Compound polyethylene glycol electrolyte and preparation method thereof

Abstract

The invention discloses a compound polyethylene glycol electrolyte composition. The compound polyethylene glycol electrolyte composition is prepared from the following components in parts by mass: 1 part of polyethylene glycol (4000), 0.01 to 0.05 part of potassium chloride, 0.02 to 0.05 part of sodium bicarbonate, 0.02 to 0.05 part of sodium chloride, 0.07 to 1.0 part of anhydrous sodium sulfate and 0.001 to 0.01 part of saccharin sodium salt. The preparation method of the compound polyethylene glycol electrolyte composition comprises the following steps: (1) respectively crushing or screening sodium bicarbonate, anhydrous sodium sulfate, potassium chloride, sodium chloride and saccharin sodium salt; (2) weighing sodium bicarbonate, anhydrous sodium sulfate, potassium chloride, sodium chloride and saccharin sodium according to the prescription amount, and mixing in a wet granulation mixer; (3) weighing the polyethylene glycol 4000 and the premixed powder according to the prescription amount, mixing the polyethylene glycol 4000 and the premixed powder in a hopper type mixer, sampling and detecting the content of an intermediate; and (4) sub-packaging: calculating the packaging amount according to the content of the intermediate, and sub-packaging by adopting a composite membrane.

Description

technical field [0001] The invention relates to a pharmaceutical solid preparation composition, in particular to a compound polyethylene glycol electrolyte powder and a preparation method thereof. Background technique [0002] Compound Polyethylene Glycol Electrolyte Powder is a new type of non-absorbable oral cleansing solution for the whole intestine. This product is mainly used for bowel cleansing preparation before surgery; bowel cleansing preparation before colonoscopy, barium enema and other examinations. Intestinal cleansers are widely used clinically, exist in various departments, and are used in large quantities. A clean intestinal tract is an important condition for successful operations, reduced complications, and smooth colonoscopy, X-ray barium enema, CT examination, B-ultrasound and other examinations to improve the accuracy of diagnosis. Because the compound polyethylene glycol electrolyte powder is safe, effective, easy for patients to accept, and convenien...

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, troublesome to use and easy to cause waste;

[0004] 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 the electrolyte and polyethylene glycol and uneven content ratio of each component, the powder is wetted with 80% ethanol after mixing, because the ethanol contains water, and the electrolyte in the particles It is very easy to dilute, and its crystal water is difficult to remove. The wetted powder is dried at 10-60°C. Since sodium bicarbonate will decompose when it exceeds 50°C, sodium bicarbonate will decompose after drying. If If the drying temperature is lowered, the water of crystallization in the electrolyte will be difficult to remove, so this method has defects

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