CN105147603A - Preparation technology for sodium chloride injection packaged in plastic bottles - Google Patents
Preparation technology for sodium chloride injection packaged in plastic bottles Download PDFInfo
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- CN105147603A CN105147603A CN201510695662.XA CN201510695662A CN105147603A CN 105147603 A CN105147603 A CN 105147603A CN 201510695662 A CN201510695662 A CN 201510695662A CN 105147603 A CN105147603 A CN 105147603A
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Abstract
The invention discloses a preparation technology for sodium chloride injection packaged in plastic bottles. The preparation technology includes the following measures that external force damage to bottle preforms and the bottles in the production process is reduced, and film scraps and fibers adhering to the insides and the outsides of bottle bodies are reduced; a filtering device is additionally arranged on a drain outlet of a sterilization cabinet, and accumulation of the film scraps in a sterilization pipeline and a heat exchanger is reduced; sterilization cabinet cleaning is enhanced, adhesion of yellowed film scraps after repeated high-temperature and high-heat treatment is reduced, the filtering device on the drain outlet of the sterilization cabinet is washed every day, and the sterilization cabinet is washed circularly with 2% NaOH solution each weak and carries out no-load sterilization once. After the measures are executed, the problem that liquid medicine in bottle bodies of the sodium chloride injection packaged in the polypropylene infusion bottles is turbid is solved, and the ratio of turbid liquid medicine in the bottle bodies is almost zero. By adjusting the formula, a new polypropylene material, a first-level recovered polypropylene granule material and thermoplastic elastomers are evenly mixed by the weight ratio of 1:1:1 and manufactured into hanging rings, the product quality is ensured while production cost is reduced, and the hanging rings will not break off.
Description
Technical field
The present invention relates to technical field of medicine, be specifically related to the preparation technology of plastic bottle dress sodium chloride injection.
Background technology
Sodium chloride injection, Main Ingredients and Appearance and chemical name thereof are: sodium chloride, molecular formula: NaCl molecular weight: 58.44.For colourless clear liquid; Taste is micro-salty.For the dehydration caused by a variety of causes, comprise hypo-osmoticity, isotonicity and hyperosmotic dehydration; Hyperosmolar nonketotic diabetic coma, applies isotonic or hypotonic sodium chloride and can correct dehydration and hyperosmotic state; Low chlorine metabolic alkalosis; External normal saline flushing eye, washing wound etc.; Also for the induction of labor with water bag of obstetrics.
Sodium chloride is a kind of electrolyte complementary medical thing.Sodium and chlorine are the important electrolyte of body, are mainly present in extracellular fluid, play very important effect to the capacity and osmotic pressure maintaining normal blood and extracellular fluid.Normal serum Na
+concentration is 135-145mmol/L, accounts for 92% of plasma cations, 90% of total osmotic pressure, therefore plasma sodium amount plays decisive role to osmotic pressure.Normal serum Cl
-concentration is 98-106mmol/L, and in human body, sodium, chloride ion regulate mainly through hypothalamus, lobus posterior hypophyseos and kidney, maintains the stable of body fluid capacity and osmotic pressure.
In prior art, the medicines such as such as sodium chloride 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, providing plastic bottle to fill the preparation technology of sodium chloride injection.
The preparation technology of plastic bottle dress sodium chloride injection of the present invention, comprises the steps:
1) weigh: prepare supplementary material;
2) densely to join: inject water for injection 300L to dense preparing tank, open and stir, sodium chloride is dropped into dense preparing tank, sodium chloride is fully dissolved, add active carbon 0.02% (w/v), adjust charcoal bucket and scoop without charcoal stain with water for injection cleaning, rinse water adds dense preparing tank, boil medicinal liquid and maintain boiling 10 minutes, cooling fluid temperature is to 70-75 DEG C;
3) rarely to join: the water for injection adding 2/3 amount of preparation to dilute preparing tank, open and stir, dense medicinal liquid of joining is delivered to dilute preparing tank after titanium rod decarbonization filtering, drip washing dense preparing tank 3 times, leacheate squeezes into dilute preparing tank, active carbon 0.01% (w/v) is added after having sent, adjust charcoal bucket and scoop without charcoal stain with water for injection cleaning, rinse water adds dilute preparing tank, stop stirring, water for injection is added to amount of preparation in dilute preparing tank, open and stir, medicinal liquid takes off charcoal through titanium rod filter, 0.45 μm of filter returns filter 20 minutes, medicinal liquid is cooled to 40-60 DEG C simultaneously, then sample, detect the content of sodium chloride, pH value and medicinal liquid inspection of foreign substance is not (if pH will suitably adjust in prescribed limit, pH adjusting agent is 1mol/LNaOH or 1mol/LHCL), qualified rear to be filled,
4) embedding is washed: polypropylene virgin material, recovery one-level PP GRANULES material, thermoplastic elastomer (TPE) are made suspension ring according to after the part by weight mix homogeneously of 1:1:1; By weld-ring, bottle blowing after the injection moulding of polypropylene virgin material;
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, setting sterilising temp 115 DEG C, constant temperature time 35 minutes, F.Value >=12 and chilling temperature 40-60 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.
In the present invention, the proportional quantity of supplementary material used conventionally specifies.
Step 4) described in polypropylene virgin material refer to brand-new original PP GRANULES material; Reclaiming one-level PP GRANULES material refers in plastic infusion bottle production process, finds that plastic bottle exists quality problems and reclaims the PP GRANULES material made before the non-sterilizing of product; Thermoplastic elastomer (TPE), being called for short TPE or TPR, is the abbreviation of Thermoplasticrubber, also known as lactoprene or synthetic rubber.
Compared with prior art, the present invention has the following advantages:
1, 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 sodium chloride 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 20-25%.
2, plastic infusion bottle have that volume is little, lightweight, good seal, do not fall bits, damaged low, to medicine without advantages such as absorption, alternative glass infusion bottle is widely used gradually clinically.Plastic infusion bottle conventional is at present rivet welding formula suspension ring plastic bottles, its main technical schemes comprises at the bottom of bottle, bottleneck and bottle, plastic rivet is utilized to rivet base ring at the bottom of bottle, base ring connects suspension ring, the middle part at the bottle end is to bottle sunken inside, formed at the bottom of basin, base ring at the bottom of plastic rivet is riveted on bottle on.The suspension ring that currently available technology is produced are generally all use polypropylene virgin material to produce, but cost is very high like this; Also the producer had is in order to cost-saving, and add some and reclaim one-level PP GRANULES material, but how the ratio no matter how added adjusts, the suspension ring produced easily fracture all the time, have a strong impact on product quality.
The present invention is through constantly test, eventually through improvement of production process, adjustment formula, polypropylene virgin material, recovery one-level PP GRANULES material, thermoplastic elastomer (TPE) are made suspension ring according to after the part by weight mix homogeneously of 1:1:1, while reduction production cost, ensure that product quality, suspension ring can not fracture.
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:
The preparation technology of plastic bottle dress sodium chloride injection, comprises the steps:
1) weigh: prepare supplementary material;
2) densely to join: inject water for injection 300L to dense preparing tank, open and stir, sodium chloride is dropped into dense preparing tank, sodium chloride is fully dissolved, add active carbon 0.02% (w/v), adjust charcoal bucket and scoop without charcoal stain with water for injection cleaning, rinse water adds dense preparing tank, boil medicinal liquid and maintain boiling 10 minutes, cooling fluid temperature is to 70-75 DEG C;
3) rarely to join: the water for injection adding 2/3 amount of preparation to dilute preparing tank, open and stir, dense medicinal liquid of joining is delivered to dilute preparing tank after titanium rod decarbonization filtering, drip washing dense preparing tank 3 times, leacheate squeezes into dilute preparing tank, active carbon 0.01% (w/v) is added after having sent, adjust charcoal bucket and scoop without charcoal stain with water for injection cleaning, rinse water adds dilute preparing tank, stop stirring, water for injection is added to amount of preparation in dilute preparing tank, open and stir, medicinal liquid takes off charcoal through titanium rod filter, 0.45 μm of filter returns filter 20 minutes, medicinal liquid is cooled to 40-60 DEG C simultaneously, then sample, detect the content of sodium chloride, pH value and medicinal liquid inspection of foreign substance is not (if pH will suitably adjust in prescribed limit, pH adjusting agent is 1mol/LNaOH or 1mol/LHCL), qualified rear to be filled,
4) embedding is washed: polypropylene virgin material, recovery one-level PP GRANULES material, thermoplastic elastomer (TPE) are made suspension ring according to after the part by weight mix homogeneously of 1:1:1; By weld-ring, bottle blowing after the injection moulding of polypropylene virgin material;
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, setting sterilising temp 115 DEG C, constant temperature time 35 minutes, F.Value >=12 and chilling temperature 60 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.
Embodiment 2:
The preparation technology of plastic bottle dress sodium chloride injection, comprises the steps:
1) weigh: prepare supplementary material;
2) densely to join: inject water for injection 300L to dense preparing tank, open and stir, sodium chloride is dropped into dense preparing tank, sodium chloride is fully dissolved, add active carbon 0.02% (w/v), adjust charcoal bucket and scoop without charcoal stain with water for injection cleaning, rinse water adds dense preparing tank, boil medicinal liquid and maintain boiling 10 minutes, cooling fluid temperature is to 70-75 DEG C;
3) rarely to join: the water for injection adding 2/3 amount of preparation to dilute preparing tank, open and stir, dense medicinal liquid of joining is delivered to dilute preparing tank after titanium rod decarbonization filtering, drip washing dense preparing tank 3 times, leacheate squeezes into dilute preparing tank, active carbon 0.01% (w/v) is added after having sent, adjust charcoal bucket and scoop without charcoal stain with water for injection cleaning, rinse water adds dilute preparing tank, stop stirring, water for injection is added to amount of preparation in dilute preparing tank, open and stir, medicinal liquid takes off charcoal through titanium rod filter, 0.45 μm of filter returns filter 20 minutes, medicinal liquid is cooled to 40-60 DEG C simultaneously, then sample, detect the content of sodium chloride, pH value and medicinal liquid inspection of foreign substance is not (if pH will suitably adjust in prescribed limit, pH adjusting agent is 1mol/LNaOH or 1mol/LHCL), qualified rear to be filled,
4) embedding is washed: polypropylene virgin material, recovery one-level PP GRANULES material, thermoplastic elastomer (TPE) are made suspension ring according to after the part by weight mix homogeneously of 1:1:1; By weld-ring, bottle blowing after the injection moulding of polypropylene virgin material;
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, 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. the preparation technology of plastic bottle dress sodium chloride injection, is characterized in that, comprise the steps:
1) weigh: prepare supplementary material;
2) densely to join: inject water for injection 300L to dense preparing tank, open and stir, sodium chloride is dropped into dense preparing tank, sodium chloride is fully dissolved, add active carbon 0.02%, adjust charcoal bucket and scoop without charcoal stain with water for injection cleaning, rinse water adds dense preparing tank, boil medicinal liquid and maintain boiling 10 minutes, cooling fluid temperature is to 70-75 DEG C;
3) rarely to join: the water for injection adding 2/3 amount of preparation to dilute preparing tank, open and stir, dense medicinal liquid of joining is delivered to dilute preparing tank after titanium rod decarbonization filtering, drip washing dense preparing tank 3 times, leacheate squeezes into dilute preparing tank, active carbon 0.01% is added after having sent, adjust charcoal bucket and scoop without charcoal stain with water for injection cleaning, rinse water adds dilute preparing tank, stop stirring, water for injection is added to amount of preparation in dilute preparing tank, open and stir, medicinal liquid takes off charcoal through titanium rod filter, 0.45 μm of filter returns filter 20 minutes, medicinal liquid is cooled to 40-60 DEG C simultaneously, then sample, detect the content of sodium chloride, pH value and medicinal liquid inspection of foreign substance, qualified rear to be filled,
4) embedding is washed: polypropylene virgin material, recovery one-level PP GRANULES material, thermoplastic elastomer (TPE) are made suspension ring according to after the part by weight mix homogeneously of 1:1:1; By weld-ring, bottle blowing after the injection moulding of polypropylene virgin material;
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, setting sterilising temp 115 DEG C, constant temperature time 35 minutes, F.Value >=12 and chilling temperature 40-60 DEG C;
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.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510695662.XA CN105147603A (en) | 2015-10-23 | 2015-10-23 | Preparation technology for sodium chloride injection packaged in plastic bottles |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510695662.XA CN105147603A (en) | 2015-10-23 | 2015-10-23 | Preparation technology for sodium chloride injection packaged in plastic bottles |
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| CN105147603A true CN105147603A (en) | 2015-12-16 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106214697A (en) * | 2016-08-26 | 2016-12-14 | 广西裕源药业有限公司 | A kind of production method of sodium chloride injection |
| CN107324262A (en) * | 2017-06-06 | 2017-11-07 | 石家庄鹏海制药股份有限公司 | The production technology of the big transfusion of plastic bottle |
| CN113116815A (en) * | 2021-06-07 | 2021-07-16 | 辰欣药业股份有限公司 | Preparation method of dexmedetomidine hydrochloride injection |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
| CN203060317U (en) * | 2013-01-22 | 2013-07-17 | 上海长征富民金山制药有限公司 | Hoisting ring structure at bottom of plastic infusion bottle |
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2015
- 2015-10-23 CN CN201510695662.XA patent/CN105147603A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN203060317U (en) * | 2013-01-22 | 2013-07-17 | 上海长征富民金山制药有限公司 | Hoisting ring structure at bottom of plastic infusion bottle |
Non-Patent Citations (2)
| Title |
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| 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》 * |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106214697A (en) * | 2016-08-26 | 2016-12-14 | 广西裕源药业有限公司 | A kind of production method of sodium chloride injection |
| CN107324262A (en) * | 2017-06-06 | 2017-11-07 | 石家庄鹏海制药股份有限公司 | The production technology of the big transfusion of plastic bottle |
| CN113116815A (en) * | 2021-06-07 | 2021-07-16 | 辰欣药业股份有限公司 | Preparation method of dexmedetomidine hydrochloride injection |
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Application publication date: 20151216 |