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Compound polyethylene glycol electrolyte granule and preparation method thereof

A polyethylene glycol and electrolyte technology, applied in the field of medicine, can solve the problems of difficult mixing, tedious patient compliance, easy secondary layering, etc., and achieve the effects of simple production process, controllable quality and increased production capacity

Inactive Publication Date: 2020-07-17
BEIJING MEDISAN TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In view of the above, the technical problem to be solved by the present invention is to provide a compound polyethylene glycol electrolyte granule and its preparation method to solve the problems of uncontrollable quality, difficult mixing and equipment operation in the preparation process of the compound polyethylene glycol electrolyte preparation. Problems such as easy secondary stratification, complicated patient compliance, etc.

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  • Compound polyethylene glycol electrolyte granule and preparation method thereof
  • Compound polyethylene glycol electrolyte granule and preparation method thereof
  • Compound polyethylene glycol electrolyte granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1 Preparation of compound polyethylene glycol electrolyte granules

[0038] 1. Formula (prepared based on 5kg of total materials per batch), as shown in Table 1:

[0039] Table 1

[0040] Polyethylene glycol 4000 6400 copies Sodium sulfate 570 copies Sodium chloride 146 copies Potassium chloride 75 servings Sodium bicarbonate 168 copies

[0041] Preparation method: Mix the above-mentioned prescription amount of materials, and use a hot melt extruder for melt granulation. The hot melt temperature and screw speed are shown in Table 2 below:

[0042] Table 2

[0043] batch number Melting temperature (℃) Screw speed (rpm) Sample-155100 Sample-250120 Sample-36080 Sample-455100 Sample-560120 Sample-65080 Sample-755100

[0044] After the mixed material is pelletized by a hot melt extrusion machine, the pellets are pelletized through a 0.85μm pore size screen using a pelletizer, and packaged in aluminum-plastic composite film bags at 73.59g / bag to complete the ...

Embodiment 2

[0053] Example 2 Preparation of compound polyethylene glycol electrolyte granules

[0054] Recipe (prepared based on 5kg of total materials per batch), as shown in Table 4:

[0055] Table 4

[0056] Polyethylene glycol 4000 6400 copies Sodium sulfate 570 copies Sodium chloride 146 copies Potassium chloride 75 servings Sodium bicarbonate 168 copies

[0057] Preparation method: pass polyethylene glycol 4000 through a 40-mesh sieve for use, and sodium sulfate, sodium chloride, potassium chloride, and sodium bicarbonate through a 60-mesh sieve for use. Weigh according to the above prescription, put it into a single-arm mixer, and mix with the parameters in Table 5 below.

[0058] table 5

[0059] batch number Mixing speed Mixing time Sample-8 10rpm 5min Sample-9 10rpm 10min Sample-10 10rpm 15min

Embodiment 3

[0060] Example 3 Inspection of the uniformity of chloride ion content

[0061] Use the chloride ion content as an indicator to test the content uniformity. The detection method of chloride ion content refers to the detection method of sodium chloride in "National Drug Standard Compound Polyethylene Glycol Electrolyte Powder" (WS1-(X-229)-2004Z). The results are shown in Table 6 below. Among them, A+2.2S≤15 are qualified products.

[0062] Table 6

[0063] batch number content(%) RSD(%) A+2.2S Sample-197.71.184.8 Sample-296.81.045.4 Sample-398.41.063.9 Sample-499.51.914.7 Sample-597.52.738.4 Sample-699.13.839.3 Sample-7100.13.057.0 Sample-881.87.1931.2 Sample-981.71.8921.7 Sample-1085.828.6668.6

[0064] It can be seen from the results that the materials (polyethylene glycol 4000, sodium chloride, potassium chloride, sodium sulfate, sodium bicarbonate) in the compound polyethylene glycol electrolyte powder are directly mixed, and the content of the product obtained is...

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Abstract

The invention discloses a compound polyethylene glycol electrolyte granule and a preparation method thereof. The compound polyethylene glycol electrolyte granule contains polyethylene glycol with an average molecular weight of 3400-4400 and an electrolyte inorganic salt, wherein the D90 particle size of the electrolyte granule is 40-80 meshes. The compound polyethylene glycol electrolyte granule is prepared by the following steps: mixing polyethylene glycol with an average molecular weight of 3400-4400 and the electrolyte inorganic salt, performing melting granulation by adopting a hot melt extruder, wherein the melting granulation temperature is 40-80 DEG C, and the screw speed is 60-140rpm; and then performing granulating by adopting a screen with a pore diameter of 0.40-4.00mm, and wrapping or packaging the granules in a packaging container in a unit dose mode to form a compound polyethylene glycol electrolyte granule product. Quality of the compound polyethylene glycol electrolytegranule provided by the invention is controllable, the problem of secondary layering in a production and preparation process of polyethylene glycol electrolyte powder is solved, and the production process is simple. The adopted melting granulation process is a continuous production process, so that production efficiency is improved, productivity is increased, and cost is reduced.

Description

Technical field [0001] The invention relates to a polyethylene glycol electrolyte particle preparation and a preparation method thereof. The invention belongs to the field of medical technology. Background technique [0002] Before many diagnoses and surgical procedures, such as colonoscopy, barium enema or surgery, colon cleansing is required. A clean intestine is an important condition for successful operation, reduction of complications, and smooth colonoscopy, X-ray barium enema, CT examination, B-ultrasound and other examinations to improve the accuracy of diagnosis. In addition, the clinical treatment of fecal retention is roughly the same as the method of colon cleansing. One method of colon cleansing is a vertical enema, that is, a large amount of electrolytes are infused by drinking or through a nasogastric tube. This enema is also considered to be a cleansing liquid for the intestine or digestive tract. Ingestion of the solution will cause fluid-induced diarrhea, the...

Claims

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Application Information

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IPC IPC(8): A61K33/14A61K9/16A61P1/00A61P1/10A61K31/765A61K33/00A61K33/04
CPCA61K9/1623A61K31/765A61K33/00A61K33/04A61K33/14A61P1/00A61P1/10A61K2300/00
Inventor 刘荣王宏媛徐佳茗
Owner BEIJING MEDISAN TECH
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