CN111759901A - 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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- CN111759901A CN111759901A CN201910257495.9A CN201910257495A CN111759901A CN 111759901 A CN111759901 A CN 111759901A CN 201910257495 A CN201910257495 A CN 201910257495A CN 111759901 A CN111759901 A CN 111759901A
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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 material medicines: white atractylodes rhizome, bitter orange, magnolia bark, white peony root, aucklandia root, corydalis tuber and licorice root. Clinically, according to physiological and pathological characteristics of children, and main pathogenesis of abdominal pain, spleen and stomach dysfunction and unsmooth qi movement of children, the spleen and stomach strengthening, qi regulating and pain relieving are taken as treatment principles, so that the infantile abdominal pain symptom can be effectively relieved, the appetite can be promoted, and the relapse can be prevented.
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 (FAP) in children is a common symptom in the pediatric period, which generally refers to paroxysmal abdominal pain, at least 3 attacks within 3 months, and when the attack is severe, the normal activity of children can be affected, and the symptom is normal in the inter-attack period. Most of them can relieve themselves, but the life quality of children is affected. The functional abdominal pain of children is caused by many reasons, and common people suffer from exogenous pathogenic factors, food retention, heat accumulation in stomach and intestine, deficiency and cold of viscera, qi stagnation and blood stasis. Clinically, it is mainly classified into abdominal pain due to cold accumulation, food retention in breast, heat accumulation in stomach and intestine, deficiency cold of viscera, qi stagnation and blood stasis.
The traditional Chinese medicine considers that children are often deficient in spleen and often redundant in liver, and the children are not hungry and full, overeat uncooked, cold and sweet and greasy food, so that spleen earth is not heavy, cold congeals intestines and stomach, and qi activity of middle energizer is blocked to cause fullness, abdominal distension and abdominal pain; most of modern society is solitary children, and people are in excessive favor, do not know to adjust emotion, or have heavy learning burden, mental stress and anxiety, so that liver qi stagnation, liver wood riding spleen soil, spleen dysfunction and abnormal ascending and descending can cause abdominal pain attack and even delay and even no cure.
The western medicine clinical application does not have a medicament for treating the functional abdominal pain of the children in a targeted way, and researches show that the effects of the medicament and the placebo in most aspects have no statistical difference in the treatment of the functional abdominal pain of the children and the teenagers. The traditional Chinese medicine has long researched gastrointestinal diseases, has rich and solid theoretical basis for the diseases and has good clinical curative effect.
Disclosure of Invention
In view of the above, the invention provides a novel traditional Chinese medicine composition for treating functional abdominal pain of children, and a preparation method, a preparation and an application thereof.
In order to achieve the purpose, the invention adopts the following technical scheme:
the invention aims to provide a traditional Chinese medicine composition for treating functional abdominal pain of children, which comprises the following raw material medicines: white atractylodes rhizome, bitter orange, magnolia bark, white peony root, aucklandia root, corydalis tuber and licorice root.
The traditional Chinese medicine composition comprises the following raw material medicines in parts by weight: 6-15 parts of bighead atractylodes rhizome, 3-15 parts of fructus aurantii, 3-15 parts of mangnolia officinalis, 6-15 parts of radix paeoniae alba, 3-8 parts of elecampane, 3-15 parts of rhizoma corydalis and 2-10 parts of liquorice.
Preferably, the composition consists of the following raw material medicines in parts by weight: 8-12 parts of bighead atractylodes rhizome, 8-10 parts of fructus aurantii, 8-10 parts of mangnolia officinalis, 8-12 parts of radix paeoniae alba, 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 consists of the following raw material medicines in parts by weight: 10 parts of bighead atractylodes rhizome, 10 parts of fructus aurantii, 10 parts of mangnolia officinalis, 10 parts of radix paeoniae alba, 6 parts of elecampane, 10 parts of rhizoma corydalis and 6 parts of liquorice.
In a specific embodiment, the traditional Chinese medicine composition disclosed by the invention consists of the following raw material medicines in parts by weight: 12 parts of bighead atractylodes rhizome, 10 parts of fructus aurantii, 8 parts of mangnolia officinalis, 8 parts of radix paeoniae alba, 5 parts of elecampane, 9 parts of rhizoma corydalis and 4 parts of liquorice.
In a specific embodiment, the traditional Chinese medicine composition disclosed by the invention consists of the following raw material medicines in parts by weight: 8 parts of bighead atractylodes rhizome, 9 parts of fructus aurantii, 9 parts of mangnolia officinalis, 11 parts of radix paeoniae alba, 4 parts of elecampane, 8 parts of rhizoma corydalis and 8 parts of liquorice.
In a specific embodiment, the traditional Chinese medicine composition disclosed by the invention consists of the following raw material medicines in parts by weight: 9 parts of bighead atractylodes rhizome, 8 parts of fructus aurantii, 8 parts of mangnolia officinalis, 8 parts of radix paeoniae alba, 6 parts of elecampane, 10 parts of rhizoma corydalis and 7 parts of liquorice.
In a specific embodiment, the traditional Chinese medicine composition disclosed by the invention consists of the following raw material medicines in parts by weight: 9 parts of bighead atractylodes rhizome, 9 parts of fructus aurantii, 9 parts of mangnolia officinalis, 9 parts of radix paeoniae alba, 6 parts of elecampane, 9 parts of rhizoma corydalis and 5 parts of liquorice.
In a specific embodiment, the licorice in the traditional Chinese medicine composition of the present invention is honey-fried licorice.
In the formula, the bighead atractylodes rhizome is a monarch drug for tonifying spleen and qi, strengthening spleen and qi, promoting forceful movement and enhancing gastrointestinal peristalsis function; fructus Aurantii and cortex Magnolia officinalis have effects of regulating qi-flowing, regulating stomach function, resolving food stagnation, and promoting digestion, and are used as ministerial drugs when combined with Atractylodis rhizoma; radix paeoniae alba, radix aucklandiae, rhizoma corydalis, liver-softening and stomach-harmonizing, qi-regulating and pain-relieving, as adjuvant drugs; prepared licorice root, radix Glycyrrhizae Praeparata, as a guiding drug, relieves spasm and pain, and coordinates the effects of the other drugs in the recipe. The medicines in the formula are combined together to regulate spleen and stomach, support transportation and transformation, tonify middle-jiao and eliminate stagnation, invigorate spleen without obstruction, regulate qi without hurting qi, and the traditional Chinese medicine is a good medicine for treating functional abdominal pain of children. The formula of the invention can strengthen spleen and stomach, regulate qi and alleviate pain; the traditional Chinese medicine composition mainly treats functional abdominal pain of children, which belongs to the syndrome of dyspepsia in milk by differentiation of symptoms, and has the symptoms of abdominal pain, abdominal fullness and distention, poor appetite, abdominal distension after eating, or nausea, night sleep restlessness, abnormal stool, pale red tongue, white and greasy or thick and greasy tongue coating and deep and smooth pulse. Clinically, according to the physiological and pathological characteristics of the children, the combination of tonification and purgation is adopted, the functional abdominal pain of the children is treated by taking the functions of strengthening the spleen and stomach and regulating qi to alleviate pain as the treatment principle, the symptoms of the abdominal pain of the children can be effectively relieved, the appetite can be promoted, the relapse can be prevented, and the ideal effect is obtained.
The properties and the functions of the raw materials of the traditional Chinese medicine composition are as follows:
atractylodis rhizoma is dried rhizome of Atractylodes macrocephala Koidz of Compositae. Bitter and sweet in taste and warm in nature. It enters spleen and stomach meridians. Invigorate spleen, replenish qi, dry dampness, induce diuresis, stop sweating, prevent abortion. Can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and threatened abortion.
Fructus Aurantii is dried immature fruit of Citrus aurantium L. of Rutaceae and its cultivar. Bitter, pungent and sour, warm in nature, has the effects of regulating qi, relieving epigastric distention, activating stagnancy and relieving distension, and is mainly used for treating qi stagnation in chest and hypochondrium, fullness and pain, indigestion, phlegm and fluid retention, and viscera prolapse.
Magnolia officinalis is dried bark, root bark and branch bark of Magnolia officinalis of Magnoliaceae, Magnolia officinalis of. Bitter and pungent in taste, warm in nature, entering spleen channel, stomach channel and large intestine channel, has the effects of eliminating dampness and phlegm, descending qi and relieving fullness, and can be used for treating damp stagnation and impairment of middle warmer, epigastric fullness, vomiting and diarrhea, food stagnation and qi stagnation, abdominal distention, constipation, phlegm, retained fluid, cough and asthma.
Radix Paeoniae alba is dried root of Paeonia lactiflora pall. Bitter and sour taste, slightly cold. It enters liver and spleen meridians. Has effects in nourishing blood, regulating menstruation, astringing yin, arresting sweating, softening liver, relieving pain, and suppressing liver yang. Can be used for treating blood deficiency, sallow complexion, menoxenia, spontaneous perspiration, night sweat, hypochondriac pain, abdominal pain, limb spasm pain, headache, and vertigo.
Radix aucklandiae is dried root of Aucklandia lappa Decne of Compositae. Pungent, bitter and warm in flavor. It enters spleen, stomach, large intestine, triple energizer and gallbladder meridians. Move qi and alleviate pain, invigorate spleen and promote digestion. Can be used for treating chest and hypochondrium, abdominal distention and pain, dysentery with diarrhea, tenesmus, dyspepsia, and anorexia.
Rhizoma corydalis is dried tuber of corydalis tuber of Papaveraceae, CArrydal yanhusuo W.T.Wang. Pungent, bitter and warm in flavor. It enters liver and spleen meridians. Activate blood, move qi and alleviate pain. Can be used for treating chest and hypochondrium, abdominal pain, thoracic obstruction, cardialgia, amenorrhea, dysmenorrhea, puerperal blood stasis, traumatic injury, and swelling and pain.
The Glycyrrhrizae radix is dried root and rhizome of Glycyrrhiza uralensis Fisch, Glycyrrhiza inflata Bat or Glycyrrhiza glabra L of Leguminosae. Sweet and mild in taste. It enters heart, lung, spleen and stomach meridians. Invigorating spleen and replenishing qi, clearing away heat and toxic material, eliminating phlegm and relieving cough, relieving spasm and pain, and harmonizing the drugs. Can be used for treating weakness of spleen and stomach, asthenia, palpitation, short breath, cough, excessive phlegm, abdominal and limb spasm, pain, carbuncle, swelling, sore, and drug toxicity and strong nature. Prepared licorice root, radix Glycyrrhizae Praeparata, is a processed product of licorice root, and is effective in invigorating qi and restoring pulse. Can be used for treating weakness of spleen and stomach, asthenia, palpitation, and intermittent pulse.
In a specific embodiment, the traditional Chinese medicine composition further comprises a pharmaceutically acceptable adjuvant. The various pharmaceutically acceptable excipients mentioned are well known to the person skilled in the art.
The traditional Chinese medicine composition can be prepared into various common formulations according to the technology known by the technical personnel in the field, such as oral medicines in solid preparation forms of granules, pills (dripping pills, honey pills, water-honeyed pills and concentrated pills), capsules (hard capsules and soft capsules), tablets (dispersible tablets, effervescent tablets, orally disintegrating tablets, buccal tablets, chewable tablets and effervescent tablets), powder, bagged tea and the like; or making into liquid preparation such as suspension, syrup or oral liquid.
The medicinal auxiliary materials can be different according to different preparations, such as common diluents, disintegrants, excipients, binders, lubricants, surfactants, fillers and the like in solid preparations such as tablets, capsules, granules and the like; surfactants, diluents, preservatives, stabilizers, flavoring agents, thickeners, glidants and the like are commonly used in liquid preparation forms such as syrups, oral liquids and the like.
It is prepared from starch, lactose, dextrin, sugar powder, microcrystalline cellulose, mannitol, xylitol, polyethylene glycol, calcium sulfate, calcium hydrogen phosphate, calcium carbonate, modified starch, sorbitol, polyvinylpyrrolidone, heavy magnesium carbonate, sodium carboxymethylcellulose, hydroxypropyl methylcellulose, ethyl cellulose, carboxymethyl starch sodium, hydroxypropyl cellulose, polyvidone K30, kaolin, pregelatinized starch, magnesium stearate, pulvis Talci, Gum Acacia, stevioside, betaine, aspartame, glycyrrhizin, saccharin sodium, citric acid, sorbic acid, potassium sorbate, ethylparaben, sucrose, starch syrup, guar gum, stevioside, sodium alginate, maltose, citric acid, malic acid, sucralose, menthol, coffee powder, monoglyceride, magnesium lauryl sulfate, betacyclodextrin, etc.
The second objective of the present invention is to provide a preparation method of the traditional Chinese medicine composition of the present invention, comprising:
the first scheme is as follows: 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
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
The third scheme is as follows: extracting Atractylodis rhizoma, fructus Aurantii, cortex Magnolia officinalis, radix Paeoniae alba, radix aucklandiae, rhizoma corydalis and Glycyrrhrizae radix with water by conventional method, 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 scheme I and the clear paste in the scheme II is 1.20-1.30 at the temperature of 60-70 ℃; the relative density of the clear paste in the third proposal of the invention is 1.15 to 1.20 at the temperature of 60 to 70 ℃, and the relative density of the concentrate in the third proposal of the invention is 1.20 to 1.30 at the temperature of 60 to 70 ℃.
Preferably, in the first embodiment, the water extraction conditions are: extracting with water 6-12 times of the total weight of the medicinal materials for 2-3 times, each time for 1-3 hr; the total weight of the medicinal materials refers to the total weight of rhizoma atractylodis macrocephalae, fructus aurantii, cortex magnoliae officinalis, radix paeoniae alba, radix aucklandiae, rhizoma corydalis and liquorice.
Preferably, in the second scheme, the ethanol extraction conditions are as follows: adding 40-80% ethanol 4-10 times of the total weight of the medicinal materials, and reflux-extracting for 2-3 times for 1-3 hr each time.
Preferably, in the third embodiment, the water extraction conditions are: extracting with water 6-12 times of the total weight of the medicinal materials for 2-3 times, each time for 1-3 hr.
The third purpose of the invention is to provide granules of the traditional Chinese medicine composition, which comprise the following components in parts by weight: 1 part of active ingredient and 0.2-2 parts of medicinal auxiliary materials; the effective components are 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.
A third aspect of the present invention provides a method for preparing the granules of the present invention, comprising the following steps in order:
mixing the effective components and excipient, adding correctant and humectant, granulating by conventional wet method, and drying.
The above preparation method is only illustrative of the preparation method of the present invention, but it should not be understood that the preparation method of the present invention is limited to the above-listed method.
The fourth purpose of the present invention is to provide an application of the traditional Chinese medicine composition of the present invention in preparing a medicine for preventing or treating functional abdominal pain in children.
Compared with the prior art, the invention has the following beneficial effects:
1. clinically, according to physiological and pathological characteristics of children, and main pathogenesis of abdominal pain, spleen and stomach dysfunction and unsmooth qi movement of children, the spleen and stomach strengthening, qi regulating and pain relieving are taken as treatment principles, so that the infantile abdominal pain symptom can be effectively relieved, the appetite can be promoted, and the relapse can be prevented.
2. The disadvantages of non-specific treatment of western medicines and high recurrence rate are avoided.
3. The Chinese medicinal composition is prepared into granules, and has the advantages of remarkable curative effect, convenient use, small irritation and good patient compliance.
4. The traditional Chinese medicine composition disclosed by the invention is scientific and rigorous 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 those skilled in the art will appreciate that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products commercially available.
Example 1
Taking 14g of bighead atractylodes rhizome, 10g of fructus aurantii, 12g of mangnolia officinalis, 8g of radix paeoniae alba, 8g of radix aucklandiae, 12g of rhizoma corydalis and 8g of radix glycyrrhizae preparata, mixing, adding water for extraction for 3 times, wherein the water amount added for each time is 8 times of the total weight of the medicinal materials, the extraction time for each time is 2 hours, combining the extracting solutions, filtering, concentrating the filtrate to obtain clear paste with the relative density of about 1.25 at 70 ℃, drying, and crushing into fine powder to obtain the traditional Chinese medicine.
Example 2
Mixing 10g of bighead atractylodes rhizome, 12g of fructus aurantii, 12g of mangnolia officinalis, 8g of radix paeoniae alba, 10g of radix aucklandiae, 8g of rhizoma corydalis and 8g of radix glycyrrhizae preparata, performing reflux extraction for 3 times by using 60% ethanol, wherein the amount of ethanol used in each time is 6 times of the total amount of the medicinal materials, the extraction time is 1 hour, combining the extracting solutions, filtering, concentrating the filtrate to obtain clear paste with the relative density of about 1.25 at 65 ℃, drying, and crushing into fine powder to obtain the traditional Chinese medicine.
Example 3
Taking 15g of bighead atractylodes rhizome, 15g of fructus aurantii, 12g of mangnolia officinalis, 15g of radix paeoniae alba, 8g of radix aucklandiae, 12g of rhizoma corydalis and 9g of radix glycyrrhizae preparata, mixing, performing reflux extraction for 3 times by using 60% ethanol, wherein the amount of the ethanol is 6 times of the total amount of the medicinal materials each time, the extraction time is 1 hour, combining the extracting solutions, filtering, concentrating the filtrate to obtain clear paste with the relative density of about 1.25 at 65 ℃, drying, and crushing into fine powder to obtain the traditional Chinese medicine.
Example 4
Mixing 9g of bighead atractylodes rhizome, 9g of fructus aurantii, 12g of mangnolia officinalis, 12g of radix paeoniae alba, 8g of radix aucklandiae, 8g of rhizoma corydalis and 8g of radix glycyrrhizae preparata, performing reflux extraction for 3 times by using 60% ethanol, wherein the amount of ethanol used in each time is 6 times of the total amount of the medicinal materials, the extraction time is 1 hour, combining the extracting solutions, filtering, concentrating the filtrate to obtain clear paste with the relative density of about 1.25 at 65 ℃, drying, and crushing into fine powder to obtain the traditional Chinese medicine.
Example 5
Taking 12g of bighead atractylodes rhizome, 10g of fructus aurantii, 12g of mangnolia officinalis, 8g of radix paeoniae alba, 4g of radix aucklandiae, 12g of rhizoma corydalis and 4g of radix glycyrrhizae preparata, mixing, adding water for extraction for 3 times, wherein the water amount added for each time is 10 times of the total weight of the medicinal materials, the extraction time for each time is 2 hours, combining the extracting solutions, filtering, concentrating the filtrate to a clear paste with the relative density of 1.17 at 60 ℃, adding ethanol to ensure that the ethanol content is 50%, standing for 18 hours, filtering, concentrating the filtrate to a concentrate with the relative density of 1.25 at 68 ℃, drying, and crushing into fine powder to obtain the.
Example 6
Decocting the traditional Chinese medicine composition with water for 3 times, wherein the weight of the water added for each time is 10 times of the total weight of the traditional Chinese medicine composition, the decocting time is 1 hour, combining the three decoctions, filtering out dregs, concentrating under reduced pressure to obtain clear paste with the relative density of 1.25 at 60 ℃, drying, and pulverizing into fine powder; fine powder according to mass ratio: dextrin: sucrose was 6.4: 3.2: 1, weighing corresponding raw materials, uniformly mixing, adding a 70% ethanol wetting agent, performing wet granulation, and drying to obtain the finished product.
Example 7
Taking 12g of bighead atractylodes rhizome, 12g of fructus aurantii, 8g of mangnolia officinalis, 8g of radix paeoniae alba, 4g of radix aucklandiae, 12g of rhizoma corydalis and 8g of radix glycyrrhizae preparata, decocting the traditional Chinese medicine composition with water for 2 times, wherein the weight of the water added for each time is 6 times of the total weight of the traditional Chinese medicine composition, decocting for 2 hours, combining the decoctions, filtering out dregs of the decoction, concentrating under reduced pressure to obtain clear paste with the relative density of 1.25 at 60 ℃, drying and crushing into fine powder; fine powder according to mass ratio: dextrin: sucrose was 6.4: 3.2: 1, weighing corresponding raw materials, uniformly mixing, adding a 70% ethanol wetting agent, performing wet granulation, and drying to obtain the finished product.
Example 8
Taking 10g of bighead atractylodes rhizome, 10g of fructus aurantii, 10g of mangnolia officinalis, 10g of radix paeoniae alba, 6g of radix aucklandiae, 10g of rhizoma corydalis and 6g of radix glycyrrhizae preparata, decocting the traditional Chinese medicine composition with water for 3 times, wherein the weight of the water added for each time is 8 times of the total weight of the traditional Chinese medicine composition, decocting for 1 hour, combining the decoctions obtained by the two times, filtering out dregs of decoction, concentrating under reduced pressure to obtain clear paste with the relative density of 1.25 at 60 ℃, drying and crushing into; fine powder according to mass ratio: dextrin: sucrose was 6.4: 3.2: 1, weighing corresponding raw materials, uniformly mixing, adding a 70% ethanol wetting agent, performing wet granulation, and drying to obtain the finished product.
Example 9
Taking 12g of bighead atractylodes rhizome, 10g of fructus aurantii, 8g of mangnolia officinalis, 8g of radix paeoniae alba, 5g of radix aucklandiae, 9g of rhizoma corydalis and 4g of radix glycyrrhizae preparata, decocting the traditional Chinese medicine composition with water for 3 times, wherein the weight of the water added for each time is 8 times of the total weight of the traditional Chinese medicine composition, decocting for 1 hour, combining the decoctions, filtering out dregs of the decoction, concentrating under reduced pressure to obtain clear paste with the relative density of 1.25 at 60 ℃, drying and crushing into fine powder.
Example 10
Taking 8g of bighead atractylodes rhizome, 9g of fructus aurantii, 9g of mangnolia officinalis, 11g of radix paeoniae alba, 4g of radix aucklandiae, 8g of rhizoma corydalis and 8g of radix glycyrrhizae preparata, decocting the traditional Chinese medicine composition with water for 3 times, wherein the weight of the water added for each time is 8 times of the total weight of the traditional Chinese medicine composition, decocting for 1 hour, combining the decoctions, filtering out dregs of the decoction, concentrating under reduced pressure to obtain clear paste with the relative density of 1.25 at 60 ℃, drying and crushing into fine powder.
Example 11
Decocting 9g of bighead atractylodes rhizome, 8g of fructus aurantii, 8g of mangnolia officinalis, 8g of radix paeoniae alba, 6g of radix aucklandiae, 10g of rhizoma corydalis and 7g of radix glycyrrhizae preparata in water for 3 times, wherein the weight of the water added in each time is 8 times of the total weight of the traditional Chinese medicine composition, decocting for 1 hour, combining the decoctions, filtering out dregs of the decoction, concentrating under reduced pressure to obtain clear paste with the relative density of 1.25 at 60 ℃, drying and crushing into fine powder.
Example 12
Decocting 9g of bighead atractylodes rhizome, 9g of fructus aurantii, 9g of mangnolia officinalis, 9g of radix paeoniae alba, 6g of radix aucklandiae, 9g of rhizoma corydalis and 5g of radix glycyrrhizae preparata in water for 3 times, wherein the weight of the water added in each time is 8 times of the total weight of the traditional Chinese medicine composition, decocting for 1 hour, combining the decoctions, filtering out dregs of the decoction, concentrating under reduced pressure to obtain clear paste with the relative density of 1.25 at 60 ℃, drying and crushing into fine powder.
Comparative example 1
Taking 10g of bighead atractylodes rhizome, 10g of fructus aurantii, 10g of white paeony root, 6g of costustoot, 10g of rhizoma corydalis and 6g of honey-fried licorice root, adding water into the traditional Chinese medicine composition, decocting for 3 times, wherein the weight of the water added in each time is 8 times of the total weight of the traditional Chinese medicine composition, decocting for 1 hour, combining the decoctions obtained in the two times, filtering out dregs, concentrating under reduced pressure to obtain clear paste with the relative density of 1.25 at the temperature of 60 ℃, drying and crushing into.
Comparative example 2
Taking 10g of bighead atractylodes rhizome, 6g of dried orange peel, 10g of fructus aurantii, 10g of white paeony root, 6g of costustoot, 10g of rhizoma corydalis, 6g of combined spicebush root and 6g of honey-fried licorice root, adding water into the traditional Chinese medicine composition, decocting for 1 hour for 3 times, filtering out dregs after the water is added each time, then concentrating under reduced pressure to obtain clear paste with the relative density of 1.25 at the temperature of 60 ℃, drying and crushing the clear paste into fine powder.
The effect of the composition according to the invention on the gastrointestinal motility of a functional dyspepsia model in young rats is further illustrated by the following test examples.
Test example 1
1. Experimental medicine and instrument
1.1 medicaments
According to example 8, 62g crude drug/person/day crude drug extract in daily prescription amount is prepared into high, medium and low concentrations, 1ml is administered to each rat by gavage, and the high, medium and low dose groups are respectively high (11.16g crude drug/kg), medium (5.58g crude drug/kg) and low (2.79g crude drug/kg). The dose groups in rats and the daily prescription of the human are converted according to the following formula: 62 × 0.018/0.2 ═ 2.79g crude drug/kg, the high dose group was twice the medium dose group, and the low dose group was one-half of the medium dose group.
Equivalent dose (unit: crude drug/kg) of experimental animal-1Day(s)-1) The conversion method is as follows:
rat (200g) human ═ 1:0.018
1.2 instruments and reagents
The instrument comprises the following steps:
one hundredth electronic balance: TP-1102, Sidoolis instruments systems, Inc. of Beijing.
One-tenth-of-ten-thousandth analytical balance: BP121S, Sartorius (Sartorius).
1.3 Experimental animals
Rat: body weight 225 ± 25g, half male and female, SPF grade (Specific Pathogen Free) purchased from sbefu (beijing) biotechnology limited; license number: SCXK (Kyoto) 2016-.
Animal house: during the experiment, animals were raised in Beijing Yingkerui pharmaceutical safety and effectiveness research Co., Ltd, laboratory facility license: SYXK (Kd) 2017-0026; the facility management follows national standard GB14925-2001 Experimental animal environment and facilities of the people's republic of China.
Feeding conditions are as follows: adopting artificial illumination for 12-hour light and shade period, maintaining the environmental temperature at 20-24 ℃, the humidity at 40-70%, and ventilating for 15 times per hour; animals are raised in polycarbonate mouse rearing cages, and each cage is raised with 5 rats of the same species in the same group; clean animal cages and bedding were changed every 2 days.
Feed: standard rat pellet feeds were provided by Schbefu (Beijing) Biotechnology Inc.
Drinking water: pure water, which can be freely ingested by animals, is replaced with fresh water bottles and fresh water every day.
2. Experimental methods
Taking 50 rats, randomly dividing into normal control group, model control group, and high, medium and low dosage groups (11.16g crude drug/kg, 5.58g crude drug/kg, 2.79g crude drug/kg) of test drug, and each group contains 10 rats, 60 rats. The normal control group is normally fed, and the rest groups of rats are fed with abnormal feeding, namely: the rats normally feed in one day, fasted in two days, freely drink water, and add hydrochloric acid (water temperature is 0 ℃, 10mol/L hydrochloric acid is 10 mL/L drinking water) into water to break the acid-base balance in the stomach, and the weight and the food intake of the rats in each group are measured for 2-4 weeks continuously. The animal has the gastric electrical arrhythmia and no obvious organic lesion, and the success of molding is verified. Infusing distilled water into normal control group and model control group after molding for 2 weeks for 1 time per day; the test drug high, medium and low dose groups were started with gavage of the drug of example 8 (fine powder prepared in example 8) at doses shown in table 1, 1 time daily for 2 weeks. Rats in each group were fasted for 24h before the end of the experiment 1 d. The animals were anesthetized with ether, the abdominal cavity was opened at about 2cm of the incision under the xiphoid process, the vascular ligation pyloric ring was avoided, the corresponding drug or normal saline was administered to the duodenum, the abdominal cavity was sequentially sutured closed, placed back in a cage for resting, and the contraction voltage and frequency of the smooth muscle of the stomach after 5h of the last administration were measured with a gastric electrical detection system for anesthesia, see table 1.
TABLE 1 rat gastric smooth muscle contraction frequency
Compared to the blank group:
compared to the model set:
as can be seen from the table, the model control group had statistically significant differences in both gastric contraction voltage and frequency compared to the normal control group. Compared with a model control group, the tested object group has the effect of improving gastric contraction voltage and frequency, the larger the gastric contraction voltage is, the stronger the gastric contraction amplitude is, and the larger the gastric contraction frequency is, the more the gastric contraction frequency is, so that the traditional Chinese medicine composition has good effects of relieving spasm and pain, promoting gastrointestinal motility, improving pepsin activity and the like.
Test example 2
150 rats were randomly divided into normal control group, model control group, and drug group 1-13. The normal control group is normally fed, and the rest groups of rats are fed with abnormal feeding, namely: the rats were fed normally on a single day, fasted on two days, water was freely drunk, hydrochloric acid (temperature 0 ℃ 10mol/L hydrochloric acid 10mL per liter of drinking water) was added to the water to disrupt the acid-base balance in the stomach, and the weight and food intake of each group of rats were measured for 2-4 weeks. The animal has the gastric electrical arrhythmia and no obvious organic lesion, and the success of molding is verified. Infusing distilled water into normal control group and model control group after molding for 2 weeks for 1 time per day; drug groups 1-7 began gavage with the drugs of examples 1-7, drug groups 9-14 began gavage with the drugs of example 9-comparative example 2, and a group of rats corresponded to one of the example drugs at doses given in table 2, 1 time daily for 2 consecutive weeks. Rats in each group were fasted for 24h before the end of the experiment 1 d. The animals were anesthetized with ether, the abdominal cavity was opened at about 2cm of the incision under the xiphoid process, the vascular ligation pyloric ring was avoided, the corresponding drug or normal saline was administered to the duodenum, the abdominal cavity was sequentially sutured closed, placed back in a cage for resting, and the contraction voltage and frequency of the smooth muscle of the stomach after 5h of the last administration were measured with a gastric electrical detection system for anesthesia, see table 2.
TABLE 2 rat gastric smooth muscle contraction frequency
Compared to the blank group:
compared to the model set:
as can be seen from the table, the model control group had statistically significant differences in both gastric contraction voltage and frequency compared to the normal control group. The drug groups 1 to 11 all had the effect of improving the frequency and voltage of gastric contraction compared to the model control group.
Claims (11)
1. A traditional Chinese medicine composition for treating functional abdominal pain of children is characterized by comprising the following raw material medicines in parts by weight: 6-15 parts of bighead atractylodes rhizome, 3-15 parts of fructus aurantii, 3-15 parts of mangnolia officinalis, 6-15 parts of radix paeoniae alba, 3-8 parts of elecampane, 3-15 parts of rhizoma corydalis and 2-10 parts of liquorice.
2. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following raw material medicines in parts by weight: 8-12 parts of bighead atractylodes rhizome, 8-10 parts of fructus aurantii, 8-10 parts of mangnolia officinalis, 8-12 parts of radix paeoniae alba, 4-6 parts of elecampane, 8-10 parts of rhizoma corydalis and 4-8 parts of liquorice.
3. The traditional Chinese medicine composition according to claim 1 or 2, which is characterized by comprising the following raw material medicines in parts by weight: 10 parts of bighead atractylodes rhizome, 10 parts of fructus aurantii, 10 parts of mangnolia officinalis, 10 parts of radix paeoniae alba, 6 parts of elecampane, 10 parts of rhizoma corydalis and 6 parts of liquorice.
4. The traditional Chinese medicine composition according to claim 1 or 2, which is characterized by comprising the following raw material medicines in parts by weight: 12 parts of bighead atractylodes rhizome, 10 parts of fructus aurantii, 8 parts of mangnolia officinalis, 8 parts of radix paeoniae alba, 5 parts of elecampane, 9 parts of rhizoma corydalis and 4 parts of liquorice.
5. The traditional Chinese medicine composition according to claim 1 or 2, which is characterized by comprising the following raw material medicines in parts by weight: 8 parts of bighead atractylodes rhizome, 9 parts of fructus aurantii, 9 parts of mangnolia officinalis, 11 parts of radix paeoniae alba, 4 parts of elecampane, 8 parts of rhizoma corydalis and 8 parts of liquorice.
6. The traditional Chinese medicine composition according to claim 1 or 2, which is characterized by comprising the following raw material medicines in parts by weight: 9 parts of bighead atractylodes rhizome, 8 parts of fructus aurantii, 8 parts of mangnolia officinalis, 8 parts of radix paeoniae alba, 6 parts of elecampane, 10 parts of rhizoma corydalis and 7 parts of liquorice.
7. The traditional Chinese medicine composition according to claim 1 or 2, which is characterized by comprising the following raw material medicines in parts by weight: 9 parts of bighead atractylodes rhizome, 9 parts of fructus aurantii, 9 parts of mangnolia officinalis, 9 parts of radix paeoniae alba, 6 parts of elecampane, 9 parts of rhizoma corydalis and 5 parts of liquorice.
8. The Chinese medicinal composition according to any one of claims 1 to 7, wherein the licorice is prepared licorice.
9. The Chinese medicinal composition according to any one of claims 1 to 8, further comprising pharmaceutically acceptable excipients; preferably, the traditional Chinese medicine composition is prepared into oral medicines in the form of granules, pills, capsules, tablets, powder or bagged tea solid preparations or medicines in the form of suspensions, syrups or oral liquid preparations.
10. The method of preparing the Chinese medicinal composition of any one of claims 1 to 8, comprising:
the first scheme is as follows: 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
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
The third scheme is as follows: extracting Atractylodis rhizoma, fructus Aurantii, cortex Magnolia officinalis, radix Paeoniae alba, radix aucklandiae, rhizoma corydalis and Glycyrrhrizae radix with water by conventional method, 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;
preferably, the relative densities of the clear paste in the scheme I and the clear paste in the scheme II at 60-70 ℃ are both 1.20-1.30; the relative density of the clear paste in the third scheme is 1.15-1.20 at the temperature of 60-70 ℃, and the relative density of the concentrate in the third scheme is 1.20-1.30 at the temperature of 60-70 ℃;
preferably, in the first embodiment, the water extraction conditions are: extracting with water 6-12 times of the total weight of the medicinal materials for 2-3 times, each time for 1-3 hr; the total weight of the medicinal materials refers to the total weight of rhizoma atractylodis macrocephalae, fructus aurantii, cortex magnoliae officinalis, radix paeoniae alba, radix aucklandiae, rhizoma corydalis and liquorice;
preferably, in the second scheme, the ethanol extraction conditions are as follows: reflux-extracting with 40-80% ethanol 4-10 times of the total weight of the medicinal materials for 2-3 times, each time for 1-3 hr;
preferably, in the third embodiment, the water extraction conditions are: extracting with water 6-12 times of the total weight of the medicinal materials for 2-3 times, each time for 1-3 hr.
11. Use of a Chinese medicinal composition according to any one of claims 1 to 8 for the preparation of a medicament for the prevention or treatment of functional abdominal pain in children.
Priority Applications (1)
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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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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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 (2)
| Title |
|---|
| 晓丽等: "温中止痛方治疗儿童功能性腹痛52例", 《中国中医药现代远程教育》 * |
| 陈永辉等: "温中止痛方治疗儿童功能性腹痛临床观察", 《中国实验方剂学杂志》 * |
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