CN108785077A - A kind of Ribavirin ampoule bottle and its production technology - Google Patents
A kind of Ribavirin ampoule bottle and its production technology Download PDFInfo
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- CN108785077A CN108785077A CN201810546221.7A CN201810546221A CN108785077A CN 108785077 A CN108785077 A CN 108785077A CN 201810546221 A CN201810546221 A CN 201810546221A CN 108785077 A CN108785077 A CN 108785077A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
- A61J1/065—Rigid ampoules, e.g. glass ampoules
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Abstract
A kind of Ribavirin ampoule bottle of present invention offer and its production technology, the ampoule bottle is cylindric or oval tubular, include the bottle of at least two adjacent connections, bottle cap is equipped at the top of the bottle, the bottle cap is connect by first connecting portion with bottle body bottom, the Bottle cap top is equipped with square plate, and square plate is equipped with reverse V-shaped groove structure with bottle cap junction, and the bottleneck that the bottle side is connect close to bottle with bottle cap is equipped with second connecting portion；The bottle is combined by outer shell, enclosing layer, sandwich layer, and the sandwich layer is between outer shell, enclosing layer.The present invention uses three-decker, reduces the additive amount of aluminium, magnesium and various auxiliary agents to the maximum extent.And common raw material may be used in most of material, can both reduce cost of material, also reduces residue index amount, complies fully with medical rank.
Description
Technical field
The present invention relates to ampoule bottle production technology, especially a kind of Ribavirin ampoule bottle and its production technology.
Background technology
Ampoule bottle is mainly used as the Packaging Bottle of medical injection, and traditional ampoule bottle is made of glass, and good airproof performance can be very
The stability of good guarantee drug, but be inconvenient to during Clinical practice to exist simultaneously many security risks, it needs when in use
It using grinding wheel by bottleneck cut, then is broken into two with one's hands with hand, is easy to hurt hand in this way, glass chip is easy to fall into when opening
It is polluted in liquid.There is the ampoule bottle of plastic production at present to substitute traditional glass system ampoule bottle, plastic ampoule bottle
Not only transport easy to produce, but also many technical problems are overcome, facilitate the use of medical staff.
Current Ji great producers of the country have introduced some plastic bottle liquid drugs injection Ampoule Production Lines from advanced country so that plastic bottle liquid drugs injection produces
Product are centainly applied in China.But in actual production, still there is also many problems.It is summed up, has some：
1. the bottle limited strength of current plastic ampoule bottle easily leads to bottle change because of illumination, temperature change during long-term storage
Shape, not anti-aging, bottle intensity declines, many times medical worker will feel that bottle quality is soft, brings drawing liquid needle
Etc. feeling uncomfortable pernicious experience.
The bottle material for the producer even having can dissolve out, and long term storage Ribavirin drug will produce to be existed seriously with bottle
The problem of compatibility.
2. since existing home made materials and Foreign Advanced Lerel also have certain gap, present domestic manufacturers be all made of entirely into
Gate material produces, therefore product cost is high, causes enterprise profit very meagre, enterprise bottle can be made it is thin with reduce at
This, but many quality problems can be caused, form vicious circle.
3. current plastic ampoule bottle if the mold base cavity to ampoule bottle does corresponding processing, then can be led in primary injection molding
It causes drag mode difficult, and then increases mechanical trauma, transparency reduces, and deteriorates product quality.
4. the ampoule bottle usually produced is conjoined structure, there is also defects for such structure, first, the excessive inconvenience of bottle cap
It opens；Second is that connection area is excessive between bottle, it has not been convenient to detach, and be not steady on one's legs, be easy lodging, there is a small amount of liquid after lodging
Outflow；It is connected between bottle and bottle too tightly, is not easy to break into two with one's hands, side thorn is too many to prick the hand；Bottle mouth position, which is right angle, has dead angle, residual liquid to deposit
Inhaling the actual application problems such as not to the utmost.
5. the sterilization link in the production of existing plastic ampoule is not comprehensive enough, can not the thorough bottom of canbe used on line sterilization
Production.
6. existing bottleneck is small, strong to drug selectivity, since many injections need cold-aseptic filling, temperature sensitive degree is high,
And existing equipment blows embedding temperature or excessively high, has negative effect to lymph Wei Lin liquids.
Invention content
The purpose of the present invention is in view of the deficiencies of the prior art, the present invention provides a kind of Ribavirin ampoule bottle and its lifes
Production. art, to solve, above-mentioned ampoule material is of high cost, transparency reduces, deterioration product quality, Ribavirin drug and bottle
For body there are compatible problem, sterilization link is not comprehensive enough, and connection area is excessive between bottle, connects too tightly, is not easy between bottle and bottle
It breaks into two with one's hands, too many problems such as pricking the hand is pierced on side.
In order to solve the above technical problem, the technical solution used in the present invention is：A kind of Ribavirin ampoule bottle, ampoule
Bottle is cylindric or oval tubular, includes the bottle of at least two adjacent connections, bottle cap, the bottle cap are equipped at the top of the bottle
It is connect with bottle body bottom by first connecting portion, the Bottle cap top is equipped with square plate, and square plate is equipped with V with bottle cap junction
Type groove structure, the bottleneck that the bottle side is connect close to bottle with bottle cap are equipped with second connecting portion；The bottle is by outer
Shell, enclosing layer, sandwich layer are combined, and the sandwich layer is between outer shell, enclosing layer, and the enclosing layer is mainly by high melt
Strength polypropylene（HMS-PP）20-30 parts squeeze out composition, and the sandwich layer is by propylene -50-60 parts of ethylene atactic copolymer, dehydrogenation
0.3-0.5 parts of blending extrusions of rosin acid soaps nucleating agent are constituted, and the outer shell is by 70-80 parts of polypropylene, zinc stearate 0.3-
0.5 part, antioxidant（1010）0.3-0.5 parts, antioxidant（168）0.3-0.5 parts, 0.2-0.3 parts of dibenzal sorbitol, hydrated aluminum
Sour magnesium carbonate 0.5-0.6 parts, 0.3-0.5 parts of 0.3-0.5 parts of nano silicon dioxide, nano-titanium dioxide blending extrusions constitute.
Preferably, the enclosing layer is most thin, outer shell is most thick, core layer thickness be located at enclosing layer and shell layer thickness it
Between.
Preferably, the Ribavirin ampoule bottle is produced by the special production system of Ribavirin ampoule bottle, it is described special
Production system includes conveyer belt, and the conveyer belt is connect with more heat pipe temperature control preheating cabinets, and more heat pipe temperature control preheating cabinets pass through conveying
Band is connect with encapsulating die is blown；
Several fixed holders are uniformly equidistantly equipped on the conveyer belt, fixed holder constitutes bottle base station,
The fixed holder is made of left holder and right holder, and being equipped with half round vase at the top of the left holder cheats, and is set on the inside of left holder
There is guide rod, being equipped with half round vase at the top of the right holder cheats, and guide hole is equipped on the inside of right holder, compression spring, guide rod are equipped in the guide hole
It is inserted into guide hole and is compressed on compression spring, the side of the left holder and right holder is equipped with pulley, and the pulley limit is in sliding rail
It is interior；
More heat pipe temperature control preheating cabinets cover conveyer belt, and the conveyer belt both sides in more heat pipe temperature control preheating cabinets are respectively equipped with heating
Pipe matrix, heating tube matrix are equipped with multirow heating tube；
The encapsulating die that blows is correspondingly arranged at least one set of die group including two rows, per mold group by left mould and right mould structure
At, the left mould and right mould are equipped with upper mold, middle mould, lower die, and the upper mold, middle mould, lower die inner surface are equipped with hot gas spray orifice,
The upper mold, middle mould are equipped with cooling water pipe in lower die, and the top between the two rows set of molds is equipped with multiple multi-functional filling
Needle, multi-functional filling needle are located on body frame；The multi-functional filling needle includes high temperature tracheae, inlet tube, cooling tracheae, the height
Wet pipe, inlet tube, cooling tracheae coaxial arrangement, wherein inlet tube are nested in cooling tracheal strips, and lower end exceeds cooling tracheae,
Bottom has spray hole；The upper end passes through cooling tracheae upper end to be connect with fluid-delivery valve, and the cooling air pipe sleeve is set in high temperature tracheae
Interior, the cooling tracheae inlet end is connected by cold air valve and cold air supervisor, the high temperature tracheae inlet end by hot-blast valve with
Hot gas supervisor's connection, the inlet tube upper end pass through cooling tracheae upper end to be connect with fluid-delivery valve, and fluid-delivery valve is connected with feed liquor supervisor,
The side wall of cooling tracheae lower part is equipped with multiple puff prots.
Preferably, hot gas supervisor bottom is equipped with hot gas umbrella, hot gas umbrella has an interlayer air cavity construction, interlayer air cavity with
High temperature tracheae is connected to, and hot gas umbrella extexine is equipped with the hot gas spray orifice being connected to interlayer air cavity, and hot gas umbrella endosexine is covered with heat preservation
Material is dissipated with obstructing under hot gas.
A kind of Ribavirin ampoule bottle production technology, includes the following steps：
（1）Bottle embryo is transmitted：Bottle embryo is sequentially inserted into the fixation holder of conveyer belt, fixes fixation of the holder to bottle embryo bottom at this time
Root carries out clamping, is then fed into more heat pipe temperature control preheating cabinets；
（2）Bottle embryo softens：The level-one heating tube is located at bottle lower part, and temperature range is from 131 DEG C to 141 DEG C；Two level heating tube,
Three-level heating tube, level Four heating tube are located among bottle, and temperature range is from 141 DEG C to 151 DEG C；Described six grades, seven grades of heating tubes
Positioned at bottle top, wherein six grades, seven grades of heating tube temperature sections be 151 DEG C to 162 DEG C, since plastics attribute is thermoplasticity modeling
Expect, plastics become softening situation after the bottle embryo high temperature after heating；
（3）Filling and molding：Multiple bottle embryos enter in mold, and multi-functional filling needle declines, and is inserted into bottle, multi-functional filling needle
The puff prot of lower part starts to blow out 5-30 DEG C of filtrated air, forms cold air curtain, and the spray hole of multi-functional filling needle is to molding pipe
Middle sprinkling irrigation sterile liquid medicine；Meanwhile the hot gas spray orifice of multi-functional filling needle blows hot gas to bottle top, keeps plastics soft state, together
When it is multi-functional filling for answering the upper mold, middle mold, lower mold of bottleneck to blow out 151-160 DEG C of filtrated air, ensure prefabricated
Bottle bottleneck spot temperature does not reduce；
（4）Multi-functional filling needle rises rapidly with sterile liquid medicine liquid level and reaches setting position, the inlet tube of multi-functional filling needle
It closes, in uphill process, spray orifice can keep neck part plastics further to soften shape to the higher hot gas of neck part blowing temp
State, middle mold and upper mold are rapidly closed bottleneck position, bottle base head are sealed closed；It is multiple multi-functional due to being arranged
Filling needle, can be simultaneously to multiple bottles filling Ribavirin medicament and heat-sealing operation；When molding, the cutter of lower die will be fixed simultaneously
Root is to cutting so that fixed root keeps cut-out and attached state with bottle；
（5）Die sinking：With the unlatching of mold, the bottle of sealing is finally sent out from products export after being come out in mold；
（6）It checks：Examine the wall thickness, seal, resistance to temperature of Ribavirin ampoule bottle whether up to standard.
The present invention uses three-decker, reduces the additive amount of aluminium, magnesium and various auxiliary agents to the maximum extent.And it is most of
Common raw material may be used in material, can both reduce cost of material, also reduces residue index amount, complies fully with medical rank.
It is more square when slightly firmly torsion square plate can both be detached with open bottle cover on square plate of the present invention in open bottle cover
Just quick.And due between adjacent ampoule bottle connecting portion area it is smaller, the setting of reinforced sheet facilitates adjacent two bottle
Stablize separation, when separation is more time saving and energy saving, it is not necessary to exert great efforts and tear, facilitate the operation of medical staff.
The present invention has the characteristics that production efficiency is high, saves resource, is sterile environmentally friendly.The ampoule bottle and one produced using equipment
As medicine bottle compare, have intensity high, the features such as pressure-bearing property is good, is conducive to long-term storage, and bottle wall is penetrating smooth.
Since bottle embryo bottom is equipped with fixed root, good stationkeeping ability can be provided, root is fixed while filling can be with
Cut away, to ensure that bottle stable quality, thickness are uniform, it is filling with molding in, by conformal-Local cooling-it is filling-envelope
Mouth-die sinking, embedding one is short at the bottle time, and the dirt of microbes in air and particle to liquid is avoided in the environment of sealing
Dye can allow in bottle local temperature to be dropped rapidly to 10 DEG C, the customer service disadvantage of traditional mode.Compared to including our company
The prior art including 201510818859.8, can really realize Ribavirin low temperature under hot mastication plastics, it is low at
This is filling, ensure that the stability of Ribavirin drug, while the mode that opposite mould closes is even more to improve production efficiency, is reduced
Equipment operating cost, reduces equipment fault.Gained townhouse ampoule bottle is even more because being mutually to melt connection after molding, and intensity just may be used
To realize that bottle detaches, facilitate the operation of medical staff.
The technology of the present invention is advanced, and the round-the-clock of drug, gamut, low cost, few failure, CR production may be implemented,
Can ensure that drug is perfectly safe, while the adaptation of product produced is strong, easy to use, thus with great market value and
Social value.
Description of the drawings
Fig. 1 is the structural schematic diagram of the present invention；
Fig. 2 is the structure left view of the present invention；
Fig. 3 is partial enlarged view at A of the present invention；
Fig. 4 is conveyer belt structure schematic diagram of the present invention；
Fig. 5 is the structural schematic diagram of the fixed holder of the present invention；
Fig. 6 is the structural schematic diagram of more heat pipe temperature control preheating cabinets in the present invention；
Fig. 7 is the vertical view of Fig. 6；
Fig. 8 is that the present invention blows the structural schematic diagram before encapsulating die molding；
Fig. 9 is that the present invention blows the cross-sectional view before encapsulating die molding；
Figure 10 is the enlarged drawing at B in Fig. 9；
Figure 11 is the enlarged drawing at C in Fig. 9；
Figure 12 is the enlarged drawing at D in Fig. 9；
Figure 13 is that the present invention blows the structural schematic diagram after encapsulating die molding.
Specific implementation mode
To facilitate the understanding of the present invention, below with reference to relevant drawings to invention is more fully described.In attached drawing
Give the present invention preferred embodiment.But the present invention can realize in different forms, however it is not limited to be retouched herein
The embodiment stated.It is opposite, purpose of providing these embodiments is make it is more thorough and comprehensive to the disclosure.
Embodiment：As shown in Figure 1, 2, 3, a kind of Ribavirin ampoule bottle 51, for cylindric or oval tubular, the bottle
52 tops are equipped with bottle cap 55, and the bottle cap 55 is connect by first connecting portion 57 with 52 bottom of bottle, and 55 top of the bottle cap is set
There are square plate 59, square plate 59 to be equipped with reverse V-shaped groove structure with 55 junction of bottle cap, groove structure, which can reduce, deforms bottle cap
Pressure and when needing medical staff to open bottle intentionally provides a kind of suitable unlatching dynamics and deformation extent so that medicine bottle
It is freely opened under suitable, comfortable dynamics, avoids usually maloperation that bottle cap is caused arbitrarily to be opened, reduce drug exposure.
59 top of square plate is equipped with rectangular channel 54, and rectangular channel 54 can stamp number according to the drug of production, space is rationally utilized.
Square plate 59 can be square or rectangle, and 52 side of the bottle is equipped with close to the bottleneck of bottle cap 55
The side of bottle strengthening portion 56, strengthening portion 56 is equipped with second connecting portion 53, and second connecting portion is easily to tear structure.
The bottle 52 of at least three adjacent connections may be constructed ampoule bottle townhouse.
As shown in figure 3, the bottle 52 is combined by outer shell 523, enclosing layer 521, sandwich layer 522, the sandwich layer 522
Between outer shell 523, enclosing layer 521, the enclosing layer is by high melt strength, propylene（HMS-PP）20-30 parts, tristearin
0.05-0.08 parts of sour calcium 0.05-0.08 parts, dehydroabietic acid soaps nucleating agent extrusion compositions, the sandwich layer 522 is by propylene-second
50-60 parts of olefinic random copolymer, 0.3-0.5 parts of dehydroabietic acid soaps nucleating agent, blending extrusion are constituted, the outer shell 523
By 70-80 parts of polypropylene, 0.3-0.5 parts of zinc stearate, antioxidant（1010）0.3-0.5 parts, antioxidant（168）0.3-0.5 parts,
0.2-0.3 parts of dibenzal sorbitol, 0.5-0.6 parts of aluminate hydrates magnesium carbonate, 0.3-0.5 parts of nano silicon dioxide, nano-silica
Change 0.3-0.5 parts of blending extrusions of titanium to constitute.Three-decker of the present invention, wherein enclosing layer are most thin, and outer shell is most thick, core layer thickness position
Between enclosing layer and shell layer thickness.
The special material and technique of the present invention can guarantee the compatibility with Ribavirin again, allow Ribavirin long term storage without
Toxic side effect.Its enclosing layer intensity is high, and component is simple, can be directly with Ribavirin Long Term Contact without being had an impact to drug.
Outer shell can anti-aging, uvioresistant, heat resistanceheat resistant, external force resistance, the enhancing secured intensity of bottle.Sandwich layer can ensure that Bottle structure is strong
Degree and transparency requirement can not only play a part of to connect ectonexine, but also can stablize enclosing layer, ensure that enclosing layer is not destroyed.
Since enclosing layer uses high melt strength, propylene（HMS-PP）, material is more pure, and can be made thin, with Li Bawei
The drugs such as woods together, will not occur bottle material be precipitated, reaction etc. compatibilities the problem of.Sandwich layer uses propylene-ethylene random
Copolymer and dehydroabietic acid soaps nucleating agent, together with the drugs such as Ribavirin, will not occur bottle material be precipitated, reaction
Etc. compatibilities the problem of.Further function as second layer safety curtain and isolation and combination, outer shell using it is many it is weather-proof,
UV resistant, reinforcing material combination are made, and play the role of support, protection, strengthen bottle.
As shown in figure 4, when equipment is run, bottle embryo is installed on fixed holder 17, fixation of the fixed holder to bottle embryo bottom
Root carries out clamping, is then fed into heating in more heat pipe temperature control preheating cabinets 15.
The fixed holder is made of left holder 172 and right holder 176, and being equipped with half round vase at the top of the left holder cheats 173,
It is equipped with guide rod 175 on the inside of left holder, half round vase is equipped at the top of the right holder and cheats 174, guide hole 177, institute are equipped on the inside of right holder
It states and is equipped with compression spring 178 in guide hole 177, guide rod 175 is inserted into guide hole 177 and is compressed on compression spring 178.
The side of the left holder and right holder 17 is equipped with pulley 170, and pulley limits in sliding rail 120.By bottle embryo 12 according to
Secondary to be inserted into the fixation holder 17 of conveyer belt, sliding rail 120 narrows in more 12 fronts of heat pipe temperature control preheating cabinet at this time, to left holder
172 and right holder 176 generate extruding, left holder 172 and right holder 176 carry out clamping to the fixation root 121 of 12 bottom of bottle embryo, so
After be sent into more heat pipe temperature control preheating cabinets 12.
The sides the conveyer belt A are equipped with tooth socket 110, are set with conveyer belt A same planes position in the shaft of stepper motor 10
There are linkage gear 11, linkage gear 11 to be engaged with tooth socket 110.
As shown in Figure 5,6, the conveyer belt A is connect with more heat pipe temperature control preheating cabinets 15, and more heat pipe temperature control preheating cabinets pass through
Conveyer belt A is connect with encapsulating die F is blown.More heat pipe temperature control preheating cabinets 15 cover conveyer belt A, in more heat pipe temperature control preheating cabinets 15
The both sides conveyer belt A are respectively equipped with heating tube matrix, and heating tube matrix is equipped with multirow heating tube, the temperature of multiple heating tube radiation
Variation, at male female curve.Heating tube matrix includes that level-one heating tube 24, two level heating tube 23, three-level heating tube 22, level Four add
Heat pipe 21,20, six grades of Pyatyi heating tube, 19, seven grades of heating tube heating tube 18.
Wherein level-one heating tube is located at bottle lower part, and temperature range is from 131 DEG C to 141 DEG C；Two level heating tube, three-level heating
Pipe, level Four heating tube is located among bottle, and temperature range is from 141 DEG C to 151 DEG C；Described six grades, seven grades of heating tubes be located at bottle
Top, wherein six grades, seven grades of heating tube temperature sections be 151 DEG C to 162 DEG C.
The heater box 15 is made of refractory metal, and chamber interior wall metal passes through polishing treatment, lower box and No.1
Metallic walls on the same traffic directions of conveyer belt A separate.The heating tube is made using the good metal material of thermal conductivity, in pipe
Equipped with heating wire, then two end seals pour into insulation and thermal insulation material, and heating wire encapsulation is fixed among pipe, it is made not connect with tube wall
It touches.The both ends of heating wire connect with power cord respectively.After energization, electric current is flowed through from heating wire, and heating wire just generates heat, by right
The length of heating wire is screened, and increases or decreases resistance to change the temperature of heating wire, the radiation of heating tube is controlled with this
Temperature.
The encapsulating die F that blows is correspondingly arranged at least one set of die group F1, F2 including two rows, per mold group by left mould
F10 and right mould F11 is constituted, the left mould and right mould be equipped with upper mold F100, middle mould F101, lower die F102, the upper mold F100,
Middle mould F101, lower die F102 inner surfaces are equipped with hot gas spray orifice 262, and the upper mold, middle mould are equipped with cooling water pipe in lower die
241, the top between the two rows set of molds is equipped with multiple multi-functional filling needles 24, and multi-functional filling needle 24 is located at body frame 26
On.
As shown in Fig. 7,8,9,10,11,12,13, the multi-functional filling needle include high temperature tracheae 252, inlet tube 243,
Cooling tracheae 241, the high temperature tracheae, inlet tube, cooling tracheae coaxial arrangement, wherein inlet tube 243 are nested in cooling tracheae
In 241, lower end exceeds cooling tracheae 241, and bottom has spray hole 2439, and the upper end passes through cooling tracheae upper end and fluid-delivery valve
2430 connections, fluid-delivery valve 2430 are connect with feed liquor supervisor 2431, and the cooling tracheae 241 is nested in high temperature tracheae 353, described
241 inlet end of cooling tracheae is connect by cold air valve 2410 with cold air supervisor 2412, and the side wall of cooling tracheae lower part is equipped with more
A puff prot 2418.252 inlet end of high temperature tracheae is connect by hot-blast valve 2520 with hot gas supervisor 2521.
As shown in figure 9, hot gas supervisor bottom is equipped with hot gas umbrella 27, there is hot gas umbrella 27 interlayer air cavity to construct 271, interbedded gas
Chamber 271 is connected to high temperature tracheae 252, and hot gas umbrella extexine is equipped with the hot gas spray orifice 270 being connected to interlayer air cavity 271, hot gas umbrella
Endosexine is covered with thermal insulation material 272, is dissipated under hot gas with obstructing.
Its production technology is：
（1）Bottle embryo is transmitted：Bottle embryo is sequentially inserted into the fixation holder 17 of conveyer belt, bottle embryo has opening, and bottom, which has, to be fixed
Root 121 fixes holder 17 and carries out clamping to the fixation root 121 of bottle embryo bottom, is then fed into more heat pipe temperature control preheating cabinets 12 at this time
It is interior；
Bottle embryo softens：Level-one heating tube is located at bottle lower part, and temperature range is from 131 DEG C to 141 DEG C；Two level heating tube, three-level add
Heat pipe, level Four heating tube are located among bottle, and temperature range is from 141 DEG C to 151 DEG C；Described six grades, seven grades of heating tubes be located at bottle
Body top, wherein six grades, seven grades of heating tube temperature sections be 151 DEG C to 162 DEG C, since plastics attribute is thermoplastic, add
Plastics become conformal and soften situation after bottle embryo high temperature after heat；
（7）Filling and molding：Multiple bottle embryos enter in mold, and multi-functional filling needle 24 declines, and are inserted into bottle, multi-functional filling
The puff prot 2418 of 24 lower part of needle starts to blow out 5-30 DEG C of filtrated air, forms cold air curtain, the spray hole of multi-functional filling needle 24
2439 spray sterile liquid medicine into molding pipe；Meanwhile the hot gas spray orifice 270 of multi-functional filling needle 24 blows hot gas to bottle top,
Plastics soft state is kept, while multi-functional filling needle 24 corresponds to 151-160 DEG C of upper mold, middle mould, lower the mold blowout of bottleneck
Filtrated air, ensure that prefabricated bottle, bottleneck spot temperature do not reduce；
（8）Multi-functional filling needle rises rapidly with sterile liquid medicine liquid level and reaches setting position, the inlet tube of multi-functional filling needle
243 close, and in uphill process, spray orifice 270 can keep neck part plastics further soft to the higher hot gas of neck part blowing temp
Change state, middle mold and upper mold are rapidly closed bottleneck position, bottle base head are sealed closed；It is multiple more due to being arranged
The filling needle 24 of function, can be simultaneously to multiple bottles filling Ribavirin medicament and heat-sealing operation；When molding, the cutter of lower die
F1021 is simultaneously by fixed root 121 to cutting so that fixed root 121 keeps cut-out and attached state with bottle.
（9）Die sinking：With the unlatching of mold, after being come out in mold, bottle continues to run with the bottle of sealing with conveyer belt
To products export, external force is slightly used at this time, and bottle, which is fallen to, to be checked on line, and then fixed root falls off with the fixed release of holder 17；
（10）It checks：Examine the wall thickness, seal, resistance to temperature of Ribavirin ampoule bottle whether up to standard.
Test example 1：
According to《Drug registration management method》With《Chemicals stability study technological guidance's principle》Related request, we are right
Self-control sample has carried out factors affecting stability experiment, including high temperature, is placed 10 days under the conditions of 60+2 DEG C of exposure experiments to light, respectively at
It takes a sample to check within 5 days, 10 days；It places 10 days under the conditions of exposure experiments to light 4500lx ± 500lx, takes a sample to check respectively at 5 days, 10 days.
Specification 1ml：0.1g
Pilot product accelerated test result
Specification 1ml：0.1g investigates condition：40℃±2℃,RH25%±5%
Pilot product long-term test results
Specification 1ml：0.1g investigates condition：25℃±2℃,RH40%±5%
By the lab scale sample that determining formulation and technology specification produces, testing result meets regulation, illustrates that formulation and technology is feasible.
According to test data it is found that this product through 40 DEG C 10 days place after each Testing index without significant change；After 60 DEG C are placed for 10 days
Each Testing index is without significant change；Each Testing index is without significant change after illumination 10 days, high humidity are placed for 10 days.
Experimental example 2：In order to as far as possible fully investigate packaging material in additive in different soda acids and opposed polarity medium
In the case where being extracted, use be strict in conventional medication production sterilization process condition extreme extraction conditions extract examination
It tests.
It is Extraction medium to select PH3.5 buffer solutions, PH8.0 buffer solutions and 15% ethanol solution respectively, takes three batches of polypropylene peaces
The smooth position 0.5cm*2cm of small jar is put into container and Extraction medium is added in 6cm2/ml ratios as test sample；Polypropylene granules
Extraction medium is added as pellet test sample in 0.2g/ml ratios in two batches.Wherein Extraction medium is PH3.5 buffer solutions, PH8.0 delays
The test sample capping of fliud flushing, which is placed in autoclave sterilizer, to be kept for 1 hour for 121 DEG C；Extraction medium is 15% ethanol solution
Test sample capping is placed in thermostatic drying chamber and is kept for 1 hour for 100 DEG C.Sample is parallel under each medium prepares two parts, and makes simultaneously
Standby blank.Using the detection method being verified through methodology, the extraction solution of each medium is checked, investigates antioxidant
1010, the extraction situation of irgasfos 168, magnesium, aluminium element in each Extraction medium.It is as follows to extract test result：
The extraction test result for be strict in conventional medication shows：Polypropylene granules（Shell material）And polypropylene ampoule exists
PH3.5 buffer solutions（121 DEG C are kept for 1 hour）, PH8.0 buffer solutions（121 DEG C are kept for 1 hour）And 15% ethanol solution（100 DEG C of guarantors
It holds 1 hour）In three kinds of different Extraction mediums, the effect of polypropylene ampoule of the present invention is clearly.
Embodiment of the present invention is only the description carried out to the preferred embodiment of the present invention, not to the present invention
Conception and scope is defined, and not departing from the present invention relates under the premise of thought, engineers and technicians are to this hair in this field
The various modifications and improvement that bright technical solution is made should all fall into protection scope of the present invention, the claimed skill of the present invention
It uses, has all been recorded in detail in the claims in art.
Claims (5)
1. a kind of Ribavirin ampoule bottle, ampoule bottle is cylindric or oval tubular, includes the bottle of at least two adjacent connections,
Bottle cap is equipped at the top of the bottle, the bottle cap is connect by first connecting portion with bottle body bottom, and the Bottle cap top is equipped with side
Shape plate, square plate are equipped with reverse V-shaped groove structure, the bottleneck that the bottle side is connect close to bottle with bottle cap with bottle cap junction
Place is equipped with second connecting portion；The bottle is combined by outer shell, enclosing layer, sandwich layer, and the sandwich layer is located at outer shell, included
Between layer, the enclosing layer is mainly by high melt strength, propylene（HMS-PP）20-30 parts squeeze out composition, and the sandwich layer is by third
0.3-0.5 parts of alkene -50-60 parts of ethylene atactic copolymer, dehydroabietic acid soaps nucleating agent blending extrusions are constituted, the shell
Layer is by 70-80 parts of polypropylene, 0.3-0.5 parts of zinc stearate, antioxidant（1010）0.3-0.5 parts, antioxidant（168）0.3-0.5
Part, 0.2-0.3 parts of dibenzal sorbitol, 0.5-0.6 parts of aluminate hydrates magnesium carbonate, 0.3-0.5 parts of nano silicon dioxide, nanometer two
0.3-0.5 parts of blending extrusions of titanium oxide are constituted.
2. a kind of Ribavirin ampoule bottle according to claim 1, it is characterised in that the enclosing layer is most thin, and outer shell is most
Thickness, core layer thickness is between enclosing layer and shell layer thickness.
3. a kind of Ribavirin ampoule bottle according to claim 1, it is characterised in that the Ribavirin ampoule bottle is by profit
The special production system production of Ba Weilin ampoule bottles, the special production system includes conveyer belt, the conveyer belt and more heat pipe temperature
Preheating cabinet connection is controlled, more heat pipe temperature control preheating cabinets are connect by conveyer belt with encapsulating die is blown；
Several fixed holders are uniformly equidistantly equipped on the conveyer belt, fixed holder constitutes bottle base station,
The fixed holder is made of left holder and right holder, and being equipped with half round vase at the top of the left holder cheats, and is set on the inside of left holder
There is guide rod, being equipped with half round vase at the top of the right holder cheats, and guide hole is equipped on the inside of right holder, compression spring, guide rod are equipped in the guide hole
It is inserted into guide hole and is compressed on compression spring, the side of the left holder and right holder is equipped with pulley, and the pulley limit is in sliding rail
It is interior；
More heat pipe temperature control preheating cabinets cover conveyer belt, and the conveyer belt both sides in more heat pipe temperature control preheating cabinets are respectively equipped with heating
Pipe matrix, heating tube matrix are equipped with multirow heating tube；
The encapsulating die that blows is correspondingly arranged at least one set of die group including two rows, per mold group by left mould and right mould structure
At, the left mould and right mould are equipped with upper mold, middle mould, lower die, and the upper mold, middle mould, lower die inner surface are equipped with hot gas spray orifice,
The upper mold, middle mould are equipped with cooling water pipe in lower die, and the top between the two rows set of molds is equipped with multiple multi-functional filling
Needle, multi-functional filling needle are located on body frame；The multi-functional filling needle includes high temperature tracheae, inlet tube, cooling tracheae, the height
Wet pipe, inlet tube, cooling tracheae coaxial arrangement, wherein inlet tube are nested in cooling tracheal strips, and lower end exceeds cooling tracheae,
Bottom has spray hole；The upper end passes through cooling tracheae upper end to be connect with fluid-delivery valve, and the cooling air pipe sleeve is set in high temperature tracheae
Interior, the cooling tracheae inlet end is connected by cold air valve and cold air supervisor, the high temperature tracheae inlet end by hot-blast valve with
Hot gas supervisor's connection, the inlet tube upper end pass through cooling tracheae upper end to be connect with fluid-delivery valve, and fluid-delivery valve is connected with feed liquor supervisor,
The side wall of cooling tracheae lower part is equipped with multiple puff prots.
4. a kind of Ribavirin ampoule bottle according to claim 3, it is characterised in that hot gas supervisor bottom is equipped with heat
Ballute, hot gas umbrella have interlayer air cavity construction, interlayer air cavity to be connected to high temperature tracheae, and hot gas umbrella extexine is equipped with and interlayer air cavity
The hot gas spray orifice of connection, hot gas umbrella endosexine are covered with thermal insulation material, are dissipated under hot gas with obstructing.
5. a kind of production technology of Ribavirin ampoule bottle according to claim 1, it is characterised in that include the following steps：
（1）Bottle embryo is transmitted：Bottle embryo is sequentially inserted into the fixation holder of conveyer belt, fixes fixation of the holder to bottle embryo bottom at this time
Root carries out clamping, is then fed into more heat pipe temperature control preheating cabinets；
（2）Bottle embryo softens：The level-one heating tube is located at bottle lower part, and temperature range is from 131 DEG C to 141 DEG C；Two level heating tube,
Three-level heating tube, level Four heating tube are located among bottle, and temperature range is from 141 DEG C to 151 DEG C；Described six grades, seven grades of heating tubes
Positioned at bottle top, wherein six grades, seven grades of heating tube temperature sections be 151 DEG C to 162 DEG C；
（3）Filling and molding：Multiple bottle embryos enter in mold, and multi-functional filling needle declines, and is inserted into bottle, multi-functional filling needle
The puff prot of lower part starts to blow out 5-30 DEG C of filtrated air, forms cold air curtain, and the spray hole of multi-functional filling needle is to molding pipe
Middle sprinkling irrigation sterile liquid medicine；Meanwhile the hot gas spray orifice of multi-functional filling needle blows hot gas to bottle top, keeps plastics soft state, together
When it is multi-functional filling for answering the upper mold, middle mold, lower mold of bottleneck to blow out 160 DEG C of filtrated air, ensure prefabricated bottleneck
Spot temperature does not reduce；
（4）Multi-functional filling needle rises rapidly with sterile liquid medicine liquid level and reaches setting position, the inlet tube of multi-functional filling needle
It closes, in uphill process, spray orifice can keep neck part plastics further to soften shape to the higher hot gas of neck part blowing temp
State, middle mold and upper mold are rapidly closed bottleneck position, bottle base head are sealed closed；It is multiple multi-functional due to being arranged
Filling needle, can be simultaneously to multiple bottles filling Ribavirin medicament and heat-sealing operation；When molding, the cutter of lower die will be fixed simultaneously
Root is to cutting so that fixed root keeps cut-out and attached state with bottle；
（5）Die sinking：With the unlatching of mold, the bottle of sealing is finally sent out from products export after being come out in mold；
（6）It checks：Examine the wall thickness, seal, resistance to temperature of Ribavirin ampoule bottle whether up to standard.
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| CN201810546221.7A CN108785077A (en) | 2018-05-31 | 2018-05-31 | A kind of Ribavirin ampoule bottle and its production technology |
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| CN201810546221.7A CN108785077A (en) | 2018-05-31 | 2018-05-31 | A kind of Ribavirin ampoule bottle and its production technology |
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Cited By (2)
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