CN112933152A - Sweet orange oil composition for enhancing intestinal motility and preparation method and application thereof - Google Patents

Sweet orange oil composition for enhancing intestinal motility and preparation method and application thereof Download PDF

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CN112933152A
CN112933152A CN202110138010.1A CN202110138010A CN112933152A CN 112933152 A CN112933152 A CN 112933152A CN 202110138010 A CN202110138010 A CN 202110138010A CN 112933152 A CN112933152 A CN 112933152A
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Shanxi Yabao Baidun Technology Co ltd
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Abstract

The invention relates to a sweet orange oil composition for enhancing intestinal motility and a preparation method and application thereof, wherein the composition consists of sweet orange oil, hemp seed oil and radish seed oil, and the corresponding weight percentages are as follows: 10-85% of hemp seed oil, 10-80% of sweet orange oil and 5-20% of radish seed oil. The raw materials used in the composition are medicinal and edible, the composition is simple, no chemical additive is added, and no toxic or side effect is caused; or making into enteric capsule, oral liquid or other dosage forms for enema by use of enteric capsule and special filling equipment. The sweet orange oil composition has the effects of enhancing intestinal motility, relaxing bowel and preventing intestinal cancer, is suitable for treating constipation or intestinal motility deficiency caused by different causes, has the effective rate of 90-100 percent, and is expected to become a preferred food and medicine for treating constipation, preventing intestinal cancer or treating intestinal obstruction.

Description

Sweet orange oil composition for enhancing intestinal motility and preparation method and application thereof
Technical Field
The invention belongs to the field of traditional Chinese medicines, particularly relates to the field of medicine-food homologous traditional Chinese medicines, and particularly relates to a sweet orange oil composition for enhancing intestinal motility as well as a preparation method and application thereof.
Background
In order to comprehensively understand the relevant technologies and the current production situations of domestic and foreign research, production, application and treatment of constipation, intestinal motility, prevention and treatment of intestinal cancer and the like, the applicant of the invention commits the 'Chinese academy of sciences literature information center' to carry out international research on a 'sweet orange oil composition with the effects of enhancing intestinal motility and treating constipation' item 12-18 th 2020, and the result shows that: no information is found which is duplicative of the entrusted novelty and the content of the patent of the invention. See the research report of the Chinese academy of sciences literature information center No. 2020 and 1978 for details.
The causes of constipation are complex, and the main symptoms and manifestations are stool frequency reduction, stool dryness, difficult defecation or defecation without strength, and can also cause local and systemic symptoms such as bitter taste in mouth, sticky sensation in mouth, fullness and distention in upper abdomen, distending pain in both ribs, belching, inappetence, listlessness, dizziness and hypodynamia, general malaise, headache, insomnia and the like, and long-term constipation can also cause stool impaction (intestinal obstruction), or cause anorectal diseases (varicose veins), even induce colorectal cancer. The incidence rate of constipation in China is about 10-30%; the incidence of constipation, obesity and colorectal cancer is higher in European and American countries due to the fact that the European and American countries lack the intake of fruit and vegetable fibers because of eating more meat. Patent application CN201180020078.4 describes in the technical background the cause of constipation: including bowel obstruction and slow colon transit (intestinal hypomotility). Causes of slow-passing constipation of the colon include: diet, hormones, drug side effects and heavy metal toxicity. The definition of constipation includes: rare bowel movements, typically 3 times per week or less; difficult defecation, strength in the defecation process, but no defecation strength; or with a sensation of incomplete bowel evacuation. Moreover, the patent application CN201180020078.4 also provides a more comprehensive description of the causes of constipation, and the most common primary causes include: inadequate dietary fiber or fluid intake, lack of physical exercise, drug side effects, hypothyroidism, and obstruction due to colorectal cancer. In addition, the causes of constipation include: spinal cord lesions, parkinson's disease, colon cancer, anal fissure, proctitis, and pelvic floor dysfunction. Reasons for functional aspects (neurological) include: anal spasm, perineal descent syndrome, and Hirschsprung's disease. In addition, certain drugs such as diuretics, antidepressants, antihistamines, antispasmodics, anticonvulsants, aluminum antacids may also cause constipation: constipation may also be caused by hypercalcemia, hypothyroidism, diabetes.
Various metanicotine (metanicotine) analogs have been proposed in the united states for the treatment of various obstructive constipation, as well as for the treatment of Irritable Bowel Syndrome (IBS) with targeted serotonin. In China, polyethylene glycol 4000 and liquid paraffin are mainly used for treating constipation clinically, and the constipation has poor taste and weak effect and can cause the malabsorption of vitamin A, D, K and calcium and phosphorus. In addition, the docusate sodium surfactant is adopted to treat constipation, and the patent CN 103070846B 'a docusate sodium soft capsule': 10-50% of docusate sodium; 35-90% of polyethylene glycol; 0-15% of polyhydric alcohol, but has potential toxic and side effects or risks.
The Chinese traditional medicine holds that the main physiological function of the large intestine is to transport and digest dregs, the large intestine receives residues left after the small intestine secretes clear and turbid, and the residual water is absorbed to form excrement which is discharged out of the body through the anus. The intestinal dryness and fluid depletion, which are caused by yin deficiency with less fluid, depletion of fluid in the old, postpartum blood deficiency, fluid recovery after illness and ischemia, may lead to dry and unhygienic intestine and constipation. Many traditional Chinese medicines for treating constipation include rheum officinale, aloe leaves, aloe rheum officinale, senna leaves and the like, but the traditional Chinese medicines are not easy to take for a long time because the medicines cause the blackening of intestinal membranes or induce the intestinal cancer.
The patent CN 102727736A discloses a medicine for treating constipation, the prescription comprises 30-50 g of prepared rehmannia root, 20-30 g of dried rehmannia root, 15-30 g of figwort root, 20-30 g of dwarf lilyturf tuber, 10-20 g of fleece-flower root, 20-30 g of whole Chinese angelica, 15-20 g of fructus cannabis, 3-8 g of fried almond, 5-8 g of fried peach kernel, 5-8 g of cimicifuga rhizome, 5-8 g of bunge cherry seed, 3-5 g of raw licorice, 20-30 g of honey and 15-30 g of cistanche; patent application CN 102078506A discloses a Chinese medicinal composition for treating constipation, which comprises 15 Chinese medicinal materials such as radix Paeoniae alba, radix Angelicae sinensis, radix scrophulariae, radix rehmanniae Preparata, Carthami flos, folium Hordei Germinatus, Atractylodis rhizoma, Mori fructus, semen Armeniacae amarum, rhizoma corydalis, fructus Perillae, rhizoma Cyperi, fructus Cannabis, Glycyrrhrizae radix, and Cistanchis herba; patent CN 1895396B discloses a Chinese medicinal preparation for nourishing yin, moistening intestines, removing stagnancy and relaxing bowels and a preparation method thereof, and the Chinese medicinal preparation comprises the following components: 1100-2000 parts of fructus cannabis, 320-600 parts of bunge cherry seed, 64-120 parts of sesame oil and 228-422 parts of radish seed, and is characterized in that an enteric hard capsule is adopted, the medicine directly reaches the colon, the taking dosage is small, the curative effect is high, but the defects are that the components are complex, and the components and the functions for enhancing the intestinal motility are lacked. Patent documents relating to constipation treatment by traditional Chinese medicines are numerous, but most of the patent documents have the defects of multiple components, complex components and single effect, and no report of a medicinal and edible composition integrating the functions of enhancing intestinal motility and relaxing bowel is found.
Most of the products for treating constipation in the market of China contain rheum officinale, aloe leaves, aloe rheum officinale, senna leaves or anthraquinone excretion components, have the main effect of stimulating the mucous membrane of the large intestine to violently wriggle and quickly discharge excrement, have obvious treatment effect, but have certain side effects (including causing the intestinal blackening) and are not suitable for long-term administration; the phenolphthalein tablets (also called fruit-guiding tablets) for treating constipation have recently been listed in the forbidden list by the drug administration in China, and the American FDA has banned the products containing aloe-emodin from being sold as over-the-counter medicines for treating constipation in 2002.
Intestinal motility and constipation have an inseparable relationship, and long-term constipation increases the incidence of intestinal cancer, so when solving the constipation problem, the relationship and prevention of intestinal motility, constipation and intestinal cancer should be considered comprehensively. Colorectal cancer (CRC), also known as colorectal cancer, affects more than 100 million people worldwide each year and causes approximately 50 million deaths. At present, medicines for treating colorectal cancer mainly comprise oxaliplatin, fluorouracil, irinotecan, folic acid, bevacizumab and the like, but the five-year survival rate after radical colorectal cancer treatment is about 50 percent. It can be seen that early diagnosis and precancerous prevention or intervention will still be a positive strategy for the prevention and treatment of colorectal cancer.
The existing medicines for treating constipation do not have the function of preventing intestinal cancer, and similar documents are few, so that a novel food and medicine which integrates the functions of enhancing intestinal motility, relaxing bowel and preventing intestinal cancer is urgently needed to be researched.
Patent document CN106890140B discloses a d-limonene anti-oral cancer synergistic composition, a preparation method and an application thereof, which can be proved by combining the existing research results of others: d-limonene has an inhibitory or apoptotic rate effect on a variety of cancer cells; in addition, the inventor of the patent application finds that the d-limonene-rich sweet orange oil not only has the effects of enhancing intestinal motility and relaxing bowel, but also has the application prospect of preventing intestinal cancer and postoperative recurrence through in-person experiments and volunteer experiments.
The invention aims to overcome the defect of single effect of the existing medicament for treating constipation, and provides a sweet orange oil composition for relaxing bowel, which has the functions of enhancing intestinal motility, treating constipation caused by different causes and integrating intestinal cancer prevention and intestinal obstruction treatment, and a preparation method and application thereof.
Disclosure of Invention
In order to overcome the defects in the prior art, the invention provides the bowel relaxing composition consisting of the hemp seed oil, the sweet orange oil and the radish seed oil, which has the function of enhancing the intestinal motility and has better functions of treating constipation and preventing intestinal cancer. The raw materials used in the composition are all medicinal and edible substances approved by the Chinese government, the safety of the composition is scientifically verified, and the eating amount or the administration amount can be not limited, and the composition is specifically as follows:
(1) hemp seed oil
The fructus cannabis oil is from fructus cannabis, which is also called as fructus cannabis or fructus cannabis and is a dried mature fruit of cannabis sativa of Moraceae, and is prepared by low-temperature cold pressing, has a natural ratio of 2.4:1 of omega-6 linoleic acid and omega-3 alpha-linolenic acid, and meets the optimal ratio of less than or equal to 4:1 recommended by the International health organization. Fructus Cannabis (oil) is rich in protein, unsaturated fatty acid, lecithin, linolenic acid, vitamins, and trace elements necessary for human body such as calcium and iron minerals. The China national health committee has listed fructus cannabis in the list of articles which are both food and medicine, and has the efficacies of moistening intestines, supplementing body fluid, nourishing yin, tonifying deficiency, preventing diseases and prolonging life.
The hemp seed oil of the present invention can be purchased from: yunnan Hanpu health products, Inc., Lingchuan county Cool Taixing agricultural product development, Inc.; yusha county, Setaria Biotech Co., Ltd. The quality standard of the hemp seed oil meets the industry standard LS/T3253-2017 Hanma seed oil in the grain industry.
Although China hemp seed oil has been reported to relax bowel, the applicant of the invention finds that the treatment effect of the constipation caused by insufficient intestinal motility or medicines is not ideal and the drug resistance is easy to appear by taking the hemp seed oil singly through a large amount of applications.
(2) Sweet orange oil
The sweet orange oil is prepared from fresh peel or whole fruit of sweet orange by cold grinding or cold squeezing process or steam distillation. The sweet orange oil contains 80-90% of d-limonene and has the density of 0.848-0.853; the refractive index is 1.473-1.475; the characteristics are as follows: yellow, orange or yellow brown liquid with natural orange smell is dissolved in ethanol and glacial acetic acid, and is mainly used for flavoring and medicine of beverage, food and toothpaste, and Chinese GB2760-2011 (national standard) approves sweet orange oil as allowable food spice. The sweet orange oil is purchased from Shanghai Jiuzhong industry Co. At present, no report on the use of sweet orange oil for treating constipation caused by intestinal hypomotility and preventing intestinal cancer is found.
However, the sweet orange oil contains more than 80% of d-limonene, also known as limonene, with the chemical name of 1-methyl-4-isopropyl-cyclo-ethyl-C10H16Molecular weight 136.23. In 1994, d-limonene was identified by the American Association of Flavor and Extract manufacturers (Flavor and Extract's Association of the United States, FEMA) as having toxicity in the GRAS (generally recognized as an ' A ')Whole) grade and is FDA approved for consumption.
Numerous studies at home and abroad have found that d-limonene has inhibitory and reversing effects on a variety of tumors (Crowell P.L, Gould M.N., chemoprediction and therapy of cancer by-limonene [ J ]. Crit Rev Oncol,1994,5(1): 1-22; Crowell P.L., Ayubi A.S., Bur Y.D, Antitumori effects of limonene and perfluoro alkyl aggregation vast and branched caner [ J ]. Adv Exp Biol,1996,401(2): 131. about 136; Elegbe J.A, Elson C.E., Quhi A., et al., inhibition of DMBA-induced cancer by gene J-luminescence J.664., Carrie J.1998, Care 5J. (1998, J.). about J.). about.. d-limonene has a prophylactic or anti-Cancer effect and has now entered clinical phase I and phase II trials (Vigushin D.M., Poon G.K., Boddy A., et al. phase I and pharmaceutical study of d-limonene in patents with advanced Cancer [ J ], Cancer chemother and Pharmacology,1998,42(2): 111-.
(3) Radish seed oil
Radish seedOil, also called orchid seed oil, is edible oil extracted or cold-pressed from mature seed of radish of BrassicaceaeOilThe appearance is clear and transparent, and the smell is fragrant. Radish seeds are mainly used for regulating intestines and stomach, promoting digestion, relieving flatulence, descending qi and eliminating phlegm. Radish seed oil is recorded in the twelfth chapter ointment of "Tiangong Kai-Hai-Shi (opening article for the New year)" published in the Ming Dynasty of China: the "Hu Ma, radish seed, soybean and Song Lai Zi" are called as "sweet and beautiful abnormal, benefiting five internal organs", and Ming Dynasty becomes palace oil for food.
Modern pharmacological studies and animal experiments have shown that raphanin has anticancer effects (anyeng, raphanin anti-hepatoma cell proteomics research [ D ], Beijing chemical university, 2016); in addition, it has been reported that radish seed oil has an action of enhancing intestinal motility in rat large intestine (Chenjinghua, male plum-iron, and Venetia Crispa. Experimental study on indirect motility of radish seed oil in rat large intestine [ J ] Chinese medicinal science and technology, 2006 (13): 1). The radish seed oil is purchased from Yunnan mu dinghai source grease limited company, the product implements the registration standard Q/MHY0001S-2014 radish seed oil of food safety enterprises in Yunnan province, and at present, no report is found for treating constipation caused by insufficient intestinal motility by combining the radish seed oil with sweet orange oil and hemp seed oil.
The invention provides a sweet orange oil composition for enhancing intestinal motility, which consists of the following raw oil in percentage by weight: 10-85% of hemp seed oil, 10-80% of sweet orange oil and 5-20% of radish seed oil.
In one embodiment of the invention, the sweet orange oil composition for enhancing intestinal motility consists of the following raw oil in percentage by weight:
(1) hemp seed oil 50%, sweet orange oil 40%, radish seed oil 10%
(2) Hemp seed oil 75%, sweet orange oil 20%, radish seed oil 5%
(3) Hemp seed oil 85%, sweet orange oil 10%, radish seed oil 5%
(4) Hemp seed oil 40%, sweet orange oil 50%, radish seed oil 10%
(5) Hemp seed oil 60%, sweet orange oil 20%, radish seed oil 20%
In one embodiment of the invention, the sweet orange oil composition for enhancing intestinal motility can be prepared into common soft capsules, enteric capsules, oral liquid or preparations for enema.
In one embodiment of the invention, the content of the composition in the common soft capsule or enteric-coated hard capsule of the intestinal power enhancing sweet orange oil composition is 0.3g, 0.5g or 1 g.
In a specific embodiment of the present invention, the intestinal motility enhancing sweet orange oil composition has a composition volume of 2mL, 5mL or 10mL in the oral liquid.
In another aspect, the present invention provides an application of a sweet orange oil composition for enhancing intestinal motility in preparing a food, a health product or a medicine for treating constipation, wherein the constipation may be constipation caused by intestinal motility deficiency, general constipation, children constipation or postpartum constipation.
The invention also provides application of the sweet orange oil composition for enhancing intestinal motility in preparing food, health-care products or medicines for preventing intestinal cancer.
The invention also provides application of the sweet orange oil composition for enhancing intestinal motility in preparing food, health-care products or medicines for preventing or treating intestinal obstruction.
In one embodiment of the invention, the dosage of the sweet orange oil composition for enhancing intestinal motility can be increased or decreased according to different ages or disease conditions; moreover, the product can be taken as a dietary nutriment or health-care edible oil for a long time.
The application of the sweet orange oil composition for enhancing intestinal motility comprises but is not limited to irritable bowel syndrome (including IBS-A and IBS-C), acute or chronic idiopathic constipation, colon cancer or intestinal atonic obstruction; endocrinology, including but not limited to pregnancy or hypothyroidism; neurological, including but not limited to parkinson's disease, multiple sclerosis, or depression; iatrogenic, including but not limited to treatment with opiates, antidepressants, antacids, or iron supplements; eating disorders such as anorexia or bulimia and eating disorders associated with stress, travel, and dietary changes; or associated with injury, including surgery, spinal cord injury, autonomic dysfunction, paraplegia, elderly or long-term patients.
The sweet orange oil composition for enhancing the intestinal motility has the characteristics of simple prescription, scientific compatibility, differentiation of medicines, body fluid and intestine nourishing, dryness moistening and tonifying, intestine clearing and toxicity removing (sweet orange oil), dialectical medicine taking, safety and effectiveness, wherein the hemp seed oil has the effects of nourishing yin and moistening dryness, tonifying body fluid, lubricating intestines and relaxing bowels and is a monarch drug; sweet orange oil has the effects of reducing stagnation, promoting qi circulation and regulating qi, and is a ministerial drug for assisting monarch; the radish seed oil has the effects of eliminating stagnation, relieving distension and descending qi, is an adjuvant drug and has the synergistic effect of the three oils, so that the large intestine can nourish the body fluid, be smooth and is healthy.
The sweet orange oil composition for enhancing the intestinal motility has the effects of enhancing the intestinal motility, exhausting air, lubricating the intestinal tract, preventing intestinal cancer and treating intestinal obstruction, has a wide application range, and can solve the problem that the constipation is easily subjected to drug resistance when the hemp seed oil is singly taken; in addition, the composition adopts 100 percent of raw materials which are homologous in medicine and food, can be eaten or used as medicines, can be eaten for a long time, has no toxic or side effect, has obvious safety advantage compared with rhubarb, aloe, fruit slices and chemical laxatives, has the detailed comparison between the intestinal motility function and the safety of different laxatives shown in table 1, has no special requirement or limitation on the taking dosage, and has simple production process, wide application range, quick effect, high cure rate and good application prospect.
TABLE 1 comparison of the bowel motility and safety of different cathartics
Figure BDA0002927501960000051
Note: the prospect of preventing intestinal cancer is based on the existing research and published documents of d-limonene, wherein the prospect comprises' CN106890140B d-limonene anti-oral cancer synergistic composition and a preparation method and application thereof "
The sweet orange oil composition capable of enhancing intestinal motility provided by the invention is adjusted in dosage according to different conditions, different application prescriptions are made, and the composition not only can treat constipation caused by insufficient intestinal motility or other reasons, but also is expected to be a preferable food for preventing intestinal cancer or treating intestinal obstruction.
Detailed Description
The technology and the application effect of the invention are further described by combining the following embodiments:
example 1: prescription for constipation caused by intestinal hypomotility
The prescription is suitable for the elderly, bedridden patients and other patients with insufficient intestinal motility or disorders, and consists of the following components in percentage by weight:
hemp seed oil 50%
Sweet orange oil 40%
Radish seed oil 10%
Prescription solution: the problems of intestinal dysfunction or intestinal insufficiency of the elderly and people who are bedridden for a long time are common. However, the sweet orange oil and the radish seed oil have the function of enhancing the intestinal motility, and are used as monarch drugs, so that the intestinal motility is enhanced; the hemp seed oil has the functions of supplementing body fluid, moistening dryness and lubricating intestines, is used as an assistant drug, is reasonably combined with three food oils, accords with the dialectical medicine theory of the traditional Chinese medicine, and has obvious advantages of treating constipation caused by insufficient intestinal motility.
The preparation method comprises the following steps: take 100kg of preparation as an example. The source information of the raw materials is firstly verified and checked to confirm the quality of the raw materials. Taking raw oil meeting the quality requirement: 50kg of hemp seed oil, 40kg of sweet orange oil and 10kg of radish seed oil are put into a common homogenizing and stirring device, the machine is started to mix for 5min at the homogenizing speed of 100 r/min, and the raw material oil of the prescription composition for treating the constipation caused by the intestinal hypomotility is prepared, the mixed and dissolved oil is filled into a sterilized packaging barrel, sealed and placed in a cool and dry place to be stored in the dark for standby.
Packaging form of prescription preparation:
1. the composition (oil) mixed and dissolved can be packaged by adopting general soft capsule production equipment and process, the content of the capsule can be 0.3g, 0.5g or 1g, the capsule skin adopts brown light-resistant, and the production equipment and process are conventional and have no special requirements;
2. or preparing enteric hard capsules and special packaging equipment, wherein the enteric capsules and the filling and sealing equipment can be purchased from Qiangji pharmaceutical factory in Chaozhou city, Huangshan capsules Co., Ltd, and elm society capsule factory. The content of the enteric-coated capsule can be 0.3g or 0.5g, the capsule shell is made of enteric-coated material, and the outer package adopts a brown lightproof bottle. Except that no other special requirements are required;
3. the preparation for enema can also be prepared into 100mL or 250mL volume by using glass bottles or plastic medicine bottles and general filling equipment.
The use method of the prescription preparation comprises the following steps:
1. is administered orally. The dosage is generally 1 day 2 times, 1 time 1g, and the specific dosage and time are according to the instruction, or consult doctor. The product is edible and medicinal, and can be used as health product or cooking oil for long-term administration without side effect.
2. And (5) performing retention enema. The specific application and dosage are determined according to the disease condition and illness, and doctors can consult when necessary.
Example 2: prescription for treating general constipation
The prescription is suitable for common constipation people, and comprises the following components in percentage by weight:
hemp seed oil 75%
Sweet orange oil 20%
Radish seed oil 5%
Prescription description (solution): the commodity name of the prescription is: chang do not stay No. 2. The prescription aims at the problems of intestinal canal lusterness and dry stool caused by insufficient intake of fruits, vegetables and dietary fibers, monophagia, sedentary, less activity and excessive internal heat, and the problems of universality and no intestinal motility disorder of constipation patients are considered, so that 75% of hemp seed oil is adopted as an intestine moistening main material, 20% of sweet orange oil and 5% of radish seed oil are adopted as intestinal motility auxiliary materials, the proportion and the medication are scientific, and the treatment requirements of common constipation patients are met.
The preparation method comprises the following steps: for example, in the case of a 100kg preparation amount, the source information of the raw material is first verified, and the quality of the raw material is checked and confirmed. 75kg of hemp seed oil, 25kg of sweet orange oil and 5kg of radish seed oil are weighed, the three kinds of oil are put into common homogenizing and stirring equipment (container) and mixed for 3min at the homogenizing speed of 500 r/min, and the formula oil for treating the common constipation can be prepared.
Taking out the mixed oil, filling into sterilized food-medicine packaging barrel, sealing, and storing in shade and dry place. The packaging form of the prescription preparation is the same as that of the example 1, and can be selected according to specific situations and requirements. The packaging form and packaging capacity of the product do not affect the application effect of the composition of the invention.
The use method of the prescription preparation comprises the following steps: is administered orally. The specific dosage and time are according to the instruction of the product or consult with doctors. The product is edible and medicinal, and can be used as health product or cooking oil or flavoring agent for long-term administration without side effect.
Example 3: prescription for treating constipation of children and postpartum women
The prescription is suitable for children and postpartum constipation, and consists of the following components in percentage by weight:
hemp seed oil 85%
Sweet orange oil 10%
Radish seed oil 5%
Prescription solution: constipation in children is mostly caused by food preference or food accumulation; postpartum constipation is mostly caused by collapse or endocrine disturbance, and intestinal motility is not problematic. Considering the weak group of the same genus of children and lying-in women, the prescription takes the hemp seed oil for moistening the intestines as a monarch drug (accounting for 85 percent), the sweet orange oil as a ministerial drug and the radish seed oil as an assistant drug (accounting for 15 percent), can achieve the expected treatment or conditioning effect by increasing the lubrication of the intestinal tract and assisting the proper intestinal motility, and has no side effect on the children, the lying-in women and the infants.
The preparation method comprises the following steps: for example, the quality of the raw material was first checked and confirmed with respect to the production amount of 100 kg. 85kg of hemp seed oil, 10kg of sweet orange oil and 5kg of radish seed oil are weighed, and the three kinds of oil are put into common homogenizing and stirring equipment (container) and mixed for 1min at the homogenizing speed of 1000 r/min, so that the formula oil for treating the common constipation can be prepared.
Taking out the mixed oil, filling into sterilized food-medicine packaging barrel, sealing, and storing in shade and dry place.
The packaging form of the prescription preparation is the same as that of the example 1, and can be selected according to specific situations and requirements.
The use method of the prescription preparation comprises the following steps:
is administered orally. The specific dosage and time are according to the instruction of the product or consult with doctors. The product is edible and medicinal, and can be used as health product or cooking oil for long-term administration without side effect.
Example 4: sweet orange oil composition prescription for preventing intestinal cancer
The prescription is suitable for people with the requirement of preventing intestinal cancer, and the specific formula proportion is as follows:
hemp seed oil 40%
50 percent of sweet orange oil
Radish seed oil 10%
Prescription solution: sweet orange oil and radish seed oil have the effect of enhancing intestinal motility, except that research has proved that the limonene contained in the sweet orange oil has the effect of inhibiting various cancer cells. Based on the aim of preventing intestinal cancer, the prescription adopts 50 percent of sweet orange oil as a monarch drug, 10 percent of radish seed oil as a ministerial drug and 40 percent of hemp seed oil as an assistant drug, can achieve the treatment or prevention effect with half the effort by reasonable combination and application and adopting a use method of combining retention enema and oral administration, is favorable for keeping intestinal tract smooth and preventing intestinal cancer, has no toxic or side effect no matter what medication mode or dosage is adopted, and is suitable for long-term administration.
The preparation method comprises the following steps: for example, the quality of the raw material was first checked and confirmed with respect to the production amount of 100 kg. Then, weighing 40kg of hemp seed oil, 50kg of sweet orange oil and 10kg of radish seed oil, putting the three oils into common homogenizing and stirring equipment (container), and mixing for 4min at a homogenizing speed of 100 r/min to obtain the sweet orange oil composition formula oil for preventing intestinal cancer.
Taking out the mixed oil from homogenizing equipment, filling into sterilized food-medicine packaging barrel, sealing, and storing in shade and dry place.
Packaging form of prescription preparation:
1. the capsule can be packaged by adopting a general soft capsule process and equipment, the content of the capsule can be 0.3g, 0.5g or 1g, and the capsule skin adopts brown light-resistant, except that no special requirement exists;
2. the capsule can also be filled by enteric-soluble hard capsules and professional equipment, the content of the capsule can be 0.3g or 0.5g, the capsule shell is made of enteric-soluble materials, and the outer package adopts a brown bottle to avoid light. Except for no special requirements. The enteric-coated capsule and the special filling equipment can be produced by Qiangji pharmaceutical factory of Chaozhou city, Huangshan capsule Co., Ltd, and elm-society capsule factory.
3. The preparation for enema can also be prepared into 100mL or 250mL volume by using glass bottle or plastic medicine bottle and general filling equipment.
The use method of the prescription preparation comprises the following steps:
1. is administered orally. The general dosage is 1 day 2 times, 1 time 0.5-1 g, and the specific dosage and time are according to the instruction, or consult the doctor. The product is edible and medicinal, and can be used as health product or cooking oil for long-term administration without side effect.
2. And (5) performing retention enema. The specific application and dosage are determined according to the disease condition and illness, and doctors can consult when necessary.
Example 5: sweet orange oil composition formula for treating intestinal obstruction
The prescription is suitable for people who prevent or treat intestinal obstruction, and has the following formula proportion:
hemp seed oil 60%
Sweet orange oil 20%
Radish seed oil 20%
Prescription solution: intestinal obstruction (intestinal adhesion) is usually treated by surgery and is easy to recur. According to the specific pharmacological actions of the hemp seed oil, the sweet orange oil and the radish seed oil, 60 percent of the hemp seed oil is used as a monarch drug, 20 percent of the sweet orange oil is used as a ministerial drug for enhancing the intestinal motility and inhibiting the cancer cell proliferation, and 20 percent of the radish seed oil is used as an assistant drug and is cooperated with the sweet orange oil for enhancing the intestinal motility and inhibiting the cancer cell. The prescription for treating intestinal obstruction highlights the functions of supplementing body fluid, moistening intestines and maintaining normal bowel, so that the stool is always kept smooth and intestinal obstruction (intestinal adhesion) is prevented.
The preparation method comprises the following steps: for example, the quality of the raw material was first checked and confirmed with respect to the production amount of 100 kg. Then, 60kg of hemp seed oil, 20kg of sweet orange oil and 20kg of radish seed oil are weighed, and the three kinds of oil are put into common homogenizing and stirring equipment (container) and mixed for 4min at the homogenizing speed of 800 r/min, so that the sweet orange oil composition prescription oil for treating intestinal obstruction can be prepared.
Taking out the mixed oil from homogenizing equipment, filling into sterilized food-medicine packaging barrel, sealing, and storing in shade and dry place.
The packaging form of the prescription preparation is the same as that of the example 1, and can be selected according to specific situations and requirements.
The use method of the prescription preparation comprises the following steps:
is administered orally. The specific dosage and time are according to the instruction of the product or consult with doctors. The product is edible and medicinal, and can be used as health product or flavoring agent for long-term administration without side effect.
The application effect of the sweet orange oil composition for enhancing intestinal motility according to the present invention will be further described below.
Effect example 1: the beneficial effects of the sweet orange oil composition according to the invention are demonstrated by animal tests:
(I) the function of enhancing the intestinal motility of mice
1.1 preparation of test drugs
The test medicine adopts the sweet orange oil composition, the mixture ratio of the hemp seed oil is 75%, the sweet orange oil is 20%, and the radish seed oil is 5%, and the test medicine is provided by Shanxi Ba dun environmental protection technical research institute. Blank control: physiological saline; positive control drug: radix et rhizoma Rhei (rhizome of Rheum palmatum. Et rhizoma Rhei Preum palmatum) is prepared by decocting radix et rhizoma Rhei powder with 10 times of water for 30min for 2 times, mixing decoctions, concentrating to 1mL solution containing 1.0g crude drug, and preserving in refrigerator.
1.2 Experimental animals
Wistar rats with the weight of 200-220 g, half male and half female, SPF grade; kunming mice, 20-22 g in weight, half in sex, SPF grade, provided by Experimental animals center of Shanxi medical university.
1.3 Experimental methods
Mice fasted for 20h, a large dose group (2.8mL/kg) of sweet orange oil composition (75% of hemp seed oil, 20% of sweet orange oil and 5% of radish seed oil), a rhubarb water extract group (15g/kg) and a normal control group (normal saline) were administered with 1g of the composition. Then 1g of the ink solution was added to the mixture in an amount of 0.1mL/10g, respectively. Taking off cervical vertebra after administration for 30min, killing, opening abdominal cavity, separating mesentery, cutting pylorus to ileocecal intestinal canal, and placing on tray.
The small intestine was gently pulled into a straight line, and the length of the intestinal tube was measured as "total length of small intestine (a)". The distance from the pylorus to the leading edge of the ink is taken as "the ink advancing distance (B) in the intestine". The percent ink push (═ B/a × 100%) was calculated using the formula.
The results show that: the sweet orange oil composition can obviously promote small intestine movement, enhance propulsive peristalsis and improve ink propulsion rate, and is shown in Table 2
Table 2 effect of sweet orange oil composition on small bowel movements in mice (n ═ 10, xxs)
Group of Dosage of mL/kg Total length of small intestine cm Ink propelling length cm Propelling rate of ink%
Normal control group 15 36.61x3.14 26.45x5.63 71.80x11.75
Rhubarb water extract 15 36.72x3.68 31.11x3.74 84.70x5.06**
Composition in large dose 2.8 34.91x3.90 29.84x4.45 85.40x7.55**
Dosage in composition 1.4 35.21x4.06 29.40x5.41 83.10x9.39*
Small dose of the composition 0.7 37.71x4.09 30.39x6.05 80.30x11.61
(II) toxicity test
1. Acute toxicity test
The result shows that the maximum tolerance of the composition of the invention for gastric lavage of mice is 72mL/kg, the composition survives after seven days, which is 1440 times of the clinical dosage, and the LD of the mice cannot be measured50。
2. Long term toxicity test
The results show that the rats are continuously orally taken or gavaged with 2.5 and 5.0mL/kg/d (which is about equal to 100 times and 200 times of clinical dosage), and 30-day toxicity tests show that the rats have no obvious influence on animal food intake and drinking amount, hair growth, respiratory circulation, behavioral activity, hematological indexes and the like. The high dose of 10mL/kg/d (maximum dose) can reduce the weight growth rate of male rats, slightly reduce the serum GOT of amphibian, slightly increase the creatinine of female rats, but all in the normal range, and ensure that the urine routine is basically normal. The weight of the major organs and histopathology, etc. have no obvious changes. After the medicine is stopped for two weeks, each biochemical index has no obvious difference compared with a normal control group, and the effects are reversible.
Test results show that the sweet orange oil composition is safe and non-toxic.
Effect example 2: the beneficial effects of the sweet orange oil composition of the present invention are illustrated by the practical application examples:
the basic formula of the composition disclosed in the embodiments 1-5 of the invention is composed of three edible oils, has the effects of enhancing intestinal motility, moistening intestines and resisting cancer, can be used for making different application formulas according to different diseases or causes and according to dialectical theories of traditional Chinese medicines, and can achieve different expected effects. The dosage form and the packaging form do not influence the application effect of the composition of the invention. As can be seen from examples 1 to 5, the formulation of the composition according to the present invention can be combined with different disease conditions or etiologies to prepare different application recipes, which have good application effects, for example, as follows:
(1) prescription for treating constipation caused by intestinal hypomotility (prescription of example 1)
The taking method comprises the following steps: the medicine is taken for the first time, 1 time is 2mL, and 1 day is 2 times (empty stomach in the morning and evening); 1mL for 1 time and 2 times for 1 day, and the effective rate is 99-100%.
For constipation caused by severe intestinal motility disorder, the medicine can be taken twice, 20mL is taken for the first time, 1 time, 2 times (morning and evening) for 1 day, and 5mL is taken for 1 time the next day; for particularly serious constipation, a retention enema method can be added, wherein 50-100 mL of retention enema is used once, 1 time for 1 day, and 3-5 days are a treatment course.
Trial effect of volunteers:
after 42 volunteers tried the prescription for treating constipation caused by intestinal hypomotility in example 1, 20 bedridden patients aged 65-70 years old had normal diet and 5 patients with intestinal hypomotility. In addition, 22 non-bedridden 65-70 years old people have problems of intestinal hypomotility or insufficiency due to normal diet.
The symptoms of the volunteers are mostly weak defecation, difficulty, abdominal distension and dry and hard stool, and the stool is 1 time in 5-7 days on average, and according to the medicine taking method, the medicine is taken for the first time, 5mL of oral liquid is taken for 1 time, and 2 times are taken for 1 day (empty stomach in the morning and evening); 2mL is changed to 1 time from the next day, 2 times are changed to 1 day (fasting in the morning and evening), after the medicine is taken for 5 days, the self-induction intestinal peristalsis is accompanied by the increase of borborborygmus and exhaust, the constipation phenomenon is obviously improved, the defecation frequency is changed from 1 time of the original 5-7 days to 1 time of 2 days, and the total effective rate is 100%.
In addition, 5 patients with severe intestinal motility disorder, 5mL oral liquid 1 time, 2 times per day (with fasting in the morning and evening), and 5 days after continuous administration are all ineffective. Then, enema is performed. The method comprises the following steps: the patient lies on the side, a 100mL syringe is used for extracting 80mL, the syringe is connected with a rubber catheter (used as a drug delivery tube) and inserted into the anus for 30-40 cm, the sweet orange oil composition is slowly injected into the intestinal tract, the retention time is better when the retention time is longer, 1 day is used, and 15 days (times) of continuous enema is taken as a treatment course. During the enema period, the sweet orange oil composition was still taken 1 time 2mL of oral liquid 1 time (morning and evening with an empty stomach). The patient experienced: after the enema, the patient feels empty or comfortable, and defecating is always smooth and smooth.
(2) Prescription for treating general constipation (prescription of example 2)
The 29 volunteers tried the prescription for treating the common constipation in example 2, the age is 20-40 years, and no chronic medical history or intestinal motility disorder exists; the symptoms of self-complaints are dry stool and difficult defecation, and the average defecation time is 1 time in 3-5 days.
According to the medication method, the medicine is taken for the first time, 5mL of oral liquid is taken for 1 time, 2 times are taken for 1 day (fasting in the morning and evening), 2mL times are taken for 1 time and 2 times are taken for 1 day from 1 time in 3-5 days), the self-induced intestinal peristalsis is increased on the second day after the medicine is taken, the defecation times are changed from 1 time in 1-2 days, the defecation is soft, the defecation is smooth, 1-time defecation in 1 day accounts for 70%, and the total effective rate is 100%.
In addition, 4 of 29 patients with severe constipation defecate 1 time in 3-5 days on average, difficult defecation and hard defecation, 5mL of the medicine is orally taken for 1 time, 2 times in 1 day and 3 days after continuous taking, and the effect is not obvious. The dosage is changed to 1 time of 10mL and 1 day of 2 times, the next day, defecation and emptying feeling are realized, the dosage is reduced to 1 time of 2mL and 1 day of 2 times after continuous taking for 3 days, and the treatment effect is ideal.
(3) Prescription for treating constipation of children and postpartum women (prescription of example 3)
The medicine is tried by 30 volunteers, wherein 10 children are 7 years old; 10 lying-in women and 10 lying-in women after cesarean section have no problems of chronic diseases and intestinal motility disorders, and the symptoms of volunteers are dry stools and difficult defecation.
The taking method comprises the following steps: the medicine is taken for the first time, 2 times in 1 day (empty stomach in the morning and evening), 2mL for 1 time, and the second day after the medicine is taken, the intestinal peristalsis is obvious, the exhaust is more, the defecation is satisfactory, and after 24 hours, the defecation is smooth, the defecation is soft, the effort is not wasted, and the effective rate is 90%.
2 parturients with particularly serious constipation had 2 times of 1 day and 2mL of the prescription preparation (common soft capsule) after being taken for 1 day, the continuous taking for 3 days was ineffective, the enteric capsule was used later, the dosage was unchanged, the dosage was still 1 day and 2 times, 1 time 2mL, the defecation occurred after taking for 24 hours, the defecation was normal on the third day, the parturient was soft, and the maintenance dosage of 1 day and 1mL was changed from the fifth day to 1 day and 2 times and 1 time, and the defecation was regular and smooth all the time. The dosage is increased, no side effect is caused to children, puerpera and infants, and the healing of the suture part of the puerpera with caesarean section is facilitated.
(4) Sweet orange oil composition for preventing intestinal cancer (example 4 prescription)
Patients with intestinal cancer or postoperative patients often have dry stools or poor defecation, and more patients are concerned about relapse.
According to the pharmacological and medicinal properties, safety and non-toxicity of the sweet orange oil composition and the treatment or postoperative prevention needs of intestinal cancer, the treatment method adopts 1 day for 2 times (with an empty stomach in the morning and at night), 1 time for 10mL, and 7 days later, the treatment method changes 1 day for 2 times and 1 time for 5mL (maintenance dose). Meanwhile, a retention enema method is adopted, and the method comprises the following steps: a patient lies on the side, a 100mL syringe is used for extracting 80mL, the syringe is connected with a rubber catheter, the catheter is a drug delivery tube and is inserted into the position of 30-40 cm of an anus, the sweet orange oil composition is slowly pushed into the intestinal tract, the retention time is better when the retention time is longer, 1 time is given for 1 day, 15 days (times) of continuous enema is taken as a treatment course, the middle rest is taken for 7 days, the second treatment course is carried out, three continuous treatment courses are carried out, the enema is suspended, and oral administration and persistence are changed.
The volunteers tried the condition of "sweet orange oil composition prescription for preventing intestinal cancer" of example 4:
(1) the inventor of the patent application technology of the invention has diagnosed rectal cancer in 1985, a tumor is located 5cm away from the anus, the sigmoid colon has an ulcer surface with the size of 1cm, pus and blood are discharged every day, and excrement is not shaped, so that the inventor chooses conservative treatment because the inventor does not want to receive artificial fecal bag operation. The self-made sweet orange oil oral liquid is taken 2 times (in the morning and evening with empty stomach) and 5mL times every day. Except for retention of enema every day, 30mL of the enema is filled for 1 time, rectal and colon lesions disappear after 2 years, stool is formed, defecation is regular, bloody purulent stool does not exist, and recurrence does not occur in fifteen years. This result has motivated the research enthusiasm of the present inventors, and thus has become the first discoverer and researcher of sweet orange oil compositions for treating intestinal cancer.
(2) Some woman, 50 years old, professional: the salesperson started taking the sweet orange oil composition for preventing intestinal cancer, which is prescribed in example 4 of the present application, in the second month after colon cancer operation for 6 years, 2 times a day (fasting in the morning and at night), and 1 time 1g (enteric capsule), except that the enema was kept for 15 days (1 time) every year, before taking, the stool was dry, and after taking for 3 days, the defecation began to be regular and gradual, the stool was soft, and all the test indexes were normal.
(3) A male, 47 years old, professional: the inventor takes a sweet orange oil composition for preventing intestinal cancer, which is prescribed in example 4 of the application, 1 time (morning and evening) and 1 time (1 g) of enteric capsules from the third month after rectal cancer operation, keeps enema for 15 days (1 time) every year except oral administration, has no side effect or relapse after taking for 4 years, has good mental state and has various examinations in a normal range.
(4) Some male, 25 years old, occupation: students, voluntarily take the sweet orange oil composition for preventing intestinal cancer, which is prescribed in the prescription of the embodiment 4 of the present application, 3 years, 1 day 2 times, 1 time and 1g enteric capsule, and keep the enema for 15 days (1 time) every year except for oral administration, so that the defecation is regular, the bowel is soft, the shape is formed, the appetite and the sleep are good, the relapse is not caused in 5 years, and various examinations are in a normal range.
(5) Some male, 48 years old, occupational: the worker voluntarily takes the sweet orange oil composition for preventing intestinal cancer according to the prescription in example 4 of the application after the operation of colon cancer 5 years, 1 day 2 times, 1 time 1g of enteric soft capsules, except that 15 days (1 time) of clystering are kept every year, the defecation rule is regular, the patient is soft, the patient relapses and transfers in the sixth year, and the patient starts to take the composition doubly, wherein the composition is changed from 1 day 2 times, 1 time 1g to 1 day 2 times, 1 time 2g, and the patient leaves the world after 1 year and a half.
(6) Some woman, 18 years old, professional: students, after colon cancer operation, voluntarily take the sweet orange oil composition for preventing intestinal cancer prescribed in example 4 of the present application 2 years, 2 times per day, 1 time 1g (enteric capsule), except 15 days (1 time) of clystering every year, regular defecation, good intestinal peristalsis, no recurrence, and still taking at present.
(7) Some male, 32 years old, occupation: after colon cancer operation, the intestinal cancer prevention sweet orange oil composition prescribed in example 4 of the present application is voluntarily taken 1 year and half, 2 times per day, 1 time and 1g (enteric capsule), and except for oral administration, the enema is kept for 15 days (1 time) per year, the defecation rule (1 day and 1 time) is regular, the defecation is smooth and soft, and no recurrence is seen.
(8) A woman, 37 years old, no business: after the rectal cancer operation, the composition of sweet orange oil for preventing intestinal cancer, which is prescribed in the example 4 of the application, is taken voluntarily for 1 year, 2 times a day, 1 time and 1g (enteric capsule), and the enema is kept for 15 days (1 time) every year except for oral administration, so that the defecation rule and the formation are realized, and the relapse is not seen through colonoscopy, and the composition is still taken so far.
(9) Some woman, 54 years old, professional: workers, after rectal cancer operation, voluntarily take the sweet orange oil composition for preventing intestinal cancer prescribed in the example 4 of the application for 4 years, 1 day for 2 times, 1 time for 1g (enteric capsule), except for oral administration, keep enema for 15 days (1 time) every year, defecate regularly, defecate softly, form, relapse and transfer in the 4 th year, and leave the world half a year after the relapse.
(10) A male, age 41, official, after the rectal cancer operation, voluntarily took 1-2 g (enteric capsule) of sweet orange oil composition for preventing intestinal cancer, which was prescribed in example 4 of the present application, 1 day 2 times 7 years, 1 time. Except for oral administration, the enema is kept for 15 days (1 time) every year, the defecation is regular, smooth and smooth, no relapse occurs, and the enema is still taken till now.
Although the number of the testers is small and the test data is not complete, the positive effect and the application prospect of the sweet orange oil composition on preventing intestinal cancer are seen, and meanwhile, the patent results of the research of the predecessor and the invention of the CN106890140B d-limonene anti-cancer synergistic composition and the preparation method thereof invented by the patent technical researchers are proved.
The above examples and the description of the application method (recipe) are more detailed and illustrate the application of the sweet orange oil composition from different points of view, but should not be construed as limiting the scope of the present invention. It should be noted that the teaching and teaching of the present invention, especially the application of sweet orange oil (d-limonene) to enhance intestinal motility, aid defecation and prevent intestinal cancer, can be modified without departing from the spirit of the present invention, and all such modifications and improvements are within the scope of the present invention.

Claims (10)

1. The sweet orange oil composition for enhancing intestinal motility is characterized by comprising the following raw oil in percentage by weight:
10-85% of hemp seed oil;
10-80% of sweet orange oil;
5-20% of radish seed oil.
2. The intestinal motility enhancing sweet orange oil composition according to claim 1, wherein the composition consists of the following raw oil in percentage by weight:
50% of hemp seed oil;
sweet orange oil 40%;
10 percent of radish seed oil.
3. The intestinal motility enhancing sweet orange oil composition according to claim 1, wherein the composition consists of the following raw oil in percentage by weight:
75% of hemp seed oil;
20% of sweet orange oil;
5 percent of radish seed oil.
4. The intestinal motility enhancing sweet orange oil composition according to claim 1, wherein the composition consists of the following raw oil in percentage by weight:
85% of hemp seed oil;
10% of sweet orange oil;
5 percent of radish seed oil.
5. The intestinal motility enhancing sweet orange oil composition according to claim 1, wherein the composition consists of the following raw oil in percentage by weight:
40% of hemp seed oil;
50% of sweet orange oil;
10 percent of radish seed oil.
6. The intestinal motility enhancing sweet orange oil composition according to claim 1, wherein the composition consists of the following raw oil in percentage by weight:
60% of hemp seed oil;
20% of sweet orange oil;
radish seed oil 20%.
7. The intestinal motility-enhancing sweet orange oil composition according to any one of claims 1 to 6, wherein the composition can be prepared into a normal soft capsule, an enteric capsule, an oral liquid or an enema preparation; wherein the content of the composition in the common soft capsule or the enteric hard capsule is 0.3g, 0.5g or 1 g; the volume of the composition in the oral liquid is 2mL, 5mL or 10 mL.
8. Use of the sweet orange oil composition for enhancing intestinal motility according to claim 1 for preparing a food, a health product or a pharmaceutical product for treating constipation, wherein the constipation may be constipation due to insufficient intestinal motility, general constipation, constipation in children or postpartum constipation.
9. Use of the sweet orange oil composition for enhancing intestinal motility according to claim 1 in the preparation of food, health product or medicine for preventing intestinal cancer.
10. Use of the sweet orange oil composition for enhancing intestinal motility according to claim 1 in the preparation of food, health care product or medicine for preventing or treating intestinal obstruction.
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* Cited by examiner, † Cited by third party
Title
蒋伟哲等: "火麻油软胶囊润肠通便作用的实验研究", 《中国现代应用药学杂志》 *

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Application publication date: 20210611