CN105168128A - Production method for preventing bottle body yellowing and liquid turbidity of plastic bottled sodium chloride injection - Google Patents
Production method for preventing bottle body yellowing and liquid turbidity of plastic bottled sodium chloride injection Download PDFInfo
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- CN105168128A CN105168128A CN201510696045.1A CN201510696045A CN105168128A CN 105168128 A CN105168128 A CN 105168128A CN 201510696045 A CN201510696045 A CN 201510696045A CN 105168128 A CN105168128 A CN 105168128A
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Abstract
The invention discloses a production method for preventing bottle body yellowing and liquid turbidity of a plastic bottled sodium chloride injection. The production method comprises the following steps: (1) reducing external force damages to a bottle preform and a bottle during production, and reducing film scraps and fiber attachment inside and outside a bottle body; (2) additionally providing a water outlet filter for a sterilizing cabinet, and reducing accumulation of the film scraps in a sterilizing pipeline and a heat exchanger; and (3) strengthening cleaning treatment of the sterilizing cabinet, reducing the attachment of yellowed film scraps after multiple times of high-temperature and high-heat treatment, cleaning the water outlet filter of the sterilizing cabinet every day, circularly cleaning the sterilizing cabinet by using 2% NaOH solution every week, and performing empty sterilization once. After implementing the steps, the problems of bottle body yellowing and in-bottle liquid turbidity for the polypropylene infusion bottled sodium chloride injection are solved, and the ratio of bottles with bottle body yellowing in-bottle liquid turbidity is almost zero.
Description
Technical field
The present invention relates to technical field of medicine, be specifically related to prevent plastic bottle from filling sodium chloride injection bottle and turn yellow and the production method of medicinal liquid muddiness.
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.But along with the development in epoch, the improvement of technology, and the requirement of environmental protection and energy saving, to the improvement of existing pharmaceutical production technology also in the middle of constantly carrying out, improving each time is all constantly perfect to prior art, is also cost-saving accordingly, save time, increase the benefit.
Summary of the invention
The object of the invention is to solve the deficiencies in the prior art, providing and preventing plastic bottle from filling the flavescence of sodium chloride injection bottle and the production method of medicinal liquid muddiness.
The plastic bottle that prevents of the present invention fills the flavescence of sodium chloride injection bottle and the production method of medicinal liquid muddiness, 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: 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, 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.
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 jaundice and bottle inner liquid medicine become turbid phenomenon.Detect through lamp inspection, jaundice bottle accounts for about 20%, and bottle inner liquid medicine becomes muddiness and accounts for about 30%.Jaundice product bottle outer surface blade is scraped gently, have yellow substance to come off, and jaundice bottle and bottle inner liquid medicine becomes the superiors and the orlop that muddy bottle mainly concentrates on vehicle of sterilization, have 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, the jaundice of bottle outside and bottle inner liquid medicine change muddiness cause owing to remaining polypropylene screen bits in sterilizing cabinet, 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.
Turn yellow to polypropylene transfusion bottle dress sodium chloride injection bottle after above measure performs and bottle inner liquid medicine becomes muddy problem is resolved, the ratio that bottle jaundice and bottle inner liquid medicine become muddy bottle reduces to less than 0.1% by 25-30%.
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 from plastic bottle from filling sodium chloride injection bottle to turn yellow and the production method of medicinal liquid muddiness, 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% (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: 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, 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.
Embodiment 2:
Prevent from plastic bottle from filling sodium chloride injection bottle to turn yellow and the production method of medicinal liquid muddiness, 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% (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: 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 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.
Claims (1)
1. prevent from plastic bottle from filling sodium chloride injection bottle to turn yellow and the production method of medicinal liquid muddiness, it 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: 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, 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 |
|---|---|---|---|
| CN201510696045.1A CN105168128A (en) | 2015-10-23 | 2015-10-23 | Production method for preventing bottle body yellowing and liquid turbidity of plastic bottled sodium chloride injection |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510696045.1A CN105168128A (en) | 2015-10-23 | 2015-10-23 | Production method for preventing bottle body yellowing and liquid turbidity of plastic bottled sodium chloride injection |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106176592A (en) * | 2016-08-26 | 2016-12-07 | 广西裕源药业有限公司 | Change to allotment of labor's skill dilute in sodium chloride injection production process |
| 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 |
| CN109528635A (en) * | 2018-12-20 | 2019-03-29 | 江西润泽药业有限公司 | The preparation method of sodium chloride injection |
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| 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 |
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2015
- 2015-10-23 CN CN201510696045.1A patent/CN105168128A/en active Pending
Patent Citations (2)
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|---|---|---|---|---|
| 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 |
Non-Patent Citations (1)
| 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》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106176592A (en) * | 2016-08-26 | 2016-12-07 | 广西裕源药业有限公司 | Change to allotment of labor's skill dilute in sodium chloride injection production process |
| 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 |
| CN109528635A (en) * | 2018-12-20 | 2019-03-29 | 江西润泽药业有限公司 | The preparation method of sodium chloride injection |
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Application publication date: 20151223 |