mechanism (3) comprises a mounting plate (10), a clamping assembly (11) arranged along the arrangement direction of the placement grooves, and a driving assembly (12) used for guiding the clamping assembly (11) to slide relative to the rack (1), a guide groove (13) is formed in the mounting plate (10), the guide groove (13) comprises a first arc part (14) with the corresponding radian of 45 degrees, a guide block (16) is connected in a sliding manner in the guide groove (13), the clamping assembly (11) is arranged on the guide block (16), and a tangent line at the upper end of the first arc part (14) is arranged along the horizontal direction, and a tangent line at the lower end of the first arc part is arranged along the vertical arc direction.
A volumetric flask (5) for collecting suspension is further arranged between the two mounting plates (10), the volumetric flask (5) comprises a collecting part (33) and a constant volume part (34), the collecting part (33) and the constant volume part (34) are detachably connected, and the opening end of the collecting part (33) is larger than the opening end of the constant volume part (34); when the constant volume part (34) is connected with the collecting part (33), the constant volume part (34) is connected with the opening end of the collecting part (33);
the constant volume part (34) comprises a connecting part (38) for covering and sealing the opening end of the collecting part (33) and a constant volume pipe (39) arranged on the connecting part (38), the lower end of the constant volume pipe (39) is communicated with the connecting part (38), and scales (42) are arranged on the constant volume pipe (39);
the upper end of the collecting part (33) is integrally provided with a sealing plate (35) for sealing the opening end of the collecting part (33), a through groove (36) is formed in the sealing plate (35) at a position corresponding to the ampoule bottle (6), and the through groove (36) is used for embedding the ampoule bottle (6); a fourth driving piece (9) for driving the placing frame (2) to rotate so as to enable the ampoule bottle (6) to be upside down is arranged on the frame (1);
a connecting seat (30) is arranged between the two mounting plates (10), a containing groove for clamping the volumetric flask (5) is formed in the connecting seat (30), sliding blocks (32) are arranged at two ends of the connecting seat (30), a circular arc-shaped sliding groove (31) with the radian of 180 degrees is formed in the mounting plates (10), and the sliding blocks (32) are slidably connected in the sliding groove (31).
2. A pretreatment method for a pharmaceutical preparation suspension content detection sample according to claim 1, characterized in that: the guide groove (13) further comprises a second arc part (15) with the corresponding radian of 45 degrees, the upper end of the second arc part (15) is connected with the lower end of the first arc part (14), the lower end of the second arc part (15) is positioned at one end, far away from the first arc part (14), of the upper end of the second arc part (15), and the detection auxiliary device further comprises a collecting box (4) for collecting the cover body of the ampoule bottle (6); when the guide block (16) is positioned at the lower end of the second circular arc part (15), the clamping assembly (11) is in a state of clamping the cover body of the ampoule bottle (6) and is positioned right above the collecting box (4).
3. A pretreatment method for a pharmaceutical preparation suspension content detection sample according to claim 1, characterized in that: the clamping assembly (11) comprises a mounting seat (20), two clamping plates (21) which are connected below the mounting seat (20) in a sliding mode, an elastic block (23) which is arranged on the inward side of the clamping plates (21), and a second driving piece (24) which is used for driving the two clamping plates (21) to be close to or far away from each other, wherein the mounting seat (20) is fixedly arranged on the guide block (16).
4. A pretreatment method for a pharmaceutical preparation suspension content detection sample according to claim 3, characterized in that: the mounting plates (10) are obliquely arranged, the two mounting plates (10) are symmetrically arranged, the lower end spacing of the mounting plates (10) is larger than the upper end spacing of the mounting plates (10), friction blocks (22) are arranged on the inner side of the mounting plates (10), the friction blocks (22) are located above the elastic blocks (23), the mounting plates (10) are slidably connected to the frame (1) along the horizontal direction, and a third driving piece (29) for driving the mounting plates (10) to slide relative to the frame (1) is arranged on the frame (1).
5. A pretreatment method for a pharmaceutical preparation suspension content detection sample according to claim 1, characterized in that: the sealing plate (35) is fixedly connected with a guide sleeve (37), each through groove (36) corresponds to one guide sleeve (37), the lower end of each guide sleeve (37) is connected with the corresponding through groove (36), and the inner diameter of the upper end of each guide sleeve (37) is larger than that of the corresponding through groove (36).
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