CN111759901B - Traditional Chinese medicine composition for treating functional abdominal pain of children and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating functional abdominal pain of children and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating functional abdominal pain of children, and a preparation method and application of the composition. The invention provides a traditional Chinese medicine composition for treating functional abdominal pain of children, which is prepared from the following raw materials: atractylodis rhizoma, fructus Aurantii, cortex Magnolia officinalis, radix Paeoniae alba, radix aucklandiae, rhizoma corydalis, and Glycyrrhrizae radix. Clinically, according to the physiological and pathological characteristics of children and the main pathogenesis of the children abdominal pain, spleen and stomach dysfunction and unsmooth qi movement, the children abdominal pain symptoms can be effectively relieved and appetite can be enhanced and recurrence can be prevented by clinically taking spleen strengthening, stomach harmonizing, qi regulating and pain relieving as treatment principles.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating functional abdominal pain of children, and a preparation method and application of the composition.
Background
Functional abdominal pain (functional abdominal pain, FAP) in children is a common symptom in childhood, generally referred to as paroxysmal abdominal pain, and has at least 3 attacks within 3 months, and can affect normal activities in children when the attacks are severe, and can be normally performed in the inter-attack period. Although mostly self-relieving, it affects the quality of life of children. The functional abdominal pain of children is caused by a plurality of reasons, and common people feel exogenous evil, milk food stagnation, heat accumulation in intestines and stomach, viscera deficiency cold, qi stagnation and blood stasis. The clinical differentiation of symptoms mainly includes cold accumulation, abdominal pain, food stagnation, gastrointestinal heat accumulation, viscera deficiency cold, qi stagnation and blood stasis.
The traditional Chinese medicine considers that the children are not enough in spleen and have excessive liver, and the children are not aware of hunger and full of food, overeat fresh cold and sweet greasy products, so that spleen soil is overwhelmed, cold congeals intestines and stomach, and middle-jiao qi movement is blocked to cause distention and abdominal pain; most of modern society is single-born, and due to excessive loving and pets, excessive regulation of emotion, or excessive learning burden, mental stress and anxiety, liver qi stagnation, liver wood riding on spleen earth, spleen failure, abnormal ascending and descending, abdominal pain onset and even lasting.
The Western medicine clinic has no medicine for treating children functional abdominal pain, and researches show that the effects of the medicine and the placebo in most aspects have no statistical difference in the treatment of children and teenager functional abdominal pain. The traditional Chinese medicine has long been researched for gastrointestinal diseases, has rich and solid theoretical basis for the diseases and has good clinical curative effect.
Disclosure of Invention
In view of this, the invention provides a novel traditional Chinese medicine composition for treating functional abdominal pain of children, and a preparation method, a preparation and application thereof.
In order to achieve the above purpose, the invention adopts the following technical scheme:
the first aim of the invention is to provide a traditional Chinese medicine composition for treating functional abdominal pain of children, which consists of the following raw materials: atractylodis rhizoma, fructus Aurantii, cortex Magnolia officinalis, radix Paeoniae alba, radix aucklandiae, rhizoma corydalis, and Glycyrrhrizae radix.
The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6-15 parts of bighead atractylodes rhizome, 3-15 parts of fructus aurantii, 3-15 parts of magnolia officinalis, 6-15 parts of white paeony root, 3-8 parts of costustoot, 3-15 parts of rhizoma corydalis and 2-10 parts of liquorice.
Preferably, the composition comprises the following raw materials in parts by weight: 8-12 parts of bighead atractylodes rhizome, 8-10 parts of fructus aurantii, 8-10 parts of magnolia officinalis, 8-12 parts of white peony root, 4-6 parts of elecampane, 8-10 parts of rhizoma corydalis and 4-8 parts of liquorice.
In a specific embodiment, the traditional Chinese medicine composition disclosed by the invention comprises the following raw materials in parts by weight: 10 parts of bighead atractylodes rhizome, 10 parts of fructus aurantii, 10 parts of magnolia officinalis, 10 parts of white paeony root, 6 parts of costustoot, 10 parts of rhizoma corydalis and 6 parts of liquorice.
In a specific embodiment, the traditional Chinese medicine composition disclosed by the invention comprises the following raw materials in parts by weight: 12 parts of bighead atractylodes rhizome, 10 parts of fructus aurantii, 8 parts of magnolia officinalis, 8 parts of white paeony root, 5 parts of costustoot, 9 parts of rhizoma corydalis and 4 parts of liquorice.
In a specific embodiment, the traditional Chinese medicine composition disclosed by the invention comprises the following raw materials in parts by weight: 8 parts of bighead atractylodes rhizome, 9 parts of fructus aurantii, 9 parts of magnolia officinalis, 11 parts of white paeony root, 4 parts of costustoot, 8 parts of rhizoma corydalis and 8 parts of liquorice.
In a specific embodiment, the traditional Chinese medicine composition disclosed by the invention comprises the following raw materials in parts by weight: 9 parts of bighead atractylodes rhizome, 8 parts of fructus aurantii, 8 parts of magnolia officinalis, 8 parts of white paeony root, 6 parts of costustoot, 10 parts of rhizoma corydalis and 7 parts of liquorice.
In a specific embodiment, the traditional Chinese medicine composition disclosed by the invention comprises the following raw materials in parts by weight: 9 parts of bighead atractylodes rhizome, 9 parts of fructus aurantii, 9 parts of magnolia officinalis, 9 parts of white paeony root, 6 parts of costustoot, 9 parts of rhizoma corydalis and 5 parts of liquorice.
In a specific embodiment, the licorice in the traditional Chinese medicine composition is honey-fried licorice.
The bighead atractylodes rhizome in the prescription of the invention has the effects of strengthening spleen and replenishing qi, so that the spleen can strengthen qi and promote forceful movement, and the gastrointestinal peristalsis function is enhanced, and the bighead atractylodes rhizome is a monarch drug; fructus Aurantii and cortex Magnolia officinalis regulate qi, harmonize stomach, promote digestion and remove fullness, and can be used as ministerial drugs for strengthening middle warmer and promoting stagnancy when combined with Atractylodis rhizoma; white peony root, costustoot and Yuan Hu Rou are used as adjuvant drugs for regulating the flow of qi and relieving pain; the honey-fried licorice root, radix Glycyrrhizae Praeparata is used as a guiding drug for relieving spasm and pain and harmonizing the drugs. The Chinese medicinal materials are used together to harmonize spleen and stomach, strengthen transportation and transformation, tonify spleen and stomach, eliminate dampness, strengthen spleen and avoid obstruction, regulate qi and avoid hurting qi, thus being a good medicament for treating functional abdominal pain of children. The prescription of the invention can strengthen spleen and stomach, regulate qi and relieve pain; the traditional Chinese medicine for treating the functional abdominal pain of children is mainly used for treating the syndrome of milk food stagnation, wherein symptoms are abdominal pain, time stop, abdominal distention, poor appetite, or abdominal distention after eating, or vomiting, insomnia, constipation, pale red tongue, white greasy tongue coating or thick greasy tongue coating, and deep and slippery pulse. Clinically, according to the physiological and pathological characteristics of children, the functional abdominal pain of the children is treated by adopting the combined actions of attacking and tonifying and taking the principles of strengthening the spleen and stomach and regulating qi to relieve pain, so that the functional abdominal pain of the children can be effectively relieved, appetite can be enhanced, recurrence can be prevented, and an ideal effect can be obtained.
The following is the nature and the function of the crude drug of the traditional Chinese medicine composition:
atractylodis rhizoma is dry rhizome of Atractylodis rhizoma Atractylodes macrocephala Koidz of Compositae. Bitter and sweet in flavor, warm in nature. Enter spleen and stomach meridians. Invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, relieving sweating, and preventing miscarriage. Can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and fetal movement.
Fructus Aurantii is dried immature fruit of Citrus aurantium L. And its cultivar. Bitter, pungent and sour taste, warm nature, and has the effects of regulating qi, relieving middle-jiao, promoting qi circulation, removing distention, and mainly treating chest and hypochondrium qi stagnation, distention and pain, indigestion, phlegm retention, internal stagnation, and viscera prolapse.
Magnolia officinalis is dried bark, root bark and branch bark of Magnoliaceae plant Magnolia officinalis Magnolia officinalis Red. Et Wils. Or Magnolia officinalis Magnolia officinalis Red. Et Wils. Var. Bioloba Red. Et Wils. Bitter and pungent taste, warm nature, and spleen meridian entered, stomach meridian and large intestine meridian entered, has effects of eliminating dampness and resolving phlegm, descending qi and removing fullness, and can be used for treating damp stagnation, gastric fullness, vomiting and diarrhea, food stagnation, abdominal distention and constipation, phlegm retention, asthma and cough.
Radix Paeoniae alba is dry root of Pall Paeonia lactiflora of Ranunculaceae. Bitter and sour in taste and slightly cold in nature. Enter liver and spleen meridians. Has effects of nourishing blood, regulating menstruation, astringing yin, suppressing sweating, softening liver, relieving pain, and suppressing liver yang. Can be used for treating sallow complexion due to blood deficiency, menoxenia, spontaneous perspiration, night sweat, hypochondriac pain, abdominal pain, limb contracture pain, headache and dizziness.
Radix aucklandiae is the dry root of Aucklandia lappa Decne. Pungent and bitter in flavor and warm in nature. It enters spleen, stomach, large intestine, triple energizer and gallbladder meridians. Promoting qi circulation, relieving pain, invigorating spleen, and resolving food stagnation. Can be used for treating chest and hypochondrium pain, abdominal distention, diarrhea, dyspepsia, anorexia.
Rhizoma corydalis is dry tuber of rhizoma corydalis CArrydalh yanhusuo W.T.Wang of Papaveraceae. Pungent and bitter in flavor and warm in nature. Enter liver and spleen meridians. Promoting blood circulation, promoting qi circulation, and relieving pain. Can be used for treating chest pain, hypochondrium pain, abdominal pain, chest pain, amenorrhea, dysmenorrhea, puerperal stagnation, and traumatic injury.
Glycyrrhrizae radix is dry root and rhizome of Glycyrrhiza uralensis Glycyrrhiza uralensis Fisch. Glycyrrhiza uralensis Glycyrrhiza inflata bat. Or Glycyrrhiza glabra Glycyrrhiza glabra L. Sweet and flat. It enters heart, lung, spleen and stomach meridians. Spleen invigorating, qi replenishing, heat and toxic materials clearing away, phlegm eliminating, cough relieving, pain relieving, and medicines regulating. Can be used for treating weakness of spleen and stomach, listlessness, debilitation, palpitation, short breath, cough with excessive phlegm, abdominal pain, limb spasm, carbuncle, swelling, sore and toxic materials, and relieving drug toxicity and intensity. The honey-fried licorice root is a processed product of the licorice root, and is used for tonifying qi and restoring pulse. Can be used for treating weakness of spleen and stomach, listlessness, debilitation, palpitation, and pulse knot.
In a specific embodiment, the traditional Chinese medicine composition further comprises pharmaceutically acceptable auxiliary materials. The various pharmaceutically acceptable excipients are well known to those skilled in the art.
The traditional Chinese medicine composition can be prepared into various common dosage forms according to the technology known by the person skilled in the art, such as oral medicines in the form of solid preparations such as granules, pills (dripping pills, honeyed pills, water-honeyed pills, concentrated pills), capsules (hard capsules, soft capsules), tablets (dispersible tablets, effervescent tablets, orally disintegrating tablets, buccal tablets, chewable tablets, effervescent tablets), powder, or bagged tea; can also be made into suspension, syrup or oral liquid.
The pharmaceutically acceptable auxiliary materials can be different according to different preparations, such as diluents, disintegrants, excipients, adhesives, lubricants, surfactants, fillers and the like which are commonly used in solid preparations such as tablets, capsules, granules and the like; surfactants, diluents, preservatives, stabilizers, flavoring agents, thickeners, glidants and the like commonly used in liquid preparation forms such as syrups, oral liquids and the like.
Commonly used pharmaceutical excipients such as starch, lactose, dextrin, powdered sugar, microcrystalline cellulose, mannitol, xylitol, polyethylene glycol, calcium sulfate, dibasic calcium phosphate, calcium carbonate, modified starch, sorbitol, polyvinylpyrrolidone, ground magnesium carbonate, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, ethylcellulose, sodium carboxymethyl starch, hydroxypropyl cellulose, povidone K30, kaolin, pregelatinized starch, magnesium stearate, talc, micronized silica gel, stevioside, betaine, aspartame, glycyrrhizin, sodium saccharin, citric acid, sorbic acid, potassium sorbate, ethylparaben, sucrose, starch slurry, syrup, guar gum, stevioside, sodium alginate, maltose, citric acid, malic acid, sucralose, menthol, coffee powder, monoglyceride, magnesium lauryl sulfate, beta-cyclodextrin, and the like.
The second object of the present invention is to provide a method for preparing the traditional Chinese medicine composition of the present invention, comprising:
scheme one: extracting Atractylodis rhizoma, fructus Aurantii, cortex Magnolia officinalis, radix Paeoniae alba, radix aucklandiae, rhizoma corydalis and Glycyrrhrizae radix with water by conventional method, filtering, concentrating the filtrate into fluid extract, drying, and pulverizing into fine powder; or (b)
Scheme II: extracting Atractylodis rhizoma, fructus Aurantii, cortex Magnolia officinalis, radix Paeoniae alba, radix aucklandiae, rhizoma corydalis and Glycyrrhrizae radix with ethanol by conventional method, filtering, concentrating the filtrate into fluid extract, drying, and pulverizing into fine powder; or (b)
Scheme III: extracting Atractylodis rhizoma, fructus Aurantii, cortex Magnolia officinalis, radix Paeoniae alba, radix aucklandiae, rhizoma corydalis and Glycyrrhrizae radix with water, filtering, and concentrating the filtrate into fluid extract; adding ethanol into the fluid extract, standing, filtering, concentrating the filtrate to obtain concentrate, drying the concentrate, and pulverizing into fine powder.
The relative density of the clear paste in the first scheme and the clear paste in the second scheme is 1.20-1.30 at 60-70 ℃; the relative density of the clear paste in the third scheme of the invention at 60-70 ℃ is 1.15-1.20, and the relative density of the concentrate in the third scheme of the invention at 60-70 ℃ is 1.20-1.30.
Preferably, in the first aspect, the water condition is: extracting with water 6-12 times of the total weight of the materials for 2-3 times for 1-3 hr; the total weight of the medicinal materials refers to the total weight of bighead atractylodes rhizome, fructus aurantii, magnolia officinalis, white peony root, costustoot, rhizoma corydalis and liquorice.
Preferably, in the second aspect, the conditions for the ethanol extraction are: reflux-extracting with 40-80% ethanol 4-10 times of the total weight of the materials for 2-3 times, each time for 1-3 hr.
Preferably, in the third aspect, the water condition is: adding water 6-12 times of the total weight of the medicinal materials, extracting for 2-3 times, wherein the extraction time is 1-3 hours each time.
The third purpose of the invention is to provide a granule of the traditional Chinese medicine composition, which comprises the following components in parts by weight: 1 part of active ingredient and 0.2 to 2 parts of pharmaceutically acceptable auxiliary materials; the effective component is one or more of the fine powder prepared in the first scheme, the fine powder prepared in the second scheme and the fine powder prepared in the third scheme.
Preferably, the pharmaceutically acceptable excipients include excipients and flavoring agents.
The third aspect of the invention provides a preparation method of the granule of the invention, which comprises the following steps in sequence:
mixing the effective components and excipient, adding correctant and wetting agent, granulating by conventional wet method, and drying.
The above-described preparation methods are only exemplified by the present invention, but it should not be construed that the preparation method of the present invention is limited to only the above-exemplified methods.
The fourth object of the invention is to provide the application of the traditional Chinese medicine composition in preparing medicines for preventing or treating functional abdominal pain of children.
Compared with the prior art, the invention has the following beneficial effects:
1. clinically, according to the physiological and pathological characteristics of children and the main pathogenesis of the children abdominal pain, spleen and stomach dysfunction and unsmooth qi movement, the children abdominal pain symptoms can be effectively relieved and appetite can be enhanced and recurrence can be prevented by clinically taking spleen strengthening, stomach harmonizing, qi regulating and pain relieving as treatment principles.
2. The method avoids the disadvantages of nonspecific treatment and high recurrence rate of western medicines.
3. The traditional Chinese medicine composition provided by the invention is prepared into granules, so that the traditional Chinese medicine composition has the advantages of remarkable curative effect, convenience in use, small irritation and good patient compliance.
4. The traditional Chinese medicine composition disclosed by the invention is scientific and strict in formula, simple in preparation method, low in preparation cost and great in clinical application value.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only for illustrating the present invention and should not be construed as limiting the scope of the present invention. The specific conditions are not noted in the examples and are carried out according to conventional conditions or conditions recommended by the manufacturer. The reagents or apparatus used were conventional products commercially available without the manufacturer's attention.
Example 1
Mixing Atractylodis rhizoma 14g, fructus Aurantii 10g, cortex Magnolia officinalis 12g, radix Paeoniae alba 8g, radix aucklandiae 8g, rhizoma corydalis 12g, and radix Glycyrrhizae Preparata 8g, extracting with water for 3 times (each time with water content 8 times of total weight of the medicinal materials and 2 hr), mixing extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of about 1.25 at 70deg.C, drying, and pulverizing into fine powder.
Example 2
Mixing Atractylodis rhizoma 10g, fructus Aurantii 12g, cortex Magnolia officinalis 12g, radix Paeoniae alba 8g, radix aucklandiae 10g, rhizoma corydalis 8g, and radix Glycyrrhizae Preparata 8g, reflux extracting with 60% ethanol for 3 times (each time with ethanol amount 6 times of the total amount of the materials for 1 hr), mixing extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of about 1.25 at 65deg.C, drying, and pulverizing into fine powder.
Example 3
Mixing Atractylodis rhizoma 15g, fructus Aurantii 15g, cortex Magnolia officinalis 12g, radix Paeoniae alba 15g, radix aucklandiae 8g, rhizoma corydalis 12g, and radix Glycyrrhizae Preparata 9g, reflux extracting with 60% ethanol for 3 times (each time with ethanol amount 6 times of the total amount of the materials for 1 hr), mixing extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of about 1.25 at 65deg.C, drying, and pulverizing into fine powder.
Example 4
Mixing Atractylodis rhizoma 9g, fructus Aurantii 9g, cortex Magnolia officinalis 12g, radix Paeoniae alba 12g, radix aucklandiae 8g, rhizoma corydalis 8g, and radix Glycyrrhizae Preparata 8g, reflux extracting with 60% ethanol for 3 times (each time with ethanol amount 6 times of the total amount of the materials for 1 hr), mixing extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of about 1.25 at 65deg.C, drying, and pulverizing into fine powder.
Example 5
Mixing Atractylodis rhizoma 12g, fructus Aurantii 10g, cortex Magnolia officinalis 12g, radix Paeoniae alba 8g, radix aucklandiae 4g, rhizoma corydalis 12g, and radix Glycyrrhizae Preparata 4g, extracting with water for 3 times (each time with water amount 10 times of total weight of the medicinal materials, each time for 2 hr), mixing extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of 1.17 at 60deg.C, adding ethanol to ethanol content of 50%, standing for 18 hr, filtering, concentrating the filtrate to concentrate with relative density of 1.25 at 68deg.C, drying, and pulverizing into fine powder.
Example 6
Decocting Atractylodis rhizoma 8g, fructus Aurantii 8g, cortex Magnolia officinalis 8g, radix Paeoniae alba 8g, radix aucklandiae 7g, rhizoma corydalis 8g, and radix Glycyrrhizae Preparata 7g with water for 3 times (each time 10 times the total weight of the Chinese medicinal composition), decocting for 1 hr, mixing the three decoctions, filtering to remove residues, concentrating under reduced pressure to obtain fluid extract with relative density of 1.25 at 60deg.C, drying, and pulverizing into fine powder; fine powder according to the mass ratio: dextrin: sucrose was 6.4:3.2:1, weighing the corresponding raw materials, uniformly mixing, adding 70% ethanol wetting agent, granulating by a wet method, and drying to obtain the finished product.
Example 7
Decocting Atractylodis rhizoma 12g, fructus Aurantii 12g, cortex Magnolia officinalis 8g, radix Paeoniae alba 8g, radix aucklandiae 4g, rhizoma corydalis 12g, and radix Glycyrrhizae Preparata 8g with water for 2 times (each time with weight 6 times of total weight of the Chinese medicinal composition) for 2 hr, mixing the decoctions, filtering to remove residue, concentrating under reduced pressure to obtain fluid extract with relative density of 1.25 at 60deg.C, drying, and pulverizing into fine powder; fine powder according to the mass ratio: dextrin: sucrose was 6.4:3.2:1, weighing the corresponding raw materials, uniformly mixing, adding 70% ethanol wetting agent, granulating by a wet method, and drying to obtain the finished product.
Example 8
Decocting Atractylodis rhizoma 10g, fructus Aurantii 10g, cortex Magnolia officinalis 10g, radix Paeoniae alba 10g, radix aucklandiae 6g, rhizoma corydalis 10g, and radix Glycyrrhizae Preparata 6g with water for 3 times (each time 8 times the total weight of the Chinese medicinal composition), decocting for 1 hr, mixing the decoctions, filtering to remove residues, concentrating under reduced pressure to obtain fluid extract with relative density of 1.25 at 60deg.C, drying, and pulverizing into fine powder; fine powder according to the mass ratio: dextrin: sucrose was 6.4:3.2:1, weighing the corresponding raw materials, uniformly mixing, adding 70% ethanol wetting agent, granulating by a wet method, and drying to obtain the finished product.
Example 9
Decocting Atractylodis rhizoma 12g, fructus Aurantii 10g, cortex Magnolia officinalis 8g, radix Paeoniae alba 8g, radix aucklandiae 5g, rhizoma corydalis 9g, and radix Glycyrrhizae Preparata 4g with water for 3 times (each time 8 times the total weight of the Chinese medicinal composition), decocting for 1 hr, mixing the decoctions, filtering to remove residues, concentrating under reduced pressure to obtain fluid extract with relative density of 1.25 at 60deg.C, drying, and pulverizing into fine powder.
Example 10
8g of bighead atractylodes rhizome, 9g of fructus aurantii, 9g of magnolia officinalis, 11g of white paeony root, 4g of costustoot, 8g of rhizoma corydalis and 8g of honey-fried licorice root are taken, the traditional Chinese medicine composition is decocted for 3 times by adding water, the weight of each time is 8 times of the total weight of the traditional Chinese medicine composition, the decoction time is 1 hour, the two decoctions are combined, the residues are filtered out, then the mixture is decompressed and concentrated to a clear paste with the relative density of 1.25 at 60 ℃, and the clear paste is dried and crushed into fine powder.
Example 11
9g of bighead atractylodes rhizome, 8g of fructus aurantii, 8g of magnolia officinalis, 8g of white paeony root, 6g of costustoot, 10g of rhizoma corydalis and 7g of honey-fried licorice root are taken, the traditional Chinese medicine composition is decocted for 3 times by adding water, the weight of each time is 8 times of the total weight of the traditional Chinese medicine composition, the decoction time is 1 hour, the two decoctions are combined, the residues are filtered out, then the mixture is decompressed and concentrated to a clear paste with the relative density of 1.25 at 60 ℃, and the clear paste is dried and crushed into fine powder.
Example 12
9g of bighead atractylodes rhizome, 9g of fructus aurantii, 9g of magnolia officinalis, 9g of white paeony root, 6g of costustoot, 9g of rhizoma corydalis and 5g of honey-fried licorice root are taken, the traditional Chinese medicine composition is decocted for 3 times by adding water, the weight of each time is 8 times of the total weight of the traditional Chinese medicine composition, the decoction time is 1 hour, the two decoctions are combined, the residues are filtered out, then the mixture is decompressed and concentrated to a clear paste with the relative density of 1.25 at 60 ℃, and the clear paste is dried and crushed into fine powder.
Comparative example 1
Decocting Atractylodis rhizoma 10g, fructus Aurantii 10g, radix Paeoniae alba 10g, radix aucklandiae 6g, rhizoma corydalis 10g, and radix Glycyrrhizae Preparata 6g with water for 3 times (each time 8 times the total weight of the Chinese medicinal composition), decocting for 1 hr, mixing the decoctions, filtering to remove residue, concentrating under reduced pressure to obtain fluid extract with relative density of 1.25 at 60deg.C, drying, and pulverizing into fine powder.
Comparative example 2
Decocting the Chinese medicinal composition with water for 3 times (each time being 8 times of the total weight of the Chinese medicinal composition), for 1 hr, mixing the decoctions, filtering out residues, concentrating under reduced pressure to obtain fluid extract with relative density of 1.25 at 60deg.C, drying, and pulverizing into fine powder.
The effect of the composition of the invention on gastrointestinal motility in a functional dyspepsia model of young rats is further illustrated by the following test examples.
Test example 1
1. Experimental medicine and instrument
1.1 medicaments
The fine powder obtained by extracting 62g crude drug/person/day of daily prescription was prepared into three concentrations of high, medium and low, 1ml was administered per rat by stomach irrigation, and the high, medium and low dose groups were high (11.16 g crude drug/kg), medium (5.58 g crude drug/kg) and low (2.79 g crude drug/kg), respectively, according to example 8. The dose group and daily prescription in rats are converted according to the following formula: 62 x 0.018/0.2=2.79 g crude drug/kg, the high dose group is twice the medium dose group, and the low dose group is half the medium dose group.
Equivalent dose of experimental animal (unit: crude drug kg) -1 Tiantian (heaven) -1 ) The conversion method is as follows:
rat (200 g): human=1:0.018
1.2 instruments and reagents
Instrument:
one percent electronic balance: TP-1102, beijing Sidoris instruments systems Co., ltd.
One ten thousandth analytical balance: BP121S, sartorius (certolis).
1.3 laboratory animals
Rats: body weight 225±25g, male and female halves, SPF grade (Specific Pathogen Free, no specific pathogen), purchased from si Bei Fu (beijing) biotechnology limited; license number: SCXK (jing) 2016-0002.
Animal house: animals were kept in beijing for the experimental facility license from the safety and effectiveness study of the fumary drugs, limited: SYXK (Beijing) 2017-0026; facility management complies with the national standard of the people's republic of China, GB 14125-2001, experimental animal Environment and facility.
Feeding conditions: adopting artificial illumination for 12 hours, wherein the ambient temperature is maintained at 20-24 ℃, the humidity is 40-70%, and ventilation is carried out 15 times per hour; animals are bred in polycarbonate mouse breeding cages, and 5 rats with the same sex are bred in each cage; the clean animal cages and litter were replaced every 2 days.
Feed: standard rat pellet feed, offered by the company si Bei Fu (beijing) biotechnology limited.
Drinking water: purified water, free intake by animals, daily replacement of fresh water and fresh water.
2. Experimental method
The rats were randomly divided into a normal control group, a model control group, and high, medium and low dose groups (11.16 g crude drug/kg, 5.58g crude drug/kg, and 2.79g crude drug/kg) of 60 rats. Normal control group was routinely fed, and the remaining groups of rats were fed non-routinely, i.e.: normal feeding is carried out on a single day, fasted feeding is carried out on two days, free drinking water is carried out, hydrochloric acid (the water temperature is 0 ℃, 10mol/L hydrochloric acid is added into each liter of drinking water for 10 mL) is added into the water to break the acid-base balance in the stomach, and the weight and the food intake of rats in each group are measured continuously for 2-4 weeks. The animal shows gastric electric arrhythmia, has no obvious organic lesions, and proves that the modeling is successful. After molding, the normal control group and the model control group are filled with distilled water for stomach, 1 time a day, and 2 weeks continuously; the high, medium and low dose groups of the test agent were administered by gastric lavage (the fine powder prepared in example 8) of example 8, the doses shown in Table 1, 1 time a day for 2 weeks. 1d before the end of the experiment, each group of rats was fasted without water for 24h. Diethyl ether anesthetizing the animal, opening abdominal cavity about 2cm from subxiphoid incision, avoiding blood vessel ligation, administering corresponding medicine or physiological saline to duodenum, sequentially suturing and closing abdominal cavity, placing into cage for rest, and measuring gastric smooth muscle contraction voltage and frequency after 5 hr of last administration by using gastric electric detection system for anesthesia, see table 1.
TABLE 1 frequency of gastric smooth muscle contraction in rats
Compared to the blank:compared with the model group: />
As can be seen from the table, the model control group has statistically significant differences in both gastric contractile voltage and frequency compared to the normal control group. Compared with a model control group, the tested object group has the effect of improving the gastric contraction voltage and frequency, the larger the gastric contraction voltage is, the stronger the gastric contraction amplitude is, the larger the gastric contraction frequency is, the more the gastric contraction frequency is, and further the traditional Chinese medicine composition has the effects of relieving spasm and pain, promoting gastrointestinal peristalsis, improving pepsin activity and the like.
Test example 2
150 rats were randomly assigned to normal control, model control, and drug groups 1-13. Normal control group was routinely fed, and the remaining groups of rats were fed non-routinely, i.e.: normal feeding is carried out on a single day, fasted feeding is carried out on two days, free drinking water is carried out, hydrochloric acid (10 mol/L hydrochloric acid is added into 10mL of drinking water per liter at the temperature of 0 ℃) is added into water to break the acid-base balance in the stomach, and the weight and the food intake of rats in each group are measured for 2-4 weeks continuously. The animal shows gastric electric arrhythmia, has no obvious organic lesions, and proves that the modeling is successful. After molding, the normal control group and the model control group are filled with distilled water for stomach, 1 time a day, and 2 weeks continuously; drug groups 1-7 began to be administered by gavage with the drugs of examples 1-7, drug groups 9-14 began to be administered by gavage with the drugs of example 9-comparative example 2, one group of rats corresponded to one example drug, and the doses given are shown in table 2, 1 time a day for 2 consecutive weeks. 1d before the end of the experiment, each group of rats was fasted without water for 24h. Diethyl ether anesthetizing the animal, opening abdominal cavity about 2cm from subxiphoid incision, avoiding blood vessel ligation, administering corresponding medicine or physiological saline to duodenum, sequentially suturing and closing abdominal cavity, placing into cage for rest, and measuring gastric smooth muscle contraction voltage and frequency after 5 hr of last administration by using gastric electric detection system for anesthesia, see table 2.
TABLE 2 frequency of gastric smooth muscle contraction in rats
Compared to the blank:compared with the model group: />
As can be seen from the table, the model control group has statistically significant differences in both gastric contractile voltage and frequency compared to the normal control group. Drug groups 1-11 all had effects of improving gastric contraction frequency and voltage compared to the model control group.
Claims (10)
1. The traditional Chinese medicine composition for treating the functional abdominal pain of children is characterized by comprising the following raw materials in parts by weight: 10 parts of bighead atractylodes rhizome, 10 parts of fructus aurantii, 10 parts of magnolia officinalis, 10 parts of white paeony root, 6 parts of costustoot, 10 parts of rhizoma corydalis and 6 parts of liquorice.
2. The traditional Chinese medicine composition according to claim 1, wherein the liquorice is honey-fried liquorice.
3. A traditional Chinese medicine preparation, which is characterized by comprising the traditional Chinese medicine composition of claim 1 or 2 and pharmaceutically acceptable auxiliary materials.
4. The Chinese medicinal preparation according to claim 3, wherein the Chinese medicinal preparation is granule, pill, capsule, tablet, powder, teabag, suspension, syrup or oral liquid.
5. The method for preparing the traditional Chinese medicine composition according to claim 1 or 2, which is characterized by comprising the following steps:
scheme one: extracting Atractylodis rhizoma, fructus Aurantii, cortex Magnolia officinalis, radix Paeoniae alba, radix aucklandiae, rhizoma corydalis and Glycyrrhrizae radix with water by conventional method, filtering, concentrating the filtrate into fluid extract, drying, and pulverizing into fine powder; or (b)
Scheme II: extracting Atractylodis rhizoma, fructus Aurantii, cortex Magnolia officinalis, radix Paeoniae alba, radix aucklandiae, rhizoma corydalis and Glycyrrhrizae radix with ethanol by conventional method, filtering, concentrating the filtrate into fluid extract, drying, and pulverizing into fine powder; or (b)
Scheme III: extracting Atractylodis rhizoma, fructus Aurantii, cortex Magnolia officinalis, radix Paeoniae alba, radix aucklandiae, rhizoma corydalis and Glycyrrhrizae radix with water, filtering, and concentrating the filtrate into fluid extract; adding ethanol into the fluid extract, standing, filtering, concentrating the filtrate to obtain concentrate, drying the concentrate, and pulverizing into fine powder.
6. The method according to claim 5, wherein the relative densities of the first and second pastes are 1.20-1.30 at 60-70deg.C; the relative density of the fluid extract in the third scheme is 1.15-1.20 at 60-70 ℃, and the relative density of the concentrate in the third scheme is 1.20-1.30 at 60-70 ℃.
7. The method according to claim 5, wherein in the first aspect, the water-extracting condition is: extracting with water 6-12 times of the total weight of the materials for 2-3 times for 1-3 hr; the total weight of the medicinal materials refers to the total weight of bighead atractylodes rhizome, fructus aurantii, magnolia officinalis, white peony root, costustoot, rhizoma corydalis and liquorice.
8. The method according to claim 5, wherein in the second embodiment, the conditions for the ethanol extraction are: reflux-extracting with 40-80% ethanol 4-10 times of the total weight of the materials for 2-3 times, each time for 1-3 hr.
9. The method according to claim 5, wherein in the third aspect, the water extraction condition is: adding water 6-12 times of the total weight of the medicinal materials, extracting for 2-3 times, wherein the extraction time is 1-3 hours each time.
10. Use of a traditional Chinese medicine composition according to claim 1 or 2 or a traditional Chinese medicine preparation according to claim 3 or 4 for preparing a medicament for preventing or treating functional abdominal pain in children.
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| CN108619282A (en) * | 2017-03-23 | 2018-10-09 | 丁海燕 | A kind of Chinese medicine for treating enterospasm of children |
| CN108653432A (en) * | 2017-04-01 | 2018-10-16 | 北京盈科瑞创新药物研究有限公司 | A kind of Chinese medicine composition and its preparation |
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| CN108619282A (en) * | 2017-03-23 | 2018-10-09 | 丁海燕 | A kind of Chinese medicine for treating enterospasm of children |
| CN108653432A (en) * | 2017-04-01 | 2018-10-16 | 北京盈科瑞创新药物研究有限公司 | A kind of Chinese medicine composition and its preparation |
Non-Patent Citations (1)
| Title |
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| 温中止痛方治疗儿童功能性腹痛临床观察;陈永辉等;《中国实验方剂学杂志》;20130731;第19卷(第14期);第317-319页，尤其是第318页第1.5.1节，第319页右栏第1-2段 * |
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