Preparation process of plastic bottled dextrose injection
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A technology for glucose injection and preparation process is applied in the field of preparation of glucose injection in plastic bottles, and can solve the problems of increasing labor and material costs and the like
Inactive Publication Date: 2015-12-30
GUANGXI YUYUAN PHARMA
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Abstract
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Problems solved by technology
[0003] In the existing technology, drugs such as glucose injection are generally produced according to the process steps recommended by the State Food Administration or Pharmacopoeia and other guidance documents. If a drug manufacturer changes the production process for a product that has already received approval, it needs to reapply for approval. , will increase the cost of manpower and material resources
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Embodiment 1
[0024] The preparation technology of plastic bottled glucose injection comprises the steps:
[0025] 1) Weighing: prepare raw and auxiliary materials;
[0026] 2) Concentrated preparation: place the weighed glucose in a concentrated preparation tank with water for injection to prepare a 40% (w / w) concentrated solution, add 0.05% (w / v) charcoal for needles, heat, and boil for 30 Minutes, pressurize, decarburize until clear, and transfer to the diluted tank;
[0027] 3) Dilute preparation: add water for injection to the full amount in the dilute preparation tank, circulate until clear, adjust the pH value to 3.8, measure the glucose content to be 98.0-104.0% of the marked amount, and filter after passing the test; take samples to check the properties and content of the liquid , pH value, after passing the test, filter through a 0.45um pore size pleated filter element connected in series with a 0.45um pore size pleated filter element, and wait for filling after passing the test;...
Embodiment 2
[0035] The preparation technology of plastic bottled glucose injection comprises the steps:
[0036] 1) Weighing: prepare raw and auxiliary materials;
[0037]2) Concentrated preparation: place the weighed glucose in a concentrated preparation tank with water for injection to prepare a 60% (w / w) concentrated solution, add 0.05% (w / v) charcoal for needles, heat, and boil for 15 Minutes, pressurize, decarburize until clear, and transfer to the diluted tank;
[0038] 3) Dilute preparation: add water for injection to the full amount in the dilute preparation tank, circulate until clear, adjust the pH value to 5.0, measure the glucose content to 98.0-104.0% of the marked amount, and filter after passing the test; take samples to check the properties and content of the liquid , pH value, after passing the test, filter through a 0.45um pore size pleated filter element connected in series with a 0.45um pore size pleated filter element, and wait for filling after passing the test;
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Abstract
The invention discloses a preparation process of a plastic bottled dextrose injection. The following measures are taken: external force damage to bottle blanks and bottles in a production process is reduced, and adhesion of membrane scraps and fibers inside and outside the bottle bodies is reduced; (2) a filtering device is arranged on a water outlet of a sterilization cabinet, and the accumulation of the membrane scraps in a sterilization pipeline and a heat exchanger is reduced; (3) cleaning treatment of the sterilization cabinet is enhanced, the adhesion of the membrane scraps yellowed after repeated high-temperature heating is reduced, the filtering device on the water outlet of the sterilization cabinet is cleaned every day, and the sterilization cabinet is circularly cleaned with 2 percent NaOH solution and idle-load sterilization is performed once every week. After execution of the measures, the problem of presence of muddy liquid medicine in a polypropylene transfusion bottled dextrose injection bottle is solved, and the muddying probability of the liquid medicine in the bottle is almost zero. A formula is adjusted, and a novel polypropylene material, recycled first-level polypropylene particles and a thermoplastic elastomer are uniformly mixed according to a weight proportion 1:1:1 to make a hoisting ring, so that the production cost is lowered; meanwhile, the product quality is ensured, and the hoisting ring is prevented from being broken.
Description
technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation process of plastic bottled glucose injection. Background technique [0002] Glucose injection, chemical name: D-(+)-glucopyranose-hydrate, chemical structural formula: molecular formula: C 6 h 12 o 6 ·H 2 O, molecular formula: 198.17, excipients: water for injection. This product is colorless or almost colorless clear liquid; sweet taste. Glucose is given intravenously directly into the blood circulation. Glucose is completely oxidized in the body to produce CO 2 And water, excreted through the lungs and kidneys, while producing energy. Can also be converted into glycogen and fat storage. Generally, the ability of a normal human body to utilize glucose per minute is 6 mg / kg. Too fast and too much fluid can cause palpitations, arrhythmia, and even acute left heart failure. Glucose in total intravenous nutrition therapy is the most import...
Claims
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Application Information
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