WO2015010449A1 - 使用维生素b组合物促进胃肠系统动力的方法 - Google Patents
使用维生素b组合物促进胃肠系统动力的方法 Download PDFInfo
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- WO2015010449A1 WO2015010449A1 PCT/CN2014/000712 CN2014000712W WO2015010449A1 WO 2015010449 A1 WO2015010449 A1 WO 2015010449A1 CN 2014000712 W CN2014000712 W CN 2014000712W WO 2015010449 A1 WO2015010449 A1 WO 2015010449A1
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Definitions
- the present invention relates to a vitamin B composition, and more particularly to a vitamin B composition which promotes gastrointestinal system motility.
- the composition is useful for preventing and/or treating a condition or disease associated with gastrointestinal motility. Background technique
- Gastrointestinal (GI) Power is a coordinated neuromuscular process that delivers nutrients through the digestive system. May be involved in gastroesophageal reflux disease, gastroparesis (eg, diabetic and postoperative gastroparesis), irritable bowel syndrome (IBS), intestinal obstruction, and constipation (eg, functional or drug-induced constipation)
- gastroparesis eg, diabetic and postoperative gastroparesis
- IBS irritable bowel syndrome
- constipation eg, functional or drug-induced constipation
- gastrointestinal motility disorders are likely to cause IBS.
- the drugs currently used to treat gastrointestinal motility are metoclopramide, domperidone and itopride.
- metoclopramide As previously described (1) metoclopramide, this drug is a dopamine receptor blocker with strong central vomiting and gastrointestinal motility.
- the drug can inhibit the relaxation of gastric smooth muscle, increase the response of gastrointestinal smooth muscle to cholinergic, accelerate gastric emptying, and increase the phase activity of gastric antrum.
- the drug also stimulates the release of prolactin.
- the side effects of metoclopramide are more common with lethargy, irritability, and fatigue.
- large doses or long-term use of the drug may be caused by Parkinson's syndrome due to blockade of dopamine receptors.
- Domperidone is a peripheral dopamine receptor antagonist that promotes normal motility and tension of the upper gastrointestinal tract, promotes gastric emptying, increases gastric antrum and duodenal bowel movement, coordinates pyloric contraction, and also Enhance the peristalsis of the esophagus and the tension of the lower esophageal sphincter. Because of its poor permeability to the blood-brain barrier, it has almost no antagonistic effect on dopamine receptors in the brain. There are reports of seizures caused by large-dose intravenous injections abroad (there is no such preparation in China), but this drug is a powerful prolactin. Hormone release drugs may cause menstrual disorders.
- Itopride has the dual effects of dopamine receptor blockade and acetylcholinesterase inhibition, which promotes gastric and duodenal movement by stimulating endogenous acetylcholine release and inhibiting its hydrolysis, and promotes gastric emptying, and Has a moderate antiemetic effect. This medicine should be used with caution in elderly or elderly patients.
- Vitamin B is a water-soluble vitamin, mostly coenzyme, which is involved in the metabolism of sugar, protein and fat in the body.
- Vitamin B1 can inhibit the activity of cholinesterase. In the absence of vitamin B1, the activity of this enzyme is too high.
- the destruction of acetylcholine causes nerve conduction to be affected, which may affect gastrointestinal motility and Secretion of digestive juice.
- Thiamine is usually produced in a more stable form such as hydrochloride or nitrate.
- Vitamin B2 (riboflavin 1 constitutes many important coenzymes involved in metabolism and release: helping to grow. It can maintain and improve Epithelial tissue, such as the health of the digestive tract mucosa.
- Vitamin B3 (nicotinic acid) constitutes a dehydrogenase coenzyme in the body. Vitamin B3 is the most needed of the B vitamins. It is not only a vitamin that maintains the health of the digestive system, but also reduces gastrointestinal disorders. Niacin is converted into nicotinamide in the human body. Niacinamide is a component of Coenzyme I and Coenzyme II, which is involved in the process of lipid metabolism, tissue oxidation and anaerobic decomposition of carbohydrates.
- vitamin B5 pantothenic acid
- coenzyme A which is an acyl carrier in the body.
- the symptoms of vitamin B5 deficiency are loss of appetite, indigestion, and susceptibility to duodenal ulcer.
- Vitamin B6 includes three kinds of pyridoxine, pyridoxal and pyridoxamine, which can be converted into each other. Studies have reported that intravenous infusion of vitamin B6 with azithromycin can reduce the side effects of azithromycin on the gastrointestinal tract.
- Deoxyadenosylcobalamin is the predominant form of vitamin B12 in the body. It is often associated with the action of folic acid. Folic acid There are many forms of breast enhancement in cells. Some studies have suggested that folic acid can interfere with the occurrence of gastrointestinal cancer. Folic acid can treat atrophic gastritis and improve the pathology of gastric mucosa.
- biotin side chain carboxyl group can be attached to the lysine residue of the enzyme via an amide bond.
- Biotin is a carboxyl carrier and is also involved in the metabolism of vitamin B12, folic acid, and pantothenic acid.
- Hydrocholine tartrate promotes the conversion of phospholipids, accelerates the functioning of fats, and acts as a choleretic agent; inositol promotes cell metabolism, promotes development, and increases appetite.
- Para-aminobenzoic acid (PABA) is actually a component of folic acid. Its role in the body is coenzyme, which works in conjunction with folic acid to promote protein metabolism and blood cell production.
- vitamin B may become a new drug or health food with high safety to promote the gastrointestinal system.
- vitamin B is motivated by the gastrointestinal system. Promote, especially under pathological conditions, the therapeutic and modulating effects of vitamin B on gastrointestinal motility disorders.
- the composition and compatibility of vitamin B is essential for the preparation of drugs or health foods for the treatment or regulation of gastrointestinal motility disorders.
- the present invention relates to a method of promoting gastrointestinal system motility in a subject in need thereof, wherein the subject has a gastrointestinal system disorder (i.e., a disorder, a condition, a symptom, or a dysfunction caused by a drug or surgery).
- the method comprises administering to a subject in need thereof a therapeutically effective amount of a vitamin B family composition.
- vitamins referred to in the present invention include their corresponding analogs or derivatives, such as vitamin B1 means thiamine and its analogs or derivatives; vitamin B2 means riboflavin and its analogues or derivatives; vitamin B3 means Niacin and its analogs or derivatives; vitamin B5 means pantothenic acid and its analogues or derivatives; vitamin B6 means pyridoxine and its analogues or derivatives; vitamin B7 is biotin and its analogues or neoplasms; Vitamin ⁇ 9 means folic acid and its analogs or derivatives; vitamin B12 means cyanocobalamin and its analogs or derivatives; and the like.
- vitamin B1 means thiamine and its analogs or derivatives
- vitamin B2 means riboflavin and its analogues or derivatives
- vitamin B3 means Niacin and its analogs or derivatives
- vitamin B5 means pantothenic acid and its analogues or derivatives
- vitamin B6 means pyridoxine and its ana
- the vitamin steroid composition is a combination comprising vitamin B1 (thiamine), vitamin ⁇ 2 (riboflavin), vitamin ⁇ 3 (nicotinic acid), vitamin ⁇ 5 (pantothenic acid), vitamin ⁇ 6, biotin. Things.
- the vitamin B group composition contains vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, vitamins.
- the invention provides a composition comprising an effective amount of a vitamin B group composition and a pharmaceutically acceptable carrier.
- the composition comprises an effective amount of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, biotin, and A pharmaceutically acceptable carrier.
- the composition comprises an effective amount of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, folic acid, Biotin, choline hydrogen tartrate, inositol, and a pharmaceutically acceptable carrier.
- the composition comprises an effective amount of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, vitamins B12, folic acid, biotin, choline hydrogen tartrate, inositol, p-aminobenzoic acid, and a pharmaceutically acceptable carrier.
- vitamin B1 thiamine
- vitamin B2 riboflavin
- vitamin B3 nicotinic acid
- vitamin B5 pantothenic acid
- vitamins B12 vitamins B12, folic acid, biotin, choline hydrogen tartrate, inositol, p-aminobenzoic acid, and a pharmaceutically acceptable carrier.
- the invention in another aspect, relates to a composition
- a composition comprising an effective amount of a vitamin B family composition and an effective amount of a medicament for the treatment and/or prevention of gastrointestinal disorders.
- the composition comprises an effective amount of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, biotin, and An effective amount of a drug for treating and/or preventing gastrointestinal diseases.
- the composition comprises an effective amount of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, folic acid, Biotin, choline hydrogen tartrate, inositol, and an effective amount of a drug for treating and/or preventing gastrointestinal diseases.
- the composition comprises an effective amount of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, vitamins B12, folic acid, biotin, choline hydrogen tartrate, inositol, p-aminobenzoic acid, and an effective amount of a medicament for treating and/or preventing gastrointestinal diseases.
- vitamin B1 thiamine
- vitamin B2 riboflavin
- vitamin B3 nicotinic acid
- vitamin B5 pantothenic acid
- vitamins B12 vitamins B12
- folic acid biotin
- choline hydrogen tartrate inositol
- p-aminobenzoic acid p-aminobenzoic acid
- the invention in another aspect, relates to a composition comprising an effective amount of a vitamin B group composition and other effective amount of a vitamin family compound.
- the composition comprises an effective amount of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, biotin, and Other effective amounts of vitamin compounds.
- the composition comprises an effective amount of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, folic acid, Biotin, choline hydrogen tartrate, inositol, and other effective amounts of vitamin compounds.
- the composition comprises an effective amount of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, vitamins B12, folic acid, biotin, choline hydrogen tartrate, inositol, p-aminobenzoic acid and other effective amounts of vitamin compounds.
- vitamin B1 thiamine
- vitamin B2 riboflavin
- vitamin B3 nicotinic acid
- vitamin B5 pantothenic acid
- vitamins B12 vitamins B12
- folic acid biotin
- choline hydrogen tartrate inositol
- p-aminobenzoic acid p-aminobenzoic acid
- other effective amounts of vitamin compounds include vitamins VIII, vitamin C, vitamin D, vitamin E, vitamin K and the like and analogs or derivatives thereof.
- Promoting gastrointestinal motility is used in a method of treating a gastrointestinal dysfunction caused by a drug (for example, an opioid such as morphine-induced intestinal dysfunction or constipation) in a subject in need thereof, the method comprising administering a treatment Effective amount of life a B group composition.
- a drug for example, an opioid such as morphine-induced intestinal dysfunction or constipation
- the subject may be using opioid or opioid for postoperative pain management or chronic pain management.
- opioids and opioids include morphine, codeine, oxycodone, hydrocod 0ne , methadone, fentanyl, and anti-inflammatory agents such as acetaminophen Or a combination of aspirin.
- the vitamin B group composition is a combination comprising vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, biotin. Things.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, folic acid, A composition of biotin, hydrogen choline tartrate, inositol.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, vitamins.
- Promoting gastrointestinal motility can be used to treat gastroparesis in a subject in need thereof by administering a therapeutically effective amount of a vitamin B composition.
- the vitamin B group composition is a combination comprising vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, biotin. Things.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, folic acid, A composition of biotin, hydrogen choline tartrate, inositol.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, vitamins.
- the method of promoting gastrointestinal motility is used in the treatment of gastroesophageal reflux disease (GERD) in a subject in need thereof, the method comprising administering a therapeutically effective amount of a vitamin B family combination.
- the vitamin B group composition is a combination comprising vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, biotin. Things.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2
- the gastroesophageal reflux disease is nocturnal gastroesophageal reflux disease.
- the invention also provides a method of promoting gastrointestinal motility to treat irritable bowel syndrome (IBS) in a subject in need thereof by administering a therapeutically effective amount of a vitamin B group composition.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, folic acid, A composition of biotin, hydrogen choline tartrate, inositol.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), A combination of vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, vitamin B12, folic acid, biotin, choline hydrogen tartrate, inositol and p-aminobenzoic acid.
- the irritable bowel syndrome may be constipation-type irritable bowel syndrome or constipation/diarrhea alternating irritable bowel syndrome.
- the present invention also provides a method of promoting gastrointestinal motility to treat constipation in a subject in need thereof by administering a therapeutically effective amount of a vitamin B group composition.
- the constipation includes functional (bad habits, eating habits, senile and other constipation without organic causes) and drug-induced constipation.
- the vitamin B group composition is a combination comprising vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, biotin. Things.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, vitamin B12. , a combination of folic acid, biotin, hydrogen choline tartrate, inositol.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, folic acid , a combination of biotin, hydrogen choline tartrate, inositol and p-aminobenzoic acid.
- the method of promoting gastrointestinal motility is used in the treatment of a gastrointestinal dysfunction caused by surgery or related to gastrointestinal dysfunction (eg, post-operative bowel movement slowing) in a subject in need thereof, the method comprising administering the therapeutically effective A quantity of vitamin B family composition.
- the vitamin B group composition is a combination comprising vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, biotin. Things.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, folic acid, A composition of biotin, hydrogen choline tartrate, inositol.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, vitamins.
- a preferred vitamin B group composition is a composition comprising vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, biotin.
- a more preferred vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, folic acid, biotin, hydrogen tartrate A composition of a base, an inositol.
- the vitamin B group composition comprises vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid), vitamin B6, vitamins.
- the dosage form of the vitamin B group composition of the present invention may be a chewable tablet, but is not limited thereto, and the composition of the present invention may also be added with various conventional excipients required for preparing different dosage forms, such as a disintegrant, a lubricant, and a binder.
- a pharmaceutically acceptable carrier such as a dissolving tablet, a granule, a capsule, an oral solution or the like can be prepared by a conventional preparation method using a pharmaceutically acceptable carrier such as a granule, an antioxidant, a complexing agent or the like.
- the vitamin B group composition of the present invention has various weight ratios of the components, and each of them has a corresponding promoting effect on the gastrointestinal system dynamics.
- it may comprise a weight ratio of: 10 parts of Vitamin Bl, 10-15 parts of vitamin B2, 6-25 parts of vitamin B3, 10-100 parts of vitamin B5, 5-10 parts of vitamin B6 and 0.01-0.1 parts of biotin.
- the vitamin B group composition comprises the following components by weight: 10 parts of vitamin B1, 15 parts of vitamin B2, 25 parts of vitamin B3, 100 parts of vitamin B5, 10 parts of vitamin B6 and 0.1 part of biotin. .
- the vitamin B group composition comprises the following components by weight: 10 parts of vitamin B1, 15 parts of vitamin B2, 25 parts of vitamin B3, 100 parts of vitamin B5, 10 parts of vitamin B6, 0.1 parts Biotin, 0.4 parts folic acid, 250 parts of choline hydrogen tartrate and 250 parts of inositol.
- the vitamin B group composition comprises the following components by weight: 10 parts of vitamin B1, 15 parts of vitamin B2, 25 parts of vitamin B3, 100 parts of vitamin B5, 10 parts of vitamin B6, 0.1 Biotin, 0.4 parts folic acid, 250 parts of choline hydrogen tartrate, 250 parts of inositol, 0.025 parts of vitamin B12 and 50 parts of p-aminobenzoic acid.
- A as used herein means “at least one” or “one or more than one” unless expressly stated in the context.
- part refers to an amount within 10% of the positive and negative deviations.
- the terms “comprises”, “comprising”, “includes”, “including”, “contains”, “containing” and any of them are used herein. Variants are intended to encompass non-exclusive inclusions, such as processes, methods, processed products, or compositions of matter that contain, include, or contain an element or a list of elements, not only those elements but also those not explicitly listed Or other elements inherent in the process, method, processed product or combination of materials.
- vitamin B family composition includes all vitamin B compounds, analogs or derivatives thereof, such as vitamin B1 ( Thiamine, vitamin B2 (riboflavin), vitamin B3 (nicotinic acid), vitamin B5 (pantothenic acid) and vitamin B6, etc.
- analog refers to approximately the same structure and having the same biological activity. However, any two or more molecules which may have different degrees of activity or fragments thereof may be used.
- derivative refers to a hydrogen atom or atom in a compound. Substituted by other atom or atomic group derived by the more complex compounds.
- Vitamin B group composition 1 comprises the following components by weight: 10 parts of vitamin B1, 15 parts of vitamin B2, 25 parts of vitamin B3, 100 parts of vitamin B5, 10 parts of vitamin B6 and 0.1 part of biotin.
- Formulation of Vitamin B Group Composition 2 comprises the following components by weight: 10 parts of vitamin B1, 15 parts of vitamin B2, 25 parts of vitamin B3, 100 parts of vitamin B5, 10 parts of vitamin B6, 0.1 part of biotin, 0.4 part of folic acid, 250 parts of choline hydrogen tartrate and 250 parts of inositol.
- Formulation of vitamin B group composition 3 comprises the following components by weight: 10 parts of vitamin B1, 15 parts of vitamin B2, 25 parts of vitamin B3, 100 parts of vitamin B5, 10 parts of vitamin B6, 0.1 part of biotin, 0.4 part of folic acid, 250 parts of choline hydrogen tartrate, 250 parts of inositol, 0.025 parts of vitamin B12 and 50 parts of p-aminobenzoic acid.
- Vitamin B Group Composition 4 contains the following components by weight: 10 parts of vitamin B1, 15 parts of vitamin B2, 25 parts of vitamin B3, 100 parts of vitamin B5, 10 parts of vitamin B6, 0.1 part of biotin, 0.4 part of folic acid, 250 parts of choline hydrogen tartrate, 250 parts of inositol and 0.025 parts of vitamin B12.
- Vitamin B Group Composition (VB) Formula 1, Formula 2 and Formula 3
- Loperamide was dissolved in 1% Tween 80 physiological saline, and mice were given a dose of 5 mg/kg of loperamide after a period of 24 hours (no water) before loperamide. After 30 minutes, the ink was administered by gavage. The administration volume was 10 ml/kg. 2.3 grouping and administration
- the administration group was intragastrically administered with VB, the positive control group was intragastrically administered with naloxone, and the other groups were given physiological saline.
- the administration volume was 20 ml/kg body weight.
- Control group Administering the same amount of normal saline
- Model group Administering the same amount of normal saline
- Naloxone group naloxone administered by gavage 50mg/kg
- Each dose group administered by gavage according to formula 1-3 (converted into the amount of mice)
- the animal After giving the ink for 20 minutes, the animal was sacrificed by cervical dislocation. Immediately open the abdominal cavity to separate the mesentery. Cut the upper end of the intestine from the pylorus and the lower end to the ileocecal area, place it on the tray, gently pull the small intestine into a straight line, and measure the total length of the small intestine. From the pylorus to the ink front, the ink advancement length is calculated, and the ink progress rate of the small intestine is calculated.
- the recipe data is as follows:
- Formulations 1-3 have a corresponding promoting effect on gastrointestinal motility of mice, and tend to increase with the increase of the dosage.
- Example 3 Effect of vitamin steroid composition on laxative function of loperamide-induced constipation mice
- mice were randomly divided into four groups, and the administration group was intragastrically administered with the compound VB formula 3, and the other groups were given drinking water.
- the administration volume was 20 ml/kg body weight.
- mice were randomly divided into three groups.
- the drug-administered group was given a compound VB formula 3 by gavage, and the other groups were given drinking water.
- the administration volume was 20 ml/kg body weight.
- the formulation was intragastrically administered with loperamide.
- Loperamide is dissolved in drinking water, administered at a dose of 4 mg/kg by intragastric administration. The volume is 10 ml/kg. After 15 minutes of modeling, the time was started. The mice were single-crowded and fasted. After 6 hours, the animals were sacrificed by cervical dislocation. The body weight before each dose, the weight at the end of the experiment, the number of defecations at 6 h and the dry weight of the defecation (60 ° C, 6 h) were recorded.
- Vitamin B Group Composition (VB) Formula 3 and Formula 4
- Loperamide was dissolved in 1% Tween 80 physiological saline, and mice were given a dose of 5 mg/kg of loperamide after a period of 24 hours (no water) before loperamide. After 30 minutes, the ink was administered by gavage. The administration volume was 10 ml/kg. 2.3 grouping and administration
- the administration group was intragastrically administered with VB, the positive control group was intragastrically administered with naloxone, and the other groups were given physiological saline.
- the administration volume was 20 ml/kg body weight.
- Control group Administration of the same amount of normal saline by intragastric administration
- Model group Administering the same amount of normal saline
- Naloxone group naloxone administered by gavage 50 mg/kg
- Each dose group administered by gavage according to formula 3-4 (converted into the amount of mice)
- the animal After giving the ink for 20 minutes, the animal was sacrificed by cervical dislocation. Immediately open the abdominal cavity to separate the mesentery. Cut the upper end of the intestine from the pylorus and the lower end to the ileocecal area, place it on the tray, gently pull the small intestine into a straight line, and measure the total length of the small intestine. From the pylorus to the front of the ink for the ink advancement length, i counts the intestinal ink propelling rate.
- the recipe data is as follows:
- test compound multivitamin B formula 3 and multivitamin B formula 4 can significantly improve the intestinal propulsion rate (%) of loperamide-induced constipation mouse model, and the effect of the two is basically the same.
- the present invention has been described in detail by the preferred embodiments of the embodiments of the invention. Make appropriate changes or modifications.
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Abstract
本发明涉及一种维生素B组合物,尤其是一种促进胃肠系统动力的维生素B组合物。该组合物适用于预防和/或治疗与胃肠动力匮乏相关的状态或疾病。
Description
使用维生素 B组合物促进胃肠系统动力的方法
技术领域
本发明涉及一种维生素 B组合物, 尤其是一种促进胃肠系统动力的维生素 B组合物。 该 组合物适用于预防和 /或治疗与胃肠动力匮乏相关的状态或疾病。 背景技术
现在, 人们生活压力普遍加大, 生活节奏加快, 竞争日益激烈, 胃肠道疾患或胃肠不适 者越来越多, 其起因是多方面的, 其症状也各有不同。
胃肠 (gastrointestinal, GI) 动力是经由消化系统输送营养物之协调的神经肌肉进程。 可 参与胃食管反流病、 胃轻瘫(例如, 糖尿病性和手术后的胃轻瘫)、 肠易激综合征(IBS)、 肠 梗阻和便秘 (例如, 功能性或药物引起的便秘)之胃肠系统动力削弱是工业化国家最大的医 疗保健负担之一。 鉴于上述情况, 有效促进胃肠系统动力是亟需的并且将成为本领域中的进 展。
功能性消化不良 (fimctional dyspepsia)及慢性胃炎常有腹部饱胀感、 上腹痛、 恶心、 食 欲减退等症状, 胃肠道动力障碍引起胃排空延缓是这类症状发生的一个重要原因。 而且胃肠 道动力障碍易导致 IBS。 现治疗胃肠动力的药物有甲氧氯普胺、 多潘立酮和伊托必利。
以往治疗胃肠疾病的药物很多, 但疗效好且无副作用者甚少, 尤其是即可作长期保健作 用,又很好改善胃肠道功能促进胃肠动力及减缓胃肠不适症状的药物或保健品更是少之又少。
如之前所述的(1 ) 甲氧氯普胺, 该药为多巴胺受体阻断药, 具有强大的中枢性镇吐和胃 肠道兴奋作用。该药可抑制胃平滑肌松弛, 使胃肠平滑肌对胆碱能的反应增加, 胃排空加快, 增加胃窦部时相活性。 此外, 该药尚有剌激催乳激素释放的作用。 甲氧氯普胺的副作用较常 见昏睡、 烦躁不安、 倦怠无力, 另该药大剂量或长期应用可能因阻断多巴胺受体, 表现为帕 金森综合症的症状。 (2) 多潘立酮是外周性多巴胺受体拮抗剂, 可促进上胃肠道的蠕动和张 力恢复正常, 促进胃排空, 增加胃窦和十二指肠肠运动, 协调幽门的收缩, 同时也能增强食 道的蠕动和食道下端括约肌的张力。 由于它对血脑屏障的渗透力差, 对脑内多巴胺受体几乎 无拮抗作用, 国外有静脉大剂量注射引起癫痫发作的报道(国内无此制剂), 但该药是一种强 有力的催乳激素释放药, 可能导致月经失调。 (3) 伊托必利具多巴胺受体阻滞和乙酰胆碱酯 酶抑制的双重作用, 通过剌激内源性乙酰胆碱释放并抑制其水解而增强胃与十二指肠运动, 促进胃排空, 并具有中度镇吐作用。 老年或高龄患者慎用此药。
维生素 B都是水溶性维生素, 多数是辅酶, 参与体内糖、 蛋白质和脂肪的代谢。
维生素 B1 (硫胺素) 能抑制胆碱酯酶活性的作用, 缺乏维生素 B1时此酶活性过高, 乙 酰胆碱 (神经递质之一) 大量破坏使神经传导受到影响, 可能累及胃肠道蠕动和消化液的分 泌。 硫胺通常会被制作为盐酸盐或硝酸盐等较稳定的形式来使用
维生素 B2 (核黄素 1构成许多重要辅酶, 参与代谢及释能: 帮助生长。 它能维持和改善
上皮组织, 如消化道黏膜组织的健康。
维生素 B3 (烟酸)在体内构成脱氢酶的辅酶, 维生素 B3是 B族维生素中人体需要量最 多者, 它不但是维持消化系统健康的维生素, 也能减轻胃肠障碍。 烟酸在人体内转化为烟酰 胺, 烟酰胺是辅酶 I和辅酶 II的组成部分, 参与体内脂质代谢, 组织呼吸的氧化过程和糖类 无氧分解的过程。
维生素 B5 (泛酸) 的活性形式是辅酶 A, 在体内是酰基载体, 缺乏维生素 B5的症状有 食欲不振、 消化不良, 易患十二指肠溃疡。
维生素 B6包括吡哆醇、 吡哆醛和吡哆胺 3种, 可互相转化。 有研究报道维生素 B6与阿 奇霉素混合静滴可减轻阿奇霉素对胃肠道副作用。
脱氧腺苷钴胺素是维生素 B12在体内主要存在形式。 它和叶酸的作用常互相关联。 叶酸 在细胞中有多种辅胸形式, 有研究提示叶酸对胃肠道癌的发生有干预作用, 叶酸可治疗萎缩 性胃炎、 改善胃粘膜病理。
生物素侧链羧基可通过酰胺键与酶的赖氨酸残基相连。 生物素是羧基载体, 还参与维生 素 B12、 叶酸、 泛酸的代谢。
酒石酸氢胆碱有促使磷脂转变、加速脂肪的运转及利胆作用;肌醇可促进细胞新陈代谢、 助长发育、 增进食欲。对氨基苯甲酸(PABA)实际上是叶酸的一种成分, 在体内它的作用是 辅酶, 它与叶酸一道工作以促进蛋白质的代谢和血细胞的生成。
从作用机制上看, 维生素 B将有可能成为一种新的具有较高安全性的促进胃肠系统动力 的药物或保健食品, 然而到目前为止还没有事实证据证明维生素 B对胃肠系统动力的促进作 用, 特别是在病理状态下, 维生素 B对胃肠系统动力紊乱的治疗和调节作用。 另外由于维生 素 B家族成员众多, 并且存在相互依赖的关系, 因此维生素 B的成分选择和配伍, 对于制备 治疗或调节胃肠系统动力紊乱的药物或保健食品至关重要。 发明内容
A. 发明概述
本发明涉及在有此需要之对象中促进胃肠系统动力的方法, 其中所述对象患有胃肠系统 疾病(即, 失调症、 病症、 症状或者药物或手术引起的功能障碍)。 该方法包括向有此需要之 对象施用治疗有效量的维生素 B族组合物。 本发明中所指的维生素包括其相应的类似物或衍 生物, 如维生素 B1是指硫胺素和其类似物或衍生物; 维生素 B2是指核黄素和其类似物或衍 生物; 维生素 B3是指烟酸和其类似物或衍生物; 维生素 B5是指泛酸和其类似物或衍生物; 维生素 B6是指吡哆醇和其类似物或衍生物; 维生素 B7是生物素和其类似物或 ϊ生物; 维生 素 Β9是指叶酸和其类似物或衍生物; 维生素 B12是指氰钴胺和其类似物或衍生物; 等等。 在一个优选实施方案中,维生素 Β族组合物是包含维生素 B1 (硫胺素)、维生素 Β2 (核黄素)、 维生素 Β3 (烟酸)、 维生素 Β5 (泛酸)、 维生素 Β6、 生物素的组合物。 在一个更优选的实施
方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3
(烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇的组合物。 在另一个更优选的实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 维生素 B12、 叶酸、 生物 素、 酒石酸氢胆碱、 肌醇和对氨基苯甲酸的组合物。
另一方面, 本发明提供了一种组合物, 该组合物包括有效量的维生素 B族组合物以及药 学上可接受的载体。在一个优选的实施方案中, 该组合物包括有效量的维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 生物素以及药学 上可接受的载体。在一个更优选的实施方案中, 该组合物包括有效量的维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇以及药学上可接受的载体。 在另一个更优选的实施方案中, 该组合物包 括有效量的维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛 酸)、 维生素 B6、 维生素 B12、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇、 对氨基苯甲酸以及药 学上可接受的载体。
另一方面, 本发明涉及一种组合物, 该组合物包括有效量的维生素 B族组合物以及有效 量的治疗和 /或预防胃肠疾病的药物。在一个优选的实施方案中, 该组合物包括有效量的维生 素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 生物素以及有效量的治疗和 /或预防胃肠疾病的药物。 在一个更优选的实施方案中, 该组合物 包括有效量的维生素 B1 (硫胺素)、维生素 B2 (核黄素)、维生素 B3 (烟酸)、维生素 B5 (泛 酸)、 维生素 B6、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇以及有效量的治疗和 /或预防胃肠疾病 的药物。 在另一个更优选的实施方案中, 该组合物包括有效量的维生素 B1 (硫胺素)、 维生 素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 维生素 B12、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇、 对氨基苯甲酸以及有效量的治疗和 /或预防胃肠疾病的药物。
另一方面, 本发明涉及一种组合物, 该组合物包括有效量的维生素 B族组合物以及其他 有效量的维生素族化合物。在一个优选的实施方案中, 该组合物包括有效量的维生素 B1 (硫 胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 生物素 以及其他有效量的维生素族化合物。 在一个更优选的实施方案中, 该组合物包括有效量的维 生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇以及其他有效量的维生素族化合物。 在另一个更优 选的实施方案中, 该组合物包括有效量的维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生 素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 维生素 B12、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇、 对氨基苯甲酸以及其他有效量的维生素族化合物。 所述其他维生素族化合物包括维生 素八、 维生素 C、 维生素 D、 维生素 E、 维生素 K等化合物和其类似物或衍生物。
促进胃肠动力被用于在有此需要之对象中治疗由药物引起的胃肠功能障碍 (例如, 阿片 类药物, 如吗啡引起之肠道功能障碍或便秘) 的方法中, 该方法包括施用治疗有效量的维生
素 B族组合物。 所述对象可正在使用阿片物质或阿片类物质进行手术后疼痛控制或慢性疼痛 控制。 阿片物质和阿片类物质的实例包括吗啡、 可待因、 羟考酮、 氢可酮 (hydrocod0ne)、 美沙酮 (methadone)、 芬太尼 (fentanyl) 以及其与抗炎剂 (例如对乙酰氨基酚或阿司匹林) 的组合。在一个优选实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 生物素的组合物。 在一个 更优选的实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇的 组合物。 在另一个更优选的实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维 生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 维生素 B12、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇和对氨基苯甲酸的组合物。
促进胃肠动力可用于在有此需要之对象中治疗胃轻瘫,其通过施用治疗有效量的维生素 B 族组合物。 在一个优选实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 生物素的组合物。 在一 个更优选的实施方案中,维生素 B族组合物是包含维生素 B1 (硫胺素)、维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇的 组合物。 在另一个更优选的实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维 生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 维生素 B12、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇和对氨基苯甲酸的组合物。
在另一实施方案中, 促进胃肠动力被用于在有此需要之对象中治疗胃食管反流病(gastro esophageal reflux disease, GERD)之方法中,该方法包括施用治疗有效量的维生素 B族组合物。 在一个优选实施方案中,维生素 B族组合物是包含维生素 B1 (硫胺素)、维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 生物素的组合物。 在一个更优选的实施 方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3
(烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇的组合物。 在另一个更优选的实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2
(核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 维生素 B12、 叶酸、 生物 素、 酒石酸氢胆碱、 肌醇和对氨基苯甲酸的组合物。 在一个具体实施方案中, 所述胃食管反 流病为夜间胃食管反流病。
本发明还提供了在有此需要之对象中促进胃肠动力以治疗肠易激综合征 (irritable bowel syndrome, IBS) 的方法, 其通过施用治疗有效量的维生素 B族组合物来实现。 在一个优选实 施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3
(烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 生物素的组合物。 在一个更优选的实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇的组合物。 在另一个更 优选的实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、
维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 维生素 B12、 叶酸、 生物素、 酒石酸氢 胆碱、 肌醇和对氨基苯甲酸的组合物。 所述肠易激综合征可为便秘型肠易激综合征或便秘 /腹 泻交替型肠易激综合征。
本发明还提供了在有此需要之对象中促进胃肠动力以治疗便秘的方法, 其通过施用治疗 有效量的维生素 B族组合物来实现。 所述便秘包括功能性 (不良生活习惯、 饮食习惯, 老年 性等无器质性病因的便秘)和药物引起的便秘。 在一个优选实施方案中, 维生素 B族组合物 是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、生物素的组合物。在一个更优选的实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 维生素 B12、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇的组合物。 在另一个更优选的实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇和对氨基苯甲酸的组合 物。
在一个实施方案中, 促进胃肠动力被用于在有此需要之对象中治疗由手术引起或相关的 胃肠功能障碍 (例如手术后肠蠕动减慢) 的方法中, 该方法包括施用治疗有效量的维生素 B 族组合物。 在一个优选实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 生物素的组合物。 在一 个更优选的实施方案中,维生素 B族组合物是包含维生素 B1 (硫胺素)、维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇的 组合物。 在另一个更优选的实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维 生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 维生素 B12、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇和对氨基苯甲酸的组合物。
优选的维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 生物素的组合物。 更优选的维生素 B族组合物是 包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇的组合物。 在另一个更优选的实施方案中, 维生素 B族组合物是包含维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6、 维生素 B12、 叶酸、 生物素、 酒石酸氢胆碱、 肌醇和对氨基 苯甲酸的组合物。
本发明的维生素 B族组合物的剂型可以为口嚼片, 但不限于此, 本发明组合物还可加入 制备不同剂型时所需的各种常规辅料, 如崩解剂、 润滑剂、 粘合剂、 抗氧剂、 络合剂等药用 载体, 以常规的制剂方法制成任何一种常用的口服剂型, 如分散片、 颗粒剂、 胶囊剂、 口服 液等其他剂型。
本发明的维生素 B族组合物, 其各组份的重量配比可有多种选择, 其均对胃肠系统动力 有相应的促进作用。 在某些实施方案中, 其可包含如下重量配比的组份: 10份维生素 Bl,
10-15份维生素 B2, 6-25份维生素 B3, 10-100份维生素 B5, 5-10份维生素 B6和 0.01-0.1 份生物素。 在一个优选实施方案中, 维生素 B族组合物包含如下重量配比的组份: 10份维生 素 Bl, 15份维生素 B2, 25份维生素 B3, 100份维生素 B5, 10份维生素 B6和 0.1份生物素。 在一个更优选的实施方案中, 维生素 B族组合物包含如下重量配比的组份: 10份维生素 Bl, 15份维生素 B2, 25份维生素 B3, 100份维生素 B5, 10份维生素 B6, 0.1份生物素, 0.4份 叶酸, 250份酒石酸氢胆碱和 250份肌醇。 在另一个更优选的实施方案中, 维生素 B族组合 物包含如下重量配比的组份: 10份维生素 Bl, 15份维生素 B2, 25份维生素 B3, 100份维 生素 B5, 10份维生素 B6, 0.1份生物素, 0.4份叶酸, 250份酒石酸氢胆碱, 250份肌醇, 0.025 份维生素 B12和 50份对氨基苯甲酸。
B.定义
除另有定义, 这里使用的所有科技术语与本发明所属技术领域的普通技术人员理解含义 相同。 所有专利文献、 专利申请文献、 公开的专利文献和其它出版物均作为参考。 如本节阐 述的定义与上述参考文献所述的定义不一致或相反时, 以本节阐述的定义为准。
除非在上下文中明确表明, 在此所用 "一个"的意思是 "至少一个"或 "一个或多于一 个"。
术语 "份", 特别是涉及一个给定的量, 是指正负偏差在 10%以内的量。 此处所使用的术语 "包含(comprises) "、 "包含(comprising) " 、 "包括(includes) "、 "包括 (including) "、 "含有(contains) ,,、 "含有(containing) " 及其任何变体旨在涵盖 非独占性的包含物, 例如包含、 包括或含有一种元素或一列表的元素的过程、 方法、 加工产 品或物质的组合物不仅包括那些元素还可能包括没有明确地列出的或该过程、 方法、 加工产 品或物质的组合物的固有的其它元素。 此处所用的术语 "维生素 B族组合物"包括所有的维生素 B化合物、 其类似物或衍生物, 如维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)和维生 素 B6等。 此处所用的术语 "类似物"是指结构大致相同、 并具有相同生物活性但可以有不同程度 活性的任何两个以上分子或者是其中片段。 所用术语 "衍生物"是指化合物中的氢原子或原 子团被其他原子或原子团取代而衍生的较复杂的化合物。
具体实施方式
实施例 1 维生素 B族组合物具体配方
维生素 B族组合物配方 1包含如下重量配比的组份: 10份维生素 Bl, 15份维生素 B2, 25 份维生素 B3, 100份维生素 B5, 10份维生素 B6和 0.1份生物素。 维生素 B族组合物配方 2包含如下重量配比的组份: 10份维生素 Bl, 15份维生素 B2, 25 份维生素 B3, 100份维生素 B5, 10份维生素 B6, 0.1份生物素, 0.4份叶酸, 250份酒石酸 氢胆碱和 250份肌醇。 维生素 B族组合物配方 3包含如下重量配比的组份: 10份维生素 Bl, 15份维生素 B2, 25 份维生素 B3, 100份维生素 B5, 10份维生素 B6, 0.1份生物素, 0.4份叶酸, 250份酒石酸 氢胆碱, 250份肌醇, 0.025份维生素 B12和 50份对氨基苯甲酸。 维生素 B族组合物配方 4包含如下重量配比的组份: 10份维生素 B1 , 15份维生素 B2, 25 份维生素 B3, 100份维生素 B5, 10份维生素 B6, 0.1份生物素, 0.4份叶酸, 250份酒石酸 氢胆碱, 250份肌醇和 0.025份维生素 B12。
实施例 2 维生素 B族组合物对洛哌丁胺致便秘小鼠的治疗作用
1. 实验材料
1.1 药物
维生素 B族组合物 (VB) 配方 1, 配方 2和配方 3
洛哌丁胺 (Loperamide): Sigma公司, 批号: 109K1107V
纳洛酮 : 北京四环制药有限公司, 批号: 20110505
1.2动物
C57BL/6小鼠, 雌性, 体重 18~22g
2. 实验方法
2.1墨汁的配制:
准确称取阿拉伯胶 100g, 加水 800ml, 煮沸至溶液透明, 称取活性炭粉 50g加入上述溶液中 煮沸 3次, 待溶液凉后加水定容到 1000ml。
2.2洛哌丁胺致小鼠便秘模型制备
洛哌丁胺用 1%吐温 80生理盐水溶解, 小鼠给洛哌丁胺前禁食 24小时(不禁水)后, 一次性 皮下注射给予剂量为 5mg/kg的洛哌丁胺。 30分钟后, 灌胃给予墨汁。 给药体积为 10ml/kg。 2.3 分组及给药
给墨汁前 60分钟, 给药组灌胃给予 VB, 阳性对照组灌胃给予纳洛酮,其它组给予生理盐水。
给药体积均为 20ml/kg体重。
对 照组: 灌胃给予等量生理盐水
模 型 组: 灌胃给予等量生理盐水
纳洛酮组: 灌胃给予纳洛酮 50mg/kg
各剂量组: 灌胃给予按照配方 1-3 (换算成小鼠的量)
2.4观察项目
灌胃给予墨汁 20分钟后, 脱颈椎处死动物, 立即打开腹腔分离肠系膜, 剪取上端自幽门、 下 端至回盲部的肠管, 置于托盘上, 轻轻将小肠拉成直线, 测量小肠总长度, 从幽门至墨汁前 沿为墨汁推进长度, 计算小肠墨汁推进率。
3. 实验结果
各配方数据如下:
纳洛酮组(n=8) 16.1±0.4 16.8±1.5** 7.6±1.7* 44.8±8.1**
配方 3 30.8mg/kg (n=8) 16.3±0·7 19.8±1.2 8.3±1.0** 41.9±5.7**
配方 3 153.8mg^g (n=8) 16.4±0.3 19.9±1.7 9.2±2.1** 42.6±9.2**
配方 3 768.7mg kg (n=8) 16.3±0.9 20.1±1.3 9.6±2.2** 43.8±10.5**
正常组 (n=8) 16.3±0.7 19.3±1.8 11.8±2.7** 61.2±11.3**
*: 与模型组相比, P<0.05; **: 与模型组相比, PO.01
从以上数据可看出, 配方 1-3对小鼠的胃肠动力都有相应的促进作用, 而且随着施用剂 量的增加而呈递增趋势。 实施例 3 维生素 Β族组合物对洛哌丁胺致便秘小鼠通便功能的影响
1. 实验材料
1.1 药物
维生素 Β族组合物 (VB)配方 3
洛哌丁胺 (Loperamide): Sigma公司, 批号: 109K1107V 1.2动物
C57BL/6小鼠, 雄性, 体重 18〜24g
2. 实验方法
2.1复合维生素 B对正常小鼠通便功能的影响
小鼠随机分为四组, 给药组灌胃给予复合 VB 配方 3, 其它组给予饮用水。 给药体积均为 20ml/kg体重。
复合维生素 B组低剂量组 (A组): 正常小鼠灌胃给予 VB配方 3 153.8mg/kg (n=14) 复合维生素 B组中剂量组 (B组): 正常小鼠灌胃给予 VB配方 3 768.7mg/kg (n=14) 复合维生素 B组中剂量组 (C组): 正常小鼠灌胃给予 VB配方 3 3843.7mg/kg (n=14) 正常组 (D组): 正常小鼠灌胃给予等量饮用水 (n=14)
给药结束开始计时, 计时 7hl5min后, 脱颈椎处死动物, 记录每只小鼠给药前体重, 实验结 束时体重, 7hl5min的排便数量和排便干重 (60°C,6h)。
2.2复合维生素 B对正常小鼠和洛哌丁胺致便秘小鼠通便功能的影响
小鼠随机分为三组, 给药组灌胃给予复合 VB 配方 3, 其它组给予饮用水。 给药体积均为 20ml/kg体重。
模 型 组 (A组): 便秘小鼠灌胃给予等量饮用水 (n=10)
复合维生素 B组 (B组): 便秘小鼠灌胃给予 VB配方 3 768.7mg/kg (n=10)
对 照 组 (C组): 正常小鼠灌胃给予等量饮用水 (n=10)
给药 60min后用洛哌丁胺灌胃造模。 洛哌丁胺用饮用水溶解, 灌胃给予剂量为 4mg/kg, 给药
体积为 10ml/kg。 造模 15分钟后, 开始计时, 小鼠单笼词养, 禁食不禁水。 计时 6h后, 脱颈 椎处死动物, 记录每只小鼠给药前体重, 实验结束时体重, 6h 的排便数量和排便干重 (60。C,6h)。
3. 实验结果
3.1复合维生素 B对正常小鼠通便功能的影响
A组与 D组相比较, 排便粒数没有显著差异, 排便干重有显著差异(P<0.05), 表明低剂 量复合 VB可以显著增加小鼠的排便干重, 但是不能显著地增加排便粒数; B组、 C组与 D 组相比较, 排便粒数和排便干重均有显著差异 (P<0.01, P<0.01 ; P<0.01 , P<0.01 ), 表明复 合 VB中剂量和高剂量能显著增加正常小鼠 7M5min内的排便数量和排便干重。 同时实验观 察还发现高剂量小鼠出现便稀, 推测可能是出现药物的毒副作用。 结果数据如下:
不同剂量复合维生素 B对正常小鼠通便功能的影响
*: 与正常组相比, PO.05: **: 与正常组相比, PO.01
3.2复合维生素 B对正常小鼠和洛哌丁胺致便秘小鼠通便功能的影响 (第一次)
C组与 A组相比较, 排便粒数和排便干重均有显著差异(P<0.01, P<0.01 ), 表明小鼠便 秘模型制备成功; B组与 A组相比较,排便粒数和排便干重均有显著差异(PO.01 , P<0.05 ), 表明复合 VB能显著增加洛哌丁胺致便秘小鼠 6小时内的排便数量和排便干重。 结果数据如 下:
*: 与模型组相比, Ρ<0.05; **: 与模型组相比, Ρ<0.01
3.3复合维生素 Β对正常小鼠和洛哌丁胺致便秘小鼠通便功能的影响 (第二次)
C组与 A组相比较, 排便粒数和排便干重均有显著差异(P<0.01, P<0.01 ), 表明小鼠便 秘模型制备成功; B组与 A组相比较,排便粒数和排便干重均有显著差异(P<0.05, P<0.05), 表明复合 VB能显著增加洛哌丁胺致便秘小鼠 6小时内的排便数量和排便干重。 结果数据如 下:
复合维生素 B对洛哌丁胺致便秘小鼠通便功能的影响 (第二次)
*: 与模型组相比, P<0.05 ; **: 与模型组相比, PO.01
由此可见, 复合维生素 B配方 3对正常小鼠和洛哌丁胺致便秘小鼠通便功能均有显著的 促进作用。 实施例 4 维生素 B族组合物配方 3和 4对洛哌丁胺致便秘小鼠的治疗作用比较
1. 实验材料
1.1 药物
维生素 B族组合物 (VB) 配方 3和配方 4
洛哌丁胺 (Loperamide): Sigma公司, 批号: 109K1107V
纳洛酮 : 北京四环制药有限公司, 批号: 20110505
1.2动物
C57BL/6小鼠, 雌性, 体重 17〜20 g
2. 实验方法
2.1墨汁的配制:
准确称取阿拉伯胶 100g, 加水 800ml, 煮沸至溶液透明, 称取活性炭粉 50g加入上述溶液中 煮沸 3次, 待溶液凉后加水定容到 1000ml。
2.2洛哌丁胺致小鼠便秘模型制备
洛哌丁胺用 1%吐温 80生理盐水溶解, 小鼠给洛哌丁胺前禁食 24小时(不禁水)后, 一次性 皮下注射给予剂量为 5mg/kg的洛哌丁胺。 30分钟后, 灌胃给予墨汁。 给药体积为 10ml/kg。 2.3 分组及给药
给墨汁前 60分钟, 给药组灌胃给予 VB, 阳性对照组灌胃给予纳洛酮,其它组给予生理盐水。 给药体积均为 20ml/kg体重。
对 照 组: 灌胃给予等量生理盐水
模 型 组: 灌胃给予等量生理盐水
纳洛酮组: 灌胃给予纳洛酮 50 mg/kg
各剂量组: 灌胃给予按照配方 3-4 (换算成小鼠的量)
2.4观察项目
灌胃给予墨汁 20分钟后, 脱颈椎处死动物, 立即打开腹腔分离肠系膜, 剪取上端自幽门、 下 端至回盲部的肠管, 置于托盘上, 轻轻将小肠拉成直线, 测量小肠总长度, 从幽门至墨汁前 沿为墨汁推进长度, i算小肠墨汁推进率。
3. 实验结果
各配方数据如下:
不同剂量 VB配方对洛哌丁胺致便秘小鼠小肠推进率的影响
*: 与模型组相比, PO.05; **: 与模型组相比, P<0.01 结果显示: 与正常组相比, 模型组的小肠推进率(%)显著降低 (46.9±7.3 VS 15.5±2.8), 表明小鼠便秘模型制备成功; 与模型组相比,各给药组的墨汁推进距离和小肠推进率 (%)均显 著增加 (p<0.01); 复合 VB配方 3和复合 VB配方 4在改善小鼠小肠推进率(%)方面的作用效 果基本一致 (25.9±4.5VS24.9±3.7)。
结论:供试品复合维生素 B配方 3和复合维生素 B配方 4均能显著改善洛哌丁胺诱导的 便秘小鼠模型的小肠推进率(%), 且二者的作用效果基本一致。 为了更清楚地描述和理解本发明, 我们通过举例的方式详细描述了本发明, 但显而易见 的是, 本技术领域中普通技术人员可以在不背离权利要求的精神和范围的前提下, 对本发明 做出适当的改变或修改。
Claims
1. 一种维生素 B族组合物,其可用于预防和 /或治疗与胃肠系统动力匮乏相关的状态或疾 病。
2. 根据权利要求 1所述的组合物,其中所述维生素 B族组合物包括维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6和生物素。
3. 根据权利要求 1或 2所述的组合物, 其中所述维生素 B族组合物还包括叶酸、 酒石酸 氢胆碱和肌醇。
4. 根据权利要求 1-3所述的任一组合物, 其中所述维生素 B族组合物还包括维生素 B12 和 /或对氨基苯甲酸。
5. 根据权利要求 1所述的组合物, 其中所述胃肠系统动力匮乏是由于使用阿片类物质所 引起的。
6. 根据权利要求 5所述的组合物, 其中所述阿片类物质选自吗啡、 可待因、 羟考酮、 氢 吗啡酮、 氢可酮、 美沙酮和芬太尼。
7. 根据权利要求 1所述的组合物, 其中所述状态或疾病包括功能性或药物引起的便秘、 与糖尿病相关的胃轻瘫或特发性胃轻瘫、 胃食管反流病、 肠易激综合征、 或手术后肠 蠕动减慢。
8. 根据权利要求 14所述的任一组合物, 其特征在于其包括有效量的维生素 B族组合物 以及药学上可接受的载体。
9. 根据权利要求 14所述的任一组合物, 其特征在于其包括有效量的维生素 B族组合物 以及有效量的治疗和 /或预防胃肠疾病的药物。
10.根据权利要求 1-4所述的任一组合物, 其特征在于其包括有效量的维生素 B族组合物 以及其他有效量的维生素类化合物。
11.根据权利要求 10所述的任一组合物, 其中所述的维生素类化合物选自维生素 A、 C、 D、 E和 K的一种或多种。
12.根据权利要求 1-4所述的任一组合物, 其特征在于剂型为口嚼片。
13.根据权利要求 1-4所述的任一组合物, 其特征在于剂型还可为分散片、 颗粒剂、 胶囊 剂和口服液。
14. 根据权利要求 2所述的组合物, 其特征在于其包含如下重量配比的组份: 10份维生素 B1 , 15份维生素 Β2, 25份维生素 Β3, 100份维生素 Β5, 10份维生素 Β6和 0.1份生 物素。
15. 根据权利要求 3所述的组合物, 其特征在于其包含如下重量配比的组份: 10份维生素 B1 , 15份维生素 Β2, 25份维生素 Β3, 100份维生素 Β5, 10份维生素 Β6, 0.1份生 物素, 0.4份叶酸, 250份酒石酸氢胆碱和 250份肌醇。
16. 根据权利要求 4所述的组合物, 其特征在于其包含如下重量配比的组份: 10份维生素 B1 , 15份维生素 B2, 25份维生素 B3, 100份维生素 B5, 10份维生素 B6, 0.1份生 物素, 0.4份叶酸, 250份酒石酸氢胆碱, 250份肌醇, 0.025份维生素 B12。
17. 根据权利要求 4所述的组合物, 其特征在于其包含如下重量配比的组份: 10份维生素 B1 , 15份维生素 B2, 25份维生素 B3, 100份维生素 B5, 10份维生素 B6, 0.1份生 物素, 0.4份叶酸, 250份酒石酸氢胆碱, 250份肌醇, 0.025份维生素 B12和 50份对 氨基苯甲酸。
18. 一种维生素 B族组合物在制备治疗和 /或预防与胃肠系统动力匮乏相关的胃肠状态或疾 病的药物或保健食品中的用途。
19. 根据权利要求 18所述的用途, 其中所述维生素 B族组合物包括维生素 B1 (硫胺素)、 维生素 B2 (核黄素)、 维生素 B3 (烟酸)、 维生素 B5 (泛酸)、 维生素 B6和生物素。
20. 根据权利要求 18或 19所述的用途, 其中所述维生素 B族组合物还包括叶酸、 酒石酸 氢胆碱和肌醇。
21. 根据权利要求 18-20所述的任一用途, 其中所述维生素 B族组合物还包括维生素 B12 和对氨基苯甲酸。
22. 根据权利要求 18所述的用途,其中所述胃肠系统动力匮乏是由于使用阿片类物质所引 起的。
23. 根据权利要求 22所述的用途, 其中所述阿片类物质选自吗啡、 可待因、羟考酮、 氢吗 啡酮、 氢可酮、 美沙酮和芬太尼。
24. 根据权利要求 18所述的用途, 其中所述状态或疾病包括功能性或药物引起的便秘、与 糖尿病相关的胃轻瘫或特发性胃轻瘫、 胃食管反流病、 肠易激综合征、 或手术后肠蠕 动减慢。
25. 根据权利要求 18所述的用途, 其中所述的药物或保健食品其施用对象是人。
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US20180353469A1 (en) * | 2015-06-12 | 2018-12-13 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Use of composition of multivitamin in preparing drug for stimulating gastrointestinal system motility |
EP3545960A4 (en) * | 2016-11-23 | 2020-07-01 | Zensun (Shanghai) Science & Technology, Co., Ltd. | MULTIVITAMINATED COMPOUND STIMULATING THE DIGESTIVE APPARATUS |
US10702585B2 (en) | 2014-01-03 | 2020-07-07 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Formula of neuregulin preparation |
US11179323B2 (en) | 2013-05-22 | 2021-11-23 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Extended release of neuregulin for treating heart failure |
US11253573B2 (en) | 2011-10-10 | 2022-02-22 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Compositions and methods for treating heart failure |
US11464797B2 (en) | 2017-03-07 | 2022-10-11 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Use of vitamin composition in preparing drug for preventing, treating, or delaying Alzheimer's disease |
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CN110840895A (zh) * | 2013-07-23 | 2020-02-28 | 上海泽生科技开发股份有限公司 | 使用维生素b组合物促进胃肠系统动力的方法 |
CN115581699A (zh) * | 2018-04-28 | 2023-01-10 | 上海泽生科技开发股份有限公司 | 促进胃肠系统动力的复合维生素组合物及其制备方法 |
CN110403945B (zh) * | 2018-04-28 | 2022-11-18 | 上海泽生科技开发股份有限公司 | 促进胃肠系统动力的复合维生素组合物及其制备方法 |
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US20080213395A1 (en) * | 2004-10-14 | 2008-09-04 | Adventures Plus Pty Ltd | Method for the Treatment of Gastrointestinal and Other Disorders with an Admixture of Vitamins |
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US11253573B2 (en) | 2011-10-10 | 2022-02-22 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Compositions and methods for treating heart failure |
US11179323B2 (en) | 2013-05-22 | 2021-11-23 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Extended release of neuregulin for treating heart failure |
US10702585B2 (en) | 2014-01-03 | 2020-07-07 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Formula of neuregulin preparation |
US11969458B2 (en) | 2014-01-03 | 2024-04-30 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Formula of neuregulin preparation |
US20180353469A1 (en) * | 2015-06-12 | 2018-12-13 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Use of composition of multivitamin in preparing drug for stimulating gastrointestinal system motility |
US10881639B2 (en) | 2015-06-12 | 2021-01-05 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Use of composition of multivitamin in preparing drug for stimulating gastrointestinal system motility |
EP3545960A4 (en) * | 2016-11-23 | 2020-07-01 | Zensun (Shanghai) Science & Technology, Co., Ltd. | MULTIVITAMINATED COMPOUND STIMULATING THE DIGESTIVE APPARATUS |
US11351171B2 (en) | 2016-11-23 | 2022-06-07 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Composite vitamin composition promoting gastrointestinal system motility |
US11759463B2 (en) | 2016-11-23 | 2023-09-19 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Composite vitamin composition promoting gastrointestinal system motility |
US11464797B2 (en) | 2017-03-07 | 2022-10-11 | Zensun (Shanghai) Science & Technology, Co., Ltd. | Use of vitamin composition in preparing drug for preventing, treating, or delaying Alzheimer's disease |
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