Production process of glucose injections filled in plastic bottles
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A technology of glucose injection and production process, which is applied in packaging, packaged food, pharmaceutical packaging, etc., and can solve the problems of increasing manpower and material costs
Inactive Publication Date: 2015-12-23
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] A production process for plastic bottled glucose injection, comprising the steps of:
[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 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;
[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] A production process for plastic bottled glucose injection, comprising the steps of:
[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 40% (w / w) concentrated solution, add 0.05% (w / v) charcoal for needles, heat, and boil for 30 Minutes, pressurized, decarburized until clear, and transferred 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 production process of glucose injections filled in plastic bottles. The problem that bodies of polypropylene infusion bottles filled with glucose injections turn yellow is solved and the rate of yellowing bottles is nearly zero after implementing the following measures: (1) reducing damages, caused by external forces, of preforms and bottles in the production process and reducing adhesion of film chips and fibers inside and outside the bottle bodies; (2) adding a sterilization cabinet outfall filter device to reduce accumulation of the film chips in sterilization pipelines and heat exchangers; and (3) reinforcing sterilization cabinet cleaning treatment to reduce adhesion of the film chips which turn yellow after multiple times of high-temperature heating, wherein the sterilization cabinet outfall filter device is cleaned every day, a sterilization cabinet is circularly cleaned by adopting a 2% NaOH solution every week, and no-load sterilization is carried out once. Rings are manufactured after adjusting a formula and uniformly mixing polypropylene new materials, recovered first-class polypropylene granules and thermoplastic rubber in a weight ratio of 1 to 1 to 1, so that the product quality is ensured while the production cost is reduced, and the rings can not be broken off.
Description
technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a production 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 bloodstream. 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 important ene...
Claims
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Application Information
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