CN105147601A - Production method for preventing medicine liquor turbidity of glucose injection packaged in plastic bottle - Google Patents
Production method for preventing medicine liquor turbidity of glucose injection packaged in plastic bottle Download PDFInfo
- Publication number
- CN105147601A CN105147601A CN201510694733.4A CN201510694733A CN105147601A CN 105147601 A CN105147601 A CN 105147601A CN 201510694733 A CN201510694733 A CN 201510694733A CN 105147601 A CN105147601 A CN 105147601A
- Authority
- CN
- China
- Prior art keywords
- bottle
- sterilization
- sterilizing
- production method
- medicinal liquid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
Abstract
The invention discloses a production method for preventing medicine liquor turbidity of glucose injection packaged in a plastic bottle. The production method comprises the following steps that firstly, external force damage of a bottle blank and the bottle in the production process is reduced, and film scraps and fibers attached inside and outside a bottle body are reduced; secondly, a filtering device is additionally arranged at a water discharging port of a sterilization cabinet, and accumulation of the film scraps in a sterilization pipeline and a heat exchanger is reduced; thirdly, cleaning treatment of the sterilization cabinet is enhanced, attached film scraps becoming yellowish after multiple times of high temperature and large heat are reduced, the filtering device arranged at the water discharging port of the sterilization cabinet is cleaned every day, the sterilization cabinet is circularly cleaned through a 2% NaOH solution every week, and empty sterilization is carried out once every week. After the measures are taken, the problem of medicine liquor turbidity in the polypropylene infusion bottled glucose injection bottle body is solved, and the ratio of medicine liquor turbidity in the bottle body is almost zero.
Description
Technical field
The present invention relates to technical field of medicine, be specifically related to a kind of production method preventing plastic bottle from filling glucose injection medicinal liquid muddiness.
Background technology
Glucose injection, chemical name: D-(+)-Glucopyranose .-hydrate, chemical structural formula: molecular formula: C
6h
12o
6˙ H
2o, molecular formula: 198.17, adjuvant: water for injection.This product is colourless or almost colourless clear liquid; Taste is sweet.Intravenous glucose injection directly enters blood circulation.Glucose in vivo complete oxidation generates CO
2and water, excrete through lung and kidney, simultaneously produce power.Also glycogen and depot fat can be changed into.Normally the human body ability of glucose that utilizes per minute is for 6mg/kg.Fluid infusion is too fast, too much, can cause cardiopalmus, arrhythmia, even acute left heart failure.Total intravenous nutrition therapy glucose is the most important Power supply material of this therapy.In nonprotein heat energy, the ratio that glucose and fat supply heat is 2:1.Indication: 1. makeup energy and body fluid; The hypoalimentation caused for a variety of causes or a large amount of body fluid lose (as vomiting, diarrhoea etc.), full intravenous nutrition, inanition ketosis.2. hypoglycin; 3. hyperpotassemia; 4. hyperosmotic solution is used as tissue dewatering agent; 5. prepare peritoneal dialysis solution; 6. pharmaceutical diluents; 7. vein method glucose tolerance test; 8. for preparation GIK (polarized solution).
In prior art, the medicines such as such as glucose injection are generally that the processing step wanting the policy paper such as Surveillance Authority or pharmacopeia to advise according to state food is produced, if pharmaceutical producing enterprise is to the change of product production technology taking certification, need declaration again, manpower and materials cost can be increased.Therefore, since there is the suggestion of policy paper, pharmaceutical production producer generally arbitrarily can not change production technology.But along with the development in epoch, the progress of technology, and the requirement of environmental protection and energy saving, improvements over the prior art are also in the middle of constantly carrying out, and improving each time is all constantly perfect to prior art, is also cost-saving accordingly.
Summary of the invention
The object of the invention is to solve the deficiencies in the prior art, a kind of production method preventing plastic bottle from filling glucose injection medicinal liquid muddiness is provided.
A kind of production method preventing plastic bottle from filling glucose injection medicinal liquid muddiness of the present invention, comprises the steps:
1) weigh: prepare supplementary material;
2) densely to join: load weighted glucose is placed in the dense preparing tank of water for injection, is made into 40-60% (w/w) concentrated solution, add 0.05% (w/v) pin charcoal, heating, boils 15-30 minute, pressurization, de-charcoal, to clear and bright, proceeds to dilute preparing tank;
3) rarely to join: add to the full amount of water for injection in dilute preparing tank, be circulated to clear and bright, adjust ph 3.8-5.0, survey glucose content is labelled amount 98.0-104.0%, after qualified, to be filtered; Sampling, checks medicinal liquid character, content, pH value, and after qualified, through 0.45um aperture foldable filter element series connection 0.45um aperture, foldable filter element filters, qualified rear to be filled;
4) embedding is washed: by weld-ring, bottle blowing after the injection moulding of polypropylene plastics particle; Open anion air channel, compressed air wash bottle pressure 0.8-1.0MPa, cooling water pressure 0.3-0.6MPa; Open sealing machine hot plate power supply, preheating makes heating-up temperature even for 3 minutes, in agitator, add polypropylene combination cover; Upper bottle, wash bottle after debugging wash bottle compressed air pressure meets the requirements; Medicinal liquid fill after 0.22 μm of frit, setting filling speed 150-200 bottle/minute, start filling machine, check medicinal liquid visible foreign matters and loading amount, start after qualified to produce;
5) sterilizing: by step 4) product subject to sterilization that obtains advances water-bath type sterilizing cabinet, setup control temperature 117 DEG C, sterilising temp 115 DEG C, sterilization time 30 minutes, the temperature that offers for sale 55 DEG C, sterilization pressure 220-245Kpa, F.Value >=8;
Increase by 0.45 μm of defecator in sterilizing cabinet discharge outlet, strengthen sterilizing cabinet cleaning treatment, every day, washing and sterilizing cabinet discharge outlet defecator, adopted weekly 2%NaOH solution circulation washing and sterilizing cabinet, unloaded sterilizing 1 time;
6) lamp inspection: by bottle, the distortion of product appearance, pollution, leakage, loading amount, weld-ring situation and visible foreign matters are checked on lamp inspection operating board by " straight, horizontal, fall, pinch " four step rule to the product transferred online after sterilizing;
7) pack, warehouse-in: the product that lamp inspection is transferred online by bottle sticker mark, vanning warehouse-in.
In the present invention, the proportional quantity of supplementary material used conventionally specifies.
Compared with prior art, the present invention has the following advantages:
The performance characteristics that plastic bottle (polypropylene vial) is infused is mainly that good stability, bottle sealability are good, strong without cast, light weight, anti-impact force, infusion products contaminated probability minimizing in process of production, energy savings, single use are hygienic and convenient.But easily occur also there is many problems, particularly sterilizing in plastic bottle infusion products production process after that bottle inner liquid medicine becomes turbid phenomenon.Detect through lamp inspection, bottle inner liquid medicine becomes muddiness and accounts for about 30%, and bottle inner liquid medicine becomes the superiors and orlop that muddy bottle mainly concentrates on vehicle of sterilization, has a strong impact on the yield rate of product.
The generation of these problems, mainly because in prior art, sterilization steps Shortcomings, the discharge outlet of sterilizing cabinet does not have defecator, is the flushing of simple and regular to the cleaning of sterilizing cabinet yet, causes having polypropylene screen to consider to be worth doing in sterilizing cabinet residual.Applicant finds through large quantity research, after sterilizing, muddy the considering to be worth doing due to polypropylene screen residual in sterilizing cabinet of bottle inner liquid medicine change causes, polypropylene granules is (containing multiple additives, especially antioxidant) after multiple high temp heating process, less stable own, in 115 DEG C of sterilization process, bottle is in softening process, and polypropylene associative key is unstable, film bits turn yellow or go bad in heating for multiple times process, along with sterilization water spray is at bottle outer surface.The product that part harmomegathus is serious easily contacts to react with the yellow film bits after multiple high temp and causes bottle to come off in sterilization process, and show as bottle and adhere to yellow substance outward, bottle inside causes the muddiness that comes off, and phenomenon clearly.
The present invention passes through following measures: 1. reduce the external force damage in process of production of bottle embryo, bottle, reduce bottle inside and outside film bits, fiber attachment; 2. increase sterilizing cabinet discharge outlet defecator, reduce film bits and accumulate in sterilizing pipeline and heat exchanger; 3. strengthen sterilizing cabinet cleaning treatment, reduce the attachment of the rear flavescence film bits of the high heat of multiple high temp, every day, washing and sterilizing cabinet discharge outlet defecator, adopted weekly 2%NaOH solution circulation washing and sterilizing cabinet, unloaded sterilizing 1 time.
Be resolved to the problem of polypropylene transfusion bottle dress glucose injection bottle inner liquid medicine muddiness after above measure performs, the ratio of bottle inner liquid medicine muddiness reduces to less than 0.1% by 15-20%.
Detailed description of the invention
With embodiment, the invention will be further described below, but the present invention is not limited to these embodiments.
Embodiment 1:
Prevent plastic bottle from filling a production method for glucose injection medicinal liquid muddiness, comprise the steps:
1) weigh: prepare supplementary material;
2) densely to join: load weighted glucose is placed in the dense preparing tank of water for injection, is made into 60% (w/w) concentrated solution, add 0.05% (w/v) pin charcoal, heating, boils 15-30 minute, pressurization, de-charcoal, to clear and bright, proceeds to dilute preparing tank;
3) rarely to join: add to the full amount of water for injection in dilute preparing tank, be circulated to clear and bright, adjust ph 35.0, survey glucose content is labelled amount 98.0-104.0%, after qualified, to be filtered; Sampling, checks medicinal liquid character, content, pH value, and after qualified, through 0.45um aperture foldable filter element series connection 0.45um aperture, foldable filter element filters, qualified rear to be filled;
4) embedding is washed: by weld-ring, bottle blowing after the injection moulding of polypropylene plastics particle; Open anion air channel, compressed air wash bottle pressure 0.8-1.0MPa, cooling water pressure 0.3-0.6MPa; Open sealing machine hot plate power supply, preheating makes heating-up temperature even for 3 minutes, in agitator, add polypropylene combination cover; Upper bottle, wash bottle after debugging wash bottle compressed air pressure meets the requirements; Medicinal liquid fill after 0.22 μm of frit, setting filling speed, at 200 bottles/minute, starts filling machine, checks medicinal liquid visible foreign matters and loading amount, starts to produce after qualified;
5) sterilizing: by step 4) product subject to sterilization that obtains advances water-bath type sterilizing cabinet, setup control temperature 117 DEG C, sterilising temp 115 DEG C, sterilization time 30 minutes, the temperature that offers for sale 55 DEG C, sterilization pressure 220-245Kpa, F.Value >=8;
Increase by 0.45 μm of defecator in sterilizing cabinet discharge outlet, strengthen sterilizing cabinet cleaning treatment, every day, washing and sterilizing cabinet discharge outlet defecator, adopted weekly 2%NaOH solution circulation washing and sterilizing cabinet, unloaded sterilizing 1 time;
6) lamp inspection: by bottle, the distortion of product appearance, pollution, leakage, loading amount, weld-ring situation and visible foreign matters are checked on lamp inspection operating board by " straight, horizontal, fall, pinch " four step rule to the product transferred online after sterilizing;
7) pack, warehouse-in: the product that lamp inspection is transferred online by bottle sticker mark, vanning warehouse-in.
Embodiment 2:
Prevent plastic bottle from filling a production method for glucose injection medicinal liquid muddiness, comprise the steps:
1) weigh: prepare supplementary material;
2) densely to join: load weighted glucose is placed in the dense preparing tank of water for injection, is made into 40% (w/w) concentrated solution, add 0.05% (w/v) pin charcoal, heating, boils 15-30 minute, pressurization, de-charcoal, to clear and bright, proceeds to dilute preparing tank;
3) rarely to join: add to the full amount of water for injection in dilute preparing tank, be circulated to clear and bright, adjust ph 3.8, survey glucose content is labelled amount 98.0-104.0%, after qualified, to be filtered; Sampling, checks medicinal liquid character, content, pH value, and after qualified, through 0.45um aperture foldable filter element series connection 0.45um aperture, foldable filter element filters, qualified rear to be filled;
4) embedding is washed: by weld-ring, bottle blowing after the injection moulding of polypropylene plastics particle; Open anion air channel, compressed air wash bottle pressure 0.8-1.0MPa, cooling water pressure 0.3-0.6MPa; Open sealing machine hot plate power supply, preheating makes heating-up temperature even for 3 minutes, in agitator, add polypropylene combination cover; Upper bottle, wash bottle after debugging wash bottle compressed air pressure meets the requirements; Medicinal liquid fill after 0.22 μm of frit, setting filling speed, at 150 bottles/minute, starts filling machine, checks medicinal liquid visible foreign matters and loading amount, starts to produce after qualified;
5) sterilizing: by step 4) product subject to sterilization that obtains advances water-bath type sterilizing cabinet, setting sterilising temp 115 DEG C, constant temperature time 35 minutes, F.Value >=12 and chilling temperature 40 DEG C;
Increase by 0.45 μm of defecator in sterilizing cabinet discharge outlet, strengthen sterilizing cabinet cleaning treatment, every day, washing and sterilizing cabinet discharge outlet defecator, adopted weekly 2%NaOH solution circulation washing and sterilizing cabinet, unloaded sterilizing 1 time;
6) lamp inspection: by bottle, the distortion of product appearance, pollution, leakage, loading amount, weld-ring situation and visible foreign matters are checked on lamp inspection operating board by " straight, horizontal, fall, pinch " four step rule to the product transferred online after sterilizing;
7) pack, warehouse-in: the product that lamp inspection is transferred online by bottle sticker mark, vanning warehouse-in.
Claims (1)
1. prevent plastic bottle from filling a production method for glucose injection medicinal liquid muddiness, it is characterized in that, comprise the steps:
1) weigh: prepare supplementary material;
2) densely to join: be placed in the dense preparing tank of water for injection by load weighted glucose, be made into 60% concentrated solution, add 0.05% pin charcoal, heating, boils 15-30 minute, pressurization, and de-charcoal, to clear and bright, proceeds to dilute preparing tank;
3) rarely to join: add to the full amount of water for injection in dilute preparing tank, be circulated to clear and bright, adjust ph 35.0, survey glucose content is labelled amount 98.0-104.0%, after qualified, to be filtered; Sampling, checks medicinal liquid character, content, pH value, and after qualified, through 0.45um aperture foldable filter element series connection 0.45um aperture, foldable filter element filters, qualified rear to be filled;
4) embedding is washed: by weld-ring, bottle blowing after the injection moulding of polypropylene plastics particle; Open anion air channel, compressed air wash bottle pressure 0.8-1.0MPa, cooling water pressure 0.3-0.6MPa; Open sealing machine hot plate power supply, preheating makes heating-up temperature even for 3 minutes, in agitator, add polypropylene combination cover; Upper bottle, wash bottle after debugging wash bottle compressed air pressure meets the requirements; Medicinal liquid fill after 0.22 μm of frit, setting filling speed 150-200 bottle/minute, start filling machine, check medicinal liquid visible foreign matters and loading amount, start after qualified to produce;
5) sterilizing: by step 4) product subject to sterilization that obtains advances water-bath type sterilizing cabinet, setup control temperature 117 DEG C, sterilising temp 115 DEG C, sterilization time 30 minutes, the temperature that offers for sale 55 DEG C, sterilization pressure 220-245Kpa, F.Value >=8;
Increase by 0.45 μm of defecator in sterilizing cabinet discharge outlet, every day, washing and sterilizing cabinet discharge outlet defecator, adopted weekly 2%NaOH solution circulation washing and sterilizing cabinet, unloaded sterilizing 1 time;
6) lamp inspection: by bottle, the distortion of product appearance, pollution, leakage, loading amount, weld-ring situation and visible foreign matters are checked on lamp inspection operating board by " straight, horizontal, fall, pinch " four step rule to the product transferred online after sterilizing;
7) pack, warehouse-in: the product that lamp inspection is transferred online by bottle sticker mark, vanning warehouse-in.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510694733.4A CN105147601A (en) | 2015-10-23 | 2015-10-23 | Production method for preventing medicine liquor turbidity of glucose injection packaged in plastic bottle |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510694733.4A CN105147601A (en) | 2015-10-23 | 2015-10-23 | Production method for preventing medicine liquor turbidity of glucose injection packaged in plastic bottle |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105147601A true CN105147601A (en) | 2015-12-16 |
Family
ID=54788897
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510694733.4A Pending CN105147601A (en) | 2015-10-23 | 2015-10-23 | Production method for preventing medicine liquor turbidity of glucose injection packaged in plastic bottle |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105147601A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106265495A (en) * | 2016-08-26 | 2017-01-04 | 广西裕源药业有限公司 | A kind of production method of glucose injection |
| CN106361687A (en) * | 2016-08-26 | 2017-02-01 | 广西裕源药业有限公司 | Improvement for concentrated preparation and diluted preparation processes during preparation process of glucose injection |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1799551A (en) * | 2005-08-12 | 2006-07-12 | 樊武良 | Process for preparing glucose injection and glucose sodium chloride injection |
| CN103083355A (en) * | 2013-01-18 | 2013-05-08 | 蚌埠丰原涂山制药有限公司 | Compound sodium chloride injection and preparation method thereof |
| CN103330681A (en) * | 2013-07-09 | 2013-10-02 | 四川科伦药业股份有限公司 | Glucose injection in inner bag of unsterilized multi-chamber infusion bag and preparation method thereof |
-
2015
- 2015-10-23 CN CN201510694733.4A patent/CN105147601A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1799551A (en) * | 2005-08-12 | 2006-07-12 | 樊武良 | Process for preparing glucose injection and glucose sodium chloride injection |
| CN103083355A (en) * | 2013-01-18 | 2013-05-08 | 蚌埠丰原涂山制药有限公司 | Compound sodium chloride injection and preparation method thereof |
| CN103330681A (en) * | 2013-07-09 | 2013-10-02 | 四川科伦药业股份有限公司 | Glucose injection in inner bag of unsterilized multi-chamber infusion bag and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 张国锋 等: ""塑瓶输液产品灭菌后瓶体发黄且药液混浊现象探讨"", 《齐鲁药事》 * |
| 程渝: ""医院自配葡萄糖注射液加注射用活性炭后质量考察"", 《现代医药卫生》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106265495A (en) * | 2016-08-26 | 2017-01-04 | 广西裕源药业有限公司 | A kind of production method of glucose injection |
| CN106361687A (en) * | 2016-08-26 | 2017-02-01 | 广西裕源药业有限公司 | Improvement for concentrated preparation and diluted preparation processes during preparation process of glucose injection |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102895181B (en) | Method for preparing mezlocillin sodium for injection | |
| CN103083355A (en) | Compound sodium chloride injection and preparation method thereof | |
| CN103961311A (en) | Heparin sodium injection and preparation method thereof | |
| CN105147601A (en) | Production method for preventing medicine liquor turbidity of glucose injection packaged in plastic bottle | |
| CN105147603A (en) | Preparation technology for sodium chloride injection packaged in plastic bottles | |
| CN106265495A (en) | A kind of production method of glucose injection | |
| CN105287369A (en) | Production method for preventing turbidity of plastic-bottle sodium chloride injection | |
| CN105193717A (en) | Preparation process of plastic bottled dextrose injection | |
| CN102274170A (en) | Method for preparing tinidazole and sodium chloride injection | |
| WO2022222630A1 (en) | Multiple electrolytes injection and preparation method therefor | |
| CN105168128A (en) | Production method for preventing bottle body yellowing and liquid turbidity of plastic bottled sodium chloride injection | |
| CN102836171A (en) | Solution for surgery and endoscope washing and preparation method thereof | |
| CN105125487A (en) | Production method for preventing liquid medicine turbidity of plastic bottled dextrose injection | |
| CN104511025A (en) | Carbocisteine oral liquid and preparation method thereof | |
| CN108619154A (en) | A kind of prescription and technique of piperacillin sodium and tazobactam sodium for injection | |
| CN105193714A (en) | Production method for preventing bottle body of plastic bottled glucose injection from turning yellow and liquor therein from turning turbid | |
| CN105168126A (en) | Production process of glucose injections filled in plastic bottles | |
| CN102274167A (en) | Method for preparing metronidazole injection | |
| CN109833330A (en) | A kind of Dextrose and Sodium Chloride Inj. production technology | |
| CN105168127A (en) | Production process of sodium chloride injections filled in plastic bottles | |
| CN105769902A (en) | Production process of sodium bicarbonate injection | |
| CN102172346A (en) | Production method of compound sodium lactate glucose injection capable of preventing yellowing | |
| CN105193718A (en) | Production method for preventing yellowing of plastic bottled sodium chloride injection bottle body | |
| CN102240261A (en) | Preparation method and medicinal purpose of glucomannan injection | |
| CN109078019B (en) | Bicarbonate dialysate packaged by double-chamber bag and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20151216 |