CN115137788B - Traditional Chinese medicine composition with intestine moistening and bowel relaxing functions and preparation method and application thereof - Google Patents

Traditional Chinese medicine composition with intestine moistening and bowel relaxing functions and preparation method and application thereof Download PDF

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CN115137788B
CN115137788B CN202210732425.6A CN202210732425A CN115137788B CN 115137788 B CN115137788 B CN 115137788B CN 202210732425 A CN202210732425 A CN 202210732425A CN 115137788 B CN115137788 B CN 115137788B
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traditional chinese
chinese medicine
medicine composition
oral liquid
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CN115137788A (en
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海洋
徐兰
任珂
冯晓莉
刘东玲
唐凤彪
李兴浩
白旭
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Gansu University of Chinese Medicine
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/39—Convolvulaceae (Morning-glory family), e.g. bindweed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/43—Cuscutaceae (Dodder family), e.g. Cuscuta epithymum or greater dodder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/535—Perilla (beefsteak plant)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/64—Orobanchaceae (Broom-rape family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A61K36/804—Rehmannia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815—Lycium (desert-thorn)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8965—Asparagus, e.g. garden asparagus or asparagus fern
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation 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
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation 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
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition with a bowel relaxing function and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1-10 parts of almond, 2-20 parts of asparagus, 1.5-15 parts of rehmannia root, 1-10 parts of cistanche, 1.5-15 parts of medlar, 1.5-15 parts of white poria, 1-10 parts of perilla seed and 1-10 parts of semen cuscutae, wherein compared with a model control group, the traditional Chinese medicine composition has obvious effect of relaxing bowel and can be used as a pharmaceutical composition or health care product for relaxing bowel; the traditional Chinese medicine composition oral liquid is prepared by decocting and concentrating medicinal materials into decoction based on the original prescription pill, and then is modified into oral liquid by alcohol precipitation so as to improve the curative effect and facilitate carrying and storage.

Description

Traditional Chinese medicine composition with intestine moistening and bowel relaxing functions and preparation method and application thereof
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition with a bowel relaxing function and a preparation method and application thereof.
Background
Constipation, also called constipation, is a common digestive system disease with the main symptoms of less times of defecation, long period, dry and hard feces and difficult defecation; some patients also have nonspecific manifestations such as gastralgia, abdominal pain, pelvic pain, and nausea. In recent years, with rapid development of society, complicated dietary structure, bad living habit, and huge psychological stress, the incidence of constipation is increasing. The traditional Chinese medicine considers that constipation is mostly formed by large intestine heat accumulation, qi stagnation, cold coagulation, yin-yang qi and blood deficiency, and abnormal large intestine conduction function. However, senile constipation is usually caused by deficiency of true yin, failure of the warmth to warm up, coagulation of yin evil, or yin deficiency with blood dryness, fluid in the large intestine being withered, failing to transport the boat, and usually due to deficiency.
At present, most of medicines for treating constipation are added with laxative medicines, and the medicines have rapid effect, but have large toxic and side effects, are easy to cause medicine dependence after long-term administration, seriously damage intestinal nerves and further aggravate constipation. For example, the invention patent CN106606550a discloses a traditional Chinese medicine composition for relaxing bowel, a preparation method thereof and a health food, and the traditional Chinese medicine composition for relaxing bowel is prepared from the following raw materials: 15-20 parts of senna leaf, 10-16 parts of Chinese magnoliavine fruit, 6-12 parts of Chinese angelica, 6-12 parts of cistanche deserticola, 6-10 parts of liquorice and 6-10 parts of honey. The senna leaves have the effect of causing diarrhea, and can cause drug dependence; therefore, the laxative medicine which has definite functions, small toxic and side effects and is suitable for long-term administration is developed by taking natural food and Chinese herbal medicines with homology of medicine and food as main raw materials.
The original prescription of the prescription studied in the invention comes from Dunhuang ancient medical prescription, namely a family life-preserving and life-prolonging prescription P.4038 (see document Li Ying, liu Changhua. Almond prescription in Dunhuang medical prescription is used for exploring non-lung disease syndrome [ J ]. Western traditional Chinese medicine, 2013,26 (11): 32-38.) the disclosed prescription comprises the following components: almond, radix asparagi, rehmannia root, hairy antler, dodder seed, medlar, white poria, gleditsia sinensis lam and white honey; the disclosed function is as follows: the formula for curing diseases, preserving health and repairing immortal is important in dispersing lung qi and eliminating phlegm, nourishing yin and tonifying kidney and prolonging life. The gleditsia sinensis in the prescription can ventilate the lung and remove phlegm, so that the qi movement is smooth; almond has effects of resolving phlegm, relieving cough, loosening bowel, and relieving constipation; rehmannia root, pilose antler, semen cuscutae, wolfberry fruit, fructus lycii, for tonifying kidney and strengthening yang to supplement congenital: poria is effective in invigorating spleen, promoting diuresis, nourishing acquired, and radix asparagi is effective in nourishing yin, strengthening bone, and white Mel is effective in invigorating qi and strengthening middle warmer. In view of the health-preserving and life-prolonging prescription, great importance is attached to the regulation of lung, spleen and kidney functions. The medicine is used for recuperating life and increasing strength to prolong life.
The inventor has unexpectedly found in the research process that the Chinese honeylocust fruit in the medicinal flavor is replaced by perilla fruit, the pilose antler with extremely high cost is replaced by cistanche deserticola with Gansu characteristic, and the obtained traditional Chinese medicine composition has the effect of relaxing bowel.
Disclosure of Invention
Aiming at the technical problems, the technical scheme of the invention is as follows:
the invention aims at providing a traditional Chinese medicine composition with a bowel relaxing function, which is prepared from the following raw materials in parts by weight: 1-10 parts of almond, 2-20 parts of asparagus, 1.5-15 parts of rehmannia root, 1-10 parts of cistanche, 1.5-15 parts of medlar, 1.5-15 parts of white poria, 1-10 parts of perilla seed and 1-10 parts of semen cuscutae.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-10 parts of almond, 10-20 parts of asparagus, 7.5-15 parts of rehmannia, 5-10 parts of cistanche, 7.5-15 parts of medlar, 7.5-15 parts of white poria, 5-10 parts of perilla seed and 5-10 parts of semen cuscutae.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of almond, 20 parts of asparagus, 15 parts of rehmannia, 10 parts of cistanche, 15 parts of medlar, 15 parts of white poria, 10 parts of perilla seed and 10 parts of semen cuscutae.
Preferably, the traditional Chinese medicine composition further comprises pharmaceutically acceptable auxiliary materials.
Preferably, the traditional Chinese medicine composition is prepared into tablets, granules, capsules, pills, suppositories, powders, ointments, drops, aerosols, powder mists, oral liquids, suspensions, syrups, mixtures, wines, tea, buccal tablets, freeze-dried powder injection or emulsions.
Preferably, the traditional Chinese medicine composition is in the form of oral liquid.
The second purpose of the invention is to provide a traditional Chinese medicine composition oral liquid with the function of relaxing bowel, and the preparation method of the traditional Chinese medicine composition oral liquid is as follows:
(1) Weighing semen Armeniacae amarum, radix asparagi, rehmanniae radix, cistanchis herba, fructus Lycii, poria, fructus Perillae and semen Cuscutae at a certain proportion, soaking in water, and decocting;
(2) After the decoction is completed, stirring, filtering, combining the filtrates, standing, pouring out the supernatant, and carrying out suction filtration;
(3) After the suction filtration is finished, concentrating the filtrate in water bath to enable the concentration of the filtrate to reach the density of 1.10-1.25;
(4) Precipitating the concentrated solution with ethanol, standing, vacuum filtering after ethanol precipitation, rotary evaporating, and removing ethanol to obtain medicinal liquid.
Preferably, the decoction in the step (1) is 3 times of decoction with 10 times of water, and each time is 1.5 hours; the concentration of the ethanol in the step (4) is 85 percent, the time of ethanol precipitation is 48 hours, and the ethanol precipitation is carried out for 3 times.
The third purpose of the invention is to provide the application of the traditional Chinese medicine composition for relaxing bowel in preparation of medicines with the function of relaxing bowel.
The fourth purpose of the invention is to provide the application of the traditional Chinese medicine composition for relaxing bowel in preparing health care products with the function of relaxing bowel.
The beneficial effects of the invention are as follows: (1) Compared with a model control group, the traditional Chinese medicine composition provided by the invention has obvious effect of relaxing bowel, and can be used as a pharmaceutical composition or health care product for relaxing bowel;
(2) The Chinese medicinal composition disclosed by the invention is prepared from almond serving as a monarch drug, and has the effects of resolving phlegm, relieving cough and relaxing bowel; radix asparagi has effects of nourishing yin, moistening dryness, clearing lung-heat and lowering fire; rehmannia root, cistanche salsa, semen cuscutae and medlar tonify kidney and strengthen yang to tonify congenital; poria invigorates spleen and promotes diuresis for nourishing the postnatal period; fructus Perillae can reduce qi and phlegm, relieve cough and asthma. The compatibility of the above medicines has synergistic effect, and all the medicines complement each other to enhance the curative effect.
(3) The traditional Chinese medicine composition oral liquid disclosed by the invention is prepared by the steps of preparing medicinal materials into decoction by a decoction and concentration method on the basis of the original formula pill, and then preparing the decoction into the oral liquid by alcohol precipitation, so that the curative effect is improved, and the oral liquid is convenient to carry and store.
(4) The invention adopts the traditional water extraction and alcohol precipitation method to prepare the oral liquid, ensures that the interaction among the components is not changed in the traditional extraction process, optimizes the decoction process and the alcohol precipitation process respectively through a twice orthogonal experiment method, and optimizes the optimal decoction condition and alcohol precipitation condition, thereby reducing the loss of active ingredients, and maximizing the drug effect when preparing the preparation. The oral liquid has the advantages of preventing and treating diseases, being convenient for people to take, having small oral dosage, being convenient for taking, being convenient for carrying, transporting and storing, and the like.
Drawings
FIG. 1 is a process flow diagram
FIG. 2 high performance liquid chromatography
Clarity contrast of FIG. 3
FIG. 4 high performance liquid chromatography for alcohol precipitation
FIG. 5 small intestine propulsive rate of mice in each group
FIG. 6 first granule of each group black stool discharging time
Figure 7 number of black bowel movements discharged within 5h of each panel
FIG. 8 quality of black stool discharged within 5h of each group
Note that: * Represents P <0.01 compared to the control group; comparison of # representative with model group P <0.05 # representative with model group P <0.01
Detailed Description
The present invention is further described below by way of specific examples, which are not intended to limit the scope of the invention. Modifications, combinations, or substitutions of the present invention within the scope of the invention or without departing from the spirit and scope of the invention will be apparent to those skilled in the art and are included within the scope of the invention.
Embodiment one, preparation of a Chinese medicinal composition oral liquid with effects of loosening bowel to relieve constipation
(1) Respectively weighing 10g of almond, 20g of asparagus, 15g of rehmannia, 10g of cistanche, 15g of medlar, 15g of white poria, 10g of perilla seed and 10g of semen cuscutae; soaking the eight medicinal materials in water for 30min, and decocting in multifunctional electromagnetic oven.
(2) After the decoction is completed, the mixture is stirred uniformly by a glass rod and then filtered by gauze, so that the liquid medicine and the dregs are separated, the filtrate is combined, the mixture is kept stand for 30min in a beaker, and the supernatant is poured out and is subjected to suction filtration by a suction filtration pump.
(3) After the suction filtration is finished, concentrating the filtrate in water bath to enable the concentration of the filtrate to reach the density of 1.10-1.25;
(4) Adding the concentrated solution into wide-mouth bottle with bottle stopper, and precipitating with ethanol. After the ethanol is added, the bottle stopper is covered and kept stand, so that the ethanol is prevented from volatilizing. And after the alcohol precipitation is finished, carrying out reduced pressure suction filtration by using a suction filtration pump. After the suction filtration is completed, the liquid medicine is subjected to rotary evaporation by a rotary evaporator to separate alcohol from water, ethanol is removed, and the liquid medicine is preserved for standby. A specific process flow diagram is shown in fig. 1. Embodiment two, a process optimization of traditional Chinese medicine composition oral liquid with bowel relaxing function
1. Optimization of the decoction process
In order to ensure that the interaction among the components is not changed in the traditional decoction process, a traditional water decoction method is adopted to prepare the water decoction. Adopts the water adding multiple, the decoction time and the decoction times as the investigation factors of experiments, and adopts the amygdalin content as the evaluation index [5] The decocting process of the medicinal materials is discussed. By L 9 (3 4 ) The orthogonal table schedules the experiments. Weighing 9 parts of single-dose medicinal materials in the original prescription, soaking in water for 30min, and mixing according to L 9 (3 4 ) The orthogonal table was set up for the experiments, and the factors and levels were tabulated as follows:
table 1L 9 (3 4 ) Factor and level setting table
Experimental arrangement and results recording: according to L 9 (3 4 ) Orthogonal table design protocol experiments were performed with the amygdalin extraction as an evaluation index and the measurement results were also counted in table 2.
Table 2 table of experimental setup and results record
2. Optimization of alcohol precipitation process
In order to ensure that the interaction among the components is not changed in the traditional alcohol precipitation process, the traditional water extraction and alcohol precipitation method is adopted to prepare a solution, and the main factors influencing the extraction process of the health-preserving and life-prolonging oral liquid are as follows: concentration of ethanol, time of ethanol precipitation and times of ethanol precipitation. The three factors are examined by adopting an orthogonal test method. By L 9 (3 4 ) The orthogonal table schedules the test. Weighing 9 parts of single-dose medicinal materials in the original prescription, soaking in 10 times of water for 30min, and decocting for 3 times each for 1.5h. According to L 9 (3 4 ) The orthogonal table was set up for the experiments, and the factors and levels were tabulated as follows:
table 3L 9 (3 4 ) Factor and level setting table
Experimental arrangement and results recording: according to L 9 (3 4 ) Orthogonal table design the test was performed with the extraction amount of amygdalin as an evaluation index, and the measurement results were also shown in table 4.
Table 4 table of experimental setup and results record
3. Content determination
Measured according to high performance liquid chromatography (general rule 0512).
4. Experimental results
(1) Decoction process
And (3) performing high performance liquid chromatography analysis on the extract liquid under different decoction processes by taking amygdalin as a detection standard. The high performance liquid chromatogram is shown in figure 2.
TABLE 5 amygdalin content analysis
And (3) data processing: the experimental results obtained were processed by an analysis of variance method, the calculation results were counted in table 6, and the optimum decoction process of amygdalin was obtained from the calculation results.
Table 6 analysis of variance of amygdalin decoction process
Visual analysis from the table, in the orthogonal experiment of the decoction process, the sequence of the factors influencing the decoction efficiency is A > B > C, namely the water adding multiple>The decoction time>The times of decoction. The optimal decoction process condition is A 1 B 3 C 3 Namely, 10 times of water is decocted for 3 times, each time lasts for 1.5 hours, and the content of amygdalin in the decoction is 311 mug/ml.
3.2 alcohol precipitation process:
clarity pairs such as shown in fig. 3, are analyzed visually from the graph: the best clarity is A3B1C3, namely 95 percent of alcohol is added, the alcohol precipitation time is 12 hours, the alcohol precipitation is 3 times, the clarity of A3B3C2 is inferior, the clarity of A3B2C1 is next, and the clarity of other groups is not obviously different. The high performance liquid chromatogram is shown in FIG. 4.
TABLE 7 amygdalin content analysis
And (3) data processing: the experimental results obtained were processed by anova, the calculation results were counted in table 7, and the optimum extraction process of amygdalin was written according to the calculation results.
Table 8 analysis of variance of amygdalin alcohol precipitation process
Visual analysis from the table, in the orthogonal experiment of the alcohol precipitation process, the order of influence of each factor on the extraction efficiency is B>A>C, i.e. time of alcohol precipitation>Ethanol concentration>The optimal extraction process condition is A 2 B 3 C 3 Namely, the ethanol concentration is 85%, the ethanol precipitation time is 48 hours, the ethanol precipitation is 3 times, and the amygdalin content in the ethanol precipitation solution is 84.6 mug/ml.
Embodiment III, an effect of the Chinese medicinal composition oral liquid with the function of relaxing bowel
In the embodiment, the traditional Chinese medicine composition oral liquid with the function of relaxing bowel prepared in the embodiment II is used.
1. Medicine and reagent
Loperamide tablets (cisamprenon pharmaceutical limited, KIJ08E 5) (each tablet containing loperamide 2 mg); activated carbon (powder): the company Miou chemical reagent, inc. of Tianjin City; gum Arabic powder (lot number F20060430, national medicine group chemical Co., ltd.)
2. Apparatus and device
Millimeter ruler, electronic balance (Beijing Saidoles instruments systems Co., ltd. ISO9001), extracting device (provided by Gansu Chinese medicine university research test center), rotary steaming instrument (Henan middle Instrument Kerui equipment Co., ltd., RE-2000)
3. Reagent preparation method
Preparation of loperamide suspension: before use, loperamide tablet (13 tablet, 26 mg) was ground into powder with a mortar, added to a 50ml container, added with pure water to 26 ml, shaken well to prepare a 1mg/ml suspension, and stored in a refrigerator at 4 ℃.
The preparation method of the ink comprises the following steps: 10g of acacia gum is added with 80 ml of distilled water, boiled until becoming clear, 10g of active carbon (powder) is weighed, added into the solution, boiled for 3 times, added with water to fix the volume to 100ml, refrigerated at 4 ℃ and shaken well before use.
4. Animal grouping method
198 SPF-class male Kunming mice of 5 weeks of age are selected and divided into two large groups of small intestine exercise group and defecation experiment according to a random number method, and 54 mice are used in each group. After the adaptive feeding is carried out for 5 days, each experiment is divided into 7 groups, namely 13 solvent control groups (pure water), 14 model control groups (loperamide), 10 groups of Chinese medicinal composition oral liquid with low (16.25 g/kg/d), medium (81.25 g/kg/d) and high (162.5 g/kg/d) dosage, 8 groups of almond, 9 groups of rehmannia, 8 groups of cistanche and 7 groups of semen cuscutae, 10 compound medicinal material groups (almond, radix asparagi, rehmannia and medlar), and the administration doses of the above 5 groups are 13.65g/kg/d, and the tested sample and the solvent distilled water are orally irrigated for 7 days.
Wherein, the dosage of the almond group, the rehmannia group, the cistanche group and the dodder group which are weighed by the compound medicinal material group is the same as the total dosage of the traditional Chinese medicine composition.
5. Animal experiment method
(1) Small intestine exercise experiment
Establishing a mouse constipation model: after 7 days of gastric lavage, no water was forbidden for each group for 20 hours. The model control group and the 5 administration groups were each intragastrically filled with loperamide hydrochloride at a body mass of 5.2mg/kg, and the negative control group was intragastrically filled with an equal volume of distilled water.
Measurement of ink advance speed: each experimental group was filled with an ink containing 10% active carbon powder and 10% gum arabic at a corresponding concentration at 30 minutes after administration, and the blank group and the model group were also filled with this ink. Immediately after 25 minutes, the mice were sacrificed by cervical dislocation, the abdominal cavity was cut open, the intestinal canal from the beginning of the pylorus, the lower end to the return dead zone was taken out, the mesentery was peeled off, the small intestine was slowly straightened on a tray, the length of the small intestine was measured as the "total length of the small intestine", the length from the pylorus to the end of the ink was recorded as the "length of ink propulsion", and the ink propulsion rate was calculated by the following formula: ink advance = ink advance length (cm)/small intestine total length (cm) ×100%
(note: according to the evaluation formula of bowel relaxing function in "health food inspection technology and evaluation Specification", the ink advancing speed under different doses calculated by the formula needs to be subjected to data conversion,(X represents the data conversion value of the ink propelling rate, p is the ink propelling rate, and the data conversion value is represented by a small number).
(2) Stool test
Establishing a mouse constipation model: the sample is continuously irrigated for 7 days, the model control group and 5 administration groups are respectively irrigated with loperamide hydrochloride with the body mass of 10.0mg/kg, and the blank control group is irrigated with distilled water with the same amount as the negative control.
Determination of the faecal time, faecal particle count and faecal mass in mice: the model group and each administration group were filled with loperamide hydrochloride and after 30min, the stomach was filled with ink. Each group was fed with food and water. After the ink is fed, the time of discharging the first black stool, the number of the first black stool in 5 hours and the quality of the first black stool in 5 hours are recorded, and the excrement before discharging the first black stool is removed.
Statistical analysis was performed using GraphPad Prism 8.0 (GraphPad inc., la Jolla, CA, USA) and SSPS (Chicago, IL, USA). Data are expressed as mean ± Standard Deviation (SD). Data were analyzed by one-way analysis of variance (ANOVA) followed by a Least Significant Difference (LSD) post hoc test. Significance was defined as P <0.05, P <0.01, and P <0.001.
6 experimental results
(1) Small intestine propulsion rate
One of the main characteristics of constipation is that the gastrointestinal vermicular ability is influenced and weakened, so the intestinal function improvement condition of a single Chinese medicinal composition oral liquid on a constipation mouse is examined by the small intestine ink propelling rate. In the test process, each group does not die, the growth condition is good, and adverse reactions such as diarrhea and the like do not occur.
The small intestine propulsion rate of each group of mice is shown in fig. 5, and the small intestine propulsion rate of the model group is obviously lower than that of the blank control group (P < 0.01), which indicates that the small intestine movement inhibition model is successfully established after the loperamide hydrochloride is infused. The push rate of the ink in the rehmannia group is lower than that in the model group, the other administration groups are higher than that in the model group, and the push rate of the small intestine of each dosage group, the cistanche group and the compound medicinal material group of the traditional Chinese medicine composition oral liquid is obviously increased (P < 0.01) compared with the model control group. The traditional Chinese medicine composition oral liquid can accelerate intestinal peristalsis of a constipation mouse by each dosage group, cistanche group and compound medicinal material group; the almond group, the rehmannia group and the dodder group have no significant difference (P > 0.05) compared with the model control group, and have no effect of obviously increasing the small intestine propulsion rate.
(2) First granule black defecation time
The first granule of each group has black stool discharge time shown in fig. 6, and the first granule of the constipation model control group has black stool discharge time significantly higher than that of the blank group (P < 0.01), which indicates that the constipation model is established. Compared with the model control group, the high, medium and low dose groups, the single drug groups and the compound drug groups of the traditional Chinese medicine composition oral liquid are obviously reduced (P is less than 0.01), which proves that the traditional Chinese medicine composition oral liquid has obvious effect on shortening the first granule of black stool and defecation time. Meanwhile, the defecation time of a high-medium-low dosage group of the traditional Chinese medicine composition oral liquid is shorter than that of each single medicine and compound medicine group (P is less than 0.01), which indicates that the traditional Chinese medicine composition oral liquid can remarkably shorten the first granule black defecation time, and the traditional Chinese medicine composition oral liquid of a high dosage group is more remarkable.
(3) Number of black excrement particles discharged within 5 hours
The number of black bowel movement in each group 5h is shown in fig. 7, and the average number of black bowel movement in the model control group 5h is obviously lower than that in the blank group (P is less than 0.01), which indicates that the constipation model is established. Compared with the model control group, the black stool quantity of each dosage group of the traditional Chinese medicine composition oral liquid is obviously increased, and the stool frequency is obviously increased (P is less than 0.01). The traditional Chinese medicine composition oral liquid of each dosage group can increase the number of grains of black stool discharged within 5 hours, and the traditional Chinese medicine composition oral liquid of the high dosage group is more obvious; the almond group, the rehmannia group and the dodder group have no significant difference (P > 0.05) compared with the model control group, and have no obvious effect on promoting defecation.
(4) Quality of black stool discharged within 5 hours
The quality of the black stool discharged in 5h of each group is shown in fig. 8, and the quality of the black stool discharged in 5h of the constipation model control group is obviously lower than that of the blank group (P is less than 0.01), which indicates that the constipation model is established. Compared with the model control group, the quality of the black discharge of each dosage group of the traditional Chinese medicine composition oral liquid is obviously improved (P is less than 0.01). The traditional Chinese medicine composition oral liquid has the advantages that each dosage group of the traditional Chinese medicine composition oral liquid can increase the quality of black stool discharge within 5 hours, each single medicine group and compound medicine group have no obvious difference (P is more than 0.05) compared with a model control group, and the single medicine group has no effect of obviously increasing the quality of stool discharge.
7. Conclusion(s)
In conclusion, compared with a model control group, the traditional Chinese medicine composition provided by the invention has obvious effect of relaxing bowel, and can be used as a pharmaceutical composition or health care product for relaxing bowel; the Chinese medicinal composition disclosed by the invention is prepared from almond serving as a monarch drug, and has the effects of resolving phlegm, relieving cough and relaxing bowel; radix asparagi has effects of nourishing yin, moistening dryness, clearing lung-heat and lowering fire; rehmannia root, cistanche salsa, semen cuscutae and medlar tonify kidney and strengthen yang to tonify congenital; poria invigorates spleen and promotes diuresis for nourishing the postnatal period; fructus Perillae has effects of reducing qi and resolving phlegm, and relieving cough and asthma; bai Mi it is effective in invigorating qi and strengthening middle warmer. The compatibility of the above medicines has synergistic effect, and all the medicines complement each other to enhance the curative effect. The traditional Chinese medicine composition oral liquid disclosed by the invention is prepared by the steps of preparing medicinal materials into decoction by a decoction and concentration method on the basis of the original formula pill, and then preparing the decoction into the oral liquid by alcohol precipitation, so that the curative effect is improved, and the oral liquid is convenient to carry and store. The invention adopts the traditional water extraction and alcohol precipitation method to prepare the oral liquid, ensures that the interaction among the components is not changed in the traditional extraction process, optimizes the decoction process and the alcohol precipitation process respectively through a twice orthogonal experiment method, and optimizes the optimal decoction condition and alcohol precipitation condition, thereby reducing the loss of active ingredients, and maximizing the drug effect when preparing the preparation. The oral liquid has the advantages of preventing and treating diseases, being convenient for people to take, having small oral dosage, being convenient for taking, being convenient for carrying, transporting and storing, and the like. In addition, a plurality of medicinal materials in the traditional Chinese medicine composition oral liquid are homologous to each other in medicine and food, and have wide development prospect.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.

Claims (9)

1. A traditional Chinese medicine composition with the function of relaxing bowel is prepared from the following raw materials in parts by weight: 5-10 parts of almond, 10-20 parts of asparagus, 7.5-15 parts of rehmannia, 5-10 parts of cistanche, 7.5-15 parts of medlar, 7.5-15 parts of white poria, 5-10 parts of perilla seed and 5-10 parts of semen cuscutae.
2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of almond, 20 parts of asparagus, 15 parts of rehmannia, 10 parts of cistanche, 15 parts of medlar, 15 parts of white poria, 10 parts of perilla seed and 10 parts of semen cuscutae.
3. The traditional Chinese medicine composition according to any one of claims 1-2, further comprising pharmaceutically acceptable excipients.
4. The Chinese medicinal composition according to claim 3, wherein the Chinese medicinal composition is prepared into tablets or oral liquid.
5. The Chinese medicinal composition according to claim 4, wherein the dosage form of the Chinese medicinal composition is an oral liquid.
6. A traditional Chinese medicine composition oral liquid with the function of relaxing bowel is characterized by comprising the following steps:
(1) The Chinese medicinal composition according to any one of claims 1-2, wherein the preparation method comprises weighing semen Armeniacae amarum, radix asparagi, rehmanniae radix, cistanchis herba, fructus Lycii, poria, fructus Perillae and semen Cuscutae in proportion, soaking in water, and decocting;
(2) After the decoction is completed, stirring, filtering, combining the filtrates, standing, pouring out the supernatant, and carrying out suction filtration;
(3) After the suction filtration is completed, concentrating the filtrate in a water bath to enable the concentration of the filtrate to reach the density of 1.10-1.25;
(4) Precipitating the concentrated solution with ethanol, standing, vacuum filtering after ethanol precipitation, rotary evaporating, and removing ethanol to obtain medicinal liquid.
7. The oral liquid of claim 6, wherein the decoction in step (1) is performed 3 times with 1.5h each time; the concentration of the ethanol in the step (4) is 85 percent, the time of ethanol precipitation is 48 hours, and the ethanol precipitation is carried out for 3 times.
8. The use of a traditional Chinese medicine composition for relaxing bowel according to any one of claims 1-2 in the preparation of a medicament for relaxing bowel.
9. The use of a traditional Chinese medicine composition for relaxing bowel according to any one of claims 1-2 in the preparation of a health care product with the function of relaxing bowel.
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* Cited by examiner, † Cited by third party
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