WO2017088749A1 - 一种治疗溃疡性结肠炎的药物组合物 - Google Patents

一种治疗溃疡性结肠炎的药物组合物 Download PDF

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WO2017088749A1
WO2017088749A1 PCT/CN2016/106870 CN2016106870W WO2017088749A1 WO 2017088749 A1 WO2017088749 A1 WO 2017088749A1 CN 2016106870 W CN2016106870 W CN 2016106870W WO 2017088749 A1 WO2017088749 A1 WO 2017088749A1
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ulcerative colitis
niacin
pharmaceutical composition
enema
patients
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PCT/CN2016/106870
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French (fr)
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王立夫
余鹰
李娟娟
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上海交通大学医学院附属瑞金医院
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone

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  • the present invention belongs to the field of medicine and, more particularly, to a pharmaceutical composition for treating ulcerative colitis.
  • Oral administration includes aminosalicylic acid, hormones, immunosuppressive drugs and emerging biological agents
  • topical drugs include suppositories of aminosalicylic acid and enema and hormonal enema.
  • the commonly used drugs aminosalicylic acid, hormones, immunosuppressive drugs are easily tolerated, and the side effects are large. Most patients have prolonged unhealed conditions and are prone to recurrence. Emerging biologics are expensive.
  • Niacin is a common clinical drug mainly used for the treatment of pellagra, and is currently used to regulate the treatment of blood lipids. However, it has not been reported in the treatment of digestive tract diseases.
  • a first object of the present invention is to provide an application of niacin in the preparation of an oral or enema medicament for the treatment of ulcerative colitis.
  • a second object of the present invention is to provide a pharmaceutical composition for treating ulcerative colitis.
  • the present invention discloses the following technical solution: the application of nicotinic acid in the preparation of an oral or enema drug for treating ulcerative colitis.
  • the present invention discloses the following technical solution: a pharmaceutical composition for treating ulcerative colitis, characterized in that the composition comprises physiological saline, metronidazole, starch, nicotinic acid and ground. Dexamethasone.
  • the pharmaceutical composition is administered by enema.
  • the content of each component in the oral or enema pharmaceutical composition for treating ulcerative colitis is: normal saline 100-200 ml, metronidazole 0.5-1 g, starch 5-10 g, nicotinic acid 300-400 mg, ground stopper Rice pine 5-10mg.
  • the drug When the drug is administered orally, the drug is 300-400 mg of niacin.
  • the invention has the advantages that one or several commonly used drugs for treating other diseases or ulcerative colitis can be combined into a formula, and the oral or enema treatment can be used to treat traditional oral or enema drugs.
  • Good or oral medications produce left-sided ulcers with high side effects Patients with colitis have significant therapeutic effects.
  • This formula is new for clinical use and is affordable. For patients who are not sensitive to conventional ulcerative colitis drugs, the effect of this formula is obvious, and the side effects of this formula are small.
  • Figure 1 is a model of mouse colitis induced by DSS to detect the therapeutic effect of niacin on ulcerative colitis. Niacin improves DSS-induced weight loss (A), reduces disease activity index (B), and reduces small Inflammatory contracture edema in the murine colon (C).
  • Figure 2 shows the effect of niacin on the survival rate of DSS-treated mice.
  • Figure 3 shows the therapeutic effect (colonoscopy) of patients with left half ulcerative colitis and proctitis plus niacin retention enema, where A is the colonoscopy picture at the initial diagnosis (ulcer, hemorrhage, purulent white moss on the surface) B is the traditional oral and enema treatment of ulcerative colitis, the effect is not good, the condition is not relieved, C is added with niacin retention enema treatment, the patient's condition is obviously relieved, the colonic mucosa is completely repaired (ulcer repair Mucosa can be seen in capillaries, etc.).
  • Figure 4 is the therapeutic effect (colonoscopy) of another patient with left half ulcerative colitis after adding niacin enema, where A is the colonoscopy picture at the initial diagnosis (ulcer, hemorrhage, purulent white moss on the surface), B After traditional oral and enema treatment of ulcerative colitis, the effect is not good, the condition is not relieved, C is treated with niacin, the patient's condition is obviously relieved, and the mucosa is completely repaired under the colonoscopy (ulcer repair, mucous membrane visible capillary) Blood vessels, etc.).
  • Figure 5 shows the patient's mayo score, and the mayo score was significantly improved in patients with ulcerative colitis after niacin treatment.
  • Figure 6 is a result of HE staining of colonic mucosal biopsy tissue in patients with ulcerative colitis. After treatment with niacin, the patient's colonic mucosal epithelial condition improved significantly, which was manifested in an increase in the number of glands, normalization, and decreased infiltrating inflammatory cells.
  • Example 1 Therapeutic effect of niacin on ulcerative colitis
  • Niacin (nicotinic acid) is a clinically used drug for the treatment of pellagra, and also has the effect of regulating blood lipids. Studies have reported that it can promote the release of PGD 2 , our previous basic research confirmed that PGD 2 has a certain protective effect in the development of ulcerative colitis.
  • the mouse colitis model was induced by DSS to detect the therapeutic effect of niacin on ulcerative colitis. Specifically, niacin can inhibit the weight loss of mice induced by DSS, the deterioration of disease activity index and the inflammatory contracture of mouse colon. See Figure 1 for details.
  • niacin can inhibit the development of ulcerative colitis.
  • metronidazole-containing formulation was continued for 2 weeks and the metronidazole-free formulation was continued for 2-4 weeks.
  • Figures 3 and 4 show the therapeutic effect (colony) of two patients after adding niacin enema.
  • Figure 3 shows patient 1 (200 ml saline, 1 g metronidazole, 10 g starch, 400 mg niacin, 10 mg dexamethasone), where A is the colonoscopy image at the initial diagnosis (ulcer, hemorrhage, purulent white moss on the surface) B is a traditional oral and enema treatment for ulcerative colitis, the effect is not good, the condition is not relieved, C is treated with niacin, the patient's condition is obviously relieved, and the mucosa is completely repaired under the colonoscopy (ulcer repair, mucosa) Visible capillaries, etc.).
  • A is the colonoscopy image at the initial diagnosis (ulcer, hemorrhage, purulent white moss on the surface)
  • B is a traditional oral and enema treatment for ulcerative colitis, the effect is not good, the condition is not relieved, C is treated with niacin, the patient's condition is obviously relieved, and the
  • Figure 4 shows the colonoscopy results of patient 2 (100 ml saline, metronidazole 0.5 g, starch 5 g, niacin 300 mg, dexamethasone 5 mg).
  • the pharmaceutical composition of the invention can treat patients who are not sensitive to conventional oral and enema treatment of ulcerative colitis drugs; the drugs in the formula are commonly used drugs for clinical treatment of other diseases or enteritis, and the technology is relatively mature; the drugs and the use in the formula The side effects of treatment are less.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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Abstract

烟酸用于制备治疗溃疡性结肠炎的药物，同时提供了一种药物组合物，包含生理盐水、甲硝唑、淀粉、烟酸和地塞米松，可口服或保留灌肠局部给药，对于溃疡性结肠炎特别是左半溃疡性结肠炎或常规药物治疗不敏感的患者治疗效果显著，副作用较小。

Description

一种治疗溃疡性结肠炎的药物组合物 技术领域
本发明属于医学领域，更具体地讲，涉及一种治疗溃疡性结肠炎的药物组合物。
背景技术
目前治疗溃疡性结肠炎患者的药物主要分口服用药和局部灌肠两类。口服用药包括氨基水杨酸类、激素、免疫抑制药及新兴的生物制剂，局部用药包括氨基水杨酸类的栓剂及灌肠剂和激素类的灌肠剂。目前常用药物氨基水杨酸类、激素、免疫抑制药容易耐受，副作用较大，多数患者病情迁延不愈，容易复发。新兴的生物制剂价格昂贵。
烟酸是一种临床常见药物，主要用于治疗糙皮病，目前也用于调节血脂的治疗。但是在消化道疾病的治疗中目前没有报道。
发明内容
本发明的第一个目的在于提供烟酸在制备治疗溃疡性结肠炎口服药物或灌肠药物中的应用。
本发明的第二个目的在于提供一种治疗溃疡性结肠炎的药物组合物。
为实现本发明第一个目的，本发明公开以下技术方案：烟酸在制备治疗溃疡性结肠炎口服药物或灌肠药物中的应用。
为实现本发明第二个目的，本发明公开以下技术方案：一种治疗溃疡性结肠炎的药物组合物，其特征在于，所述组合物包括生理盐水，甲硝唑，淀粉，烟酸和地塞米松。
作为一个优选方案，所述药物组合物是灌肠给药。
作为一个优选方案，治疗溃疡性结肠炎的口服或灌肠药物组合物中各组分含量为：生理盐水100－200ml，甲硝唑0.5-1g，淀粉5-10g，烟酸300-400mg，地塞米松5-10mg。
当药物是口服给药时，所述药物为300-400mg烟酸。
本发明的优点在于：将一种或几种临床常用的治疗其他疾病或者溃疡性结肠炎的常用药物组合成配方，采用口服治疗或者保留灌肠局部治疗，可以给对传统口服或灌肠治疗药物效果不佳或者口服药物产生副作用较大的左半溃疡 性结肠炎患者带来显著的治疗效果。此配方药为临床老药新用，价格实惠。对常规治疗溃疡性结肠炎药物不敏感的患者，采用此配方药治疗效果明显，且此配方药副作用较小。
附图说明
图1为用DSS诱导小鼠结肠炎模型，检测烟酸对溃疡性结肠炎的治疗作用，烟酸改善了DSS引起的体重减轻(A)，降低了疾病活动指数(B)，也减轻了小鼠结肠的炎症性挛缩水肿(C)。
图2为烟酸对DSS处理的小鼠的生存率的影响。
图3为左半溃疡性结肠炎及直肠炎患者加用烟酸保留灌肠后的治疗效果(肠镜)，其中A为初次诊断时的肠镜图片(溃疡、出血、表面有脓性白苔)，B为传统口服和灌肠治疗溃疡性结肠炎药物治疗后，效果不好，病情无缓解，C为加用烟酸保留灌肠治疗后，患者的病情明显缓解，肠镜下黏膜完全修复(溃疡修复、黏膜可见毛细血管等)。
图4为另一左半溃疡性结肠炎患者加用烟酸灌肠后的治疗效果(肠镜)，其中A为初次诊断时的肠镜图片(溃疡、出血、表面有脓性白苔)，B为传统口服和灌肠治疗溃疡性结肠炎药物治疗后，效果不好，病情无缓解，C为加用烟酸治疗后，患者的病情明显缓解，肠镜下黏膜完全修复(溃疡修复、黏膜可见毛细血管等)。
图5为患者的mayo评分，经烟酸治疗后，溃疡性结肠炎患者的mayo评分明显改善。
图6是溃疡性结肠炎患者结肠粘膜活检组织的HE染色结果。经烟酸治疗后，患者结肠粘膜上皮情况明显改善，具体表现在腺体数量增多，正常化，浸润的炎症细胞减少。
具体实施方式
下面结合具体实施例，进一步阐述本发明。下述实施例中所使用的实验方法如无特殊说明，均为常规方法。下述实施例中所用的材料、试剂等，如无特殊说明，均可从商业途径得到。应理解，这些实施例仅用于说明本发明而不用于限制本发明的范围。
实施例1.烟酸对溃疡性结肠炎的治疗作用
小鼠实验：(Niacin用法：600mg/kg一天一次灌胃)
Niacin(烟酸)是一种临床常用治疗糙皮病的药物，也具有调节血脂的作用。有研究报道它能够促进PGD2的释放，我们前期的基础研究证实PGD2在溃疡性结肠炎的发生发展中具有一定的保护作用。
(1)用DSS诱导小鼠结肠炎模型，检测烟酸对溃疡性结肠炎的治疗作用。具体体现在烟酸能够抑制DSS诱导的小鼠体重的减轻、疾病活动指数的恶化及小鼠结肠的炎性挛缩。具体参见图1。
(2)我们也检测了烟酸对DSS处理的小鼠的生存率的影响，结果如图2所示，烟酸抑制DSS引起的小鼠的死亡。
通过以上动物实验，我们得到的结论是烟酸可以抑制溃疡性结肠炎的发生发展。
实施例2.药物组合物临床试验
将几类药物按照一定的比例组合成配方，采用保留灌肠的方式对溃疡性结肠炎患者进行治疗。配方如下：生理盐水100－200ml  甲硝唑0.5-1g  淀粉5-10g  烟酸300-400mg  地塞米松5-10mg。
含甲硝唑的配方用2周，继续用不含甲硝唑的配方2－4周。
我们接下来选取了数十例对常规治疗药物不敏感或无效左半溃疡性结肠炎患者，在其知情同意下加用烟酸灌肠治疗，4-6周后复查血及肠镜，观察其疗效。所选患者用烟酸灌肠前都用过传统的灌肠治疗，具体药物(生理盐水、甲硝唑、淀粉、地塞米松)结果如图3-6，加用保留烟酸灌肠后，患者的症状明显改善。
(1)图3和图4为两个患者加用烟酸灌肠后的治疗效果(肠镜)。
图3为患者一(生理盐水200ml，甲硝唑1g，淀粉10g，烟酸400mg，地塞米松10mg)，其中A为初次诊断时的肠镜图片(溃疡、出血、表面有脓性白苔)，B为传统口服和灌肠治疗溃疡性结肠炎药物治疗后，效果不好，病情无缓解，C为加用烟酸治疗后，患者的病情明显缓解，肠镜下黏膜完全修复(溃疡修复、黏膜可见毛细血管等)。
图4为患者二(生理盐水100ml，甲硝唑0.5g，淀粉5g，烟酸300mg，地塞米松5mg)的肠镜结果。
(2)我们也统计了患者的mayo评分，结果如图5所示，患者在加用烟酸保留灌肠后，患者的mayo评分明显降低了，代表烟酸对溃疡性结肠炎患者具有显著的保护作用。
(3)我们也对溃疡性结肠炎患者结肠粘膜活检组织进行了HE染色。如图6所示，经烟酸治疗后，患者结肠粘膜上皮情况明显改善，具体表现在腺体数量增多，正常化，浸润的炎症细胞减少。
本发明药物组合物可以治疗对常规口服和灌肠治疗溃疡性结肠炎药物不敏感的患者；配方中的药物均为临床治疗其他疾病或肠炎的常用药物，技术较成熟；此配方中的药物及采用的治疗方式所带来的副作用较小。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。

Claims (4)

  1. 烟酸在制备治疗溃疡性结肠炎口服药物或灌肠药物中的应用。
  2. 一种治疗溃疡性结肠炎的药物组合物，其特征在于，所述组合物包括生理盐水，甲硝唑，淀粉，烟酸和地塞米松。
  3. 根据权利要求2所述的一种治疗溃疡性结肠炎的药物组合物，其特征在于，所述药物组合物是灌肠给药。
  4. 根据权利要求2所述的一种治疗溃疡性结肠炎的药物组合物，其特征在于，各组分含量为：生理盐水100－200ml，甲硝唑0.5-1g，淀粉5-10g，烟酸300-400mg，地塞米松5-10mg。
PCT/CN2016/106870 2015-11-25 2016-11-23 一种治疗溃疡性结肠炎的药物组合物 WO2017088749A1 (zh)

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CN115105514A (zh) * 2022-06-14 2022-09-27 邯郸制药股份有限公司 一种保护胃黏膜、治疗胃溃疡的药物组合物及其制备方法和应用

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CN106860463A (zh) * 2017-02-15 2017-06-20 沂南县迎辉农业开发有限公司 一种降低醋酸地塞米松片临床副作用的药剂

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