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CN107375207A - A kind of sodium bromophenolate eye drops and its preparation technology - Google Patents

A kind of sodium bromophenolate eye drops and its preparation technology Download PDF

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Publication number
CN107375207A
CN107375207A CN201710759704.0A CN201710759704A CN107375207A CN 107375207 A CN107375207 A CN 107375207A CN 201710759704 A CN201710759704 A CN 201710759704A CN 107375207 A CN107375207 A CN 107375207A
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CN
China
Prior art keywords
funnel
stirring
staving
interior
charge groove
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Pending
Application number
CN201710759704.0A
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Chinese (zh)
Inventor
娄飞
齐琦
贾盼盼
李丽
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Liaoning Mei Lin Pharmaceutical Co Ltd
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Liaoning Mei Lin Pharmaceutical Co Ltd
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Priority to CN201710759704.0A priority Critical patent/CN107375207A/en
Publication of CN107375207A publication Critical patent/CN107375207A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0048Eye, e.g. artificial tears
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F27/00Mixers with rotary stirring devices in fixed receptacles; Kneaders
    • B01F27/05Stirrers
    • B01F27/11Stirrers characterised by the configuration of the stirrers
    • B01F27/19Stirrers with two or more mixing elements mounted in sequence on the same axis
    • B01F27/192Stirrers with two or more mixing elements mounted in sequence on the same axis with dissimilar elements
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F27/00Mixers with rotary stirring devices in fixed receptacles; Kneaders
    • B01F27/80Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis
    • B01F27/90Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis with paddles or arms 

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Ophthalmology & Optometry (AREA)
  • Inorganic Chemistry (AREA)
  • Mixers Of The Rotary Stirring Type (AREA)

Abstract

A kind of sodium bromophenolate eye drops and its preparation technology, it is related to a kind of eye drops and its preparation technology, is 0.001~0.15% bacteriostatic agent potassium sorbate comprising percentage by weight;Percentage by weight is 0.10~3.25% antioxidant sodium hydrogensulfite;Percentage by weight is 0.04~2.52% lubricant Stepanol MG;Percentage by weight is 0.15~0.55% bromfenac sodium;PH adjusting agent and water for injection, sodium bromophenolate eye drops are made by a series of mixing steps;The present invention is fanned and stirred the upper set fine bar of stirring of fan by the stirring on the rabbling mechanism and riser on bottom plate and realizes that the part within 1 cubic centimetre stirs, suspended things can be substantially reduced by local stirring, shorten mixing time, realize uniform dissolution, make each component content in sodium bromophenolate eye drops active compound material uniform, water velocity when greatly promoting the stirring efficiency of active compound material, and stirring.

Description

A kind of sodium bromophenolate eye drops and its preparation technology
Technical field
The present invention relates to a kind of agitating device, more particularly, to a kind of sodium bromophenolate eye drops and its preparation technology.
Background technology
In medicine produces, mixing is one and is mainly extensively using pharmaceutical technology, its purpose:1. prepare uniform mixing Thing;2. provide good condition for the operation of some units or chemical reaction process.When preparing homogeneous mixture, mixed effect with The mixability of mixture is weighed.
So-called mixing, it is exactly in the presence of external force, various material components blend mutually, are allowed to the micro- of in volume various components Grain is uniformly distributed.It is to ensure that quality of material and improves the important step of material effect.The purpose of mixing is made in prescription Each component content is uniform, to ensure that dosage is accurate, safely and effectively, ensures being uniformly distributed for each composition in formulation products, closes The married operation of reason is one of important measures for ensureing the quality of the pharmaceutical preparations.
Using trickle powder as main object in pharmacy mixed process, thus it is small with granularity, and density is small, tack, coagulates Poly- property, the features such as dustability is strong.Shape, size, the surface roughness of particle are uneven;Blending constituent is more, sometimes up to ten numbers Kind;During minipool, the blending ratio of minimum composition(Extension rate)Larger etc., the characteristic requirements of these pharmaceutical technologies are all to mixed Closing operation brings certain difficulty, but the meaning of married operation is but very great in formulation manufacturing processes.
For currently marketed sodium bromophenolate eye drops preparation technology, main medicament preparation technology is exactly to mix Stirring, the quality for mixing result directly affects the outward appearance and inherent quality of preparation, and influences curative effect of medication, but publication No. It is CN10313899B institutes for a kind of bromfenac sodium hydrate eye-gel preparation disclosed in CN101322683B and publication No. A kind of disclosed medical composite for eye containing bromfenac sodium, it is simple in the preparation method disclosed in its specification Each decoction is mixed by existing stirring technique in pharmaceutical technology, but for for eye drops class I liquid I shape medicine, mixing Stirring is to prepare the key technology of decoction, in conventional medicament dissolving whipping process, suspended things usually occurs, suspended things are due to Caused by current agitating device can not be stirred locally, suspended things are finally sunk to the bottom, and not only make it that the decoction of final dissolving allotment is dense Degree is unable to reach required standard, and also results in waste, can realize that the efficient mixing locally stirred is stirred there is presently no a kind of Mix device;In addition, traditional during the feeding intake of active compound before active compound material dissolves and stirs, be mostly by active compound one brain launch into In stirring container, even if adding in batches, active compound easily causes active compound material to accumulate also due to Action of Gravity Field is directly sunk to the bottom, and former Spice comes once accumulating it is difficult to be sufficiently stirred again, does not only result in waste and also make it that stirring efficiency is low, stirring is uneven to be led Cause each decoction effect not to be sufficiently mixed, residual impurity in decoction, influence medicine and play curative effect, and eye drops is applied in human body Sensitive organ-eye, be afraid of to stimulate, mix the uneven generation for also resulting in ocular side effect.
The content of the invention
In order to overcome the shortcomings of in background technology, the invention discloses a kind of sodium bromophenolate eye drops and its preparation technology, The present invention provides a kind of special mixed stirring device, is fanned by the stirring on the rabbling mechanism and riser on bottom plate and stirring is fanned The upper set fine bar of stirring realizes the local stirring within 1 cubic centimetre, and suspended things can be substantially reduced by local stirring, Shorten mixing time, realize uniform dissolution, realize the stirring of comprehensive, high efficiency, make in sodium bromophenolate eye drops active compound material respectively into Divide content uniform, be convenient for people to stir, water velocity relaxes when greatly promoting the stirring efficiency of active compound material, and stirring, and realizes complete It is water-soluble, free from admixture is filling, provide strong support for sodium bromophenolate eye drops preparation technology.
Realize that technical scheme is as follows:A kind of sodium bromophenolate eye drops and its preparation technology, include weight percent Than for 0.001~0.15% bacteriostatic agent potassium sorbate;Percentage by weight is 0.10~3.25% antioxidant sodium hydrogensulfite; Percentage by weight is 0.04~2.52% lubricant Stepanol MG;Percentage by weight is that 0.15~0.55% bromine is fragrant Sour sodium;PH adjusting agent and water for injection.
The preparation technology of described sodium bromophenolate eye drops:
Step 1:It is 0.001~0.15% bacteriostatic agent that percentage by weight is added in funnel:Potassium sorbate, rotate rotating bar A Funnel is turned to the upper cover plate top of charge groove on rotating disc, after its lower portion opening to be aligned to the perforation on upper cover plate, beaten Capping at open-drain bucket bottom opening so that the potassium sorbate of filling is fallen into charge groove by perforation in funnel, and funnel is taken Under clean up;
Step 2:It is 0.10~3.25% antioxidant that percentage by weight is added in funnel:Sodium hydrogensulfite, rotate rotating bar A turns to funnel on the upper cover plate top of another charge groove on rotating disc, and its lower portion opening is aligned into the perforation on upper cover plate Afterwards, the capping of funnel bottom opening is opened so that the sodium hydrogensulfite of filling falls into another charge groove by perforation in funnel It is interior, funnel is removed and cleaned up;
Step 3:It is 0.04~2.52% lubricant that percentage by weight is added in funnel:Stepanol MG, rotate Lever A turns to funnel on the upper cover plate top of another charge groove on rotating disc, and its lower portion opening is aligned on upper cover plate After perforation, the capping of funnel bottom opening is opened so that the Stepanol MG of filling is fallen into another by perforation in funnel In one charge groove, funnel is removed and cleaned up;
Step 4:It is 0.15~0.55% bromfenac sodium that percentage by weight is added in funnel, rotates rotating bar A and turns funnel Move to the upper cover plate top of another charge groove on rotating disc, after its lower portion opening to be aligned to the perforation on upper cover plate, open leakage Capping at bucket bottom opening so that the bromfenac sodium of filling is fallen into another charge groove by perforation in funnel, and funnel is taken Under clean up;
Step 5:More water pipes are connected to multiple water inlets on staving top, add the injection of total batch volume amount 85% Water, the control button on pressing operations platform so that the top rotary electric machine on staving top slowly rotates, so as to drive rotating disc to turn It is dynamic, the water filling into staving by water inlet while top rotary electric machine starts;Decoction in the charge groove of each network structure In the injecting process, water flows into via several perforation and carries out more sufficiently dissolving in charge groove to decoction, due to rotating disc Rotate, the L-type puddler of the upper cover plate bottom of charge groove is slided by ball via inertia along sliding groove, is accelerated in charge groove The quick dissolving of decoction and water, decoction is stirred while water carries out punching solution to decoction, avoids decoction from being adhered to charge Groove inwall;
Step 6:PH conditioning agents are added in funnel, rotate the upper lid that rotating bar A turns to funnel charge groove on rotating disc Plate top, after its lower portion opening to be aligned to the perforation on upper cover plate, open the capping of funnel bottom opening so that in funnel The pH conditioning agents of filling are fallen into charge groove by perforation, by with place the water inlets that are connected of charge groove of pH conditioning agents with Water pipe is connected, and adjusts pH value of solution to 8-8.5, benefit to inject water to whole batch volume amounts;
Step 7:After solution floods the riser of staving bottom completely in staving, bucket is started by the control button on operating desk Internal lower rotational motor, rotated by the several risers of lower rotational motor driven so that the first mixed liquor of decoction and water Body carries out rotation stirring in staving, in the rotation whipping process of riser, more vertical rods being brought into close contact with staving madial wall Rotated by the drive of riser along staving madial wall, so as to which staving inner sidewall part decoction be also sufficiently stirred;
Step 8:After step 7 herb liquid stirring 15min-20min, lower rotational electricity is lifted by the control button on operating desk The rotating speed of machine, after certain rotating speed to be achieved, on the inside of vertical rod the small-sized stirring fan on the stirring fan of side lever front end and stirring fan top and The small-sized stirring fan on side lever top passes through caused current trend in the inertia and mixing liquid whipping process after vertical rod rotation Stirring fan and small-sized stirring fan can be driven to rotate, several stirring fibre bars on the small-sized stirring fan on stirring fan top pass through inertia belt The dynamic stirring that can be carried out in regional area, realize the stirring in the region between outside in the middle part of liquid;
Step 9:Top rotary electric machine is closed by the control button on operating desk after stirring, reduces lower rotational motor Rotating speed, open the closure on the liquid outlet of staving bottom side, by upper surface for the low structure of middle high surrounding bottom plate with And the rotation of riser, it may be such that the mixing liquid in staving is collected via liquid outlet outflow;
Step 10:Resulting solution is filling in normal by solution after filter again after qualified with 0.1 μm of filtering with microporous membrane, sampling detection Advise in the clean eye drops bottle of technique.
The invention has the advantages that the present invention provides a kind of sodium bromophenolate eye drops and its preparation technology, pass through bottom plate On rabbling mechanism and riser on stirring fan and the upper set fine bar of stirring of stirring fan realize office within 1 cubic centimetre Portion is stirred, and can be substantially reduced suspended things by local stirring, be shortened mixing time, realize uniform dissolution, can not only improve The speed of stirring, moreover it is possible to which water velocity relaxes when improving the efficiency of stirring, and stirring, and avoids accumulating, and realizes complete water-soluble;By setting Funnel is put, metering placement can be carried out to sodium bromophenolate eye drops active compound material, realize rational medicine stirring and dissolving;Expanded by setting Rong Huan, the volume of funnel can be increased as needed, and then increase the meltage of active compound material, meet the needs of Large Copacity;By setting Multiple charge grooves are put, can be achieved to carry out active compound material scattered placement stirring, avoid active compound material from being stirred after accumulating insufficient;By setting Put rotating disc so that in active compound material whipping process is carried out, active compound material in charge groove can sufficiently be rocked, accelerate active compound Material dissolving;By setting L-type puddler so that, can be to the active compound material accumulated in charge groove in active compound material whipping process is carried out Activity is stirred, avoids active compound material in charge groove from accumulating;By setting riser, the stirring of active compound material can be carried out from staving bottom Dissolving;By setting vertical rod, cleaning can be carried out to staving interior side-wall surface and scraped, avoid adhering to active compound material on staving madial wall; By setting stirring fan, can be achieved to be sufficiently stirred the mixture of active compound material and water;So that in staving madial wall and staving The mixing liquid of compartment is sufficiently stirred between portion;By setting small-sized stirring to fan, pass through bottom in whipping process The rotation of rotary electric machine and mixing liquid drives small-sized stirring fan to be rotated so that between in the middle part of staving madial wall and staving Mixing liquid every part is sufficiently stirred;By being threaded the bottom plate of connection, the dismounting to bottom plate can be facilitated, so as to real Now riser, rotating bar, helix swiveling plate, stirring fan etc. are cleared up;
The Stepanol MG added in the present invention primarily serves lubrication, effect that is anti-stick, helping stream, is more favorable for bromfenac sodium Mixing in eye drops preparation process.
The present invention can not only realize that people carry out the stirring of quick and convenient sodium bromophenolate eye drops active compound material, and greatly The stirring efficiency of active compound material is improved, water velocity relaxes when realizing comprehensive, high efficiency stirring, and stirring, and can make Bromfenac Various materials are mutually disperseed and reach certain uniformity coefficient in sodium eye drops active compound material, make each component content in medicine uniform, with Ensure that dosage is accurate, safely and effectively, ensure being uniformly distributed for each composition in formulation products, ensure the quality of pharmaceutical preparation, Realization is entirely water-soluble, free from admixture is filling, and strong support is provided for sodium bromophenolate eye drops preparation technology.
Brief description of the drawings
The present invention is further described with reference to the accompanying drawings and examples.
Fig. 1 is the sodium bromophenolate eye drops preparation technology mixed stirring device overall structure diagram of the present invention.
Fig. 2 is the sodium bromophenolate eye drops preparation technology mixed stirring device rotating disc overall structure diagram of the present invention.
Fig. 3 is the sodium bromophenolate eye drops preparation technology mixed stirring device rotating disc structural representation of the present invention.
Fig. 4 is the sodium bromophenolate eye drops preparation technology mixed stirring device charge slot structure schematic diagram of the present invention.
Fig. 5 is the sodium bromophenolate eye drops preparation technology mixed stirring device upper cover plate structural representation of the present invention.
Fig. 6 is the sodium bromophenolate eye drops preparation technology mixed stirring device internal structure schematic diagram of the present invention.
In figure:1. funnel, 2. rotating bar A, 3. water inlets, 4. rotating discs, 5. stavings, 6. control buttons, 7. operating desks, 8. Closure, 9. liquid outlets, 10. dilatation rings, 11. connecting rods, 12. rotating bar B, 13. fixation poles, 14. top rotary electric machines, 15. upper cover plate, 16. charge grooves, 17. scales, 18. cappings, 19. openings, 20. necking down cards put ring, 21. perforation, the stirring of 22.L types Bar, 23. balls, 24. sliding grooves, 25. internal threads, 26. small-sized stirring fans, the 27. fine bars of stirring, 28. stirring fans, 29. rotating shafts, 30. side lever, 31. risers, 32. vertical rods, 33. lower rotational motors, 34. bottom plates, 35. external screw threads.
Embodiment
In conjunction with the accompanying drawings, the present invention is further explained in detail.These accompanying drawings are simplified schematic diagram, only with Illustration illustrates the basic structure of the present invention, therefore it only shows the composition relevant with the present invention.
Mixed stirring device used in sodium bromophenolate eye drops preparation technology with reference to given by accompanying drawing 1~6, in staving 5 bottoms are provided with bottom plate 34 of the upper surface for middle high surrounding low dip surface, and interior spiral shell is provided with the lower inside wall of staving 5 Line 25, the external screw thread 35 to match with the internal thread 25 on the lower inside wall of staving 5 is provided with the outside of the bottom plate 34, The bottom plate 34 is threadedly coupled by external screw thread 35 with the internal thread 25 on the lower inside wall of staving 5, and this is allowed for can be right Bottom plate 34 is dismantled, convenient to carrying out cleaning maintenance inside staving 5, and lower rotational motor is provided with the middle part of bottom plate 34 33, several risers 31 are provided with the outside of the motor output end of the lower rotational motor 33, on several outer ends of riser 31 Portion is respectively equipped with the vertical rod 32 to match with the staving 5, and several side levers are sequentially provided with several medial surfaces of vertical rod 32 30, the front end of several side levers 30 on several medial surfaces of vertical rod 32 is provided with stirring fan 28, and the stirring fan 28 passes through rotating shaft 29 are flexibly connected with the front end of side lever 30, and the flabellum top on several upper surfaces of side lever 30 and several stirring fans 28 is set respectively There are several small-sized stirring fans 26 being flexibly connected by rotating shaft 29, several small-sized stirring fans 26 on 28 flabellums of the stirring fan On be respectively equipped with the fine bar 27 of stirring, be provided with top rotary electric machine 14, the top on the rotating disc 4 on the top of staving 5 The outside of rotary electric machine 14 is respectively equipped with several fixation poles 13 being fixedly connected with the inwall of staving 5, is rotated on the top The motor output end of the bottom of motor 14 is provided with rotating disc 4, several openings 19 is provided with the rotating disc 4, in the rotating disc 4 On several openings 19 madial wall on be respectively equipped with necking down card and put ring 20, in several openings 19 on the rotating disc 4 point Not She You network structure charge groove 16, on the charge groove 16 be provided be fixedly connected with the screw thread of charge groove 16 or buckle it is upper Cover plate 15, the charge groove 16 blocks the necking down card being placed in opening 19 by upper cover plate 15 puts realization and rotating disc 4 on ring 20 Card puts connection, and dismounting cleaning can conveniently be carried out by blocking the charge groove 16 put, and several perforation 21 is provided with the upper cover plate 15, in institute State the bottom surface of upper cover plate 15 and be provided with sliding groove 24, the upper end of L-type puddler 22 be provided with the lower surface of upper cover plate 15 The ball 23 that sliding groove 24 matches, the L-type puddler 22 pass through the sliding groove 24 on ball 23 and the lower surface of upper cover plate 15 Gap cooperation is carried out, the L-type coordinated with the gap of sliding groove 24 is provided with the sliding groove 24 of the bottom surface of upper cover plate 15 and is stirred Bar 22, the rotating bar A2 being flexibly connected with the top rotary electric machine 14 is provided with the top of top rotary electric machine 14, in institute The side for stating rotating bar A2 is provided with connecting rod 11, funnel 1 is provided with the other end of the connecting rod 11, in the inwall of funnel 1 Scale 17 is provided with, the opening in the bottom of funnel 1 is provided with the capping 18 being articulated and connected with the funnel 1, passes through capping 18 can carry out back cover to funnel 1, and so as to realize the filling of quantitative active compound material, rotating bar B12 is provided with the rotating bar A2 tops, The dilatation ring 10 being adapted with the funnel 1 is provided with by connecting rod 11 in the rotating bar B12 sides, on the staving 5 Several water inlets 3 are provided with the outside of portion, operating desk 7 is provided with the side of staving 5, are respectively equipped with the operating desk 7 and institute The control button 6 that top rotary electric machine 14 and lower rotational motor 33 are electrically connected is stated, is provided with the bottom side of staving 5 Liquid outlet 9, the closure 8 being threadedly coupled with the liquid outlet 9 is provided with the liquid outlet 9 of the bottom side of staving 5.
Described top rotary electric machine 14 and lower rotational motor 33 are excellent by the side power line external power supply of operating desk 7 The top rotary electric machine 14 and lower rotational motor 33 of choosing can use three-phase frequency-conversion speed-regulation motor YVP200L-4 level 30kw/380v, Electric efficiency height, obvious energy conservation, have a wide range of application, smooth speed control, can the stepless time adjustment in the range of 5 ~ 100HZ, during low-frequency start Torque is small to load shock, and starting current is small, without adding starting equipment.
Sodium bromophenolate eye drops of the present invention and its preparation technology:Comprising percentage by weight be 0.001~ 0.15% bacteriostatic agent potassium sorbate;Percentage by weight is 0.10~3.25% antioxidant sodium hydrogensulfite;Percentage by weight is 0.04~2.52% lubricant Stepanol MG;Percentage by weight is 0.15~0.55% bromfenac sodium;PH is adjusted Agent and water for injection.
The preparation technology of described sodium bromophenolate eye drops:
Step 1:It is 0.001~0.15% bacteriostatic agent that percentage by weight is added in funnel 1:Potassium sorbate, rotate rotating bar A2 turns to funnel 1 on the top of upper cover plate 15 of charge groove 16 on rotating disc 4, and the lower openings of funnel 1 are aligned on upper cover plate 15 Perforation 21 after, open the bottom opening of funnel 1 at capping(18)So that the potassium sorbate of filling passes through perforation 21 in funnel 1 Fall into charge groove 16, funnel 1 is removed and cleaned up;
Step 2:It is 0.10~3.25% antioxidant that percentage by weight is added in funnel 1:Sodium hydrogensulfite, rotate Bar A2 turns to funnel 1 on the top of upper cover plate 15 of another charge groove 16 on rotating disc 4, will be covered in the alignment of the lower openings of funnel 1 After perforation 21 on plate 15, the capping 18 at the bottom opening of funnel 1 is opened so that the sodium hydrogensulfite of filling passes through in funnel 1 Perforation 21 is fallen into another charge groove 16, and funnel 1 is removed and cleaned up;
Step 3:It is 0.04~2.52% lubricant that percentage by weight is added in funnel 1:Stepanol MG, rotate Rotating bar A2 turns to funnel 1 on the top of upper cover plate 15 of another charge groove 16 on rotating disc 4, and the lower openings of funnel 1 are aligned After perforation 21 on upper cover plate 15, the capping 18 at the bottom opening of funnel 1 is opened so that the dodecyl sulphur of filling in funnel 1 Sour magnesium is fallen into another charge groove 16 by perforation 21, and funnel 1 is removed and cleaned up;
Step 4:It is 0.15~0.55% bromfenac sodium that percentage by weight is added in funnel 1, rotates rotating bar A2 by funnel 1 The top of upper cover plate 15 of another charge groove 16 on rotating disc 4 is turned to, the lower openings of funnel 1 are directed at the perforation on upper cover plate 15 After 21, the capping 18 at the bottom opening of funnel 1 is opened so that the bromfenac sodium of filling is fallen into another by perforation 21 in funnel 1 In charge groove 16, funnel 1 is removed and cleaned up;
Step 5:At multiple water inlets 3 that more water pipes are connected to the top of staving 5, the injection of total batch volume amount 85% is added Water, the control button 6 on pressing operations platform 7 so that the top rotary electric machine 14 on the top of staving 5 slowly rotates, so as to turn Moving plate 4 rotates, and top rotary electric machine 14 passes through the water filling into staving 5 of water inlet 3 while startup;The charge of each network structure In the injecting process, water flows into more sufficiently molten to decoction progress in charge groove 16 decoction in groove 16 via several perforation 21 Solution, due to the rotation of rotating disc 4, the L-type puddler 22 of the bottom of upper cover plate 15 of charge groove 16 is by ball 23 via inertia edge Sliding groove 24 to slide, accelerate the quick dissolving of the inner liquid medicine of charge groove 16 and water, to medicine while water carries out punching solution to decoction Liquid is stirred, and avoids decoction from being adhered to the inwall of charge groove 16;
Step 6:PH conditioning agents are added in funnel 1, rotating bar A2 is rotated and funnel 1 is turned into charge groove 16 on rotating disc 4 The top of upper cover plate 15, by the lower openings of funnel 1 be aligned upper cover plate 15 on perforation 21 after, open the bottom opening of funnel 1 at Capping 18 so that the pH conditioning agents of filling are fallen into charge groove 16 by perforation 21 in funnel 1, by with placing pH conditioning agents The water inlet 3 that charge groove 16 is connected is connected with water pipe, adjusts pH value of solution to 8-8.5, benefit to inject water to whole batch volumes Amount;
Step 7:After solution floods riser 31 of the bottom of staving 5 completely in staving 5, pass through the control button 6 on operating desk 7 Start the lower rotational motor 33 in staving 5, drive several risers 31 to rotate by lower rotational motor 33 so that decoction and water First mixing liquid rotation stirring is carried out in staving 5, it is tight with the madial wall of staving 5 in the rotation whipping process of riser 31 More vertical rods 32 of closely connected conjunction are rotated by the drive of riser 31 along the madial wall of staving 5, so as to by the inner side wall portion of staving 5 Decoction is divided also to be sufficiently stirred;
Step 8:After step 7 herb liquid stirring 15min-20min, lower rotational is lifted by the control button 6 on operating desk 7 The rotating speed of motor 33, after certain rotating speed to be achieved, 28 tops of stirring fan 28 and stirring fan of the front end of 32 inner side side lever of vertical rod 30 Small-sized stirring fan 26 and the small-sized stirring fan 26 on the top of side lever 30 are stirred by the inertia after the rotation of vertical rod 32 and mixing liquid During caused current trend can drive stirring fan 28 and small-sized stirring fan 26 rotate, stirring fan 28 tops small-sized stirring fan Several stirring fibre bars 27 on 26 drive the stirring that can be carried out in regional area by inertia, realize in the middle part of liquid between outside The stirring in region;
Step 9:Top rotary electric machine 14 is closed by the control button 6 on operating desk 7 after stirring, reduces lower rotational The rotating speed of motor 33, the closure 8 on the bottom side liquid outlet 9 of staving 5 is opened, be the low structure of the high surrounding in centre by upper surface Bottom plate 34 and riser 31 rotation, may be such that mixing liquid in staving 5 is collected via the outflow of liquid outlet 9;
Step 10:Resulting solution is filling in normal by solution after filter again after qualified with 0.1 μm of filtering with microporous membrane, sampling detection Advise in the clean eye drops bottle of technique.
After active compound material distinguishes filling in batches, at multiple water inlets 3 on more water pipes connection staving 5 top, pass through Control button 6 on pressing operations platform 7 so that the top rotary electric machine 14 on the top of staving 5 slowly rotates, so as to drive rotating disc 4 rotate, and inject water for injection into staving 5 by water inlet 3 while top rotary electric machine 14 starts;Because active compound material is point Criticize and be seated in the charge groove 16 of network structure, this is allowed in the injecting process, and water for injection flows into via several perforation 21 Dissolving more can be sufficiently washed away to active compound material, in charge groove 16 due to the rotation of rotating disc 4, the upper cover plate of charge groove 16 The L-type puddler 22 of 15 bottoms can enter line slip via inertia by ball 23 along sliding groove 24, so as in water for injection pair Active compound material active compound material is stirred while punching solution, not only allows water for injection to be carried out with active compound material fully molten Solution, and effectively prevent active compound material and be adhered to the inwall of charge groove 16, in the injecting process, because not stalling for rotating disc 4 is dynamic, So that several charge grooves 16 can be also rotated so as to accelerate the quick dissolving of active compound material and water for injection in charge groove 16;
After the water for injection of injection floods riser 31 of the bottom of staving 5 completely, started by the control button 6 on operating desk 7 Lower rotational motor 33 in staving 5, drive several risers 31 to be rotated by lower rotational motor 33 so that active compound material with The first mixing liquid of water for injection carries out rotation stirring in staving 5, active compound material at this moment and the mixing liquid of water for injection Inside there is more active compound material particle, these particles are easy to be adhered on the madial wall of staving 5 in whipping process, and polylith is stood Vertical rod 32 on the outer end of plate 31 can solve this problem, due to polylith riser 31 be bonded with the madial wall of staving 5 it is more compact so that Also be bonded with the vertical rod 32 that staving 5 matches with the madial wall of staving 5 it is more compact, it is more in the rotation whipping process of riser 31 Root vertical rod 32 can be rotated by the drive of riser 31 along the madial wall of staving 5, so as to be adhered to the original of the madial wall of staving 5 Spice particle is scraped to being stirred in mixing liquid;
Stirred during, can be achieved to mixing liquid bottom in the rotation to mixing liquid by rotating disc 4, riser 31, vertical rod 32 Portion, middle part, outside and top more sufficiently stir, and this residual particles allowed in mixing liquid can flow to mixing Region between liquid middle part and outside, when being stirred for this region, staff can pass through the control on operating desk 7 Button 6 lifts the rotating speed of lower rotational motor 33, after certain rotating speed to be achieved, the stirring fan 28 of the front end of 32 inner side side lever of vertical rod 30 And the small-sized stirring fan 26 on 28 tops of stirring fan and the small-sized stirring fan 26 on the top of side lever 30 pass through the inertia after the rotation of vertical rod 32 And caused current trend can drive stirring fan 28 and small-sized stirring fan 26 to rotate in mixing liquid whipping process, so as to realize For the stirring in region between in the middle part of mixing liquid and outside, in for this region whipping process, 28 tops of stirring fan Several stirring fibre bars 27 on small-sized stirring fan 26 drive the stirring that can be carried out in regional area by inertia, and this allows for being directed to The stirring in region is more abundant between outside in the middle part of mixing liquid;
It may be such that by above-mentioned stirring and sufficiently dissolving stirring carried out to active compound material, pass through the control on operating desk 7 after stirring Button 6 processed closes top rotary electric machine 14, reduces the rotating speed of lower rotational motor 33, opens on the bottom side liquid outlet 9 of staving 5 Closure 8, the rotation by upper surface for the bottom plate 34 and riser 31 of the low structure of middle high surrounding, may be such that in staving 5 Mixing liquid via liquid outlet 9 outflow be collected;
, can be by charge by the perforation 21 on the upper cover plate 15 on charge groove 16 when carrying out cleaning and maintenance to mixed stirring device Groove 16 proposes out of opening 19 on rotating disc 4, by the way that upper cover plate 15 and charge groove 16 are disassembled come can be to charge groove 16 Cleaned;When to carrying out cleaning and maintenance inside staving 5, the bottom plate 34 that is threadedly coupled by rotating staving 5 with staving 5 Separated with staving 5, after will staving 5 be removed, you can to the riser 31 on bottom plate 34, vertical rod 32, stirring fan 28 and small-sized stir Mix fan 26 and carry out cleaning and maintenance;
The present invention can not only realize that people carry out the stirring of quick and convenient sodium bromophenolate eye drops active compound material, and greatly be lifted Water velocity relaxes when the stirring efficiency of active compound material, realizing comprehensive, high efficiency stirring, and stirring, and can drip bromfenac sodium Various materials are mutually disperseed and reach certain uniformity coefficient in ocular fluid active compound material, make each component content in medicine uniform, to ensure Dosage is accurate, safely and effectively, ensures being uniformly distributed for each composition in formulation products, ensures the quality of pharmaceutical preparation, realize It is complete it is water-soluble, free from admixture is filling, provide strong support for sodium bromophenolate eye drops preparation technology.
It is complete by above-mentioned description, those skilled in the art using the above-mentioned desirable embodiment according to the present invention as enlightenment Various changes and amendments can be carried out without departing from the scope of the technological thought of the present invention'.This invention it is technical Scope is not limited to the content on specification, it is necessary to determines its technical scope according to right.

Claims (2)

1. a kind of sodium bromophenolate eye drops, it is characterized in that:It is 0.001~0.15% bacteriostatic agent sorbic acid comprising percentage by weight Potassium;Percentage by weight is 0.10~3.25% antioxidant sodium hydrogensulfite;Percentage by weight is 0.04~2.52% lubrication Agent Stepanol MG;Percentage by weight is 0.15~0.55% bromfenac sodium;PH adjusting agent and water for injection.
2. the preparation technology of sodium bromophenolate eye drops according to claim 1, it is characterized in that:
Step 1:In funnel(1)Interior addition percentage by weight is 0.001~0.15% bacteriostatic agent:Potassium sorbate, rotate Bar A(2)By funnel(1)Turn to rotating disc(4)Upper charge groove(16)Upper cover plate(15)Top, by funnel(1)Lower openings It is directed at upper cover plate(15)On perforation(21)Afterwards, funnel is opened(1)Capping at bottom opening(18)So that funnel(1)It is built-in The potassium sorbate filled out passes through perforation(21)Fall into charge groove(16)It is interior, by funnel(1)Remove and clean up;
Step 2:In funnel(1)Interior addition percentage by weight is 0.10~3.25% antioxidant:Sodium hydrogensulfite, rotate Lever A(2)By funnel(1)Turn to rotating disc(4)Upper another charge groove(16)Upper cover plate(15)Top, by funnel(1)Under Portion's opening alignment upper cover plate(15)On perforation(21)Afterwards, funnel is opened(1)Capping at bottom opening(18 so that funnel(1) The sodium hydrogensulfite of interior filling passes through perforation(21)Fall into another charge groove(16)It is interior, by funnel(1)Remove and clean up;
Step 3:In funnel(1)Interior addition percentage by weight is 0.04~2.52% lubricant:Stepanol MG, turn Turn lever A(2)By funnel(1)Turn to rotating disc(4)Upper another charge groove(16)Upper cover plate(15)Top, by funnel (1)Lower openings are directed at upper cover plate(15)On perforation(21)Afterwards, funnel is opened(1)Capping at bottom opening(18)So that Funnel(1)The Stepanol MG of interior filling passes through perforation(21)Fall into another charge groove(16)It is interior, by funnel(1)Remove clear Wash clean;
Step 4:In funnel(1)Interior addition percentage by weight is 0.15~0.55% bromfenac sodium, rotates rotating bar A(2)Will Funnel(1)Turn to rotating disc(4)Upper another charge groove(16)Upper cover plate(15)Top, by funnel(1)Lower openings are aligned Upper cover plate(15)On perforation(21)Afterwards, funnel is opened(1)Capping at bottom opening(18)So that funnel(1)Interior filling Bromfenac sodium passes through perforation(21)Fall into another charge groove(16)It is interior, by funnel(1)Remove and clean up;
Step 5:More water pipes are connected into staving(5)Multiple water inlets on top(3)Place, add the note of total batch volume amount 85% Penetrate and use water, pressing operations platform(7)On control button(6)So that staving(5)The top rotary electric machine on top(14)Slowly turn It is dynamic, so as to drive rotating disc(4)Rotate, top rotary electric machine(14)Pass through water inlet while startup(3)To staving(5)Interior note Water;The charge groove of each network structure(16)Interior decoction is in the injecting process, and water is via several perforation(21)Flow into charge groove (16)It is interior that more sufficiently dissolving is carried out to decoction, due to rotating disc(4)Rotation, charge groove(16)Upper cover plate(15)Bottom L-type puddler(22)Pass through ball(23)Via inertia along sliding groove(24)Slide, accelerate charge groove(16)Inner liquid medicine with The quick dissolving of water, decoction is stirred while water carries out punching solution to decoction, avoids decoction from being adhered to charge groove(16) Inwall;
Step 6:In funnel(1)Interior addition pH conditioning agents, rotate rotating bar A(2)By funnel(1)Turn to rotating disc(4)On Charge groove(16)Upper cover plate(15)Top, by funnel(1)Lower openings are directed at upper cover plate(15)On perforation(21)Afterwards, open Funnel(1)Capping at bottom opening(18)So that funnel(1)The pH conditioning agents of interior filling pass through perforation(21 fall into charge groove (16)It is interior, by the charge groove with placing pH conditioning agents(16)The water inlet being connected(3)It is connected with water pipe, adjusts pH value of solution to 8- 8.5, benefit injects water to whole batch volume amounts;
Step 7:Work as staving(5)Interior solution floods staving completely(5)The riser of bottom(31)Afterwards, operating desk is passed through(7)On control Button processed(6)Start staving(5)Interior lower rotational motor(33), pass through lower rotational motor(33)Drive several risers(31) Rotate so that the first mixing liquid of decoction and water is in staving(5)Rotation stirring is inside carried out, in riser(31)Rotation it is stirred Cheng Zhong, with staving(5)The more vertical rods that madial wall is brought into close contact(32)Pass through riser(31)Drive along staving(5)Madial wall Rotated, so as to by staving(5)Inner sidewall part decoction is also sufficiently stirred;
Step 8:After step 7 herb liquid stirring 15min-20min, pass through operating desk(7)On control button(6)Lift bottom Rotary electric machine(33)Rotating speed, after certain rotating speed to be achieved, vertical rod(32)Inner side side lever(30)The stirring fan of front end(28)And stir Mix fan(28)The small-sized stirring fan on top(26)And side lever(30)The small-sized stirring fan on top(26)Pass through vertical rod(32)After rotation Inertia and mixing liquid whipping process in caused current trend can drive stirring fan(28)Fanned with small-sized stirring(26)Turn It is dynamic, stirring fan(28)The small-sized stirring fan on top(26)On several stirring fibre bars(27)Partial zones can be carried out by being driven by inertia Stirring in domain, realize the stirring in the region between outside in the middle part of liquid;
Step 9:Pass through operating desk after stirring(7)On control button(6)Close top rotary electric machine(14), under reduction Portion's rotary electric machine(33)Rotating speed, open staving(5)Bottom side liquid outlet(9)On closure(8), in being by upper surface Between the low structure of high surrounding bottom plate(34)And riser(31)Rotation, may be such that staving(5)Interior mixing liquid is via going out liquid Mouthful(9)Outflow is collected;
Step 10:Resulting solution is filling in normal by solution after filter again after qualified with 0.1 μm of filtering with microporous membrane, sampling detection Advise in the clean eye drops bottle of technique.
CN201710759704.0A 2017-08-30 2017-08-30 A kind of sodium bromophenolate eye drops and its preparation technology Pending CN107375207A (en)

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Publication number Priority date Publication date Assignee Title
CN108097139A (en) * 2017-12-05 2018-06-01 芜湖市诺康生物科技有限公司 A kind of solid-liquid drug mixing arrangement
CN110664737A (en) * 2018-07-02 2020-01-10 盘锦雨源新创意开发推广有限公司 Bromfenac sodium eye drops and preparation process thereof
CN110801749A (en) * 2019-11-22 2020-02-18 姚鸿 Novel disconnect-type of cutting fluid agitator prevents deposiing puddler
CN114011263A (en) * 2021-11-11 2022-02-08 臻味之(烟台)食品科技有限公司 Beverage enzymolysis device
CN118416737A (en) * 2024-07-03 2024-08-02 江西农业大学 A kind of cinnamaldehyde nanoemulsion antibacterial agent preparation equipment and preparation method

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CN104523587A (en) * 2014-12-31 2015-04-22 辰欣药业股份有限公司 Bromfenac sodium eye drops and preparation method thereof
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CN1823754A (en) * 2006-03-28 2006-08-30 卢秀莲 Sodium bromophenolate eye drops and its preparation method
US20100227928A1 (en) * 2009-03-05 2010-09-09 Kamran Hosseini Non-steroidal anti-inflammatory ophthalmic compositions
CN202778330U (en) * 2012-06-20 2013-03-13 潮州市饶花玻璃实业有限公司 High-efficiency uniform mixing machine
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108097139A (en) * 2017-12-05 2018-06-01 芜湖市诺康生物科技有限公司 A kind of solid-liquid drug mixing arrangement
CN110664737A (en) * 2018-07-02 2020-01-10 盘锦雨源新创意开发推广有限公司 Bromfenac sodium eye drops and preparation process thereof
CN110801749A (en) * 2019-11-22 2020-02-18 姚鸿 Novel disconnect-type of cutting fluid agitator prevents deposiing puddler
CN114011263A (en) * 2021-11-11 2022-02-08 臻味之(烟台)食品科技有限公司 Beverage enzymolysis device
CN114011263B (en) * 2021-11-11 2023-12-22 广州广氏食品有限公司 Beverage enzymolysis device
CN118416737A (en) * 2024-07-03 2024-08-02 江西农业大学 A kind of cinnamaldehyde nanoemulsion antibacterial agent preparation equipment and preparation method

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