CN106994141B - Traditional Chinese medicine composition for treating constipation and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating constipation and preparation method thereof Download PDF

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CN106994141B
CN106994141B CN201610048579.8A CN201610048579A CN106994141B CN 106994141 B CN106994141 B CN 106994141B CN 201610048579 A CN201610048579 A CN 201610048579A CN 106994141 B CN106994141 B CN 106994141B
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constipation
ethanol
traditional chinese
chinese medicine
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CN106994141A (en
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肖艳皎
郑少辉
李刚
刘瑞东
易斌
易怀东
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Beijing Silian Pharmaceutical Industry Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232Angelica
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/31Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481Astragalus (milkvetch)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/60Moraceae (Mulberry family), e.g. breadfruit or fig
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/63Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • A61K36/638Ligustrum, e.g. Chinese privet
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/64Orobanchaceae (Broom-rape family)
    • AHUMAN NECESSITIES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/72Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
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    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/37Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps

Abstract

The invention discloses a traditional Chinese medicine composition for treating constipation and a preparation method thereof. The effective components of the traditional Chinese medicine composition are prepared from the following medicinal materials in parts by weight: 5-40 parts of seabuckthorn leaves, 2-20 parts of cistanche, 2-20 parts of fructus cannabis, 2-30 parts of astragalus membranaceus, 2-20 parts of glossy privet fruit, 5-20 parts of angelica sinensis, 3-10 parts of hovenia dulcis thumb and 1-10 parts of fried radish seeds. The Chinese medicinal composition has effects of invigorating spleen and kidney, enhancing immunity, and loosening bowel to relieve constipation, and is safe and has no adverse side effect.

Description

Traditional Chinese medicine composition for treating constipation and preparation method thereof
Technical Field
The invention belongs to the field of traditional Chinese medicines. More particularly, relates to a traditional Chinese medicine composition for treating constipation and a preparation method thereof.
Background
Constipation is short for constipation, and constipation is called constipation when the stool stays in the intestinal tract for too long, the defecation time is prolonged, and the defecation time is less than 3 times per week. Constipation is a common symptom in clinic, but although not a big disease, it has great harm to human body, even can be fatal. Constipation has the most common effect on the digestive system, and can cause abdominal distension, abdominal pain, excessive exhaust, inappetence, dyspepsia, rectal ulcer and the like, so that the incidence rate of intestinal cancer can be increased; in addition, constipation can cause autotoxicity, cause mental and endocrine disorders, cause facial darkness, acne, headache, vexation, insomnia, irritable bowel syndrome, dry stool, cause difficulty in defecation, cause increased abdominal pressure and blood pressure, and induce angina pectoris, arrhythmia, myocardial infarction, cerebral infarction, etc. In addition, severe constipation can also cause acute bowel wall necrosis, rupture, perforation, torsion, and death in severe cases. Therefore, constipation is a healthy enemy.
It is generally believed that constipation is caused by a combination of age, decreased food intake and physical activity of the body, decreased gastrointestinal secretion, decreased colonic tension and motility, and decreased rectal-anal canal migration in the anal pad area, decreased epithelial sensitivity, and the like. The theory of traditional Chinese medicine considers that the occurrence of constipation mainly comes from insufficient body fluids in the body and the lack of nourishment of the intestinal tract, thus stagnation is formed. In the golden season, the famous doctor Lidongyuan in the theory of spleen and stomach and spleen-stomach Shengshui means that the deficiency of both spleen and stomach is the disease. It is characterized by insufficiency of yang-qi and excess of yin-qi, so nine orifices are obstructed, all yang-qi is rooted in yin-blood, yin-blood is exuberant by fire, yin-exuberance is superior to yang-qi, yang-channel is not moving, and qi for growing hair and rising is absent. Fire hidden in blood dissipates true yin and causes insufficient body fluid, which can lead to constipation. When the spleen and stomach are damaged by the homologous body fluids and blood, the transportation and transformation disorders may cause the acquired origin, blood system is dry and astringent, and the intestine loses its moistening property, resulting in constipation. Lidongyuan for treating constipation is mainly based on weakness of spleen and stomach and unsmooth blood, mainly nourishes, ascends and moistens, and can obtain satisfactory curative effect.
At present, the prevalence rate of constipation is on a gradual rising trend along with the influence of various aspects such as the dietary structure, spirit and social factors of residents. The incidence of constipation is generally higher in developed countries than in developing countries from a global perspective. The prevalence rate of constipation of common adult people in China reported in the literature at present is 3.19% -11.6%, wherein the prevalence rate of functional constipation is 6%. The incidence of the disease is obviously higher in women than in men. Adult constipation people have constipation due to weakness of the spleen and the stomach and incapability of transporting and transforming the coarse cereals. Especially, the elderly, who are high-incidence people with constipation, have a total incidence of 11.5%, and the incidence of the disease is increasing with the age. The traditional Chinese medicine considers that the constipation of the old is caused by deficiency of qi and blood, yin and yang, the hypofunction of viscera, weakness of spleen and stomach, deficiency of qi and blood and weakness of large intestine due to qi deficiency. The blood deficiency causes the intestine to be unwetted, and the yin and body fluids are deficient, which causes the body fluids to be deficient and the intestine to be dry, the yang deficiency causes the yin-cold to be abundant internally, the dregs are astringed and unable to descend, thus causing constipation.
The treatment method of constipation mainly comprises diet adjustment, exercise therapy, defecation guidance, psychological adjustment and nursing, drug therapy, operation therapy and the like. Of these, the first 4 methods are fundamental treatments and require long-term adherence. The inefficiency and recurrence rate of surgical treatment are high, the symptoms can be relieved only in a short time, the cost is high, and the patient can not be identified. Therefore, the drug therapy is the most frequently used method at present, but the drug therapy basically takes purgative drugs as main components, although the effect is quick, the side effects are more, the drug dependence is easy to generate after long-term administration, and the symptoms can be relieved only by short-term administration, for example, the old and the weak patients and the patients with weak spleen and stomach use the drugs, the illness condition of the patients is actually aggravated, so that the development of a safe and effective health product is very necessary.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating constipation, which has the remarkable effects of tonifying spleen and kidney, enhancing immunity and relaxing bowel by selecting proper medicinal and edible raw materials and a mixture ratio thereof, and is safe and free of toxic and side effects.
The second purpose of the invention is to provide a preparation method of the traditional Chinese medicine composition for treating constipation.
The third purpose of the invention is to provide a medicine for treating constipation, which comprises the traditional Chinese medicine composition.
In order to achieve the purpose, the invention adopts the following technical scheme:
the invention provides a traditional Chinese medicine composition for constipation, which comprises the following effective components in parts by weight: 5-40 parts of seabuckthorn leaves, 2-20 parts of cistanche, 2-20 parts of fructus cannabis, 2-30 parts of astragalus membranaceus, 2-20 parts of glossy privet fruit, 5-20 parts of angelica sinensis, 3-10 parts of hovenia dulcis thumb and 1-10 parts of fried radish seeds.
Furthermore, the effective components can also be prepared from the following medicinal materials in parts by weight: 5-30 parts of seabuckthorn leaves, 2-18 parts of cistanche, 2-15 parts of fructus cannabis, 2-20 parts of astragalus membranaceus, 2-15 parts of glossy privet fruit, 5-15 parts of angelica sinensis, 5-8 parts of hovenia dulcis thunb and 1-8 parts of fried radish seeds.
Folium Hippophae: is dried leaf of Hippophae rhamnoides L (Hippophae rhamnoides L.) belonging to genus Hippophae of family Elaeagnaceae. Sour, astringent and warm in nature and flavor, and enter spleen, stomach, lung and heart meridians. Has effects of invigorating spleen, resolving food stagnation, relieving cough, eliminating phlegm, promoting blood circulation, and removing blood stasis, and can be used for treating spleen deficiency, anorexia, abdominal pain due to dyspepsia, cough, excessive phlegm, thoracic obstruction, cardialgia, blood stasis, amenorrhea, and traumatic injury. Folium Hippophae contains flavonoids as main active ingredients, wherein quercetin, isorhamnetin, kaempferol and its glycosides rutin are used as main ingredients. Has effects in relieving myocardial ischemia and arrhythmia, improving anoxia tolerance, reducing serum cholesterol, inhibiting platelet aggregation, resisting ulcer, tumor, inflammation, allergy, oxidation, aging, radiation, bacteria and virus. The total flavone content of the sea-buckthorn leaves is reported to be obviously higher than that of other medicinal parts of sea-buckthorn.
Cistanche deserticola: is succulent stem of Cistanche deserticola (Cistanche Deserticola Y.C.Ma) or Cistanche tubulosa (Cistanche tubulosa (Schenk) light) belonging to family Orobanchaceae. Sweet, salty and warm in nature and taste. It enters kidney and large intestine meridians. Has effects in invigorating kidney yang, nourishing blood and essence, and loosening bowel to relieve constipation. Can be used for treating kidney yang deficiency, essence and blood deficiency, sexual impotence, infertility, soreness of waist and knees, weakness of tendons and bones, intestinal dryness, and constipation.
Fructus cannabis: is dry mature fruit of Cannabis sativa L. Sweet in flavor and neutral in nature, enter spleen, stomach and large intestine meridians, moisten intestines for relaxing bowels and nourish deficiency. Is suitable for the elderly, puerpera, and patients with constipation due to intestinal dryness due to deficiency of body fluid and blood. There is literature (progress in research on chemical composition and pharmacological activity of joghaibo, simondon, hemp seed, chinese folk medicine, 2010,15:56-57) showing: cannabinols are addictive and toxic components of the hemp seed, mainly in the leaves, stems and roots, in the nuts at very low levels and mostly in the pericarp. In order to reduce the addiction of the product, the prescription is preferably fructus Cannabis without pericarp.
Astragalus root: is dried root of Astragalus membranaceus bge or Astragalus membranaceus bge of Leguminosae. It is sweet and warm in nature, entering lung and spleen meridians. Has effects in invigorating qi, invigorating yang, consolidating superficial resistance, arresting sweating, inducing diuresis, relieving swelling, promoting fluid production, nourishing blood, activating stagnancy, relieving arthralgia, removing toxic substance, expelling pus, healing sore, and promoting granulation. The astragalus can promote the metabolism of organisms, resist fatigue and promote the renewal of serum and liver proteins; has obvious diuretic effect, and can eliminate urine protein of experimental nephritis; can improve anemic animal phenomena; can increase hypoglycemia and reduce hyperglycemia; the respiration can be excited; can enhance and regulate organism immunity, promote interferon system, and improve disease resistance of organism; the astragalus can prolong the peak potential release time of the small intestine, improve the blood circulation of smooth muscle of the intestinal canal and promote the excitation and movement of the small intestine.
Glossy privet fruit: is dried fruit of Ligustrum lucidum Ait (Ligustrum lucidum Ait.) belonging to Ligustrum genus of Oleaceae family. Sweet in nature, cool, bitter in taste, entering liver and kidney meridians. Has effects in nourishing liver and kidney, improving eyesight, blackening hair, and strengthening waist and knees. Can be used for treating yin deficiency, internal heat, dizziness, blurred vision, tinnitus, soreness of waist and knees, and premature gray hair.
Chinese angelica: is root of Angelica gigas nakai (Angelica sinensis (Oliv.) Diels) belonging to family Pacifoliaceae. Sweet, pungent and warm in flavor. It enters liver, heart and spleen meridians. Has effects in replenishing blood, promoting blood circulation, regulating menstruation, relieving pain, and loosening bowel to relieve constipation. Can be used for treating blood deficiency, sallow complexion, giddiness, palpitation, menoxenia, amenorrhea, dysmenorrhea, asthenia cold, abdominal pain, constipation due to intestinal dryness, rheumatalgia, traumatic injury, superficial infection, pyocutaneous disease, etc.
Raisin tree seed: is fruit with fleshy fruit stem of Hovenia dulcis Thunb of Rhamnaceae. The medicinal effect was first seen in Tang Ben Cao. Li Shizhen (compendium of materia Medica) considers that it is an ideal fruit for diabetics, which is sweet in taste, mild in nature, non-toxic, has the effects of quenching thirst, relieving restlessness, removing diaphragm heat, moistening five internal organs, and facilitating urination and defecation, and is the same as honey.
Radish seed: is dried mature seed of Raphanus sativus L (Raphanus sativus L.) belonging to family Brassicaceae. Pungent and sweet in property and mild in flavor. It enters lung, spleen and stomach meridians. Has effects in promoting digestion, relieving flatulence, lowering qi, and eliminating phlegm. Can be used for treating food stagnation, abdominal pain, constipation, stagnation, dysentery, phlegm accumulation, cough and asthma. The stir-fried radish seeds are preferred in the invention, and have the characteristics of rising raw materials, cooking and descending, so that the stir-fried radish seeds have the effects of descending qi and relieving depression without damaging yin, and have the effects of descending qi and relaxing bowels superior to those of immature bitter orange magnolia officinalis.
The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
(1) pulverizing fructus Cannabis and Raphani semen (parched) to obtain coarse powder mixture, and extracting with supercritical CO2Extracting to obtain oil for later use;
(2) soaking herba cistanches, radix astragali, radix Angelicae sinensis, semen Hoveniae, fructus Ligustri Lucidi and folium Hippophae in 6-10 times of water for at least 1 hr, then decocting in sealed condition for 2-3 times (0.5-2 hr each time), mixing decoctions, adding ethanol to make the ethanol content in the decoction reach 50% -70%, standing overnight, collecting supernatant, concentrating to relative density of 1.0-1.2 at 60 deg.C, and drying to obtain extract;
(3) mixing the oil obtained in step (1) and the extract obtained in step (2) to obtain the effective component.
Further, in the above method, the drying is spray drying, reduced pressure drying or fluidized bed drying.
The invention also provides a medicine for treating constipation, which comprises the traditional Chinese medicine composition, and further, in order to facilitate use and carrying, the medicine can also comprise pharmaceutically acceptable auxiliary materials, and various dosage forms can be prepared by a conventional process.
Further, the pharmaceutically acceptable auxiliary materials comprise one or more of starch, microcrystalline cellulose, sucrose, dextrin, lactose, glucose, sodium chloride, sodium carboxymethylcellulose, crosslinked polyvinylpyrrolidone, magnesium stearate, aerosil, vitamin C, citric acid, sodium sulfite, xylitol, polyethylene glycol, simple syrup, calcium hydrogen phosphate, silicon dioxide, ethanol, sodium benzoate and tween 80.
In the present invention, the dosage form of the medicament for treating constipation is preferably an oral preparation, including but not limited to tablets, capsules, granules, pills, syrups or oral liquids.
The invention has the following beneficial effects:
the pharmaceutical composition and the preparation thereof have obvious function of relaxing bowels, and are safe and have no toxic or side effect. The product has the effects of tonifying and nourishing, nourishing and moistening, nourishing spleen and kidney, moistening intestine and relaxing bowels by fructus cannabis, invigorating qi and nourishing yin, replenishing blood and moistening intestine, and relieving flatulence and swelling by semen raphani, and has the effects of tonifying kidney and spleen, and relaxing bowels by nourishing yin and strengthening spleen. The formula has the effects of reinforcing and counteracting the pathogen simultaneously, treats both principal and secondary aspects of diseases, and is particularly suitable for patients with deficiency of spleen-stomach qi or old physical weakness. The selected medicinal materials are medicinal and edible materials, are safe and effective to eat, have a certain prevention effect, and can be taken for a long time. Is suitable for the old and the weak spleen and kidney patients such as the weak body, the weak body due to long-term illness and the like, has great value in clinical application and is worthy of clinical popularization and application.
Detailed Description
In order to more clearly illustrate the invention, the invention is further described below in connection with preferred embodiments. It is to be understood by persons skilled in the art that the following detailed description is illustrative and not restrictive, and is not to be taken as limiting the scope of the invention.
Example 1
20 parts of seabuckthorn leaves, 15 parts of cistanche, 10 parts of fructus cannabis, 15 parts of astragalus membranaceus, 10 parts of glossy privet fruit, 12 parts of angelica, 10 parts of hovenia dulcis thunb and 8 parts of fried radish seed
The preparation method comprises the following steps:
1) pulverizing fructus Cannabis and Raphani semen (parched), sieving with No. 2 sieve to obtain coarse powder mixture, and subjecting to supercritical CO2Extracting to obtain oil for later use;
2) taking cistanche, astragalus, angelica, hovenia dulcis thunb, glossy privet fruit and sea backthern leaves according to the prescription amount, adding 10 times of pure water for soaking for 1 hour, then carrying out closed decoction for 2 times, each time for 1 hour, combining the decoction, adding a proper amount of ethanol to ensure that the ethanol content in the decoction reaches 50%, standing overnight, taking the supernatant, recovering the ethanol, concentrating to the relative density of 1.0-1.2 at the temperature of 60 ℃, and carrying out spray drying to obtain an extract for later use;
3) mixing the oil obtained by the process of the step 1) and the extract powder obtained by the process of the step 2) to obtain an effective component; mixing the effective components with appropriate amount of microcrystalline cellulose, lactose, and croscarmellose sodium, adding wetting agent to prepare soft material, granulating, drying, grading, making into capsule, and packaging to obtain capsule.
Example 2
30 parts of seabuckthorn leaves, 15 parts of cistanche, 15 parts of fructus cannabis, 30 parts of astragalus membranaceus, 12 parts of glossy privet fruit, 15 parts of angelica, 10 parts of hovenia dulcis thunb and 8 parts of fried radish seed
The preparation method comprises the following steps:
1) pulverizing fructus Cannabis and Raphani semen (parched), sieving with No. 2 sieve to obtain coarse powder mixture, and subjecting to supercritical CO2Extracting to obtain oil for later use;
2) taking cistanche, astragalus, angelica, hovenia dulcis thunb, glossy privet fruit and sea backthern leaves according to the prescription amount, adding 8 times of pure water for soaking for 2 hours, then carrying out closed decoction for 2 times, each time for 1 hour, combining the decoction, adding a proper amount of ethanol to ensure that the ethanol content in the decoction reaches 70%, standing overnight, taking the supernatant, recovering the ethanol, concentrating to the relative density of 1.0-1.2 at the temperature of 60 ℃, and drying under reduced pressure to obtain an extract for later use;
3) mixing the oil obtained by the process of the step 1) and the extract powder obtained by the process of the step 2) to obtain an effective component; mixing the effective components with appropriate amount of microcrystalline cellulose, lactose, crosslinked sodium carboxymethyl cellulose, calcium hydrogen phosphate, and silicon dioxide, granulating with dry granulating machine, and sieving with 20 mesh sieve;
4) mixing the prepared granules with sodium croscarmellose and magnesium stearate, adjusting tablet weight and hardness, tabletting, and packaging to obtain tablet.
Example 3
Folium Hippophae 10 parts, Cistanchis herba 10 parts, fructus Cannabis 8 parts, radix astragali 8 parts, fructus Ligustri Lucidi 5 parts, radix Angelicae sinensis 8 parts, semen Hoveniae 5 parts, and Raphani semen (parched) 4 parts
The preparation method comprises the following steps:
1) pulverizing fructus Cannabis and Raphani semen (parched), sieving with No. 2 sieve to obtain coarse powder mixture, and subjecting to supercritical CO2Extracting to obtain oil for later use;
2) taking cistanche, astragalus, angelica, hovenia dulcis thunb, glossy privet fruit and sea backthern leaves according to the prescription amount, adding 6 times of pure water for soaking for 1 hour, then carrying out closed decoction for 2 times, each time for 1 hour, combining the decoction, adding a proper amount of ethanol to ensure that the ethanol content in the decoction reaches 65%, standing overnight, taking the supernatant, recovering the ethanol, concentrating to the relative density of 1.0-1.2 at the temperature of 60 ℃, and drying by a fluidized bed to obtain an extract for later use;
3) mixing the oil obtained by the process of the step 1) and the extract powder obtained by the process of the step 2) to obtain an effective component; mixing the effective components with appropriate amount of sucrose and dextrin, preparing soft material with water, granulating, drying, grading, and packaging to obtain granule.
Example 4
15 parts of seabuckthorn leaves, 10 parts of cistanche, 10 parts of fructus cannabis, 8 parts of astragalus membranaceus, 6 parts of glossy privet fruit, 10 parts of angelica, 10 parts of hovenia dulcis thunb and 8 parts of fried radish seed
The preparation method comprises the following steps:
1) pulverizing fructus Cannabis and Raphani semen (parched), sieving with No. 2 sieve to obtain coarse powder mixtureUsing supercritical CO2Extracting to obtain oil for later use;
2) taking cistanche, astragalus, angelica, hovenia dulcis thunb, glossy privet fruit and sea backthern leaves according to the prescription amount, adding 10 times of pure water to soak for 1 hour, then carrying out closed decoction for 2 times, each time for 1 hour, combining the decoction, adding a proper amount of ethanol to ensure that the ethanol content in the decoction reaches 65%, standing overnight, taking the supernatant, recovering the ethanol, concentrating to the relative density of 1.0-1.2 at the temperature of 60 ℃, and carrying out spray drying to obtain an extract for later use;
3) mixing the oil obtained in step 1) with microcrystalline cellulose (PH-102NF type) and calcium hydrogen phosphate, adding silicon dioxide and magnesium stearate, mixing, adjusting tablet weight and pressure, and making into tablet 1.
4) Mixing the extract obtained in step 2) with appropriate amount of microcrystalline cellulose, lactose, and croscarmellose sodium, granulating with dry granulating machine, sieving with 20 mesh sieve, mixing the granules with magnesium stearate, adjusting tablet weight and hardness, and tabletting to obtain tablet 2.
5) And (3) filling the tablets 1 and 2 into a 00# capsule, and carrying out aluminum-plastic packaging to obtain the capsule.
Example 5
25 parts of seabuckthorn leaves, 15 parts of cistanche, 10 parts of fructus cannabis, 20 parts of astragalus membranaceus, 10 parts of glossy privet fruit, 10 parts of angelica sinensis, 10 parts of hovenia dulcis thunb and 8 parts of fried radish seed
The preparation method comprises the following steps:
1) pulverizing fructus Cannabis and Raphani semen (parched), sieving with No. 2 sieve to obtain coarse powder mixture, and subjecting to supercritical CO2Extracting to obtain oil for later use;
2) taking cistanche, astragalus, angelica, hovenia dulcis thunb, glossy privet fruit and sea backthern leaves according to the prescription amount, adding 10 times of pure water for soaking for 1 hour, then carrying out closed decoction for 2 times, each time for 1 hour, combining the decoction, adding a proper amount of ethanol to ensure that the ethanol content in the decoction reaches 50%, standing overnight, taking the supernatant, recovering the ethanol, concentrating to the relative density of 1.0-1.2 at the temperature of 60 ℃, and carrying out spray drying to obtain an extract for later use;
3) dissolving xanthan gum with purified water, adding tween 80 after completely dissolving, and shaking to obtain emulsifier;
4) dissolving the extract obtained in the step 2) in a mixture of purified water and ethanol, adding an emulsifier after complete dissolution, and stirring uniformly to obtain a mixed solution of a water phase and the emulsifier for later use;
5) stirring the mixed solution obtained in the step 4) at a constant speed, slowly adding the oil solution obtained in the step 1) into the mixed solution, and starting an emulsifying machine to emulsify after the oil solution is completely added to obtain the oral liquid.
Example 6
30 parts of seabuckthorn leaves, 15 parts of cistanche, 15 parts of fructus cannabis, 20 parts of astragalus membranaceus, 10 parts of glossy privet fruit, 8 parts of angelica, 8 parts of hovenia dulcis thunb and 8 parts of fried radish seed
The preparation method comprises the following steps:
1) pulverizing fructus Cannabis and Raphani semen (parched), sieving with No. 2 sieve to obtain coarse powder mixture, and subjecting to supercritical CO2Extracting to obtain oil for later use;
2) taking cistanche, astragalus, angelica, hovenia dulcis thunb, glossy privet fruit and sea backthern leaves according to the prescription amount, adding 10 times of pure water for soaking for 1 hour, then carrying out closed decoction for 2 times, each time for 1 hour, combining the decoction, adding a proper amount of ethanol to ensure that the ethanol content in the decoction reaches 50%, standing overnight, taking the supernatant, recovering the ethanol, concentrating to the relative density of 1.0-1.2 at the temperature of 60 ℃, and carrying out spray drying to obtain an extract for later use;
3) mixing the oil solution obtained in the step 1) and the extract obtained in the step 2), adding a proper amount of 5% sodium carboxymethylcellulose aqueous solution to prepare a soft material, adding into an extrusion spheronizer to prepare a mother pill, and putting the prepared mother pill into the spheronizer to carry out spheronization treatment to obtain the pill.
Example 7
20 parts of seabuckthorn leaves, 15 parts of cistanche, 10 parts of fructus cannabis, 15 parts of astragalus membranaceus, 10 parts of glossy privet fruit, 8 parts of angelica, 8 parts of hovenia dulcis thunb and 8 parts of fried radish seed
The preparation method comprises the following steps:
1) pulverizing fructus Cannabis and Raphani semen (parched), sieving with No. 2 sieve to obtain coarse powder mixture, and subjecting to supercritical CO2Extracting to obtain oil for later use;
2) taking cistanche, astragalus, angelica, hovenia dulcis thunb, glossy privet fruit and sea backthern leaves according to the prescription amount, adding 10 times of pure water for soaking for 1 hour, then carrying out closed decoction for 2 times, each time for 1 hour, combining the decoction, adding a proper amount of ethanol to ensure that the ethanol content in the decoction reaches 50%, standing overnight, taking the supernatant, recovering the ethanol, concentrating to the relative density of 1.0-1.2 at the temperature of 60 ℃, and carrying out spray drying to obtain an extract for later use;
3) taking the extract obtained in the step 2), adding a proper amount of purified water for dissolving, adding cane sugar to saturation after complete dissolution, and filtering to obtain filtrate for later use;
4) mixing ethanol with the oil solution obtained in the step 1), adding into the filtrate obtained in the step 3), and stirring to obtain syrup.
Test example 1 clinical observation of treatment of constipation with the drug of the present invention
General data: 80 patients (45 men and 35 women, age 40-81 years) in this group were randomly divided into experimental group A, experimental group B, experimental group C, experimental group D, and control group (taking Fusong), and each group had 16 patients.
Experimental group a: the laxative preparation obtained in example 1 was administered 2 times a day, 3 granules at a time;
experimental group B: the difference from the formula of the embodiment 1 is that the formula is free of cistanche salsa, the dosage of the seabuckthorn leaves is 35 parts, and the cathartic preparation is prepared according to the method of the embodiment 1, 2 times a day and 3 grains at a time;
experimental group C: the difference from the formula of the embodiment 1 is that the formula is free of angelica, the dosage of astragalus is increased to 27 parts, and the laxative preparation is prepared according to the method of the embodiment 1, 2 times a day and 3 granules at a time;
experimental group D: the formula of the embodiment 1 is prepared into a daily dosage by a conventional decocting method, and the steps comprise: soaking with water for 30min, decocting with strong fire, and decocting with slow fire for 30 min; filtering to obtain filtrate, adding water, decocting, and decocting with strong fire for the second time, and then with slow fire for 20 min. The two times of medicine liquid are mixed together, and about two bowls of medicine liquid are taken for 2 times, and the medicine liquid is taken after one day. Decocting one dose before taking every day;
control group: fusong (polyethylene glycol 4000 powder), 10g each time 2 times a day;
sex, age, course of disease, and disease degree of 5 groups of patients are measured by X2The difference is not statistically significant (P) by inspection>0.05), comparable.
The method comprises the following steps: the daily symptoms and changes were observed for each group of subjects after oral administration of each drug. The observation period was half a month.
And (3) judging the curative effect: the clinical symptom score criterion was (1) the defecation interval: 0min for 48h or less, 2 min for 48-72 h, 4 min for 72h or more, (2) defecation time: 0min is less than or equal to 5min, 2 min is 5-10 min, 4 min is more than or equal to 10min (3) stool characters: the standard for the treatment effect is that the patients who are not dry in shape are divided into 0 score, the patients who are dry in stool are divided into 2 score, the patients who are dry in stool like sheep manure are divided into 4 score: and (3) healing: the stools returned to normal, all symptoms disappeared and the score dropped to 0. The effect is shown: the stool is normal or basically normal, the stool interval time is within 48h, other symptoms basically disappear, and the score is reduced by more than or equal to 2/3. The method has the following advantages: the stool dryness and hardness degree is obviously improved, the defecation interval time is shortened by 24 hours, other symptoms are obviously improved, and the integral is reduced between 1/3 and 2/3. And (4) invalidation: the stool condition is not improved, the defecation interval time is not changed, other symptoms are not improved, and the integral reduction is less than or equal to 1/3.
The clinical results are shown in the following table:
TABLE 1 comparison of the two therapeutic effects
The main component of the Fusong is polyethylene glycol 4000, which belongs to osmotic cathartic and has the functions of moistening, softening stool and stimulating colon, compared with a control group, the cure rate and the total effective rate of the experimental group A are obviously higher than those of the control group, and no adverse reaction of abdominal pain and diarrhea exists; compared with the experimental group B, C, the curative effect is better than that of the B, C group, which shows that the experimental group A has reasonable formula and has synergistic effect among the medicinal materials; compared with the experimental group D, the experimental group A has better results than the experimental group D, which shows that the oily part in the formula is independently extracted, and the oily component is enriched, thereby being beneficial to improving the curative effect of the product.
Test example 2: the influence of the product on the intestinal movement of constipation-treated mice
Animals: healthy Kunming mice with the weight of 18-22g and 60 mice with half male and female parts (provided by Beijing Wittingli laboratory animals company) are selected;
reagent: compound diphenoxylate tablet (manufacturer, batch number), active carbon and gelatin.
Experimental group drugs:
experimental group a: the pharmaceutical preparation granules of the invention are prepared according to the above example 3, and are administrated by gastric gavage according to the ratio of 7.45g crude drug/kg;
experimental group B: the difference from the formula in the embodiment 3 is that the formula is free of cistanche, the dosage of the seabuckthorn leaves is 20 parts, the cathartic preparation is prepared according to the method in the embodiment 3, and the cathartic preparation is administrated by gastric lavage according to 7.45g crude drugs/kg;
experimental group C: the difference from the formula in the embodiment 3 is that the formula is free of angelica, the dosage of the astragalus is 16 parts, the cathartic preparation is prepared according to the method in the embodiment 3, and the preparation is administrated according to the stomach irrigation of 7.45g crude drugs/kg;
1) preparing ink: accurately weighing 10g of gelatin, grinding in a grinding bowl, adding 50ml of distilled water, boiling until the solution is transparent, adding 5g of accurately weighed activated carbon, boiling again, adding distilled water after the solution is cooled to constant volume of 100ml, and shaking uniformly before use.
2) Preparation of 0.25% compound diphenoxylate suspension: taking 25mg of compound diphenoid tablets, grinding into powder by using a mortar, adding distilled water to a constant volume of 100mL, and preparing before use.
The method comprises the following steps:
after 7 days of acclimatization, 60 mice were randomly divided into 5 groups of 12 mice each. Respectively a blank control group, a model group (compound diphenoxylate group), an experimental group A, an experimental group B and an experimental group C. By adopting a gastric perfusion method, a blank control group and a model group are filled with distilled water (0.4 ml/mouse), after a drug group is continuously administered with a test object for 14 days, mice of each group are fasted for 24 hours without water prohibition, and are weighed, and the drug group is administered with the test object, the control group and the model group are administered with the same amount of distilled water. After 30min, the other groups except the blank control group were gavaged with 5mg/kg of compound diphenoxylate. After 30min, each group had 0.4mL of gastric lavage ink per mouse. After 20min, the cervical vertebrae are removed, the animal is killed, the abdomen is opened, the small intestine is taken, the intestinal canal from the pylorus at the upper end, the lower end to the ileocecal part is cut and pulled into a straight line, the whole length of the small intestine and the displacement from the pylorus to the front edge of ink movement are measured, and the ink propulsion rate of the small intestine is calculated.
TABLE 2 Effect on Diphenoate-induced Constipation model mouse intestinal ink propulsion Rate
P <0.01 in comparison to model group
As can be seen from the above table, the intestinal ink propulsion rate of the model group mice is significantly lower than that of the blank control group, indicating that the constipation model is successfully established. Through statistical analysis, the ink propulsion rate of the experimental group A, B, C mouse is higher than that of the model group, which shows that the Chinese ink has the function of promoting the small intestine movement of the mouse. The ink propulsion rate of the experimental group A is far higher than that of the experimental group B and the experimental group C, and the synergistic effect of the medicines of the experimental group A is better than that of the experimental group B and the experimental group C.
It should be understood that the above-mentioned embodiments of the present invention are only examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention, and it will be obvious to those skilled in the art that other variations or modifications may be made on the basis of the above description, and all embodiments may not be exhaustive, and all obvious variations or modifications may be included within the scope of the present invention.

Claims (9)

1. The traditional Chinese medicine composition for treating constipation is characterized in that the effective components are prepared from the following medicinal materials in parts by weight: 5-40 parts of seabuckthorn leaves, 2-20 parts of cistanche, 2-20 parts of fructus cannabis, 2-30 parts of astragalus membranaceus, 2-20 parts of glossy privet fruit, 5-20 parts of angelica sinensis, 3-10 parts of hovenia dulcis thumb and 1-10 parts of fried radish seeds;
and is prepared by the following steps:
(1) pulverizing fructus Cannabis and parched Raphani semen to obtain coarse powder mixture, and extracting with supercritical CO2Extracting to obtain oil for later use;
(2) soaking herba cistanches, radix astragali, radix Angelicae sinensis, semen Hoveniae, fructus Ligustri Lucidi and folium Hippophae in 6-10 times of water for at least 1 hr, then decocting in sealed condition for 2-3 times (0.5-2 hr each time), mixing decoctions, adding ethanol to make the ethanol content in the decoction reach 50% -70%, standing overnight, collecting supernatant, concentrating to relative density of 1.0-1.2 at 60 deg.C, and drying to obtain extract;
(3) mixing the oil obtained in step (1) and the extract obtained in step (2) to obtain the effective component.
2. The traditional Chinese medicine composition as claimed in claim 1, wherein the effective components are prepared from the following medicinal materials in parts by weight: 5-30 parts of seabuckthorn leaves, 2-18 parts of cistanche, 2-15 parts of fructus cannabis, 2-20 parts of astragalus membranaceus, 2-15 parts of glossy privet fruit, 5-15 parts of angelica sinensis, 5-8 parts of hovenia dulcis thumb and 1-8 parts of fried radish seeds.
3. The method for preparing the traditional Chinese medicine composition of claim 1 or 2, which is characterized by comprising the following steps:
(1) pulverizing fructus Cannabis and parched Raphani semen to obtain coarse powder mixture, and extracting with supercritical CO2Extracting to obtain oil for later use;
(2) soaking herba cistanches, radix astragali, radix Angelicae sinensis, semen Hoveniae, fructus Ligustri Lucidi and folium Hippophae in 6-10 times of water for at least 1 hr, then decocting in sealed condition for 2-3 times (0.5-2 hr each time), mixing decoctions, adding ethanol to make the ethanol content in the decoction reach 50% -70%, standing overnight, collecting supernatant, concentrating to relative density of 1.0-1.2 at 60 deg.C, and drying to obtain extract;
(3) mixing the oil obtained in step (1) and the extract obtained in step (2) to obtain the effective component.
4. The method according to claim 3, wherein in the step (2), the drying is spray drying, reduced pressure drying or fluidized bed drying.
5. A medicament for treating constipation, which comprises the Chinese medicinal composition of claim 1 or 2.
6. The medicament of claim 5, further comprising a pharmaceutically acceptable excipient.
7. The medicament according to claim 6, wherein the pharmaceutically acceptable excipients comprise one or more of starch, microcrystalline cellulose, sucrose, dextrin, lactose, glucose, sodium chloride, sodium carboxymethylcellulose, crospovidone, magnesium stearate, aerosil, vitamin C, citric acid and sodium sulfite, xylitol, polyethylene glycol, simple syrup, calcium hydrogen phosphate, silicon dioxide, ethanol, sodium benzoate, Tween 80.
8. The medicament of claim 5, wherein the medicament is in a form of an oral preparation.
9. The medicament of claim 8, wherein the oral preparation is a tablet, a capsule, a granule, a pill, a syrup or an oral liquid.
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