CN104546949A - Improved compound drug for treating ulcerative colitis - Google Patents

Improved compound drug for treating ulcerative colitis Download PDF

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Publication number
CN104546949A
CN104546949A CN201510024738.6A CN201510024738A CN104546949A CN 104546949 A CN104546949 A CN 104546949A CN 201510024738 A CN201510024738 A CN 201510024738A CN 104546949 A CN104546949 A CN 104546949A
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China
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vitamin
ulcerative colitis
compound drug
improved compound
dissolve
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CN201510024738.6A
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Chinese (zh)
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李立和
白景珍
高绍华
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Tianjin Baodi Hospital
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Tianjin Baodi Hospital
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Abstract

The invention discloses an improved compound drug for treating ulcerative colitis. The improved compound drug contains a mixed jelly including balsalazide disodium, Yunnan baiyao powder, chlortrimeton, metronidazole, vitamin C, vitamin B1 and aluminum phosphate gel. A preparation method of the improved compound drug comprises the following steps: dissolving balsalazide disodium into 30ml of 80DEG C hot physiological brine, adding 20g by weight of aluminum phosphate gel, cooling to 48DEG C, then dissolving Yunnan baiyao powder, vitamin C, vitamin B1, chlortrimeton and metronidazole, thoroughly dissolving and then cooling to 37DEG C, and applying from an anus through an administrating device. The improved compound drug has the beneficial effects that the improved compound drug has the advantages of being good in efficacy, short in treatment course, less in side effect, convenient to use and the like on the ulcerative colitis.

Description

One treats ulcerative colitis modified model combination drug formula
Technical field
The present invention relates to pharmaceutical technology, specifically refer to a kind of pharmaceutical preparation and using method for the treatment of ulcerative colitis.
Background technology
Inflammatory bowel (inflammatory bowel disease, IBD) be a kind of cause of disease chronic nonspecific bowl inflammatory diseases still not fully aware of, comprise ulcerative colitis (ulcerative colitis, and Crohn disease (Crohn ' s disease, CD) UC).IBD is the commonly encountered diseases in North America and Europe, and over nearly 30 years, Japanese IBD sickness rate is also in progressively increasing trend.Though China there is no the epidemiologic data of general population, nearly primary disease during the last ten years goes to a doctor number in progressively increasing trend then clearly, and IBD has become the commonly encountered diseases of digestive system in China.UC lacks the goldstandard of diagnosis, mainly comprehensively analyzes in conjunction with clinical manifestation, scope and histopathology, and diagnosis is made on the basis getting rid of infectious and noninfectious colitis.UC the most often betides the between twenty and fifty phase, according to the China's Statistical data onset peak age be 20 ~ 49 years old, gender's difference little (men and women's ratio is about 1.0 ~ 1.3:1).Clinical manifestation is lasting or the diarrhoea of recurrent exerbation, mucopurulent bloody stool companion stomachache, tenesmus and General Symptoms in various degree, and the course of disease is many more than 4 ~ 6 weeks.Mucocutaneous, joint can be had, the intestinal such as eye and liver and gall shows outward.Mucosanguineous feces is the most common sympton of UC.The diarrhoea course of disease more than 6 weeks can be differentiated with most infective enteritis.Colonoscopy biopsy are the Main Basiss of UC diagnosis.Under colonoscope, UC pathological changes is many from rectum, in seriality, diffusivity distribution, show as: mucosa vascular lake is fuzzy, disorderly or disappearances, hyperemia, edema, matter are crisp, spontaneous or contact bleeding and purulent secretion adhere to, also common mucosa coarse, in fine particulate; Pathological changes obviously locates visible diffusivity, multiple erosion or ulcer; Visible haustra of colon shoals, rust or disappearance and pseudopolyp and bridge mucosa etc.Endoscopic inferior mucosa staining technique can improve the identification ability of scope to mucosa infection, in conjunction with magnifying endoscope technology, by the observation of mucosa fine structure and the differentiation of characteristics of lesion, can improve the accuracy rate of diagnosis of UC.
The main method adopting Drug therapy and operative treatment for the treatment of, western medicine is based on oral, and the dose for oral use that the pathological changes due to colon section far away adopts is large, and curative effect is unsatisfactory, and easily causes more side reaction, and operative treatment wound is large, the more difficult acceptance of patient.Herbal retention enema method at Clinical practice for many years, is a reasonable route of administration, and the coloclysis Chinese drugs agentia for the treatment of this disease exists therapeutic effect difference, take effect slow problem.At present, apply appearing in the newspapers of the Drug therapy colitis such as balsalazide sodium, Fosfalugel (Yamanouchi), metronidazole clinically, the present invention improves on this basis, to reach better therapeutic effect.
Summary of the invention
In order to make up the deficiencies in the prior art, the invention provides the composite drug of a kind of good effect, short treating period, side effect treatment ulcerative colitis little, easy to use.Realize particular by following technical scheme: in 30 milliliters of 80 DEG C of hot physiological waters, dissolve balsalazide sodium 2.25g, add Fosfalugel (Yamanouchi) 20 grams, after equitemperature drops to 48 DEG C, dissolve YUNNAN BAIYAO 1g, vitamin C 100mg, vitamin B 1200mg, metronidazole 0.6g, chlorphenamine 8mg, fully dissolve after mixing and treat that temperature drops to 37 DEG C by administrator anum administration.
Ulcerative colitis is immunity inflammatory reaction, show as intestinal mucosa hyperemia, edema, permeability changes, even ulcer, a kind of prodrug for balsalazide sodium in above symptom formula of the present invention, arrive colon with former medicine after oral, under the effect of colon bacteria, discharge 5-aminosalicylic acid effective ingredient and 4-aminobenzoyl-Beta-alanine.5-aminosalicylic acid may be play its effect reduced inflammation by the generation of arachidonic acid metabolite in blocking-up colon; This research coordinates normal saline enema after being ground by balsalazide sodium, and medicine can be made to go directly focus, and local drug concentration is high, makes intestinal mucosa protected, and promotes that it is repaired.YUNNAN BAIYAO is succeeded in developing in 1902 by Yunnan doctor Qu Huanzhang among the people, original name " Qu Huanzhang cure-all ".It is made up of rare medicinal herbs, has effect of removing stasis to stop bleeding, promoting blood circulation and stopping pain, removing toxic substances and promoting subsidence of swelling.YUNNAN BAIYAO can make prothrombin time shorten, and increases prothrombin content, and the gathering of energy induced platelet and release; Ulcerative colitis has been caused bleeding good therapeutic effect; Have inhibitory action to the release of anti-inflammatory agent, for improving, the aspect such as microcirculation, change vascular permeability is all effective; Also have antibacterial effect, the infection that ulcerative colitis causes can be prevented; The secretion of adrenocortical hormone can be promoted, have therapeutical effect for disease of immune system.Vitamin C, vitamin B 1there is accelerating wound effect, because it is poor to temperature stability, configure and appropriate to the occasionly to dissolve under 48 DEG C of water temperatures; Chlorphenamine has antiallergic effect, and after reducing coloclysis, medicine is discharged immediately; Fosfalugel (Yamanouchi) can form colloid protectiveness thin film, can isolate and protect damaged tissue, and more direct water-soluble medicine more can play drug effect for a long time, and the holdup time is long in the rectum, thus reaches better curative effect.Medicinal liquid warm in addition also can promote and improve intestinal blood circulation, impels inflammatory resolution and absorption, reduces the sensitivity of pain nerve.Thus improve intestinal resistance and the power of reparation, alleviate mucosa edema, remove intestinal cramps, ease the pain.Meanwhile, avoid the impact of gastric acid on medicine, have good antiinflammatory, promote the effects such as ulcer healing.This Therapeutic Method is easy to operation, soon effective, and has Shorten the Treatment Process, reduces relapse rate, reduces the effect of untoward reaction.
The medication for the treatment of ulcerative colitis of the present invention: before sleeping every night, after emptying stool, urine, get right arm reclining, buttocks is made to shift near edge of bed, adopt administrator and mark 5 centimetres, 10 centimetres, 15 centimeter scale from its end, Exhaust Gas, end coats a small amount of lubricant, insert rectum about 15cm from anus slowly, medicinal liquid is slowly injected 15 milliliters; Retreat to 10 centimeters and slowly inject 15 milliliters again, retreat to 5 centimeters and slowly inject 15 milliliters again.As observed the administration of ulcer degree of depth emphasis by colonoscope, its drug effect is better, and fluid temperature is advisable with about 37 DEG C, and pressure is low, and liquid level more than 30cm, after having filled with, must not be lain up apart from anus as far as possible.Coloclysis 1 time before sleeping every night, after comprising the configuration of this pharmaceutical formulation of normal saline, volume is about 50ml, 15 milliliters every section, and after injecting 3 times, remaining about 5ml in pipe can not discharge.Within 1 month, be 1 course for the treatment of, general 2 courses for the treatment of can fully recover.Adopt administrator as shown in Figure 1,50 milliliters of aseptic medicine dissolving devices of single use connect No. 14 catheters, and there is side opening its end, infusion of medicine intestinal wall and enter enteric cavity less, and adopt enema tube drug residue large, patient suffering is many; The medicament for the treatment of ulcerative colitis of the present invention, its beneficial effect is: have the advantages such as good effect, short treating period, side effect be little, easy to use for ulcerative colitis.
Accompanying drawing explanation
Fig. 1 is administrator figure of the present invention.
Detailed description of the invention:
Below in conjunction with embodiment and case, the present invention is further illustrated.
Embodiment 1:
In 30 milliliters of 80 DEG C of hot physiological waters, dissolve balsalazide sodium 2.25g, add Fosfalugel (Yamanouchi) 20 grams, after equitemperature drops to 48 DEG C, dissolve YUNNAN BAIYAO 1g, vitamin C 100mg, vitamin B 1200mg, metronidazole 0.6g, chlorphenamine 8mg, fully dissolve after mixing and treat that temperature drops to 37 DEG C by administrator anum administration.
Embodiment 2:
Change the balsalazide sodium in embodiment 1 into sulfasalazine, concentration is constant, and other materials are constant, and administering mode is constant.
Clinical testing data of the present invention:
During in June, 2012 ~ 2014 year June, choose Tianjin Baodi Hospital's patients of ulcerative colitis 153 example, wherein male 77 example, women 76 example, 17 ~ 58 years old age, 39 years old mean age.Diagnostic criteria: the mucus hemafecia 1, having persistence or recurrent exerbation, stomachache, with General Symptoms in various degree.2, the visible mucosa of colonoscope multiple fester companion congestion and edema, pathological changes is mostly from rectum, and the distribution in diffusivity; Mucosa is coarse in fine particulate, and mucosa blood vessel is fuzzy, crisp, easily hemorrhage or with purulent secretion; Visible false polyp, haustra of colon is rust or disappearance often.3, the diseases such as infectious colitis and Crohn disease, ischemic colitis, radiation colitis such as bacillary dysentery, ameba, schistosomicide, tuberculosis of intestine are got rid of.
By random for this 152 routine patient, be equally divided into two treatment groups, often organize 76 examples.Wherein, treatment group 1 adopts the inventive method to treat; Treatment group 2 adopts each 50 milliliters of treatments of common method for the treatment of mesalazine enema clinically at present.
All to avoid eating anything raw or cold greasy, pungent product at treatments period, taboo is drunk.
Efficacy assessment standard:
Cure: clinical symptom disappearance, colonoscope check mucosa is normal, and drug withdrawal observes 6 months without recurrence; Therapeutic effect is chosen as 10 points.
Effective: clinical symptoms substantially disappears or alleviates, intestinal mirror check mucosa only slight pathological changes; Therapeutic effect is chosen as 5 points.
Invalid: clinical symptoms and non-cancer lesion are without improvement, and therapeutic effect is chosen as 0 point.
Therapeutic outcome is in table 1:
In Table 1 after 152 routine patients of ulcerative colitis application this patent treatments, symptom scores compares highly significant sex differernce t=75.3, P<0.05, and this patent therapeutic effect is obvious.
Conclusion:
In clinical trial process, patient finds no any untoward reaction.Each measurement routine blood test, hepatic and renal function before and after treatment, every all normal before and after the treatment of result treatment group, therefore, medicament use safety of the present invention, 100% is reached to the total effective rate of ulcerative colitis, wherein best, the cure rate of the curative effect of medicament to ulcerative colitis of embodiment 1 reaches 98.0%, is the active drug for the treatment of ulcerative colitis, has well clinical and dissemination.
The above, be only preferred embodiment of the present invention, be not intended to limit protection scope of the present invention.One skilled in the art will appreciate that protection scope of the present invention is as the criterion with appending claims.

Claims (3)

1. treat a ulcerative colitis modified model combination drug formula, it is characterized in that in prescription containing balsalazide sodium, YUNNAN BAIYAO, chlorphenamine, vitamin C, vitamin B 1what form with Fosfalugel (Yamanouchi) mixes jelly.
2. one according to claim 1 treats ulcerative colitis modified model combination drug formula, it is characterized in that compound method is: in 30 milliliters of 80 DEG C of hot physiological waters, dissolve balsalazide sodium 2.25g, add Fosfalugel (Yamanouchi) 20 grams, after equitemperature drops to 48 DEG C, dissolve YUNNAN BAIYAO 1g, vitamin C 100mg, vitamin B 1200mg, metronidazole 0.6g, chlorphenamine 8mg, fully dissolve after mixing and treat that temperature drops to 37 DEG C by administrator anum administration.
3. one according to claim 1 treats ulcerative colitis modified model combination drug formula, it is characterized in that administrator connects No. 14 catheters by 50ml medicine dissolving device to be made.
CN201510024738.6A 2015-01-19 2015-01-19 Improved compound drug for treating ulcerative colitis Pending CN104546949A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116726009A (en) * 2023-07-27 2023-09-12 吉林大学 Application of chlorphenamine in preparation of medicament for treating neonatal necrotizing enterocolitis

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101015518A (en) * 2007-02-12 2007-08-15 山西安特生物制药股份有限公司 Balsalazide sodium enteroclyster and its preparing method
CN101247812A (en) * 2005-08-24 2008-08-20 萨利克斯药品公司 Balsalazide formulations and manufacture and use thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101247812A (en) * 2005-08-24 2008-08-20 萨利克斯药品公司 Balsalazide formulations and manufacture and use thereof
CN101015518A (en) * 2007-02-12 2007-08-15 山西安特生物制药股份有限公司 Balsalazide sodium enteroclyster and its preparing method

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
李林运: "愈溃散保留灌肠治疗非特异性溃疡性结肠炎46例", 《陕西中医》 *
田士军: "溃疡性结肠炎的药物治疗进展", 《医学综述》 *
钱振美: "临床分析18例溃疡性结肠炎", 《中外医疗》 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116726009A (en) * 2023-07-27 2023-09-12 吉林大学 Application of chlorphenamine in preparation of medicament for treating neonatal necrotizing enterocolitis
CN116726009B (en) * 2023-07-27 2024-03-22 吉林大学 Application of chlorphenamine in preparation of medicament for treating neonatal necrotizing enterocolitis

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Application publication date: 20150429