Compound polyethylene glycol electrolyte pulvis and preparation method thereof

Abstract

The invention relates to a compound polyethylene glycol electrolyte pulvis and a preparation method thereof. The compound polyethylene glycol electrolyte pulvis comprises the following components: 1 part of polyethylene glycol (4000), 0.01-0.06 part of sodium chloride, 0.05-0.12 part of anhydrous sodium sulfate, 0.007-0.04 part of potassium chloride, and 0.009-0.046 part of sodium bicarbonate. The preparation method of the compound polyethylene glycol electrolyte pulvis comprises the following steps: respectively smashing, screening and drying the polyethylene glycol 4000, the sodium chloride, the anhydrous sodium sulfate, the potassium chloride and the sodium bicarbonate; weighting the polyethylene glycol 4000, the sodium chloride, the anhydrous sodium sulfate, the potassium chloride andthe sodium bicarbonate according to the prescription for later use; putting the materials into a mixer for mixing; sampling and detecting the content of intermediates; calculating the package quantity according to the content of the intermediates and then packaging in batch; and sealing, thereby acquiring the compound polyethylene glycol electrolyte pulvis.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a polyethylene glycol electrolyte powder and a preparation method thereof. Background technique [0002] The osmotic activity of macromolecular polyethylene glycol (4000) and the concentration of electrolytes do not affect the absorption and discharge of ions or water, and a large number of applications will not significantly change the balance of liquid and electrolytes, and will not cause electrolyte disorders, dehydration and intestinal flora Decomposition, its good intestinal cleansing effect has been reported at home and abroad. [0003] Polyethylene glycol electrolyte powder is a new type of non-absorbable isotonic oral whole intestinal cleansing solution with a slightly sweet taste. Polyethylene glycol 4000 is a long-chain linear polymer. After oral administration, it hardly absorbs and does not decompose. It combines water molecules with hydrogen bonds, effe...

AI Technical Summary

Problems solved by technology

The problems brought by such multi-package powders are (1) the production process is cumbersome, energy-consuming, and not environmentally friendly; (2) due to the large number of packages, the loading capacity is uneven, the quality is uncontrollable, and the yield is low; Too many bags are troublesome to use and easy to cause waste; (5) when the powder is prepared into a solution, the concentration is inaccurate, and the osmotic pressure ratio of the solution cannot be guaranteed to be 1, which affects the cleaning effect

[0005] In order to overcome the uneven mixing of components in the polyethylene glycol electrolyte powder and the inaccurate concentration of the solution, CN200610056712.0 discloses a polyethylene glycol-electrolyte oral solution, which is composed of polyethylene glycol, sodium chloride , Potassium Chloride, Sodium Bicarbonate, Sodium Sulfate, Edetate, Sweetener, Edible Flavor, add deionized water to make oral solution, the oral solution is sterilized by boiling water or steam at 100℃

As sodium bicarbonate decomposes slowly in humid air, the aqueous solution is left for a long time, or shaken, or heated, and the alkalinity will increase. When it exceeds 50°C, sodium bicarbonate will slowly decompose. When it exceeds 65°C, sodium bicarbonate will decompose. Decompose rapidly, so this polyethylene glycol-electrolyte oral solution decomposes sodium bicarbonate in the process of high-temperature sterilization process, and long-term placement, the sodium bicarbonate in polyethylene glycol-electrolyte oral solution can continue to decompose slowly, Bicarbonate ions will be converted into carbonate ions, which will degrade the efficacy of the drug; in addition, the oral solution is inconvenient to store, transport and carry

[0006] CN101766648 discloses a polyethylene glycol electrolyte particle preparation and a preparation method thereof. In the method, polyethylene glycol and electrolyte are pulverized into fine powder, wherein the particle diameter of polyethylene glycol is 150-250 μm, and the particle diameter of electrolyte is 125-250μm, mixed together to make a package, theoretically fine powder is easy to mix evenly, but this is only one of the influencing factors, the patent does not disclose how to overcome the problem of uneven mixing caused by different densities

In addition, in the preparation process, in order to avoid stratification of electrolyte and polyethylene glycol and uneven content ratio of each component, the powder is wetted with 80% ethanol after mixing. The electrolyte is very easy to dilute, and its crystal water is even more difficult to remove. The wetted powder is dried at 10-60°C. Since sodium bicarbonate will decompose when it exceeds 50°C, the sodium bicarbonate will decompose after drying. If the drying temperature is lowered, the water of crystallization in the electrolyte will be difficult to remove, so this method has defects

Images