Application of Jian indigo naturalis in preparation of medicine for treating ulcerative colitis

A technology for ulcerative colitis and drugs, applied in the field of drugs, can solve the problems of increasing treatment intolerance and economic burden, and achieve the effects of no serious adverse reactions, relief of blood in the stool, and convenient administration

Inactive Publication Date: 2020-10-30
顾思臻
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is known that mesalamine granules, the first-line drug for UC, are pH-dependent preparations, mainly released in the terminal ileum, and the concentration in the colon gradually decreases from near to far. Therefore, for the rectal type (E1), the left colon (E2, usually r...

Method used

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  • Application of Jian indigo naturalis in preparation of medicine for treating ulcerative colitis
  • Application of Jian indigo naturalis in preparation of medicine for treating ulcerative colitis
  • Application of Jian indigo naturalis in preparation of medicine for treating ulcerative colitis

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Experimental program
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Effect test

Embodiment 1

[0028] Take 10 parts of Jianqingdai, and use Eudragit S100 as the capsule skin to prepare capsules. The density of Qingdai / capsule is 1.0g / ml.

[0029] A single-center, open-label, prospective single-arm clinical trial was carried out with the prepared Jianqingdai to evaluate the efficacy and safety of oral Jianqingdai in the treatment of active UC. The specific process is as follows:

[0030] Effect verification 1: A total of 20 patients with moderately active UC were included, taking 4 Jianqingdai capsules every day, 2 times a day, 2 capsules each time, and the course of treatment was 8 weeks. 60% of the patients were refractory cases ( Ineffective to glucocorticoids, immunomodulators and / or anti-TNF-α therapy), all patients did not receive leukapheresis, prednisolone ≥ 40 mg, adalimumab, tacrolimus within 2 weeks before the start of the study or cyclosporine A, did not receive infliximab within the previous 4 weeks, did not allow changes in the dose of azathioprine within ...

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Abstract

The invention provides application of Jian indigo naturalis in preparation of medicine for treating ulcerative colitis. The result shows that the clinical response, clinical remission and mucous membrane healing effects of the single Jian indigo naturalis after oral administration for 8 weeks are satisfactory, and the Jian indigo naturalis has a good curative effect on hormone-dependent or anti-TNF-alpha refractory UC. Clinical tests and animal experiments show that the Jian indigo naturalis has a good curative effect, is convenient for administration, the ulcerative colitis can be effectivelytreated; no severe adverse reactions, the Jian indigo naturalis can be orally taken to quickly relieve hematochezia; the clinical response rate, the clinical remission rate and the mucous membrane healing rate are higher than those of a placebo group; meanwhile, animal experiments also prove that the Jian indigo naturalis can effectively reduce the disease activity index of model animals, maintain animal weight, improve colon pathological injury, reduce the serum pro-inflammatory factor level, inhibit activation of related inflammatory signal channels and promote mucosal healing, and has goodclinical application prospects.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to the application of Jianqingdai in the preparation of medicines for treating ulcerative colitis. Background technique [0002] Ulcerative colitis is a non-specific inflammatory bowel disease, which is called idiopathic colitis by the World Health Organization. It is a chronic nonspecific inflammatory process of unknown etiology limited to the colonic mucosa and submucosa. The lesions are mostly located in the sigmoid colon and rectum, and can also extend to the descending colon or even the entire colon. The disease mostly occurs in young adults aged 20 to 40 years old. With the changes in diet structure, living habits and rhythm of life, and the improvement of diagnostic methods, in recent years, the incidence of elderly patients has an upward trend. The disease persists for a long time, and there is a potential risk of malignant transformation. The main clinical manifestation...

Claims

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Application Information

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IPC IPC(8): A61K36/704A61K36/315A61K36/195A61K9/48A61K47/32A61P1/04A61P1/00
CPCA61K9/4866A61K36/195A61K36/315A61K36/704A61P1/00A61P1/04
Inventor 顾思臻窦丹波薛艳高阳张玉丽李鹏帆薛仕贵唐旖旎
Owner 顾思臻
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