Preparation method of sodium ascorbyl phosphate oral solution

Abstract

The invention relates to the field of oral purgative prescription, in particular to a preparation method of sodium ascorbyl phosphate oral solution, comprising the following steps: raw material is dissolved, boiled and sterilized, and filtered and disinfected, the step of boiling and sterilization is that sodium benzoate with 0.02-0.03 percent of mass-volume ratio is added in the solution obtained in the step of the dissolution of the raw material, the solution is evenly stirred and is heat-insulated for 1-2 hours at the temperature of 98-100 DEG C; the step of the filtering and disinfection is that the boiled and sterilized solution is cooled to below 40 DEG C, essence with 0.10-0.13 percent of mass-volume ratio is added, and then the solution is filtered with a 0.22mum of a microfiltration membrane for obtaining the sodium ascorbyl phosphate oral solution. The total bacterial count in microorganism of the solution obtained by the invention is extremely low, thereby reducing the stimulation of the solution to intestinal canals.

Description

technical field [0001] The invention relates to the field of oral laxatives, in particular to a preparation method of sodium phosphate oral solution. Background technique [0002] Bowel preparation is a necessary part of preparation before colonoscopy, colorectal cancer, some gynecology, urology and other operations, and is the key to the success of colonoscopy and surgery. Traditional methods of bowel preparation include the following: [0003] 1. Diet control: Diet control is the basic auxiliary method for intestinal preparation. The traditional dietary management is to give a low-residue (semi-liquid) diet 2 to 3 days before the examination or operation, and enter a liquid diet 1 day before. Preoperative diet restriction will result in insufficient intake of protein, vitamins and other nutrients and energy, which will affect tissue repair and wound healing; and the starvation state of the body will lead to intestinal mucosal atrophy and intestinal mucosal barrier functi...

AI Technical Summary

Problems solved by technology

[0017] The existing oral solution production process adopts the above steps, in which ordinary filters are used for filtration, and the pore size is generally 75-150 μm. The finished product is generally packaged in polyester bottles. Because polyester bottles are not resistant to high temperatures, they will be deformed above 40 ° C, so in In its production process, the packaged samples cannot be sterilized by dry heat (generally 135°C for more than 0.5 hours) or moist heat (generally 100°C for more than 0.5 hours), so Its hygienic control mainly adopts the method of boiling and sterilizing the medicinal liquid before packaging and adding an appropriate amount of bacteriostatic agent. The sterilization effect is poor, so the number of microorganisms in the sample is relatively high: the total number of bacteria in the existing oral solution requires According to the second part of "Chinese Pharmacopoeia" 2005 edition, the number of molds and yeasts should not exceed 100 per 100ml of solution, and the number of mold and yeast should not exceed 100 per 100ml of solution, and Escherichia coli should not be detected