Balsalazide sodium enteroclyster and its preparing method

Abstract

the invention relates to a Balsalazide disodium enteroclyster which is prepared from the following ingredients (by weight portions): Balsalazide disodium 1-18, xanthan gum 0.125-2.25, pectin 0.0625-1.25. The invention also provides the process for preparing the enteroclyster which contains no anti-oxidant agent, complexing agent, preservative agent and acid-base balancing agent, thereby has better stability.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a balsalazide sodium enema and a preparation method thereof. Background technique [0002] An American research report showed that in ulcerative colitis (UC), total colitis (total colitis) accounted for 37%, left-side colitis (left-side colitis) accounted for 17%, and proctosigmoidotis (proctosigmoidotis) accounted for 46%. According to statistics in Japanese literature, pancolitis accounts for 35%, left-sided colitis accounts for 35%, rectal colitis accounts for 25%, and right-sided or regional colitis accounts for only 5%. Worldwide, nearly 90% of UC patients are mild or moderate UC, and more than 2 / 3 of them involve the colon from the distal end to the splenic flexure. It can be seen that it is of great significance to find effective rectal drug and therapy for left or distal UC. [0003] For the above-mentioned common left colon and distal UC, various oral 5-aminosalicylic acid (5-...

AI Technical Summary

Problems solved by technology

Although this method solves the problem of stability and packaging, in addition to adding multiple antioxidants such as sodium disulfide and titanium dioxide, complexing agent EDTA, preservative sodium benzoate, acid-base balance agent sodium dihydrogen sulfate are also added. , and sodium hydroxide, etc.

In addition, the packaging of various liquid enemas is complicated, so the price is expensive. For example, in 2006, the price of Salofalk enema 4g / 60ml X7 imported from Germany was 1476 yuan, and the daily cost of using it on patients was as high as 220 yuan; Although 5-ASA suppositories or sulfasalazine suppositories, the prodrug of 5-ASA, are cheaper, they have a limited anal access depth, and have poor curative effects on other types of UC except rectal UC.

Oral administration of 5-ASA prodrugs such as sulfasalazine or olsalazide has good curative effect but severe side effects; oral administration of 5-ASA prodrug balsalazide has a significant effect on left and distal UC. Good curative effect and less side effects, but the dose is relatively large (6.75g / day abroad, 6.0g / day domestically), and the cost is also high