CN115944699B - Traditional Chinese medicine composition with effects of activating spleen and tonifying qi, and promoting digestion and resolving stagnation, preparation method and application thereof - Google Patents

Traditional Chinese medicine composition with effects of activating spleen and tonifying qi, and promoting digestion and resolving stagnation, preparation method and application thereof Download PDF

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CN115944699B
CN115944699B CN202211605634.0A CN202211605634A CN115944699B CN 115944699 B CN115944699 B CN 115944699B CN 202211605634 A CN202211605634 A CN 202211605634A CN 115944699 B CN115944699 B CN 115944699B
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fried
ethanol
weight
chinese medicine
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CN115944699A (en
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展月
石菊
鄢必新
王鑫
赵俞
任晶
李双
李敏
宋永清
李芳�
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Jilin Xiuzheng Pharmaceutical New Medicine Development Co ltd
Xiuzheng Pharmaceutical Group Co ltd
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Jilin Xiuzheng Pharmaceutical New Medicine Development Co ltd
Xiuzheng Pharmaceutical Group Co ltd
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Abstract

The invention provides a traditional Chinese medicine composition with the effects of activating spleen and tonifying qi, and promoting digestion and resolving food stagnation, which comprises the following raw materials in parts by weight: 6-14 parts of bran-fried bighead atractylodes rhizome, 6-14 parts of dried orange peel, 6-14 parts of fried chicken's gizzard-skin, 6-14 parts of fried malt, 6-14 parts of fried medicated leaven, 4-10 parts of fried betel nut, 4-10 parts of fried hawthorn, 4-10 parts of radix pseudostellariae, 2-8 parts of fructus amomi, 2-8 parts of nutmeg and 2-8 parts of poria cocos; 1 to 6 parts of coix seed, 1 to 6 parts of yam, 1 to 6 parts of green tangerine peel and 1 to 4 parts of honey-fried licorice root. The invention adopts the specific components and the mixture ratio, has a synergistic effect, has obvious treatment effect on diseases such as spleen dysfunction, dyspepsia and the like, and has the efficacy obviously superior to that of the stomach strengthening and digestion promoting tablet prepared by the traditional process.

Description

Traditional Chinese medicine composition with effects of activating spleen and tonifying qi, and promoting digestion and resolving stagnation, 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 the effects of activating spleen and replenishing qi, and promoting digestion and resolving stagnation, a preparation method and application thereof.
Background
Along with the improvement of the living standard of people, the living rhythm is accelerated, and the like, wherein diseases such as functional dyspepsia caused by weakness of spleen and stomach have obvious rising trend, and the living quality is influenced.
The existing stomach-invigorating digestion-promoting tablet comprises radix pseudostellariae, dried orange peel, chinese yam, roasted malt and hawthorn; pulverizing half of radix Pseudostellariae and rhizoma Dioscoreae powder into fine powder, decocting pericarpium Citri Tangerinae, rhizoma Dioscoreae, parched fructus Hordei Germinatus, fructus crataegi and the rest radix Pseudostellariae in water twice for 2 hr each time, mixing decoctions, filtering, concentrating the decoction at low temperature to obtain soft extract, or concentrating into fluid extract with relative density of 1.08-1.12 (65deg.C). The extraction method is a traditional Chinese medicine preparation method, has low content of active ingredients, slow onset of action and large dosage, and is 3-6 tablets for each administration, 3 times a day.
Therefore, it is very important to provide a tablet for invigorating stomach and promoting digestion, which has obviously better drug effect than the tablet prepared by the traditional process.
Disclosure of Invention
In view of the above, the traditional Chinese medicine composition provided by the invention has the effects of activating spleen, tonifying qi, promoting digestion and resolving food stagnation.
The invention provides a traditional Chinese medicine composition with the effects of activating spleen and tonifying qi, and promoting digestion and resolving food stagnation, which comprises the following raw materials in parts by weight:
6-14 parts of bran-fried bighead atractylodes rhizome, 6-14 parts of dried orange peel, 6-14 parts of fried chicken's gizzard-skin, 6-14 parts of fried malt, 6-14 parts of fried medicated leaven, 4-10 parts of fried betel nut, 4-10 parts of fried hawthorn, 4-10 parts of radix pseudostellariae, 2-8 parts of fructus amomi, 2-8 parts of nutmeg, 2-8 parts of poria cocos, 1-6 parts of coix seed, 1-6 parts of Chinese yam, 1-6 parts of green tangerine peel and 1-4 parts of honey-fried licorice root.
Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:
6-13 parts of bran-fried bighead atractylodes rhizome, 6-13 parts of dried orange peel, 6-13 parts of fried chicken's gizzard-skin, 6-13 parts of fried malt, 6-13 parts of fried medicated leaven, 4-10 parts of fried betel nut, 4-10 parts of fried hawthorn, 4-10 parts of radix pseudostellariae, 2-8 parts of fructus amomi, 2-8 parts of nutmeg, 2-8 parts of poria cocos, 1-6 parts of coix seed, 1-6 parts of Chinese yam, 1-6 parts of green tangerine peel and 1-3 parts of honey-fried licorice root.
Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:
6-12 parts of bran-fried bighead atractylodes rhizome, 6-12 parts of dried orange peel, 6-12 parts of fried chicken's gizzard-skin, 6-12 parts of fried malt, 6-12 parts of fried medicated leaven, 4-10 parts of fried betel nut, 4-10 parts of fried hawthorn, 4-10 parts of radix pseudostellariae, 2-8 parts of fructus amomi, 2-8 parts of nutmeg, 2-8 parts of poria cocos, 1-6 parts of coix seed, 1-6 parts of Chinese yam, 1-6 parts of green tangerine peel and 1-2 parts of honey-fried licorice root.
The invention provides a preparation method of a traditional Chinese medicine composition with the effects of activating spleen, tonifying qi, promoting digestion and resolving food stagnation, which comprises the following steps:
a) Pulverizing pericarpium Citri Tangerinae, fructus Amomi, semen Myristicae, and pericarpium Citri Reticulatae viride, soaking in water, and extracting to obtain volatile oil and residue liquid; dissolving the volatile oil with ethanol, and clathrating with cyclodextrin to obtain a first extractive solution;
b) Pulverizing the fried hawthorn, the bran-fried bighead atractylodes rhizome, the poria cocos and the radix pseudostellariae, and extracting with 60% -70% ethanol to obtain an ethanol extract; loading the ethanol extract to macroporous adsorption resin, eluting, and concentrating the eluent to obtain a second extract;
c) Reflux extracting endothelium corneum Gigeriae Galli preparata, coicis semen, fructus Hordei Germinatus preparata, rhizoma Dioscoreae, massa Medicata Fermentata preparata, arecae semen preparata, and radix Glycyrrhizae Preparata with the residue liquid, concentrating, mixing with ethanol, standing, and filtering to obtain primary extractive solution; loading the primary extract on resin, eluting, and concentrating to obtain a third extract;
d) Mixing the first extractive solution, the second extractive solution and the third extractive solution, and drying.
Preferably, the number of the crushed meshes in the step A) is 40-50 meshes; the soaking time is 0.5-1 h; the feed-liquid ratio is 1:10-14; the extraction is a steam distillation extraction method, and the extraction time is 6-8 hours; the mass ratio of the cyclodextrin to the volatile oil is 6-10:1; the inclusion temperature is 45-55 ℃ and the inclusion time is 3-5 h.
Preferably, the number of times of extraction in the step B) is 2 to 4; each time is 4-8 min; the mass concentration of the alcohol extract is 0.5g/mL; the macroporous adsorption resin is CAD-45 resin; the elution is specifically as follows: eluting with 4-6 times of water, discarding eluent, and eluting with 70% ethanol of 5 times of column volume; the concentration is reduced pressure concentration at 45-50 ℃.
Preferably, the number of times of reflux extraction in the step C) is 1-2 times; the reflux time is 1 to 1.5 hours; the concentration is specifically to be concentrated into thick paste with the relative density of 1.10-1.20; mixing with ethanol to obtain ethanol content of 60%; the standing time is 20-24 hours.
Preferably, the mass concentration of the primary extract in the step C) is 0.5g/mL; the resin is CAD-45 resin; eluting with water of 4 times of column volume, discarding eluent, and eluting with 55% ethanol of 6-8 times of column volume; the concentration is reduced pressure concentration at 45-50 ℃.
The invention provides an application of the composition or the composition prepared by the preparation method in preparing products for activating spleen, tonifying qi, promoting digestion and resolving food stagnation.
The invention provides a product for activating spleen and replenishing qi, and promoting digestion and resolving food stagnation, which comprises the composition of any one of the above or the composition prepared by any one of the preparation methods.
Compared with the prior art, the invention provides a traditional Chinese medicine composition with the effects of activating spleen and replenishing qi, and promoting digestion and resolving food stagnation, which comprises the following raw materials in parts by weight: 6-14 parts of bran-fried bighead atractylodes rhizome, 6-14 parts of dried orange peel, 6-14 parts of fried chicken's gizzard-skin, 6-14 parts of fried malt, 6-14 parts of fried medicated leaven, 4-10 parts of fried betel nut, 4-10 parts of fried hawthorn, 4-10 parts of radix pseudostellariae, 2-8 parts of fructus amomi, 2-8 parts of nutmeg and 2-8 parts of poria cocos; 1 to 6 parts of coix seed, 1 to 6 parts of yam, 1 to 6 parts of green tangerine peel and 1 to 4 parts of honey-fried licorice root. The invention adopts the specific components and the mixture ratio, has a synergistic effect, has obvious treatment effect on diseases such as spleen dysfunction, dyspepsia and the like, and has the efficacy obviously superior to that of the stomach strengthening and digestion promoting tablet prepared by the traditional process.
Detailed Description
The invention provides a traditional Chinese medicine composition with the effects of activating spleen and tonifying qi, and promoting digestion and resolving food stagnation, a preparation method and application thereof, and a person skilled in the art can refer to the content of the traditional Chinese medicine composition and properly improve the technological parameters. It is expressly noted that all such similar substitutions and modifications will be apparent to those skilled in the art, and they are intended to be within the scope of the present invention. While the methods and applications of this invention have been described in terms of preferred embodiments, it will be apparent to those skilled in the relevant art that the invention can be practiced and practiced with modification and alteration and combination of the methods and applications herein without departing from the spirit and scope of the invention.
The invention provides a traditional Chinese medicine composition with the effects of activating spleen and tonifying qi, and promoting digestion and resolving food stagnation, which comprises the following raw materials in parts by weight:
6-14 parts of bran-fried bighead atractylodes rhizome, 6-14 parts of dried orange peel, 6-14 parts of fried chicken's gizzard-skin, 6-14 parts of fried malt, 6-14 parts of fried medicated leaven, 4-10 parts of fried betel nut, 4-10 parts of fried hawthorn, 4-10 parts of radix pseudostellariae, 2-8 parts of fructus amomi, 2-8 parts of nutmeg, 2-8 parts of poria cocos, 1-6 parts of coix seed, 1-6 parts of Chinese yam, 1-6 parts of green tangerine peel and 1-4 parts of honey-fried licorice root.
The invention is not limited to the sources of the traditional Chinese medicines, and can be sold in the market.
The traditional Chinese medicine composition provided by the invention comprises 6-14 parts by weight of bran-fried bighead atractylodes rhizome; preferably comprises 6 to 13 parts by weight; more preferably 6 to 12 parts by weight.
The traditional Chinese medicine composition provided by the invention comprises 6-14 parts by weight of dried orange peel; preferably comprises 6 to 13 parts by weight; more preferably 6 to 12 parts by weight.
The traditional Chinese medicine composition provided by the invention comprises 6-14 parts by weight of fried chicken gizzard-membrane; preferably comprises 6 to 13 parts by weight; more preferably 6 to 12 parts by weight.
The traditional Chinese medicine composition provided by the invention comprises 6-14 parts by weight of roasted malt; preferably comprises 6 to 13 parts by weight; more preferably 6 to 12 parts by weight.
The traditional Chinese medicine composition provided by the invention comprises 6-14 parts by weight of stir-fried medicated leaven; preferably comprises 6 to 13 parts by weight; more preferably 6 to 12 parts by weight.
The traditional Chinese medicine composition provided by the invention comprises 4-10 parts by weight of fried betel nuts; specifically, the weight of the composition can be 4 weight parts, 6 weight parts, 8 weight parts or 10 weight parts; or a point value between any two of the above.
The traditional Chinese medicine composition provided by the invention comprises 4-10 parts by weight of fried hawthorn; specifically, the weight of the composition can be 4 weight parts, 6 weight parts, 8 weight parts or 10 weight parts; or a point value between any two of the above.
The traditional Chinese medicine composition provided by the invention comprises 4-10 parts by weight of radix pseudostellariae; specifically, the weight of the composition can be 4 weight parts, 6 weight parts, 8 weight parts or 10 weight parts; or a point value between any two of the above.
The traditional Chinese medicine composition provided by the invention comprises 2-8 parts by weight of fructus amomi; specifically, the weight of the composition can be 2 weight parts, 4 weight parts, 6 weight parts or 8 weight parts; or a point value between any two of the above.
The traditional Chinese medicine composition provided by the invention comprises 2-8 parts by weight of nutmeg; specifically, the weight of the composition can be 2 weight parts, 4 weight parts, 6 weight parts or 8 weight parts; or a point value between any two of the above.
The traditional Chinese medicine composition provided by the invention comprises 2-8 parts by weight of poria cocos; specifically, the weight of the composition can be 2 weight parts, 4 weight parts, 6 weight parts or 8 weight parts; or a point value between any two of the above.
The traditional Chinese medicine composition provided by the invention comprises 1-6 parts by weight of coix seed; specifically, 1 part by weight, 2 parts by weight, 4 parts by weight or 6 parts by weight; or a point value between any two of the above.
The traditional Chinese medicine composition provided by the invention comprises 1-6 parts by weight of Chinese yam; specifically, 1 part by weight, 2 parts by weight, 4 parts by weight or 6 parts by weight; or a point value between any two of the above.
The traditional Chinese medicine composition provided by the invention comprises 1-6 parts by weight of green tangerine peel; specifically, 1 part by weight, 2 parts by weight, 4 parts by weight or 6 parts by weight; or a point value between any two of the above.
The traditional Chinese medicine composition provided by the invention comprises 1-4 parts by weight of honey-fried licorice root; specifically, 1 part by weight, 2 parts by weight and 4 parts by weight can be used; or a point value between any two of the above.
In a part of preferred embodiments of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:
6-13 parts of bran-fried bighead atractylodes rhizome, 6-13 parts of dried orange peel, 6-13 parts of fried chicken's gizzard-skin, 6-13 parts of fried malt, 6-13 parts of fried medicated leaven, 4-10 parts of fried betel nut, 4-10 parts of fried hawthorn, 4-10 parts of radix pseudostellariae, 2-8 parts of fructus amomi, 2-8 parts of nutmeg and 2-8 parts of poria cocos; 1 to 6 parts of coix seed, 1 to 6 parts of yam, 1 to 6 parts of green tangerine peel and 1 to 3 parts of honey-fried licorice root.
In a part of preferred embodiments of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:
6-12 parts of bran-fried bighead atractylodes rhizome, 6-12 parts of dried orange peel, 6-12 parts of fried chicken's gizzard-skin, 6-12 parts of fried malt, 6-12 parts of fried medicated leaven, 4-10 parts of fried betel nut, 4-10 parts of fried hawthorn, 4-10 parts of radix pseudostellariae, 2-8 parts of fructus amomi, 2-8 parts of nutmeg and 2-8 parts of poria cocos; 1 to 6 parts of coix seed, 1 to 6 parts of yam, 1 to 6 parts of green tangerine peel and 1 to 2 parts of honey-fried licorice root.
In one preferred embodiment of the invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 12 parts of bran-fried bighead atractylodes rhizome, 12 parts of dried orange peel, 12 parts of fried chicken's gizzard-membrane, 12 parts of fried malt, 12 parts of fried medicated leaven, 10 parts of fried betel nut, 10 parts of fried hawthorn, 10 parts of radix pseudostellariae, 8 parts of fructus amomi, 8 parts of nutmeg and 8 parts of poria cocos; 6 parts of coix seed, 6 parts of Chinese yam, 6 parts of green tangerine peel and 2 parts of honey-fried licorice root;
in one preferred embodiment of the invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of bran-fried bighead atractylodes rhizome, 10 parts of dried orange peel, 10 parts of fried chicken's gizzard-membrane, 10 parts of fried malt, 10 parts of fried medicated leaven, 8 parts of fried betel nut, 8 parts of fried hawthorn, 8 parts of radix pseudostellariae, 6 parts of fructus amomi, 6 parts of nutmeg and 6 parts of poria cocos; 4 parts of coix seed, 4 parts of Chinese yam, 4 parts of green tangerine peel and 2 parts of honey-fried licorice root;
in one preferred embodiment of the invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of bran-fried bighead atractylodes rhizome, 10 parts of dried orange peel, 12 parts of fried chicken's gizzard-membrane, 12 parts of fried malt, 8 parts of fried medicated leaven, 8 parts of fried betel nut, 6 parts of fried hawthorn, 6 parts of radix pseudostellariae, 6 parts of fructus amomi, 6 parts of nutmeg and 6 parts of poria cocos; 4 parts of coix seed, 4 parts of Chinese yam, 4 parts of green tangerine peel and 2 parts of honey-fried licorice root;
in one preferred embodiment of the invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 8 parts of bran-fried bighead atractylodes rhizome, 8 parts of dried orange peel, 8 parts of fried chicken's gizzard-membrane, 8 parts of fried malt, 8 parts of fried medicated leaven, 6 parts of fried betel nut, 6 parts of fried hawthorn, 6 parts of radix pseudostellariae, 4 parts of fructus amomi, 4 parts of nutmeg and 4 parts of poria cocos; 2 parts of coix seed, 2 parts of Chinese yam, 2 parts of green tangerine peel and 2 parts of honey-fried licorice root;
in one preferred embodiment of the invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6 parts of bran-fried bighead atractylodes rhizome, 6 parts of dried orange peel, 6 parts of fried chicken's gizzard-membrane, 6 parts of fried malt, 6 parts of fried medicated leaven, 4 parts of fried betel nut, 4 parts of fried hawthorn, 4 parts of radix pseudostellariae, 2 parts of fructus amomi, 2 parts of nutmeg and 2 parts of poria cocos; 1 part of coix seed, 1 part of Chinese yam, 1 part of green tangerine peel and 1 part of honey-fried licorice root.
The invention increases stir-fried medicated leaven and stir-fried betel nut, namely stir-fried four-immortal, increases the effects of bighead atractylodes rhizome, poria cocos, coix seed and stir-fried chicken's gizzard-skin, enhances the efficacy of strengthening spleen and stomach, increases the qi-flowing of long Yu Jianpi of fructus amomi, nutmeg and pericarpium citri reticulatae viride, eliminates food retention and stagnation, and stir-fried liquorice for relieving urgency and pain, harmonizes the medicines, and simultaneously enriches, separates and purifies the effective parts of the medicines.
The invention provides a preparation method of a traditional Chinese medicine composition with the effects of activating spleen, tonifying qi, promoting digestion and resolving food stagnation, which comprises the following steps:
a) Pulverizing pericarpium Citri Tangerinae, fructus Amomi, semen Myristicae, and pericarpium Citri Reticulatae viride, soaking in water, and extracting to obtain volatile oil and residue liquid; dissolving the volatile oil with ethanol, and clathrating with cyclodextrin to obtain a first extractive solution;
b) Pulverizing the fried hawthorn, the bran-fried bighead atractylodes rhizome, the poria cocos and the radix pseudostellariae, and extracting with 60% -70% ethanol to obtain an ethanol extract; loading the ethanol extract to macroporous adsorption resin, eluting, and concentrating the eluent to obtain a second extract;
c) Reflux extracting endothelium corneum Gigeriae Galli preparata, coicis semen, fructus Hordei Germinatus preparata, rhizoma Dioscoreae, massa Medicata Fermentata preparata, arecae semen preparata, and radix Glycyrrhizae Preparata with the residue liquid, concentrating, mixing with ethanol, standing, and filtering to obtain primary extractive solution; loading the primary extract on resin, eluting, and concentrating to obtain a third extract;
d) Mixing the first extractive solution, the second extractive solution and the third extractive solution, and drying.
The preparation method of the traditional Chinese medicine composition with the effects of activating spleen and replenishing qi and promoting digestion and resolving stagnation provided by the invention comprises the steps of firstly crushing dried orange peel, fructus amomi, nutmeg and green tangerine orange peel.
The mesh number of the crushing is 40-50 mesh; more preferably 40 mesh. The feed-liquid ratio is 1:10-14; namely, the mass ratio of the dried orange peel, the fructus amomi, the nutmeg, the green tangerine orange peel and the water is 1:10-14; the soaking time is 0.5-1 h; the extraction is a steam distillation extraction method, volatile oil is extracted by steam distillation for 6-8 hours, and the volatile oil is collected and dissolved by equal amount of ethanol for standby.
And (3) weighing cyclodextrin with the oil quantity of 6-10 times of the volatile oil to prepare a saturated aqueous solution with the temperature of 45-55 ℃, adding the volatile oil while stirring, continuously stirring for 3-5 hours at the temperature of 45-55 ℃, refrigerating overnight, filtering, and airing to obtain the cyclodextrin.
Pulverizing the fried hawthorn, the bran-fried bighead atractylodes rhizome, the poria cocos and the radix pseudostellariae into coarse powder, performing flash extraction with 60% -70% ethanol for 2-4 times for 4-8 minutes each time, filtering the extracted residues, and recovering ethanol below 50 ℃. And (3) adding water into the obtained extracting solution to dilute the extracting solution to 0.5g crude drug per milliliter, namely the mass concentration of the alcohol extracting solution is 0.5g/mL.
Passing through treated macroporous adsorbent resin, wherein the macroporous adsorbent resin is CAD-45; the elution is specifically as follows: eluting with 4-6 times of water, discarding eluent, and eluting with 70% ethanol of 5 times of column volume; the concentration is reduced pressure concentration at 45-50 ℃.
Reflux-extracting endothelium corneum Gigeriae Galli preparata, coicis semen, fructus Hordei Germinatus preparata, rhizoma Dioscoreae, massa Medicata Fermentata preparata, arecae semen preparata, and radix Glycyrrhizae Preparata with the residue liquid. The medicine residue liquid is the medicine residue liquid obtained in the step A). The times of reflux extraction is 1-2 times; the reflux time is 1 to 1.5 hours; more preferably, the number of times of reflux extraction is 1 to 2; the reflux time is 1.1-1.4 h; filtering, concentrating the filtrate to obtain soft extract with relative density of 1.10-1.20 deg.C, adding 95% ethanol to make alcohol content reach 60%, and standing; the standing time is 20-24 hours; more preferably 24h.
Filtering, and recovering ethanol from the filtrate. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, which is: the mass concentration of the primary extract is 0.5g/mL; through the treated CAD-45 resin; eluting with water of 4 times of column volume, discarding eluent, and eluting with 55% ethanol of 6-8 times of column volume; the concentration is reduced pressure concentration at 45-50 ℃.
Mixing the first extractive solution, the second extractive solution and the third extractive solution, and drying. The present invention is not limited to the mixing method, and those skilled in the art will recognize that the present invention is not limited thereto. The present invention is not limited to the specific manner of drying, and may be well known to those skilled in the art.
The method adopts the technical means of steam distillation extraction, ethanol flash extraction, ethanol heating reflux extraction, macroporous adsorption resin and the like to enrich, separate and purify the effective parts of different medicinal herbs, and can extract active ingredients such as hesperidin, adenosine and the like in the raw materials to the maximum extent. The preparation method of the invention is used for enriching, separating and purifying the effective parts, and experiments show that the traditional Chinese medicine composition has obvious treatment effect on diseases such as functional dyspepsia caused by weakness of spleen and stomach.
The invention provides an application of the composition or the composition prepared by the preparation method in preparing products for activating spleen, tonifying qi, promoting digestion and resolving food stagnation.
The invention provides a product for activating spleen and replenishing qi, and promoting digestion and resolving food stagnation, which comprises the composition of any one of the above or the composition prepared by any one of the preparation methods.
Products of the invention include, but are not limited to, pharmaceutical products. Also comprises auxiliary materials or ingredients commonly used in the pharmaceutical field.
The pharmacodynamics experiment proves that the traditional Chinese medicine composition prepared by the invention has obvious medicine effect, high bioavailability and stable and reliable quality, and can be prepared into different dosage forms according to the needs of patients, and is convenient to carry and easy to take.
The dosage forms of the present invention include, but are not limited to, tablets, powders, granules, pills, and the like.
The invention provides a traditional Chinese medicine composition with the effects of activating spleen and tonifying qi, and promoting digestion and resolving food stagnation, which comprises the following raw materials in parts by weight: 6-14 parts of bran-fried bighead atractylodes rhizome, 6-14 parts of dried orange peel, 6-14 parts of fried chicken's gizzard-skin, 6-14 parts of fried malt, 6-14 parts of fried medicated leaven, 4-10 parts of fried betel nut, 4-10 parts of fried hawthorn, 4-10 parts of radix pseudostellariae, 2-8 parts of fructus amomi, 2-8 parts of nutmeg and 2-8 parts of poria cocos; 1 to 6 parts of coix seed, 1 to 6 parts of yam, 1 to 6 parts of green tangerine peel and 1 to 4 parts of honey-fried licorice root. The invention adopts the specific components and the mixture ratio, has a synergistic effect, has obvious treatment effect on diseases such as spleen dysfunction, dyspepsia and the like, and has the efficacy obviously superior to that of the stomach strengthening and digestion promoting tablet prepared by the traditional process.
In order to further illustrate the invention, the following embodiment is used for describing in detail the traditional Chinese medicine composition with the effects of activating spleen and replenishing qi, and promoting digestion and resolving stagnation, and the preparation method and application thereof.
Example 1
The formula comprises the following components: 12 parts of bran-fried bighead atractylodes rhizome, 12 parts of dried orange peel, 12 parts of fried chicken's gizzard-membrane, 12 parts of fried malt, 12 parts of fried medicated leaven, 10 parts of fried betel nut, 10 parts of fried hawthorn, 10 parts of radix pseudostellariae, 8 parts of fructus amomi, 8 parts of nutmeg and 8 parts of poria cocos; 6 parts of coix seed, 6 parts of Chinese yam, 6 parts of green tangerine peel and 2 parts of honey-fried licorice root
(1) Pulverizing pericarpium Citri Tangerinae, fructus Amomi, semen Myristicae, and pericarpium Citri Reticulatae viride into fine powder, sieving with 40 mesh sieve, adding 10 times of water, soaking for 1 hr, extracting volatile oil by steam distillation for 6 hr, collecting volatile oil, and dissolving with equal amount of ethanol; and (3) weighing cyclodextrin with the oil quantity of 8 times of volatile oil to prepare a saturated aqueous solution with the temperature of 45-55 ℃, adding the volatile oil while stirring, continuously stirring for 3 hours at the temperature of 45-55 ℃, refrigerating overnight, filtering, and airing to obtain the aqueous emulsion.
(2) Pulverizing parched fructus crataegi, atractylodis rhizoma, poria and radix Pseudostellariae into coarse powder, flash extracting with 70% ethanol for 4 min each time for 2-4 times, filtering the residue after extraction, and recovering ethanol below 50deg.C. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, passing through treated macroporous adsorbent resin, eluting with 4 times of column volume water, discarding eluate, eluting with 70% ethanol of 5 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
(3) Collecting parched endothelium corneum Gigeriae Galli, coicis semen, parched fructus Hordei Germinatus, rhizoma Dioscoreae, parched Massa Medicata Fermentata, parched Arecae semen, and radix Glycyrrhizae Preparata, extracting the residue and extractive solution in step (1) under reflux for 2 times each for 1 hr, filtering, concentrating the filtrate to obtain soft extract with relative density of 1.10-1.20 deg.C, adding 95% ethanol to make ethanol content reach 60%, standing for 24 hr, filtering, and recovering ethanol from the filtrate. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, eluting with 4 times of column volume of water through treated CAD-45 resin, discarding eluate, eluting with 55% ethanol of 6-8 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
And (4) taking the extracting solutions obtained in the step (1), the step (2) and the step (3), uniformly mixing, and drying to obtain the finished product.
Example 2
The formula comprises the following components: 10 parts of bran-fried bighead atractylodes rhizome, 10 parts of dried orange peel, 10 parts of fried chicken's gizzard-membrane, 10 parts of fried malt, 10 parts of fried medicated leaven, 8 parts of fried betel nut, 8 parts of fried hawthorn, 8 parts of radix pseudostellariae, 6 parts of fructus amomi, 6 parts of nutmeg and 6 parts of poria cocos; 4 parts of coix seed, 4 parts of Chinese yam, 4 parts of green tangerine peel and 2 parts of honey-fried licorice root
Pulverizing pericarpium Citri Tangerinae, fructus Amomi, semen Myristicae, and pericarpium Citri Reticulatae viride into fine powder, sieving with 40 mesh sieve, adding 10 times of water, soaking for 1 hr, extracting volatile oil by steam distillation for 6 hr, collecting volatile oil, and dissolving with equal amount of ethanol; and (3) weighing cyclodextrin with the oil quantity of 8 times of volatile oil to prepare a saturated aqueous solution with the temperature of 45-55 ℃, adding the volatile oil while stirring, continuously stirring for 3 hours at the temperature of 45-55 ℃, refrigerating overnight, filtering, and airing to obtain the aqueous emulsion.
And (2) crushing the fried hawthorn, the bighead atractylodes rhizome, the poria cocos and the radix pseudostellariae into coarse powder, performing flash extraction for 2-4 times with 70% ethanol for 4 minutes each time, filtering the extracted residues, and recovering ethanol below 50 ℃. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, passing through treated macroporous adsorbent resin, eluting with 4 times of column volume water, discarding eluate, eluting with 70% ethanol of 5 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
And (3) taking fried chicken's gizzard-skin, coix seeds, fried malt, chinese yam, fried medicated leaven, fried betelnut and honey-fried licorice root, carrying out hot reflux extraction on the dregs and the extracting solution in the step (1) for 2 times, each time for 1 hour, filtering, concentrating the filtrate to thick paste with the relative density of 1.10-1.20 ℃ and adding 95% ethanol to enable the ethanol content to reach 60%, standing for 24 hours, filtering, and recovering ethanol from the filtrate. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, eluting with 4 times of column volume of water through treated CAD-45 resin, discarding eluate, eluting with 55% ethanol of 6-8 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
And (4) taking the extracting solutions obtained in the step (1), the step (2) and the step (3), uniformly mixing, and drying to obtain the finished product.
Example 3
The formula comprises the following components: 10 parts of bran-fried bighead atractylodes rhizome, 10 parts of dried orange peel, 12 parts of fried chicken's gizzard-membrane, 12 parts of fried malt, 8 parts of fried medicated leaven, 8 parts of fried betel nut, 6 parts of fried hawthorn, 6 parts of radix pseudostellariae, 6 parts of fructus amomi, 6 parts of nutmeg and 6 parts of poria cocos; 4 parts of coix seed, 4 parts of Chinese yam, 4 parts of green tangerine peel and 2 parts of honey-fried licorice root
Pulverizing pericarpium Citri Tangerinae, fructus Amomi, semen Myristicae, and pericarpium Citri Reticulatae viride into fine powder, sieving with 40 mesh sieve, adding 10 times of water, soaking for 1 hr, extracting volatile oil by steam distillation for 6 hr, collecting volatile oil, and dissolving with equal amount of ethanol; and (3) weighing cyclodextrin with the oil quantity of 8 times of volatile oil to prepare a saturated aqueous solution with the temperature of 45-55 ℃, adding the volatile oil while stirring, continuously stirring for 3 hours at the temperature of 45-55 ℃, refrigerating overnight, filtering, and airing to obtain the aqueous emulsion.
And (2) crushing the fried hawthorn, the bighead atractylodes rhizome, the poria cocos and the radix pseudostellariae into coarse powder, performing flash extraction for 2-4 times with 70% ethanol for 4 minutes each time, filtering the extracted residues, and recovering ethanol below 50 ℃. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, passing through treated macroporous adsorbent resin, eluting with 4 times of column volume water, discarding eluate, eluting with 70% ethanol of 5 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
And (3) taking fried chicken's gizzard-skin, coix seeds, fried malt, chinese yam, fried medicated leaven, fried betelnut and honey-fried licorice root, carrying out hot reflux extraction on the dregs and the extracting solution in the step (1) for 2 times, each time for 1 hour, filtering, concentrating the filtrate to thick paste with the relative density of 1.10-1.20 ℃ and adding 95% ethanol to enable the ethanol content to reach 60%, standing for 24 hours, filtering, and recovering ethanol from the filtrate. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, eluting with 4 times of column volume of water through treated CAD-45 resin, discarding eluate, eluting with 55% ethanol of 6-8 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
And (4) taking the extracting solutions obtained in the step (1), the step (2) and the step (3), uniformly mixing, and drying to obtain the finished product.
Example 4
The formula comprises the following components: 8 parts of bran-fried bighead atractylodes rhizome, 8 parts of dried orange peel, 8 parts of fried chicken's gizzard-membrane, 8 parts of fried malt, 8 parts of fried medicated leaven, 6 parts of fried betel nut, 6 parts of fried hawthorn, 6 parts of radix pseudostellariae, 4 parts of fructus amomi, 4 parts of nutmeg and 4 parts of poria cocos; 2 parts of coix seed, 2 parts of Chinese yam, 2 parts of green tangerine peel and 2 parts of honey-fried licorice root
Pulverizing pericarpium Citri Tangerinae, fructus Amomi, semen Myristicae, and pericarpium Citri Reticulatae viride into fine powder, sieving with 40 mesh sieve, adding 10 times of water, soaking for 1 hr, extracting volatile oil by steam distillation for 6 hr, collecting volatile oil, and dissolving with equal amount of ethanol; and (3) weighing cyclodextrin with the oil quantity of 8 times of volatile oil to prepare a saturated aqueous solution with the temperature of 45-55 ℃, adding the volatile oil while stirring, continuously stirring for 3 hours at the temperature of 45-55 ℃, refrigerating overnight, filtering, and airing to obtain the aqueous emulsion.
And (2) crushing the fried hawthorn, the bighead atractylodes rhizome, the poria cocos and the radix pseudostellariae into coarse powder, performing flash extraction for 2-4 times with 70% ethanol for 4 minutes each time, filtering the extracted residues, and recovering ethanol below 50 ℃. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, passing through treated macroporous adsorbent resin, eluting with 4 times of column volume water, discarding eluate, eluting with 70% ethanol of 5 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
And (3) taking fried chicken's gizzard-skin, coix seeds, fried malt, chinese yam, fried medicated leaven, fried betelnut, dregs and extracting solution in the step (1), carrying out heat reflux extraction for 2 times, each time for 1 hour, filtering, concentrating filtrate to thick paste with the relative density of 1.10-1.20 ℃, adding 95% ethanol to ensure that the ethanol content reaches 60%, standing for 24 hours, filtering, and recovering ethanol from the filtrate. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, eluting with 4 times of column volume of water through treated CAD-45 resin, discarding eluate, eluting with 55% ethanol of 6-8 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
And (4) taking the extracting solutions obtained in the step (1), the step (2) and the step (3), uniformly mixing, and drying to obtain the finished product.
Example 5
The formula comprises the following components: 6 parts of bran-fried bighead atractylodes rhizome, 6 parts of dried orange peel, 6 parts of fried chicken's gizzard-membrane, 6 parts of fried malt, 6 parts of fried medicated leaven, 4 parts of fried betel nut, 4 parts of fried hawthorn, 4 parts of radix pseudostellariae, 2 parts of fructus amomi, 2 parts of nutmeg and 2 parts of poria cocos; 1 part of coix seed, 1 part of Chinese yam, 1 part of green tangerine peel and 1 part of honey-fried licorice root
Pulverizing pericarpium Citri Tangerinae, fructus Amomi, semen Myristicae, and pericarpium Citri Reticulatae viride into fine powder, sieving with 40 mesh sieve, adding 10 times of water, soaking for 1 hr, extracting volatile oil by steam distillation for 6 hr, collecting volatile oil, and dissolving with equal amount of ethanol; and (3) weighing cyclodextrin with the oil quantity of 8 times of volatile oil to prepare a saturated aqueous solution with the temperature of 45-55 ℃, adding the volatile oil while stirring, continuously stirring for 3 hours at the temperature of 45-55 ℃, refrigerating overnight, filtering, and airing to obtain the aqueous emulsion.
And (2) crushing the fried hawthorn, the bighead atractylodes rhizome, the poria cocos and the radix pseudostellariae into coarse powder, performing flash extraction for 2-4 times with 70% ethanol for 4 minutes each time, filtering the extracted residues, and recovering ethanol below 50 ℃. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, passing through treated macroporous adsorbent resin, eluting with 4 times of column volume water, discarding eluate, eluting with 70% ethanol of 5 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
And (3) taking fried chicken's gizzard-skin, coix seeds, fried malt, chinese yam, fried medicated leaven, fried betelnut and honey-fried licorice root, carrying out hot reflux extraction on the dregs and the extracting solution in the step (1) for 2 times, each time for 1 hour, filtering, concentrating the filtrate to thick paste with the relative density of 1.10-1.20 ℃ and adding 95% ethanol to enable the ethanol content to reach 60%, standing for 24 hours, filtering, and recovering ethanol from the filtrate. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, eluting with 4 times of column volume of water through treated CAD-45 resin, discarding eluate, eluting with 55% ethanol of 6-8 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
And (4) taking the extracting solutions obtained in the step (1), the step (2) and the step (3), uniformly mixing, and drying to obtain the finished product.
Comparative example 1
The formula comprises the following components: 12 parts of roasted astragalus root, 12 parts of pinellia tuber, 12 parts of fried chicken's gizzard-membrane, 12 parts of fried rice sprout, 12 parts of fried medicated leaven, 10 parts of fried betel nut, 10 parts of fried hawthorn, 10 parts of radix pseudostellariae, 8 parts of fructus amomi, 8 parts of nutmeg and 8 parts of poria cocos; 6 parts of coix seed, 6 parts of Chinese yam, 6 parts of green tangerine peel and 2 parts of honey-fried licorice root
Pulverizing fructus Amomi, semen Myristicae and pericarpium Citri Reticulatae viride into fine powder, sieving with 40 mesh sieve, adding 10 times of water, soaking for 1 hr, extracting volatile oil by steam distillation for 6 hr, collecting volatile oil, and dissolving with equal amount of ethanol; and (3) weighing cyclodextrin with the oil quantity of 8 times of volatile oil to prepare a saturated aqueous solution with the temperature of 45-55 ℃, adding the volatile oil while stirring, continuously stirring for 3 hours at the temperature of 45-55 ℃, refrigerating overnight, filtering, and airing to obtain the aqueous emulsion.
And (2) crushing the fried hawthorn, the pinellia tuber, the roasted astragalus root, the poria cocos and the radix pseudostellariae into coarse powder, performing flash extraction for 2-4 times with 70% ethanol for 4 minutes each time, filtering the extracted residues, and recovering ethanol below 50 ℃. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, passing through treated macroporous adsorbent resin, eluting with 4 times of column volume water, discarding eluate, eluting with 70% ethanol of 5 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
And (3) taking fried chicken's gizzard-skin, coix seeds, fried rice sprouts, chinese yam, fried medicated leaven, fried betelnut and honey-fried licorice root, carrying out hot reflux extraction on the dregs and the extracting solution in the step (1) for 2 times, each time for 1 hour, filtering, concentrating the filtrate into thick paste with the relative density of 1.10-1.20 ℃, adding 95% ethanol to enable the ethanol content to reach 60%, standing for 24 hours, filtering, and recovering ethanol from the filtrate. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, eluting with 4 times of column volume of water through treated CAD-45 resin, discarding eluate, eluting with 55% ethanol of 6-8 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
And (4) taking the extracting solutions obtained in the step (1), the step (2) and the step (3), uniformly mixing, and drying to obtain the finished product.
Comparative example 2
The formula comprises the following components: 12 parts of fried chicken's gizzard-membrane, 12 parts of fried malt, 12 parts of fried medicated leaven, 10 parts of fried betel nut, 10 parts of fried hawthorn, 8 parts of fructus amomi, 8 parts of nutmeg and 8 parts of poria cocos; 6 parts of coix seed, 6 parts of Chinese yam, 6 parts of green tangerine peel and 2 parts of honey-fried licorice root
(1) Pulverizing fructus Amomi, semen Myristicae, and pericarpium Citri Reticulatae viride into fine powder, sieving with 40 mesh sieve, adding 10 times of water, soaking for 1 hr, extracting volatile oil by steam distillation for 6 hr, collecting volatile oil, and dissolving with equal amount of ethanol; and (3) weighing cyclodextrin with the oil quantity of 8 times of volatile oil to prepare a saturated aqueous solution with the temperature of 45-55 ℃, adding the volatile oil while stirring, continuously stirring for 3 hours at the temperature of 45-55 ℃, refrigerating overnight, filtering, and airing to obtain the aqueous emulsion.
(2) Pulverizing parched fructus crataegi and Poria into coarse powder, flash extracting with 70% ethanol for 4 min each time for 2-4 times, filtering the residue after extraction, and recovering ethanol below 50deg.C. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, passing through treated macroporous adsorbent resin, eluting with 4 times of column volume water, discarding eluate, eluting with 70% ethanol of 5 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
(3) Collecting parched endothelium corneum Gigeriae Galli, coicis semen, parched fructus Hordei Germinatus, rhizoma Dioscoreae, parched Massa Medicata Fermentata, parched Arecae semen, and radix Glycyrrhizae Preparata, extracting the residue and extractive solution in step (1) under reflux for 2 times each for 1 hr, filtering, concentrating the filtrate to obtain soft extract with relative density of 1.10-1.20 deg.C, adding 95% ethanol to make ethanol content reach 60%, standing for 24 hr, filtering, and recovering ethanol from the filtrate. Diluting the obtained extractive solution with water to 0.5g crude drug per ml, eluting with 4 times of column volume of water through treated CAD-45 resin, discarding eluate, eluting with 55% ethanol of 6-8 times of column volume, collecting ethanol eluate, and concentrating under reduced pressure below 50deg.C.
And (4) taking the extracting solutions obtained in the step (1), the step (2) and the step (3), uniformly mixing, and drying to obtain the finished product.
Verification example pharmacodynamic study
1 Experimental materials
1.1 test drug
The stomach strengthening and digestion promoting tablet, the original stomach strengthening and digestion promoting tablet, the deficiency prescription and the replacement preparation are provided by Jilin correction pharmaceutical industry new medicine development limited company.
1.2 animals
Wistar rats, 110, each male and female half; ICR mice, 110 animals, and male and female animals are SPF grade, and animal production license number is SCXK (Ji) -2020-0002, and high protein, high calorie feed and SPF size mouse maintenance feed are provided by Gibbs laboratory animal technology Limited company of Changchun.
1.3 reagents
Gastrin kit, motilin kit, cholinesterase kit were purchased from south Beijing established biotechnology Co.
2 Experimental methods
2.1 Effect on secretion of gastrointestinal hormone (gastrin, motilin) and neurotransmitter (cholinesterase) in rats in spleen deficiency food stagnation model
2.1.1 Experimental methods
After animals purchased back, the animals were fed with free diet drinking water and were fed for 3d, and the animals were randomly divided into 11 groups according to their body mass, 10 animals each, which were a blank group, a model group, a CN200710017728.5 preparation group, an original stomach-invigorating digestion-promoting tablet group, a formula-lacking group, an alternative group, example 1, example 2, example 3, example 4, and example 5, and the body mass, abdominal circumference, and average food and stool amounts of each mouse in the day of the model were recorded. The blank group was fed normally, and distilled water was irrigated with 2ml/100g stomach. The rats in the model group are fed with homemade high-protein and high-calorie feed (the feed is prepared from dried fish floss, bean flour, flour and milk powder according to the proportion of 1:2:1:1), after being uniformly stirred, the mixture is added with water to be made into biscuits, and then the biscuits are dried by an electrothermal constant-temperature blast drying oven, and simultaneously 50% of milk is fed, 2ml/100g is continuously fed for 7 days, so that a spleen deficiency stagnation model is formed, and after the model is successfully formed, the body mass, abdominal circumference and average food and stool volume of each rat in each group of animals are recorded. Each group of animals is respectively filled with 2ml/100g of corresponding liquid medicine, the model group and the normal control group are respectively provided with distilled water with equal volume, once daily for 7 days, and the body mass, the abdominal circumference and the average food and stool of each mouse in the day of each group of animals are recorded after treatment. The rats of each group are fasted and not forbidden for 24 hours before the last administration, after the last administration or distilled water filling, the orbit vein is taken for blood, the blood is centrifuged for 15min at 3000r/min, serum is separated, the levels of gastrin, motilin and cholinesterase in the serum are measured by using an ELISA kit, and the specific operation is carried out according to the instructions in the kit.
2.1.2 experimental results
The levels of gastrin, motilin and cholinesterase were very significantly reduced in the model group (P < 0.001) compared to the blank group. The levels of gastrin, motilin and cholinesterase were all significantly increased (P < 0.001) for each dosing group compared to the model group, with examples 1-5 all acting better than the original stomach invigorating and digestion promoting tablet, CN200710017728.5 formulation, formula lack and alternative formulation. Details are shown in Table 1.
TABLE 1 Effect on gastrin and cholinesterase in serum of spleen deficiency food stagnation model rats
Note that: in comparison with the blank set of the cells, △△△ P<0.001; in comparison with the set of models, ### P<0.001; compared with the original stomach-invigorating digestion-promoting tablet group, * P<0.05, ** P<0.01, *** P<0.001; in comparison with the formulation group of CN200710017728.5, P<0.05, ▲▲ P<0.01, ▲▲▲ P<0.001。
2.2 Effect on intestinal progression in spleen deficiency food stagnation model mice
2.2.1 Experimental methods
After animals purchased back, the animals were fed with free diet drinking water and were fed for 3d with adaptability, and the animals were randomly divided into 11 groups according to their body mass, 10 animals in each group, which were blank control group, model group, CN200710017728.5 preparation group, original stomach strengthening and digestion promoting tablet group, formula lacking group, replacement group, example 1, example 2, example 3, example 4, and example 5, respectively. The blank group is normally fed, distilled water is filled into the stomach for 0.2ml/10g, the other groups of mice are fed with self-made high-protein and high-calorie feed (the feed is prepared by mixing dried fish floss, bean flour, flour and milk powder according to the proportion of 1:2:1:1), after being stirred uniformly, the feed is added with water to be made into biscuits, and the biscuits are dried by an electrothermal constant-temperature blast drying oven), and simultaneously, 50% of cow milk is fed for 0.2ml/10g, and the mice are fed with water and eat freely, and are continuously fed for 7 days, so that a spleen deficiency stagnation model is caused. The groups are respectively filled with 0.2ml/10g of corresponding liquid medicine, the model group and the normal control group are given with equal volumes of distilled water once a day for 7d, and the mice in the groups are fasted and not forbidden before 18h of the last administration. After the last administration or 1h of distilled water, each group of mice was given 0.2ml/10g of freshly prepared 5% carbon powder suspension by gavage. After 10min, the small intestine was rapidly removed, the mesentery gently peeled off and laid flat, and the total length of the small intestine was measured with the distance of the carbon powder suspension from the pyloric sphincter to the distal end of the small intestine. The small intestine thrust rate was calculated as "(distance from pylorus to leading edge of black carbon powder suspension/total small intestine length) ×100%".
2.2.2 experimental results
The small intestine fraction was significantly reduced (P < 0.001) in the model group compared to the blank group, indicating inhibition of gastrointestinal motility in the model group. Compared with the model group, each administration group can obviously improve the small intestine propulsion rate (P <0.01, P < 0.001) of spleen deficiency food stagnation model mice, wherein the effects of the examples 1-5 are better than the original stomach strengthening digestion promoting tablet, CN200710017728.5 preparation, deficiency formula and replacement preparation. Details are shown in Table 2.
TABLE 2 Effect on intestinal progression in spleen deficiency food stagnation model mice/>
Note that: in comparison with the blank set of the cells, △△△ P<0.001; in comparison with the set of models, ## P<0.01, ### P<0.001; compared with the original stomach-invigorating digestion-promoting tablet group, *** P<0.001; in comparison with the formulation group of CN200710017728.5, P<0.05, ▲▲ P<0.01, ▲▲▲ P<0.001。
conclusion 3
Through the above-mentioned pharmacodynamic experiment carried out on the traditional Chinese medicine composition, the traditional Chinese medicine composition disclosed by the invention can improve the small intestine propulsion rate of spleen deficiency food stagnation model animals, promote the secretion of gastrin and motilin, improve the level of cholinesterase, promote gastrointestinal peristalsis through double regulation of gastrointestinal hormone and neurotransmitter, and enable the movement function of the digestive tract of organisms to be normal. The effect is obviously better than the original stomach strengthening and digestion promoting tablet, CN200710017728.5 preparation, deficiency prescription and replacement preparation.
The foregoing is merely a preferred embodiment of the present invention and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the present invention, which are intended to be comprehended within the scope of the present invention.

Claims (10)

1. A traditional Chinese medicine composition with the effects of activating spleen and tonifying qi and promoting digestion and resolving stagnation is characterized by being prepared from the following raw materials in parts by weight:
6-14 parts of bran-fried bighead atractylodes rhizome, 6-14 parts of dried orange peel, 6-14 parts of fried chicken's gizzard-skin, 6-14 parts of fried malt, 6-14 parts of fried medicated leaven, 4-10 parts of fried betel nut, 4-10 parts of fried hawthorn, 4-10 parts of radix pseudostellariae, 2-8 parts of fructus amomi, 2-8 parts of nutmeg, 2-8 parts of poria cocos, 1-6 parts of coix seed, 1-6 parts of Chinese yam, 1-6 parts of green tangerine peel and 1-4 parts of honey-fried licorice root.
2. The composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
6-13 parts of bran-fried bighead atractylodes rhizome, 6-13 parts of dried orange peel, 6-13 parts of fried chicken's gizzard-skin, 6-13 parts of fried malt, 6-13 parts of fried medicated leaven, 4-10 parts of fried betel nut, 4-10 parts of fried hawthorn, 4-10 parts of radix pseudostellariae, 2-8 parts of fructus amomi, 2-8 parts of nutmeg, 2-8 parts of poria cocos, 1-6 parts of coix seed, 1-6 parts of Chinese yam, 1-6 parts of green tangerine peel and 1-3 parts of honey-fried licorice root.
3. The composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
6-12 parts of bran-fried bighead atractylodes rhizome, 6-12 parts of dried orange peel, 6-12 parts of fried chicken's gizzard-skin, 6-12 parts of fried malt, 6-12 parts of fried medicated leaven, 4-10 parts of fried betel nut, 4-10 parts of fried hawthorn, 4-10 parts of radix pseudostellariae, 2-8 parts of fructus amomi, 2-8 parts of nutmeg, 2-8 parts of poria cocos, 1-6 parts of coix seed, 1-6 parts of Chinese yam, 1-6 parts of green tangerine peel and 1-2 parts of honey-fried licorice root.
4. A method for preparing a traditional Chinese medicine composition with the effects of activating spleen, tonifying qi, promoting digestion and resolving food stagnation according to any one of claims 1 to 3, which is characterized by comprising the following steps:
a) Pulverizing pericarpium Citri Tangerinae, fructus Amomi, semen Myristicae, and pericarpium Citri Reticulatae viride, soaking in water, and extracting to obtain volatile oil and residue liquid; dissolving the volatile oil with ethanol, and clathrating with cyclodextrin to obtain a first extractive solution;
b) Pulverizing the fried hawthorn, the bran-fried bighead atractylodes rhizome, the poria cocos and the radix pseudostellariae, and extracting with 60% -70% ethanol to obtain an ethanol extract; loading the ethanol extract to macroporous adsorption resin, eluting, and concentrating the eluent to obtain a second extract;
c) Reflux extracting endothelium corneum Gigeriae Galli preparata, coicis semen, fructus Hordei Germinatus preparata, rhizoma Dioscoreae, massa Medicata Fermentata preparata, arecae semen preparata, and radix Glycyrrhizae Preparata with the residue liquid, concentrating, mixing with ethanol, standing, and filtering to obtain primary extractive solution; loading the primary extract on resin, eluting, and concentrating to obtain a third extract;
d) Mixing the first extractive solution, the second extractive solution and the third extractive solution, and drying.
5. The method according to claim 4, wherein the number of the crushed meshes in the step A) is 40-50 mesh; the soaking time is 0.5-1 h; the feed-liquid ratio is 1:10-14; the extraction is a steam distillation extraction method, and the extraction time is 6-8 hours; the mass ratio of the cyclodextrin to the volatile oil is 6-10:1; the inclusion temperature is 45-55 ℃ and the inclusion time is 3-5 h.
6. The method according to claim 4, wherein the number of times of extraction in the step B) is 2 to 4; each time is 4-8 min; the mass concentration of the alcohol extract is 0.5g/mL; the macroporous adsorption resin is CAD-45 resin; the elution is specifically as follows: eluting with 4-6 times of column volume of water, discarding eluent, and eluting with 5 times of column volume of 70% ethanol; the concentration is reduced pressure concentration at 45-50 ℃.
7. The method according to claim 4, wherein the number of reflux extractions in step C) is 1 to 2; the reflux time is 1 to 1.5 hours; the concentration is specifically to be concentrated into thick paste with the relative density of 1.10-1.20; mixing with ethanol to obtain ethanol content of 60%; the standing time is 20-24 hours.
8. The method according to claim 4, wherein the primary extract in the step C) has a mass concentration of 0.5g/mL; the resin is CAD-45 resin; eluting with water of 4 times of column volume, discarding eluent, and eluting with 55% ethanol of 6-8 times of column volume; the concentration is reduced pressure concentration at 45-50 ℃.
9. Use of a composition according to any one of claims 1 to 3 or a composition according to any one of claims 4 to 8 in the manufacture of a medicament for activating spleen and replenishing qi, promoting digestion and resolving food stagnation.
10. A medicament for activating spleen and replenishing qi, and promoting digestion and resolving food stagnation, which is characterized by comprising the composition according to any one of claims 1 to 3 or the composition prepared by the preparation method according to any one of claims 4 to 8.
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