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Inverted sugar injection and preparation technology

A preparation process and technology for injections, applied in the field of injections and preparation processes, can solve the problems of increasing filtration costs, loss of drug efficacy, etc., achieve good sterilization effects, reduce the total amount of bacteria, and achieve good therapeutic effects

Inactive Publication Date: 2019-12-06
SICHUAN TAIPINGYANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Therefore, in the existing production method of injecting invert sugar injection, it is desired to better control the number of bacteria, but also worry about losing the efficacy of the drug and increasing the cost of filtration, which is a problem that is difficult to solve.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment one: the composition of this product unit dose prescription

[0044] Element Dosage Excessive addition effect Executive standard anhydrous glucose 12.5g none active substance Chinese Pharmacopoeia 2010 Edition Part Two 927 pages fructose 12.5g none active substance Chinese Pharmacopoeia 2010 Edition, Volume 2, Page 1204 Dilute hydrochloric acid Appropriate amount none pH regulator Chinese Pharmacopoeia 2010 Edition, Volume 2, Page 1215 Water for Injection 250ml none solvent Chinese Pharmacopoeia 2010 Edition, Volume II, 500 pages

Embodiment 2

[0045] Embodiment two: make the invert sugar injection of specification 250ml, altogether 1750L.

[0046] Element Dosage(Kg) Excessive addition effect Executive standard anhydrous glucose 87.5 none active substance Chinese Pharmacopoeia 2010 Edition Part Two 927 pages fructose 87.5 none active substance Chinese Pharmacopoeia 2010 Edition, Volume 2, Page 1204 Dilute hydrochloric acid Appropriate amount none pH regulator Chinese Pharmacopoeia 2010 Edition, Volume 2, Page 1215 Water for Injection 1750L none solvent Chinese Pharmacopoeia 2010 Edition, Volume II, 500 pages

Embodiment 3

[0048] 1. Concentrated formula: put the full amount of 60% water for injection into the concentrated formula irrigation, add anhydrous glucose and fructose in turn according to the prescription amount, and stir to dissolve.

[0049] 2. Add activated carbon of 0.02% (W / V) dilute volume, stir for about 15 minutes, filter and decarbonize through a titanium rod, beat the rinse water to the dilute tank, add water for injection to the full amount, and circulate to make the liquid medicine even.

[0050] 3. Dilute formulation: add water for injection to nearly the full amount, adjust the pH value with 10% HCL: 4.7-5.3, add water to the full amount, and circulate evenly. After testing the content and pH value of the semi-finished product to pass the test, the liquid medicine is filtered through a 0.22 μm microporous filter until the visible foreign matter is qualified.

[0051] 4. Filling and sealing. Sterilize in a hot water bath at 121°C for 10 minutes. Light inspection, packing. ...

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PUM

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Abstract

The invention provides an inverted sugar injection and a preparation technology. The inverted sugar injection is formed in a way that anhydrous dextrose and fructose are added into water used for injection. The preparation technology of the inverted sugar injection comprises the following steps of: injecting water used for injection into a concentrated solution preparation tank, adding the anhydrous dextrose and the fructose in sequence according to a prescription dose, carrying out stirring and dissolving, adding activated carbon, and carrying out stirring, adsorption and decarburization; injecting a medicine liquid into a diluted solution preparation tank, supplementing the water used for injection into the diluted solution preparation tank to a full dose, and regulating a pH value; andcarrying out filling, sterilization and packaging. The invention provides the new proportioning ingredients and the new proportioning ratio of the inverted sugar injection. The inverted sugar injection disclosed by the invention has a better treatment effect. The invention provides a new production and preparation technology for the inverted sugar injection. The production and preparation technology has a good sterilization and disinfection effect.

Description

technical field [0001] The invention relates to an injection and a preparation process. It belongs to the field of injection medicine production. Background technique [0002] Invert Sugar Injection belongs to parenteral nutrition drugs. It is a sterilized aqueous solution composed of equal amounts of fructose and glucose. It is suitable for rehydration therapy for patients who need to supplement water or energy through non-oral channels, or as a diluent for other drugs. The human preparation ratio of invert sugar injection has never been better, so that the existing invert sugar injection has low drug efficacy, and the therapeutic effect needs to be further improved. [0003] In the production process of injections, aseptic production has always been the key to the production of injections. During the production of injections, multiple sterilizations must be carried out to control the total number of bacteria within the qualified number. [0004] The same is true in the p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7004A61P3/02A61L2/02A61L2/025
CPCA61K9/0019A61K9/08A61K31/7004A61L2/0011A61L2202/21A61P3/02A61K2300/00
Inventor 张加宇许艳春文娟王利华
Owner SICHUAN TAIPINGYANG PHARMA