CN102172346A - Production method of compound sodium lactate glucose injection capable of preventing yellowing - Google Patents
Production method of compound sodium lactate glucose injection capable of preventing yellowing Download PDFInfo
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- CN102172346A CN102172346A CN 201110049447 CN201110049447A CN102172346A CN 102172346 A CN102172346 A CN 102172346A CN 201110049447 CN201110049447 CN 201110049447 CN 201110049447 A CN201110049447 A CN 201110049447A CN 102172346 A CN102172346 A CN 102172346A
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Abstract
The invention belongs to the technical field of medicine, and in particular relates to a production method of a compound sodium lactate glucose injection capable of preventing yellowing. The invention aims to solve the problems of immature production process conditions, yellowing of liquid medicine, instable quality, low product percent of pass and the like of polypropylene bottled sodium lactate glucose injection. The invention has the technical scheme that: the production method of the compound sodium lactate glucose injection capable of preventing yellowing comprises the following steps of: firstly, dissolving a certain amount of raw materials completely in a thick preparation tank, adding active carbon, then cyclically filtering the active carbon, transferring the solution into a thin preparation tank for quantification; sterilizing in a high-temperature superheated water shower bath mode; and performing lamp detection, leak detection and packing to obtain the compound sodium lactate glucose injection. The invention changes the sequence of adding the raw materials such as glucose, sodium chloride, potassium chloride, sodium lactate and calcium chloride, simultaneously changes the production process conditions, prevents the product liquid medicine from yellowing, ensures stable medicine quality and improves the product percent of pass.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of Compound Sodium Lactate and Glucose Injection production method that prevents flavescence.
Background technology
The Compound Sodium Lactate and Glucose Injection of producing adopts glass bottle more at present, because running into because of nurse operation error or other reasons through regular meeting, vial causes the bottleneck breakage in clinical application, there is chips of glass in the medicinal liquid, in the intravenous drip process, chips of glass can enter human body, causes extra injury to the patient; Vial often occurs in transportation because of the disruptive problem of collision in addition; Therefore adopt extremely liking of consumer of the bottled Compound Sodium Lactate and Glucose Injection of polypropylene, but because the bottled sodium lactate and glucose injection manufacturing condition of polypropylene is immature, there are problems such as medicinal liquid flavescence in the finished product of producing, and then cause the quality of liquid medicine instability, product is defective, has increased production cost.
Summary of the invention
The objective of the invention is at adopting the bottled sodium lactate and glucose injection of polypropylene to exist manufacturing condition immature, there is the medicinal liquid flavescence in the finished product of producing, problems such as quality instability, product percent of pass are not high provide the Compound Sodium Lactate and Glucose Injection production method that prevents flavescence that a kind of quality of liquid medicine is stable, product percent of pass is high.
The present invention addresses the above problem the scheme of taking to be:
A kind of Compound Sodium Lactate and Glucose Injection production method that prevents flavescence may further comprise the steps:
1) dense joining: a, in dense preparing tank, add 300～400 liters water for injection, open dense preparing tank cool cycles penstock the dense preparing tank temperature is reduced to 55～65 ℃, open and add 50 kilograms of glucoses, 6 kilograms of sodium chloride, 0.3 kilogram of potassium chloride, 0.2 kilogram of calcium chloride successively after dense preparing tank stirs, fully after the dissolving, adding mass fraction again and be 11.2%～12% sodium lactate solution to the quality of sodium lactate is 3.1 kilograms, the active carbon that adds 15～40 kilograms then, insulated and stirred 10～15 minutes;
B, open the dense preparing tank circulating pump,, open dense preparing tank liquid outlet and dilute preparing tank inlet after filtering fully, the solution in the dense preparing tank is squeezed into dilute preparing tank by the active carbon in the coarse filter circulating filtration dense preparing tank;
C, treat that solution is all squeezed into dilute preparing tank after, close the dense preparing tank circulating pump, the water for injection that in dense preparing tank, adds 100～150 liters again, the washing dense preparing tank is also squeezed into dilute preparing tank once more with cleaning mixture, and repeated washing 2～3 times to filter and pipeline residual medicinal liquid all is collected into dilute preparing tank;
2) rare joining: a, to add an amount of water for injection to liquor capacity in dilute preparing tank be 900 liters, open dilute preparing tank circulating pump, cooling water valve and cooling water back-water valve (BWV) then, solution temperature in the dilute preparing tank is reduced to 40～45 ℃, and be that 0.05～0.2% dilute hydrochloric acid solution regulates that the solution pH value is 4.0～4.3 in the dilute preparing tank with mass fraction;
B, unlatching dilute preparing tank circulating pump adopt the solution in the fine filter filtration dilute preparing tank, check the solution in the dilute preparing tank then, adding an amount of water for injection to overall solution volume after qualified once more is 1000 liters, sample examination behind the mix homogeneously, qualified back input bulking system is packed in the polypropylene vial, is sealed according to dosage then;
3) sterilization: adopt hyperthermia and superheating water shower mode to sterilize, make Compound Sodium Lactate and Glucose Injection through lamp inspection, leak detection, packing.
The present invention adopts technique scheme, change the interpolation order of raw materials of glucose, sodium chloride, potassium chloride, sodium lactate and calcium chloride, changed the process conditions of producing simultaneously, prevented the flavescence of product medicinal liquid, guarantee the stable of drug quality, improved the qualification rate of product.
The specific embodiment
Embodiment 1
A kind of Compound Sodium Lactate and Glucose Injection production method that prevents flavescence may further comprise the steps:
1) dense joining: a, in dense preparing tank, add 300 liters water for injection, open dense preparing tank cool cycles penstock the dense preparing tank temperature is reduced to 55 ℃, open and add 50 kilograms of glucoses, 6 kilograms of sodium chloride, 0.3 kilogram of potassium chloride, 0.2 kilogram of calcium chloride successively after dense preparing tank stirs, fully after the dissolving, adding mass fraction again and be 11.2% sodium lactate solution to the quality of sodium lactate is 3.1 kilograms, the active carbon that adds 15 kilograms then, insulated and stirred 10 minutes;
B, open the dense preparing tank circulating pump, the active carbon in the coarse filter circulating filtration dense preparing tank of titanium filter stick is housed by inside, open dense preparing tank liquid outlet and dilute preparing tank inlet after filtering fully, the solution in the dense preparing tank is squeezed into dilute preparing tank;
C, treat that solution is all squeezed into dilute preparing tank after, close the dense preparing tank circulating pump, the water for injection that in dense preparing tank, adds 100 liters again, the washing dense preparing tank is also squeezed into dilute preparing tank once more with cleaning mixture, and repeated washing 2 times to filter and pipeline residual medicinal liquid all is collected into dilute preparing tank;
2) rare joining: a, to add an amount of water for injection to liquor capacity in dilute preparing tank be 900 liters, open dilute preparing tank circulating pump, cooling water valve and cooling water back-water valve (BWV) then, solution temperature in the dilute preparing tank is reduced to 40 ℃, and be that 0.05% dilute hydrochloric acid solution regulates that the solution pH value is 4.0 in the dilute preparing tank with mass fraction;
B, the inner fine filter that the polyether sulfone filter element of 0.22 μ m is housed of unlatching dilute preparing tank circulating pump employing filter the solution in the dilute preparing tank, then according to the solution in " visible foreign matters inspection technique " inspection dilute preparing tank in the Chinese Pharmacopoeia, adding an amount of water for injection to overall solution volume after qualified once more is 1000 liters, sample examination behind the mix homogeneously, qualified back input bulking system is packed in the polypropylene vial, is sealed according to dosage then;
3) sterilization: adopt hyperthermia and superheating water shower mode to sterilize, make Compound Sodium Lactate and Glucose Injection through lamp inspection, leak detection, packing.
Embodiment 2
A kind of Compound Sodium Lactate and Glucose Injection production method that prevents flavescence may further comprise the steps:
1) dense joining: a, in dense preparing tank, add 350 liters water for injection, open dense preparing tank cool cycles penstock the dense preparing tank temperature is reduced to 60 ℃, open and add 50 kilograms of glucoses, 6 kilograms of sodium chloride, 0.3 kilogram of potassium chloride, 0.2 kilogram of calcium chloride successively after dense preparing tank stirs, fully after the dissolving, adding mass fraction again and be 11.5% sodium lactate solution to the quality of sodium lactate is 3.1 kilograms, the active carbon that adds 25 kilograms then, insulated and stirred 12 minutes;
B, open the dense preparing tank circulating pump, the active carbon in the coarse filter circulating filtration dense preparing tank of titanium filter stick is housed by inside, open dense preparing tank liquid outlet and dilute preparing tank inlet after filtering fully, the solution in the dense preparing tank is squeezed into dilute preparing tank;
C, treat that solution is all squeezed into dilute preparing tank after, close the dense preparing tank circulating pump, the water for injection that in dense preparing tank, adds 120 liters again, the washing dense preparing tank is also squeezed into dilute preparing tank once more with cleaning mixture, and repeated washing 3 times to filter and pipeline residual medicinal liquid all is collected into dilute preparing tank;
2) rare joining: a, to add an amount of water for injection to liquor capacity in dilute preparing tank be 900 liters, open dilute preparing tank circulating pump, cooling water valve and cooling water back-water valve (BWV) then, solution temperature in the dilute preparing tank is reduced to 42 ℃, and be that 0.1% dilute hydrochloric acid solution regulates that the solution pH value is 4.1 in the dilute preparing tank with mass fraction;
B, the inner fine filter that the polyether sulfone filter element of 0.22 μ m is housed of unlatching dilute preparing tank circulating pump employing filter the solution in the dilute preparing tank, then according to the solution in " visible foreign matters inspection technique " inspection dilute preparing tank in the Chinese Pharmacopoeia, adding an amount of water for injection to overall solution volume after qualified once more is 1000 liters, sample examination behind the mix homogeneously, qualified back input bulking system is packed in the polypropylene vial, is sealed according to dosage then;
3) sterilization: adopt hyperthermia and superheating water shower mode to sterilize, make Compound Sodium Lactate and Glucose Injection through lamp inspection, leak detection, packing.
Embodiment 3
A kind of Compound Sodium Lactate and Glucose Injection production method that prevents flavescence may further comprise the steps:
1) dense joining: a, in dense preparing tank, add 400 liters water for injection, open dense preparing tank cool cycles penstock the dense preparing tank temperature is reduced to 65 ℃, open and add 50 kilograms of glucoses, 6 kilograms of sodium chloride, 0.3 kilogram of potassium chloride, 0.2 kilogram of calcium chloride successively after dense preparing tank stirs, fully after the dissolving, adding mass fraction again and be 12% sodium lactate solution to the quality of sodium lactate is 3.1 kilograms, the active carbon that adds 40 kilograms then, insulated and stirred 15 minutes;
B, open the dense preparing tank circulating pump, the active carbon in the coarse filter circulating filtration dense preparing tank of titanium filter stick is housed by inside, open dense preparing tank liquid outlet and dilute preparing tank inlet after filtering fully, the solution in the dense preparing tank is squeezed into dilute preparing tank;
C, treat that solution is all squeezed into dilute preparing tank after, close the dense preparing tank circulating pump, the water for injection that in dense preparing tank, adds 150 liters again, the washing dense preparing tank is also squeezed into dilute preparing tank once more with cleaning mixture, and repeated washing 2 times to filter and pipeline residual medicinal liquid all is collected into dilute preparing tank;
2) rare joining: a, to add an amount of water for injection to liquor capacity in dilute preparing tank be 900 liters, open dilute preparing tank circulating pump, cooling water valve and cooling water back-water valve (BWV) then, solution temperature in the dilute preparing tank is reduced to 45 ℃, and be that 0.2% dilute hydrochloric acid solution regulates that the solution pH value is 4.3 in the dilute preparing tank with mass fraction;
B, the inner fine filter that the polyether sulfone filter element of 0.22 μ m is housed of unlatching dilute preparing tank circulating pump employing filter the solution in the dilute preparing tank, then according to the solution in " visible foreign matters inspection technique " inspection dilute preparing tank in the Chinese Pharmacopoeia, adding an amount of water for injection to overall solution volume after qualified once more is 1000 liters, sample examination behind the mix homogeneously, qualified back input bulking system is packed in the polypropylene vial, is sealed according to dosage then;
3) sterilization: adopt hyperthermia and superheating water shower mode to sterilize, make Compound Sodium Lactate and Glucose Injection through lamp inspection, leak detection, packing.
Claims (1)
1. Compound Sodium Lactate and Glucose Injection production method that prevents flavescence is characterized in that may further comprise the steps:
1) dense joining: a, in dense preparing tank, add 300～400 liters water for injection, open dense preparing tank cool cycles penstock the dense preparing tank temperature is reduced to 55～65 ℃, open and add 50 kilograms of glucoses, 6 kilograms of sodium chloride, 0.3 kilogram of potassium chloride, 0.2 kilogram of calcium chloride successively after dense preparing tank stirs, fully after the dissolving, adding mass fraction again and be 11.2%～12% sodium lactate solution to the quality of sodium lactate is 3.1 kilograms, the active carbon that adds 15～40 kilograms then, insulated and stirred 10～15 minutes;
B, open the dense preparing tank circulating pump,, open dense preparing tank liquid outlet and dilute preparing tank inlet after filtering fully, the solution in the dense preparing tank is squeezed into dilute preparing tank by the active carbon in the coarse filter circulating filtration dense preparing tank;
C, treat that solution is all squeezed into dilute preparing tank after, close the dense preparing tank circulating pump, the water for injection that in dense preparing tank, adds 100～150 liters again, the washing dense preparing tank is also squeezed into dilute preparing tank once more with cleaning mixture, and repeated washing 2～3 times to filter and pipeline residual medicinal liquid all is collected into dilute preparing tank;
2) rare joining: a, to add an amount of water for injection to liquor capacity in dilute preparing tank be 900 liters, open dilute preparing tank circulating pump, cooling water valve and cooling water back-water valve (BWV) then, solution temperature in the dilute preparing tank is reduced to 40～45 ℃, and be that 0.05～0.2% dilute hydrochloric acid solution regulates that the solution pH value is 4.0～4.3 in the dilute preparing tank with mass fraction;
B, unlatching dilute preparing tank circulating pump adopt the solution in the fine filter filtration dilute preparing tank, check the solution in the dilute preparing tank then, adding an amount of water for injection to overall solution volume after qualified once more is 1000 liters, sample examination behind the mix homogeneously, qualified back input bulking system is packed in the polypropylene vial, is sealed according to dosage then;
3) sterilization: adopt hyperthermia and superheating water shower mode to sterilize, make Compound Sodium Lactate and Glucose Injection through lamp inspection, leak detection, packing.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2011100494474A CN102172346B (en) | 2011-03-02 | 2011-03-02 | Production method of compound sodium lactate glucose injection capable of preventing yellowing |
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| CN2011100494474A CN102172346B (en) | 2011-03-02 | 2011-03-02 | Production method of compound sodium lactate glucose injection capable of preventing yellowing |
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| CN102172346A true CN102172346A (en) | 2011-09-07 |
| CN102172346B CN102172346B (en) | 2012-08-22 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103372022A (en) * | 2012-04-28 | 2013-10-30 | 徐连秀 | Glucose health-care oral solution and preparation method |
| CN106692184A (en) * | 2017-01-02 | 2017-05-24 | 江苏恒丰强生物技术有限公司 | Compound sodium chloride injection containing sodium lactate |
| CN110840913A (en) * | 2018-08-20 | 2020-02-28 | 刘力 | Chiral electrolyte glucose capacity therapeutic pharmaceutical composition |
| CN113694795A (en) * | 2021-09-27 | 2021-11-26 | 成都倍特药业股份有限公司 | Liquid preparation system and preparation method |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002145782A (en) * | 2000-11-02 | 2002-05-22 | Shimizu Pharmaceutical Co Ltd | Glucose-containing pharmaceutical preparation and method for producing the same |
| JP2002253667A (en) * | 2000-12-28 | 2002-09-10 | Terumo Corp | Peritoneum dialyzate |
-
2011
- 2011-03-02 CN CN2011100494474A patent/CN102172346B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002145782A (en) * | 2000-11-02 | 2002-05-22 | Shimizu Pharmaceutical Co Ltd | Glucose-containing pharmaceutical preparation and method for producing the same |
| JP2002253667A (en) * | 2000-12-28 | 2002-09-10 | Terumo Corp | Peritoneum dialyzate |
Non-Patent Citations (3)
| Title |
|---|
| 《中国医院药学杂志》 19891130 肖岳翔等 复方乳酸钠葡萄糖注射液的制备 558-559 第9卷, 第10期 * |
| 《海南医学》 19990430 孙玉光等 乳酸钠葡萄糖注射液（3:2:1注射液）配制方法改进与研究 260 第10卷, 第4期 * |
| 《陕西医学杂志》 19830731 许佩苓等 复方乳酸钠注射液配制的探讨 60 , 第07期 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103372022A (en) * | 2012-04-28 | 2013-10-30 | 徐连秀 | Glucose health-care oral solution and preparation method |
| CN106692184A (en) * | 2017-01-02 | 2017-05-24 | 江苏恒丰强生物技术有限公司 | Compound sodium chloride injection containing sodium lactate |
| CN110840913A (en) * | 2018-08-20 | 2020-02-28 | 刘力 | Chiral electrolyte glucose capacity therapeutic pharmaceutical composition |
| CN113694795A (en) * | 2021-09-27 | 2021-11-26 | 成都倍特药业股份有限公司 | Liquid preparation system and preparation method |
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| CN102172346B (en) | 2012-08-22 |
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Effective date of registration: 20200525 Address after: 352, floor 3, unit 2, building 21, No. 26, Chang'an Road, airport economic comprehensive experimental zone, Zhengzhou City, Henan Province 451162 Patentee after: Henan Hezhi Pharmaceutical Technology Co., Ltd Address before: 038300 hi tech Industrial Zone, Huairen County, Shanxi, Shuozhou Patentee before: SHANXI NUOCHENG PHARMACEUTICAL Co.,Ltd. |